Patent Law and TRIPS: Refining the Patent Law of Iraq to Ensure Compliance with TRIPS

TESIS DE DOCTORADO PATENT LAW AND TRIPS: REFINING THE PATENT LAW OF IRAQ TO ENSURE COMPLIANCE WITH TRIPS Saman Abdulrahman Ali ESCUELA DE DOCTORADO INTERNACIONAL PROGRAMA DE DOCTORADO EN DERECHO SANTIAGO DE COMPOSTELA 2018 DECLARACIÓN DEL AUTOR DE LA TESIS PATENT LAW AND TRIPS: REFINING THE PATENT LAW OF IRAQ TO ENSURE COMPLIANCE WITH TRIPS D. Saman Abdulrahman Ali Presento mi tesis, siguiendo el procedimiento adecuado al Reglamento, y declaro que: 1) La tesis abarca los resultados de la elaboración de mi trabajo. 2) En su caso, en la tesis se hace referencia a las colaboraciones que tuvo este trabajo. 3) La tesis es la versión definitiva presentada para su defensa y coincide con la versión enviada en formato electrónico. 4) Confirmo que la tesis no incurre en ningún tipo de plagio de otros autores ni de trabajos presentados por mí para la obtención de otros títulos. En Santiago de Compostela, 24 de Mayo de 2018 Fdo. Saman Abdulrahman Ali AUTORIZACIÓN DEL DIRECTOR DE LA TESIS PATENT LAW AND TRIPS: REFINING THE PATENT LAW OF IRAQ TO ENSURE COMPLIANCE WITH TRIPS D. Ángel García Vidal INFORMA: Que la presente tesis, corresponde con el trabajo realizado por D. Saman Abdulrahman Ali, bajo mi dirección, y autorizo su presentación, considerando que reúne los requisitos exigidos en el Reglamento de Estudios de Doctorado de la USC, y que como director de ésta no incurre en las causas de abstención establecidas en Ley 40/2015. En Santiago de Compostela, 24 de Mayo de 2018 Fdo. Prof. Ángel García Vidal ACKNOWLEDGEMENTS All praises be to Allah (God), the Almighty for His blessings and spiritual support. During the process of pursuing my PhD, I have received massive supports and encouragements from a number of individuals and institution, without them this thesis would have been impossible. First and foremost, I would like to express my sincere appreciation to my supervisor Prof. Ángel García Vidal for his continuous support and motivation. His immense knowledge, guidance and insightful feedback during the process of research and writing has made this thesis possible. I would like to thank the Erasmus Mundus Marhaba for the outstanding financial scholarship and supportive team. Indeed, without their opportunity this PhD would have not become a reality. I would like to thank my mother, brothers and sisters for their continuous supports and prayers. I am very indebted to my wife for being with me throughout the process of writing this thesis. I thank her very much and never forget her support and attention. Likewise, I am indebted to my two beautiful angels Sidra and Niga who arrived into this world at the early stages of this thesis. They are sources for inspiring me all the time. Last but not least I would like to ask my dearest friend Dr. Yadgar Kamal Ahmmad to accept my sincere thanks for all his supports and encouragements that I received from him. His believing in me for completing this thesis was stronger than mine. I would like also to thank all those who have supported, helped and contributed in completing this thesis. 9 Table of Content: ABBREVIATIONS ..................................................................................... 15 SUMMARY ................................................................................................. 17 RESUMEN ................................................................................................... 31 1 INTRODUCTION .................................................................................. 47 2 OBJECTIVES ........................................................................................ 53 3 METHODOLOGY ................................................................................. 55 4 RESULTS ............................................................................................... 57 CHAPTER I: TRIPS AGREEMENT AND IRAQI PATENT LEGISLATION ...................................................................................... 59 1 TRIPS HISTORY, BACKGROUND, NEGOTIATION: DEVELOPED AND DEVELOPING COUNTRIES STAND DURING NEGOTIATIONS. ................................................................... 61 1.1 INTRODUCTION ........................................................................................ 61 1.2 REASONS BEHIND THE EXISTENCE OF THE TRIPS AGREEMENT ............................................................................................. 63 1.3 STEPS TAKEN BY DEVELOPED COUNTRIES (UNITED STATES OF AMERICA IN PARTICULAR): .................................................................... 66 1.4 DEVELOPING COUNTRIES PERSPECTIVE TO THE TRIPS AGREEMENT AND ITS SHAPING .............................................................. 74 1.5 CONCLUSION ............................................................................................ 80 2 NATURE, SCOPE, OBJECTIVES AND PRINCIPLES OF THE TRIPS AGREEMENT ............................................................................. 81 2.1 INTRODUCTION ........................................................................................ 81 2.2 PURPOSE, NATURE AND SCOPE OF THE TRIPS AGREEMENT ............ 82 2.2.1 Purposes and Objectives of the TRIPS Agreement According to the Preamble ......................................................... 82 SAMAN ABDULRAHMAN ALI 16 TPRG Trade policy Review Group TPSC Trade Policy Staff Committee TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights UNCTAD United Nations Conference on Trade and Development UNEP United Nations Environment Programme UNESCO United Nations Educational, Scientific and Cultural Organization UPOV International Convention for the Protection of New Varieties of Plants USTR United States Trade Representative WIPO World Intellectual Property Organization WTO World Trade Organization 17 SUMMARY 1. One of the most important international treaties that Iraq is not part of is the TRIPS agreement. Iraq is not one of the members of WTO, but it is in the process and right now is in the list of observer governments. In the same way Iraq is not a member of the most treaties and unions under WIPO except for Paris Convention (1976) and WIPO Convention (1976). However, it is the TRIPS agreement that provides for the wide range of protections of intellectual property rights. Therefore, it is the purpose of this research to analyse all possibilities of implementing the TRIPS agreement, especially in the area of patent by the Iraqi government. Therefore, the key hypothesis of this research is that Iraq should implement a law that fulfils the requirements of the TRIPS Agreement and at the same time include all the legal flexibilities that help to develop the country with minimum costs and sacrifices. For this reason, the main question that this research asks is whether the CPA Order No. 81 after its dramatical amendments has achieved this goal. The main objective of this research is to examine and analyse the original Iraqi Patent and Industrial Design Law No. 65 of 1970 (The Patent Laws only) in comparison to the amendments in particular the CPA Order No. 81, then compare these with the provisions of the TRIPS Agreement in order to find out the confirmations and contradictions among them. The main results achieved are summarized below: 2. TRIPS Agreement is one of the most important agreement which have standardized the intellectual property protection by stating the minimum requirement. There are other international conventions which were established long before the TRIPS Agreement such as Paris and Berne Conventions. Nevertheless, colonial countries exercised pressures and drove their colonies and foreign possessions SAMAN ABDULRAHMAN ALI 18 into the Berne Convention through its Article 19. Therefore, many least developed and developing countries joined the Berne Convention without their free will, and even the new independent countries that did not have any economic and cultural experience joined the convention based on their colonial countries. Other developing countries that tried to enact national laws in their own interest were opposed by developed countries and their companies. The reason was that many of the developing countries in their national laws provided for little protection, for example in the area of pharmaceuticals. Before the TRIPS Agreement, the countries around the world were unhappy about the existing conventions and agreements that regulate intellectual property rights and were trying to amend them. The reason was that the developing countries were always trying for better regulations that allow them to access to foreign technologies and developed countries were condemning them for lacking enforcement mechanism and not being able to sanction the noncompliance countries effectively. In order for the United States of America to be able to enforce its interest in the new agreement that regulate the intellectual property rights, it chose the GATT forum as it has strong position in the GATT. This was a new step because up to that moment intellectual property rights were looked at as an obstacle to free trade. Within GATT the developed countries could establish a single agreement that incorporate all intellectual property rights. The developing countries did not have a choice except to accept the TRIPS Agreement with the hope to benefit from GATT (WTO) over all. Nevertheless, the United States of America used its entities such as the Office of the United States Trade Representative (USTR) and the United States International Trade Commission (ITC). These entities provided necessary information to government and enforced the requests of congress and interest groups. USTR has taken many actions under section 301 and special 301 of the Trade Act 1974 such as imposing trade sanctions on foreign countries, impose duties on their goods or threat of using unilateral retaliation if not reforming their intellectual property practices. USTR’s pressured developing Summary 19 countries such as Chile and Indonesia, and also pressured developed countries such as Japan. Another advantage of United States of America that had over other countries during the negotiation process at GATT was continuously receiving information from associations such as International Intellectual Property Alliance (IIPA) and Business Software Alliance (BSA), in which thousands of companies were their member. Accepting high standard of protection refused by the developing countries (in Group Ten) as it was not in their best interests and resisted the GATT forum, but they did not succeed due to economic threatening and political pressures from the United States and eventually the TRIPS Agreement came into existence. 3. The main purposes and objectives of the TRIPS Agreement that can be inferred from the Preamble are; presentation of intellectual property protection in a manner that reduce distortions and impediments to international trade; and recognition of intellectual property rights as private rights so that can be protected against any arbitrary and unjust acts of governments. Creating connection between intellectual property protection and international trade was due to the attempts of the United States and its big corporations so that insert intellectual property protection into the Uruguay round as it is an important principle of the WTO Agreement as well. Though, the Preamble of the TRIPS Agreement has no legal power as any other Articles of the Agreement, nevertheless, it is very useful in clarifying the ambiguity of the Articles and helpful in interpreting them. Article 1 of the TRIPS Agreement provides for the nature and scope of the Agreement by stating the TRIPS Agreement is not selfexecuting and the minimum standard of protection provided for have to be given effect by the member countries in their own jurisdictions. The TRIPS Agreement does not state any procedures on how this process to be carried out, therefore this may cause problems for the developing countries as it requires reform in many domestic legislations. Even though the member countries are given freedom to choose the best method of implementation, but they have to prove that it was the best method available at the time. However, the TRIPS Agreement provides for opportunity for the member countries to SAMAN ABDULRAHMAN ALI 20 implement more extensive protection than what provided for by the Agreement. Article 1 also determines the scope of the TRIPS Agreement by including all categories that are stated in section 1 to 7 of Part II of the TRIPS Agreement within the term of ‘intellectual property’. Article 7 of the TRIPS Agreement states the objectives of the Agreement by emphasizing that the TRIPS Agreement should have positive effects on progressing technological and economic development and social welfare of the developing countries. This was proposed by developing countries so that the TRIPS Agreement should not be in favour of the developing countries only through high standard of protection. If this objective is not achieved the developing countries have right to object the exclusive rights of the right holders. It is also the objective of the TRIPS Agreement that in all types of intellectual property rights the balance of rights and obligations has to be kept, and the interest of the right holders and users have to be balanced. Even though this objective inserted on the request of the developing countries, but nevertheless, the balance between rights and obligations considered superseding objective of the WTO system. The important principles of the TRIPS Agreement can be found in Article 8. According to this Article member countries are allowed to adopt measures ‘to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socioeconomic and technological development’. These measures can be taken from the provisions of the TRIPS Agreement such as exceptions to exclusive rights and compulsory licences, or other measures that have no base in the TRIPS Agreement but consistent with the provisions of the Agreement. Promoting public interest can include many areas and the member countries are allowed to determine their own sectors of vital importance. Therefore, the member countries in general, and the developing countries have great chance of adopting measures that benefit their societies by preventing abuse of intellectual property rights by the right holders, practices which unreasonably restrain trade or practices which have adverse effect on the international transfer of technology. Summary 21 4. Patent Law No. 61 of 1935 was enacted during the Kingdom of Iraq. However, this law regulated the law of patent in a very basic manner such as having a simple and plain definition of invention that includes mere discovery. Besides that, it excludes some areas from patentability for example pharmaceutical formulations and medicines which made it to the next Law No. 65 of 1970. Law No. 61 of 1935 granted patent to an invention without making any investigation of the usefulness, correctness, truthfulness or correctness of its data or compare the data with the invention that submitted for patent to make sure it matches the invention. The law also stated that the government will not guarantee any of these matters. Even though this law went through a few amendments by law No. 64 of 1940, law No. 27 of 1949 and the last amendment was during the Republic of Iraq by law No. 210 of 1968. After all these amendments the law No. 61 of 1935 was not up to the standard of protection of intellectual property rights. Therefore, Patent and Industrial Design Law No. 65 of 1970 for the first time enacted during the Republic of Iraq to repeal the law No. 61 of 1935. The new law also has undergone few amendments in order to keep with the international standard of protection. The most important of those amendments were by law No. 28 of 1999 and CPA Order No. 81. The CPA has issued many regulations, memoranda, public notices and orders, in order to rebuild a strong Iraq economically and establish justice after the long run of dictatorship. Through Order No. 81 the CPA has changed the title of the law No. 65 of 1970 to ‘Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law’. This Order has added a few more chapter to the original law including a chapter on ‘Protection of New Varieties of Plants’. The Order made 22 amendments on the first chapter (Patent), in which some of them were simple amendments while some other repealed the whole section and replaced them with new ones. 5. The term ‘invention’ in the original law No. 65 of 1970 and its amendments has gone through some changes. The law defined the invention in section 1.4 as ‘every new innovation that industrially exploitable whether relates to new industrial products or innovative SAMAN ABDULRAHMAN ALI 22 methods and means or both of them together’. This definition included and could be used to identify the major important criteria of patentability because the law did not state the criteria of patentability in other sections of the law. Then the law No. 28 of 1999 added the words of (achieve some specific development). Even though all the traditional criteria of patentability could be found in this definition, but still the CPA Order No. 81 repealed this definition and introduced another one. The new definition contains all the elements of the old one but changed the words. After examining relevant factors, this thesis argues that since the TRIPS Agreement does no define the term ‘invention’ and it is left for the member countries to define them in the best way that suit their legal system, therefore, one can say that the both of the definitions are in compliance with the requirement of the TRIPS Agreement. The thesis furthermore examines the original law No. 65 of 1970, in which section 2 states that ‘Patents of invention shall be granted according to the provisions of this Law’. However, the CPA Order No. 81 repealed this section and replaced it with new section to include all the criteria of patentability in much clear and similar manner to the TRIPS Agreement. The new section 2 states that ‘Patents of invention shall be granted pursuant to the provisions of this Law for each invention that is industrially applicable, novel and involves an inventive step, either concerning new industrial products, new industrial methods, or new application of known industrial methods’. This is clearly an improvement to the Iraqi patent law that eliminate any doubts in non-compliance to the TRIPS Agreement. 6. Exclusion from patentability is another important principle that the TRIPS Agreement which will be another important topic of the thesis to cover. Both subparagraphs of number 2 and 3 of article 27 provide options for the member countries to exclude some areas from patentability. Article 27.2 provides that the member countries may exclude any invention that its exploitation in the territory of a member country goes against ordre public and morality. Including these two types of exclusion was based on the proposals by the EEC, Japan and developing countries, because it was common to exclude invention on Summary 23 these bases by the member countries and other international conventions long before the TRIPS Agreement. However, the TRIPS Agreement does not provide for definition of these terms. In this context, the researcher argues that the member countries are free to determine what situations lead to arise the implementation of these exclusions. Ordre public can be determined by referring to some situations such as riots and public disorder. Nevertheless, member countries are free to apply the ordre public to new situations that do not have prior application and not known at international level. It can be applied if the commercial exploitation of the invention endangers the structure of civil society or simply disharmonize the livelihood of individuals to live in peace and security. The term morality in the TRIPS Agreement is referring to public morality and not individual morality. Article XX(a) of GATT of 1947 under the general exception refers to ‘public moral’. Hence, the researcher suggests that if the commercial exploitation of an invention in the territory of a member country caused collective immorality or has negative effect on the morality of the community at large, then that member country is allowed to exclude such invention from patentability. To compare the above matter with the original Iraqi patent law No. 65 of 1970, section 3.1 provides for exclusions of ‘Inventions in which their exploitations cause breaches of public moral or ordre public or contradict the public interest’. The term exploitation refers to exploitation in any ‘fields of work related to industry, agriculture, profession, and services in broader understanding’. Here in same way of the TRIPS Agreement, the Iraqi patent law provides for exclusion base on public moral and ordre public. These exclusions are very important of Iraqi society because of ethnic and religious diversity of Iraq. However, this provision provides for one more base of exclusion which is public interest. Public interest is much wider concept than the ordre public and public moral, as it can include these two concepts and more. It has not been used by Article 27.2 of the TRIPS Agreement. Nevertheless, the protection of public interest is allowed under Article 8.1 which allow the member countries to take measures to promote their ‘public interest in sectors of vital importance to their SAMAN ABDULRAHMAN ALI 24 socio-economic and technological development’. Therefore, the researcher suggests that the Iraqi patent law is in compliance with the TRIPS Agreement. From the silence of the CPA Order No. 81 on this issue by not repealing or amending this section it can be inferred that the CPA was of the opinion that this section does not violate the provisions and principles of the TRIPS Agreement. 7. Subsequently, the thesis turns into another relevant topic which is covered by Article 27.3 (a) of the TRIPS Agreement. This provision states that the member countries may exclude from patentability the ‘diagnostic, therapeutic and surgical methods for the treatment of humans or animals’. Therefore, methods of treatment of humans and animals are excluded from patentability. This exclusion cannot be extended to products and process that are part of humans and animals treatments. Many countries around the world have excluded such methods and some countries have excluded methods of treatment from patentability base on the lack of industrial applicability. On the other hand, some developed countries such as Australia, New Zealand and United States of America are allowing these methods to be patented as long as they satisfy the criteria of patentability. In comparison the Iraqi patent law No. 65 of 1970 does not contain any provision in regard of the method of treatment of humans and animals to exclude them from patentability. This silence can be interpreted so that these methods are patentable as a general rule. None of the amendments that passed on added regulation in this regard. The CPA Order No. 81 repealed and amended many provisions of the law No. 65 of 1970 but kept silence on this issue. Maybe it is due to the fact that in the United States of America method of treatment is patentable. Therefore, the CPA in this issue followed the United States patent law rather than using the option of exclusion stated in the TRIPS Agreement, which supposed to enhance the Iraqi patent law to the international standard (TRIPS Agreement). 8. The TRIPS Agreement has been blamed for allowing patenting medicines and drugs which caused rising of prices of medicines beyond capacity of least developed and developing countries. These Summary 25 countries relying on generic drugs to solve their public health crises but once they joined the TRIPS Agreement they will not be allowed to do so any more, and the problem is that these countries are not able to access patented drugs due to their high prices. The effort of these countries led to the adoption of the Doha Declaration on the TRIPS Agreement and Public Health (14 November 2001). The Doha Declaration addresses the issue of public health and tries to find solutions for the developing countries to solve their public health issues. This declaration emphasizes that the TRIPS Agreement should not prevent member countries from adopting necessary measures to protect their public health and requested the General Council to find a solution for those member countries that cannot benefit from the compulsory licence due to insufficient or no manufacturing capacities in the pharmaceutical sectors. Nevertheless, the CPA Order No. 81 did not add any provision in this regard to help Iraq to have access to inexpensive medicines to support public health in crises, or to take necessary measures to protect Iraqi public health. 9. Next, due to the importance of plants and saving seeds, there are many international conventions and agreements that regulate this issue, such as UPOV Convention, TRIPS Agreement, International Treaty on Plant Genetic Resources for Food and Agriculture and CBD. UPOV Convention is one of the important convention in this area especially after the TRIPS Agreement requested all member countries to protect plant varieties whether through a patent or sui generis system. Interestingly, Article 27.3 (b) of the TRIPS Agreement provides for excluding plants and animals from patentability. Nevertheless, this provision requires that the member countries provide for some form of protection of plant varieties through patent, an effective sui generis system or any combination of thereof. This causes problem for the developing countries because many of them never had any form of protection of plant varieties. This protection will have huge impact on their farming practices in the area of saving seeds, genetic diversity and food security. As societies in these countries still farm on the traditional way of saving seeds for next year planting and exchange SAMAN ABDULRAHMAN ALI 32 protección de los derechos de propiedad industrial e intelectual exigiendo una tutela mínima. Con anterioridad al Acuerdo ADPIC se concertaron otros tratados internacionales, como las convenciones de París y Berna, a las cuales se sumaron muchos países menos desarrollados y países en vías de desarrollo, a los que faltaba la adecuada experiencia económica y cultural, pero que lo hicieron por la presión de los países coloniales. Así sucedió, por ejemplo, con el Convenio de Berna, al que muchos países se adhirieron por medio de su artículo 19 en contra de su libre voluntad. En ese contexto, los países en desarrollo que intentaron promulgar leyes nacionales que atendían a sus intereses nacionales se encontraron con la oposición de los países desarrollados y sus empresas, porque estos países en desarrollo ofrecían en sus legislaciones nacionales un reducido nivel de protección de los derechos de propiedad industrial e intelectual, por ejemplo, en el ámbito de los productos farmacéuticos. En consecuencia, en el período anterior a la celebración del Acuerdo ADPIC, distintos países a lo largo del mundo estaban insatisfechos con los convenios y acuerdos existentes en materia de propiedad industrial e intelectual e intentaron modificarlos. Los países en vías desarrollo pretendían una mejor regulación que le permitiera acceder a tecnologías extranjeras, mientras que los países desarrollados les imputaban una falta de mecanismos de defensa y aplicación de dichos derechos, sin que pudiesen sancionar efectivamente a esos países por no cumplimiento. Para poder hacer valer sus intereses en el nuevo acuerdo que regula los derechos de propiedad industrial e intelectual, Estados Unidos de América eligió el foro del GATT, donde ya tenía una posición fuerte. Este fue un paso novedoso porque hasta ese momento los derechos de propiedad industrial e intelectual se consideraban un obstáculo para el libre comercio. Dentro del GATT, los países desarrollados pudieron establecer un acuerdo único que incorporase todos los derechos de propiedad industrial e intelectual. Y los países en desarrollo no tuvieron otra opción que aceptar el Acuerdo sobre los ADPIC con la esperanza de beneficiarse del GATT (OMC). Resumen 33 Los Estados Unidos de América utilizaron sus entidades, tales como la Oficina del Representante de Comercio de los Estados Unidos (Office of the United States Trade Representative, USTR) y la Comisión de Comercio Internacional (United States International Trade Commission, ITC). Estas entidades proporcionaron la información necesaria al gobierno y aplicaron las peticiones del congreso y los grupos de presión. La USTR adoptó distintas medidas en virtud de la sección 301 y 301 de la Ley de Comercio de 1974, como imponer sanciones comerciales a países extranjeros, imponer aranceles a sus productos o amenazar con utilizar represalias unilaterales si no modificaban sus prácticas de propiedad intelectual. Entre los países presionados por la USTR se encuentran países en desarrollo como Chile e Indonesia, y también países desarrollados como Japón. Asimismo, otra ventaja de los Estados Unidos de América durante el proceso de negociación en el GATT fue recibir continuamente información de asociaciones como la Alianza Internacional de la Propiedad Intelectual [International Intellectual Property Alliance (IIPA)] y la Alianza de Software Empresarial (Business Software Alliance, BSA), integradas por miles de compañías. Finalmente, los países en desarrollo tuvieron que aceptar los altos niveles de protección de la propiedad industrial e intelectual (que inicialmente rechazaron en el Grupo 10), debido a amenazas económicas y presiones políticas de los Estados Unidos, y el Acuerdo sobre los ADPIC se convirtió en una realidad. 3. Los principales propósitos y objetivos del Acuerdo sobre los ADPIC pueden inferirse ya del Preámbulo y son la protección de la propiedad intelectual (término con el que se engloban tanto los derechos de propiedad industrial como los del propiedad intelectual en sentido estricto) de manera que se reduzcan las distorsiones y los obstáculos al comercio internacional; y el reconocimiento de los derechos de propiedad intelectual como derechos privados para que puedan protegerse contra actos arbitrarios e injustos de los gobiernos. La conexión entre la protección de la propiedad intelectual y el comercio internacional se debió a los intentos de los Estados Unidos y sus grandes empresas de insertar la protección de la propiedad SAMAN ABDULRAHMAN ALI 34 intelectual en la Ronda de Uruguay, ya que también es un principio importante del Acuerdo sobre la OMC. Con todo, aunque es de gran utilidad a los efectos interpretativos, el Preámbulo del Acuerdo sobre los ADPIC no tiene un valor jurídico equiparable al de los artículos del Acuerdo. El artículo 1 del Acuerdo sobre los ADPIC establece la naturaleza y el alcance de las obligaciones del Acuerdo, disponiendo que no es de aplicación automática y que los miembros respetarán en sus legislaciones el nivel mínimo de protección previsto. El Acuerdo sobre los ADPIC no establece ningún método para que los miembros apliquen sus disposiciones en el marco de su propio sistema y práctica jurídicos, lo que puede causar problemas para los países en desarrollo, cuyas legislaciones nacionales deberán ser reformadas. En todo caso, aunque los países miembros tienen libertad para elegir el mejor método de implementación, deben demostrar que fue el mejor método disponible en ese momento. Por lo demás, el Acuerdo sobre los ADPIC permite que los países miembros implementen una protección más amplia que la prevista en el Acuerdo. El artículo 1 también determina el alcance del Acuerdo sobre los ADPIC al incluir todas las categorías que figuran en las secciones 1 a 7 de la Parte II del Acuerdo sobre los ADPIC dentro del término de «propiedad intelectual». El artículo 7 del Acuerdo sobre los ADPIC establece los objetivos del Acuerdo al hacer hincapié en que éste deberá tener efectos positivos en la promoción de la innovación tecnológica y el bienestar social y económico de los países en desarrollo. Esta disposición fue propuesta por los países en desarrollo para que el Acuerdo no beneficiase únicamente a los países desarrollados estableciendo un estándar elevado de protección. Si no se logra este objetivo, los países en desarrollo tienen derecho a oponerse a los derechos exclusivos de los titulares de los derechos. Asimismo, otro objetivo del Acuerdo es que en todos los tipos de derechos de propiedad intelectual se mantenga el equilibrio de derechos y obligaciones, equilibrando el interés de los titulares de derechos y los usuarios. Aunque este objetivo también se insertó a petición de los países en desarrollo, el equilibrio entre los derechos y obligaciones es considerado un objetivo general del sistema de la OMC. Resumen 35 Por su parte, los principios del Acuerdo sobre los ADPIC se recogen en su artículo 8. De conformidad con este artículo, los países miembros pueden adoptar medidas «para proteger la salud pública y la nutrición de la población, o para promover el interés público en sectores de importancia vital para su desarrollo socioeconómico y tecnológico». Estas medidas pueden consistir en medidas expresamente recogidas en el Acuerdo sobre los ADPIC, como las excepciones a los derechos exclusivos y las licencias obligatorias, o en otras medidas que no se recogen expresamente en el Acuerdo pero que son coherentes con sus disposiciones. En este sentido, la promoción del interés público puede incluir muchas áreas y los países miembros pueden determinar sus propios sectores de vital importancia. Por lo tanto, los países miembros en general, y los países en desarrollo en particular, tienen grandes posibilidades de adoptar medidas que beneficien a sus sociedades, previniendo el abuso de los derechos de propiedad intelectual por parte de sus titulares, las prácticas que restrinjan injustificadamente el comercio o las prácticas que tienen un efecto negativo en la transferencia internacional de tecnología. 4. La Ley iraquí de Patentes n.º 61 de 1935 se promulgó durante el Reino de Iraq. Sin embargo, esta ley regulaba las patentes de una manera muy básica, hasta el punto de contener una definición de invención que incluía los meros descubrimientos. Además, establecía determinadas prohibiciones de patentabilidad, como las referentes a las fórmulas farmacéuticas y los medicamentos, prohibiciones que llegaron hasta la siguiente Ley n.º 65 de 1970. Por lo demás, de acuerdo con la Ley n.º 61 de 1935 las patentes se concedían sin realizar ningún tipo de examen sobre la utilidad, corrección, veracidad o la exactitud de los datos y sin comparar los datos suministrados con la invención para la que se solicitaba la patente. De hecho, la ley declaraba expresamente que el Gobierno no garantizaba ninguno de estos extremos. Esta ley fue sometida a algunas enmiendas por la ley n.º 64 de 1940 y la ley n.º 27 de 1949. Y la última modificación tuvo lugar durante la República del Iraq por medio la ley n.º 210 de 1968. Aún después de todas estas enmiendas, la ley n.º 61 de 1935 no estaba a la altura del nivel de protección de los derechos de propiedad SAMAN ABDULRAHMAN ALI 36 intelectual. Esto hizo que fuese derogada por la Ley de Patentes y Diseño Industrial n.º 65 de 1970, promulgada durante la República del Iraq, nueva ley que también ha sido objeto de algunas modificaciones posteriores para cumplir con el estándar internacional de protección. Los más importantes de esos cambios fueron los realizados por la Ley n.º 28 de 1999 y por la Orden n.º 81 de la Autoridad Provisional de la Coalición (CPA). La CPA aprobó numerosas reglamentaciones, memorandos, avisos públicos y órdenes para reconstruir económicamente a Iraq y establecer justicia después del largo período de dictadura. A través de la Orden n.º 81, la CPA cambió el título de la ley n.º 65 de 1970, que pasó a denominarse Ley de «patentes, diseño industrial, secreto empresarial, topografías de productos semiconductores y de variedades vegetales». Además, la Orden añadió algunos capítulos nuevos a la ley original, incluido un capítulo sobre «Protección de nuevas variedades vegetales», e hizo 22 enmiendas en el primer capítulo (Patentes), algunas de las cuales fueron simples modificaciones menores mientras que otras implicaron la derogación de secciones y la sustitución por otras nuevas. 5. La definición del término «invención» contenida en la ley original n.º 65 de 1970 y sus enmiendas ha sufrido algunos cambios. La ley definía la invención en la sección 1.4 como «toda innovación nueva susceptible de aplicación industrial, consistente en nuevos productos industriales, métodos o medios innovadores, o en ambos tipos de innovación». Por lo tanto, esta definición incluía y podría utilizarse para identificar los principales requisitos de patentabilidad, porque la ley no los establecía en otras secciones. Posteriormente, la ley n.º 28 de 1999 agregó la referencia a la necesidad de lograr algún desarrollo específico. A pesar de que todos los requisitos tradicionales de patentabilidad se podían encontrar en esta definición, la Orden de CPA n.º 81 derogó dicha definición e introdujo otra que contiene todos los elementos del antiguo texto legal, pero cambiando las palabras utilizadas. Después de examinar los factores relevantes, en esta tesis sea argumenta que, dado que el Acuerdo sobre los ADPIC no define el Resumen 37 término «invención» y se permite que los países miembros lo definan de la mejor manera que se adapte a su sistema legal, se puede concluir que ambas definiciones respetan en este punto el Acuerdo sobre los ADPIC. La presente tesis también examina los requisitos de patentabilidad. La ley n.º 65 de 1970, en su versión inicial, establecía en su sección 2 que «las patentes de invención se otorgarán de acuerdo con las disposiciones de esta Ley». Sin embargo, la Orden n.º 81 de la CPA derogó dicha sección y la reemplazó por otra para incluir todos los criterios de patentabilidad de una manera muy clara y similar al Acuerdo sobre los ADPIC. Así, la nueva sección 2 establece que «las patentes de invención se otorgarán de conformidad con las disposiciones de esta Ley para cada invención susceptible de aplicación industrial, novedosa y que implique una actividad inventiva, ya sea en relación con nuevos productos industriales, nuevos métodos industriales o una nueva aplicación de métodos industriales ya conocidos». Se trata, claramente, de una mejora de la ley iraquí de patentes que elimina cualquier duda sobre la coincidencia con lo dispuesto en el Acuerdo sobre los ADPIC. 6. Las exclusiones de patentabilidad constituyen otro de los principios importantes del Acuerdo sobre los ADPIC y es, en consecuencia, otro de los temas examinados con detalle en la presente tesis doctoral. Los dos subpárrafos de los números 2 y 3 del artículo 27 del Acuerdo permiten que los países miembros establezcan algunas exclusiones de patentabilidad. El artículo 27.2 dispone que los países miembros podrán excluir de la patentabilidad las invenciones cuya explotación comercial en su territorio deba impedirse necesariamente para proteger el orden público o la moralidad. La inclusión de estos dos tipos de exclusión obedeció a las propuestas de la CEE, Japón y los países en desarrollo, porque era común la existencia de este tipo de exclusiones en los países miembros, al amparo de otros convenios internacionales anteriores al Acuerdo sobre los ADPIC. Sin embargo, el Acuerdo sobre los ADPIC no prevé la definición de estos términos. Y en este contexto, en la tesis se argumenta que los países miembros SAMAN ABDULRAHMAN ALI 38 son libres de determinar qué situaciones conducen a la implementación de estas exclusiones. Así, el orden público se puede delimitar por referencia a algunas situaciones como disturbios y desordenes públicos. Sin embargo, los países miembros son libres de aplicar el orden público a situaciones nuevas que no tienen aplicación previa y no se conocen a nivel internacional. Así, se puede aplicar si la explotación comercial de la invención pone en peligro la estructura de la sociedad civil o simplemente afecta a las condiciones de las personas para vivir en paz y seguridad. Por su parte, el término moralidad en el Acuerdo sobre los ADPIC se refiere a la moral pública y no a la moral individual. De hecho, el apartado a) del artículo XX del GATT de 1947 se refiere a la «moral pública». En este sentido, en la tesis se sugiere que, si la explotación comercial de una invención en el territorio de un país miembro provoca inmoralidad colectiva o tiene un efecto negativo sobre la moralidad de la comunidad en general, entonces ese país miembro puede excluir dicha invención de la patentabilidad. Analizando esta cuestión en la legislación nacional iraquí, se constata que en la ley de patentes iraquí n.º 65 de 1970, la sección 3.1 excluye la patentabilidad de las «invenciones cuya explotación viola la moral o el orden públicos o contradice el interés público». El término explotación se refiere a la explotación en cualquier «campo de trabajo relacionado con la industria, la agricultura, la profesión y los servicios en sentido amplio». En este punto, de la misma manera que el Acuerdo sobre los ADPIC, la ley iraquí de patentes utiliza la moral pública y el orden público como base para la exclusión de la patentabilidad. Y estas exclusiones son muy importantes para la sociedad iraquí debido a la diversidad étnica y religiosa del país. Pero además esta disposición añade un motivo adicional para la exclusión de la patentabilidad, a saber: que la invención sea contraria al interés público, el cual es un concepto mucho más amplio que el de orden público y moral pública, ya que puede incluir más elementos además de esos. El artículo 27.2 del Acuerdo sobre los ADPIC no alude al «interés público». Sin embargo, la protección del interés público está permitida Resumen 39 por el artículo 8.1, que faculta a los países miembros para tomar medidas para promover su «interés público en sectores de importancia vital para su desarrollo socioeconómico y tecnológico». Por lo tanto, en la tesis se concluye que la ley iraquí de patentes cumple con el Acuerdo sobre los ADPIC. Del silencio de la Orden n.º 81 sobre esta cuestión, al no derogar ni modificar esta sección, se puede inferir que la CPA consideró que esta sección no viola las disposiciones y principios del Acuerdo sobre los ADPIC. 7. Posteriormente, la tesis analiza otro tema relevante, regulado por el artículo 27.3 (a) del Acuerdo sobre los ADPIC; a saber: la posibilidad de excluir la patentabilidad de «los métodos de diagnóstico, terapéuticos y quirúrgicos para el tratamiento de personas o animales»; exclusión que no se puede extender a los productos y procesos que son parte de los tratamientos de humanos y animales. Muchos países de todo el mundo han excluido tales métodos, algunos basándose en la falta de aplicación industrial. En cambio, otros países desarrollados como Australia, Nueva Zelanda y los Estados Unidos de América permiten que estos métodos sean patentados siempre que satisfagan los criterios de patentabilidad. Por su parte, la ley de patentes iraquí n.º 65 de 1970 no contiene ninguna disposición excluyendo la patentabilidad de este tipo de métodos, lo cual puede interpretarse en el sentido de que estos métodos son, como regla general, patentables. A este respecto, ninguna de las modificaciones posteriores de la ley introdujo cambios en este punto. La Orden n.º 81 de la CPA derogó y enmendó muchas disposiciones de la ley n.º 65 de 1970, pero guardó silencio sobre este tema. Tal vez se deba al hecho de que en los Estados Unidos de América el método de tratamiento es patentable. Por lo tanto, la CPA en esta cuestión siguió la ley de patentes de los Estados Unidos en lugar de acoger la posibilidad establecida en el Acuerdo ADPIC de excluir la patentabilidad de estos métodos. 8. Una de las críticas que se ha formulado contra el Acuerdo sobre los ADPIC es que permite la concesión de patentes sobre medicamentos, originando el aumento de su precio por encima de la capacidad de los SAMAN ABDULRAHMAN ALI 40 países menos adelantados y en desarrollo. Estos países dependen de medicamentos genéricos para resolver sus crisis de salud pública, pero una vez que ratifican al Acuerdo sobre los ADPIC ya no pueden hacerlo, y el problema es que estos países no pueden acceder a medicamentos patentados debido a sus altos precios. El esfuerzo de estos países condujo a la adopción de la Declaración de Doha sobre el Acuerdo sobre los ADPIC y la Salud Pública (14 de noviembre de 2001). La Declaración de Doha aborda el problema de la salud pública e intenta encontrar soluciones para que los países en desarrollo resuelvan sus problemas de salud pública. Esta declaración enfatiza que el Acuerdo ADPIC no debe impedir que los países miembros adopten medidas necesarias para proteger su salud pública y en ella se solicita al Consejo General que encuentre una solución para aquellos países miembros que no pueden beneficiarse de la licencia obligatoria debido a capacidades de fabricación insuficientes o inexistentes en el país en el sector farmacéutico. Sin embargo, la Orden n.º 81 de la CPA no añadió ninguna disposición a este respecto para ayudar a Iraq a tener acceso a medicinas de bajo costo para apoyar la salud pública en crisis o para tomar las medidas necesarias para proteger la salud pública iraquí. 9. Por otra parte, debido a la importancia de las plantas y a la práctica de los agricultores consistente en conservar semillas de su propia producción para proceder a sembrarlas en el siguiente ciclo de cultivo, existen muchos convenios y acuerdos internacionales que regulan esta cuestión, como el Convenio de la UPOV (Convenio internacional para la protección de las obtenciones vegetales, firmado en París el 2 de diciembre de 1961 y posteriormente modificado por las Actas de 10 de noviembre de 1972, 23 de octubre de 1978 y 19 de marzo de 1991), el Acuerdo sobre los ADPIC, el Tratado internacional sobre los recursos fitogenéticos para la alimentación y la agricultura y el Convenio sobre la Diversidad Biológica, hecho en Río de Janeiro el 5 de junio de 1992. El Convenio de la UPOV es uno de los convenios importantes en esta área, especialmente después de que el Acuerdo sobre los ADPIC haya establecido que los Miembros otorgarán protección a todas las obtenciones vegetales mediante patentes, Resumen 41 mediante un sistema eficaz sui generis o mediante una combinación de aquéllas y éste. En efecto, el artículo 27.3 (b) del Acuerdo sobre los ADPIC permite la exclusión de la patentabilidad de las plantas y animales. Sin embargo, esta disposición requiere que los países miembros proporcionen alguna forma de protección a las obtenciones vegetales a través de patentes, un sistema sui generis efectivo o cualquier combinación de los mismos. Esto causa un problema para los países en desarrollo, porque muchos de ellos nunca tuvieron ninguna forma de protección de variedades vegetales, y la previsión de la protección tendrá un gran impacto en las prácticas agrícolas de conservación de semillas para proceder a sembrarlas en el siguiente ciclo de cultivo, así como en la diversidad genética y seguridad alimentaria. Porque, en efecto, los agricultores en estos países todavía cultivan en la forma tradicional de guardar semillas para el próximo año, plantando e intercambiando buenas semillas entre ellos. Además, Iraq es uno país en desarrollo que tiene una gran tierra fértil, pero debido a las guerras ininterrumpidas, la mayoría de sus tierras agrícolas y bancos de semillas han sido destruidos. La ley de patentes iraquí n.º 65 de 1970 no contiene, en su versión inicial, ninguna referencia a la protección de animales y plantas ni a la exclusión de su patentabilidad. Sin embargo, después de la invasión de Iraq, la Orden n.º 81 de la CPA añadió el capítulo tresquater para la protección de variedades vegetales. La mayoría de las disposiciones de este nuevo capítulo se tomaron del Convenio de la UPOV de 1991. Por ejemplo, la definición de variedad vegetal es la misma definición del Convenio de la UPOV y todos los requisitos para la protección de las variedades vegetales son los de la UPOV (novedad, distinción, uniformidad y estabilidad). Sin embargo, en 2013 se promulgó una nueva ley bajo el título de «Ley de Registro, Acreditación y Protección de Variedades Agrícolas», Ley n.º 15 de 2013, que derogó y reemplazó el mencionado capítulo tresquater. La Orden n.º 81 de la CPA impidió la reutilización de semillas de variedades protegidas. Pero la nueva ley n.º 15 de 2013 introdujo la excepción opcional recogida en el Convenio de la UPOV que permite SAMAN ABDULRAHMAN ALI 48 to the status it deserves. A law that help the country to access necessary technology to build a technological country that be able to rely on itself for every type of production including medical products. A technology for rebuilding agricultural sector so that it can secure food production for the need of the whole country instead of relying on importation. Right now, Iraq is considered to be developing rapidly commercially, therefore, it is necessary to import all kinds of equipment, materials and products without knowing their IP rights and being able to respect these rights. There may be many reasons for this; however, one of the reasons is due to Iraq’s nonparticipation in the international conventions and treaties that related to IPR. One of the most important international treaties that Iraq is not part of is the TRIPS agreement. Iraq is not one of the members of WTO, but it is in the process and right now is in the list of observer governments. In the same way Iraq is not a member of the most treaties and unions under WIPO except for Paris Convention (1976) and WIPO Convention (1976). However, it is the TRIPS agreement that provides for the wide range of protections of intellectual property rights. Therefore, it is the purpose of this research to analyse all possibilities of implementing the TRIPS agreement, especially in the area of patent by the Iraqi government. Therefore, the key hypothesis of this research is that Iraq should implement a law that fulfils the requirements of the TRIPS Agreement and at the same time include all the legal flexibilities that help to develop the country with minimum costs and sacrifices. For this reason, the main question that this research asks is whether the CPA Order No. 81 after its dramatical amendments has achieved this goal. The TRIPS Agreement is not the first international agreement in the area of intellectual property rights, other international conventions such as the Paris Convention and the Berne Convention existed long before the TRIPS Agreement. However, the developed countries and in particular the United States of America, were not happy with the outcome of these international conventions. Therefore, their effort was to establish a strong international agreement that be able to reduce distortions and impediments to international trades and can take the Introduction 49 member countries accountable of their breaches of the agreement. Nevertheless, the developing countries created their own frontier with the aim of inserting some provisions in their own interest. The enforcement of the TRIPS Agreement should be for the mutual advantages of both producers and users in the same time and balance of rights and obligations should be kept at all the times. Developing countries have right to protect their public health and public interest within the scope of the TRIPS Agreement, as long as the minimum standard which is required by the TRIPS Agreement is implemented. Patent law is very important for the development of society as it will grant exclusive right to the patent owners. Patent owner will receive exclusive right to use, make and exploit his invention so that gain economic profit. This is an incentive for every inventors and government will guarantee patentee’s rights. In return his invention will be disclosed to public to study and research, and even after the expiry of the patent everyone will be able to use the invention for economic benefits as will. In order for a patent to be granted to an invention, it should have some requirements. Even though the TRIPS Agreement does not define the term invention nevertheless it states the traditional requirements of patentability which they are novelty, inventive step and industrial applicability. Therefore, this research will discuss the requirements of patentability of the original Iraqi patent law No. 65 of 1970 and its amendment of the CPA Order No. 81, in order to see whether the amendment has brought the Iraqi patent law closer to the TRIPS Agreement or not. Whether such amendments were necessary or not. The TRIPS Agreement provides some exclusions from patentability. This is one of the most important area for the developing countries. Article 27.2 of the TRIPS Agreement provides an option that the member countries can exclude inventions from patentability, if the exploitation of such inventions goes against the principles of public ordre and morality. The TRIPS Agreement does not define any such principles and left for member countries to define them and implement them. However, if exploitation of any invention endangers the structure of civil society and its institutions, or negatively affect SAMAN ABDULRAHMAN ALI 50 the community’s immorality then member countries are allowed to exercise its rights under this provision of the TRIPS Agreement and exclude such invention from patentability. therefore, this research will discuss in detail these exclusions and the relevant provisions under the original Iraqi patent law and its amendment by the CPA Order No.81. The TRIPS Agreement also provides another option for excluding from patentability that relate to method of treatment which they are the diagnostic, therapeutic and surgical methods for treatment of humans or animals. The research will examine this provision in order to find out what can be excluded from patentability. Positions of member countries on this type of exclusion will be analysed even before the existence of this provision and position of those member countries that allow patenting such methods of treatment. Then position of Iraqi patent law and CPA Order will be analysed as well. Access to medicines and fulfilling the public health needs are always one of the problems of the least developed and developing countries. The sources of these medicines are usually the developed countries and their higher prices has always been problem for poor countries especially with the higher standard of protection of the TRIPS Agreement. Because it will prevent the least developed and developing countries from having access to generic drugs. Notwithstanding, the fact the higher standard of protection will help the pharmaceutical companies to make better profits and in return this encourage them to conduct expensive research and development for discovering new medicines. Eventually, the least developed and developing countries attempt to balance the result of the Uruguay Round, led to the adoption of the Doha Declaration on the TRIPS Agreement and Public Health (14 November 2001). This declaration to acknowledge the problem of these countries and emphasizes that the TRIPS Agreement should not be an obstacle in solving their public health problems. Therefore, this research will discuss the Doha Declaration in detail to find out to what extend it has solved the public health concerns and access to medicines by the member countries, and the Iraqi patent law position will be discussed as well. The TRIPS Agreement also provides for exclusion from patentability of plants and animals. This is another important area of Introduction 51 exclusion; however, the TRIPS Agreement require from the member countries to provide for the protection of plant varieties. This protection can be through a patent or an effective sui generis system or both of them. The research has discussed this area of exclusion in detail with reference to some other important international agreements that have regulated the protection of plant varieties including saving seeds. Iraq has vast area of fertile land that can be used for agriculture. Therefore, providing protection of plant varieties and seeds will affect the farmers significantly. The Iraqi laws in this regard will be examined and analysed with reference to the amendments as well. The last part of the research will focus on the exceptions to exclusive rights of patent owners in the TRIPS Agreement and Iraqi patent law. The TRIPS Agreement states that member countries have right to provide for limited exceptions to right conferred, without naming any type of exceptions. However, long before the TRIPS Agreement countries around the world were used to limit the exclusive rights of the patent holders by introducing some important exceptions according to their needs. By not naming specific type of exception the TRIPS Agreement offers flexibilities to the member countries to include the exceptions in their domestic law that best serve circumstances. However, the conditions in the TRIPS Agreement have to be abide by the member countries. Beside the above exception, the TRIPS Agreement provides for another type of exception which names it ‘Other Use Without Authorization of the Right Holder’, as commonly known as (Compulsory licence). compulsory licence is very powerful tool at the hand of the local authorities to rectify any unbalanced circumstances created due to the exclusive rights of the patent owners. This type of licence imposed on the right holders without their consent. Therefore, the TRIPS Agreement has states a list of conditions and restrictions that have to be followed before any member countries be able to grant a compulsory licence under the TRIPS Agreement. The research will examine and analyse in detail the conditions and circumstances in which this exception can be applied in. However, due to the strict conditions for applying the compulsory licence, that made many member countries especially the least SAMAN ABDULRAHMAN ALI 52 developed and developing countries unable to utilise the compulsory licence to supply the needs medicines for themselves. This eventually leads to an amendment to the TRIPS Agreement and introducing special compulsory licence for the purpose supplying pharmaceutical products for the need of the member countries. The research will discuss this new compulsory licence in detail and explain the situations that can be applied on. The original Iraqi patent law provided for compulsory licence. However, the amendment of the CPA Order No. 81 replaced all the provisions that related to compulsory licence. the research will examine all the provisions of the of the Iraqi patent law before the amendment and after the amendment by the CPA and analyse the weaknesses and advantages that introduced by the CPA Order No. 81. 53 2 OBJECTIVES The main objective of this research is to examine and analyse the original Iraqi Patent and Industrial Design Law No. 65 of 1970 (The Patent Laws only) in comparison to the amendments in particular the CPA Order No. 81, then compare these with the provisions of the TRIPS Agreement in order to find out the confirmations and contradictions among them. Apart from the above main objective, there is a significant number of other objectives as follows: First: To find out whether the TRIPS Agreement established on bases of fair negotiations and without any coercion from the powerful developed countries and their companies such as big pharmaceutical companies. Second: Analyse and examine the nature, scope, purposes, objectives and principles of the TRIPS Agreement in order for the member countries (least developed, developing and developed countries, and particularly the Iraqi law makers) have clear vision on how to deal with the TRIPS Agreement and be able to benefit from it. Third: Examine the historical development of the Iraqi patent law and assess the requirement of patentability under the original Iraqi patent law and its amendments to find out to what extend compatible with the requirement of patentability under the TRIPS Agreement. Fourth: Analyse the provisions of the TRIPS Agreement that provide for exceptions and exclusion from patentability and compare them to the Iraqi patent law and its amendments made by the CPA Order No. 81 in order to find compatibility among them, and to find out to what extent they have been utilised by the Iraqi patent law. 55 3 METHODOLOGY The thesis methodology is comprised of legal comparative and analytical approaches to all existing significant provisions of the Iraqi patent law before and after amendments among themselves and in comparison, to the provisions of the TRIPS Agreement. The justification for the research analyses is to identify the reasons behind the existence of the TRIPS Agreement and the negotiations that occurred between the developed and developing countries. Analysing the process of standardizing the minimum protection of patent rights before the TRIPS Agreement and tactics used by the each developed and developing countries to gain most out of the TRIPS Agreement and reasons made the developing countries to accept the TRIPS Agreement. The research compares and analyses the provisions of the original Iraqi patent law with the amendments that followed by the CPA. In this way the research will be able to arrive to conclusion whether the progresses and amendments were made for the benefits of Iraq as a country. For arriving at this conclusion, examining the history of creating the TRIPS Agreement and the provisions of this agreement is necessary. Comparing the original Iraqi patent law and CPA Order No. 81 of the provisions of the TRIPS Agreement will be the best way to find discrepancies among them and a good attempt to make harmonization among them. 4 RESULTS SAMAN ABDULRAHMAN ALI 64 In the same way the developed countries were unhappy about the international standards protection, as they were aiming for stronger protection and realized that such protection cannot be achieved by World Intellectual Property Organization (hereinafter the “WIPO”) and other forums like the United Nations Conference on Trade and Development (hereinafter the “UNCTAD”) and the United Nations Educational, Scientific and Cultural Organization (hereinafter the “UNESCO”) because its position in these forums is weak and can easily be defeated by developing countries. 10 United States’ failed attempts lead to think about shifting to a forum where it is the strongest influential party and can impose its interest without effective opposition. This forum was the GATT forum. This made United States to think again and propose that the issue of intellectual property protection has to be considered as an issue of multilateral trade negotiation. 11 Since developing countries were not sympathetic to the United States intellectual property needs, it had no choice but to create a link between international trade regime and enforcement of intellectual property standards so that be able to stop free riding and ‘rebalance the equation’. 12 In fact up to that moment intellectual property rights were looked at as an obstacle to free trade, but due to the United States and United States big businesses, the contracting parties to the GATT meeting in Punta del Este (Uruguay) agreed that in the next round (which is known as Uruguay Round) to include trade related aspects of intellectual property rights as a subject for negotiations. 13 This process was not sudden but it was planned long before Uruguay Round. Some attempts were made during the Tokyo Round on the issue of trade in counterfeit goods which was led by the Levi Strauss Corporation, even though the attempt was unsuccessful to frame the intellectual property rights a trade related issue, but it was 10 Crowne, p. 79. 11 Drahos, ‘Developing Countries and International Intellectual Property Standard-Setting’, p. 769. 12 Peter Drahos, ‘GLOBAL PROPERTY RIGHTS IN INFORMATION: The Story of TRIPS at the GATT’, Prometheus, 13.1 (1995), 6–19 (p. 8). 13 Crowne, p. 79. Trips history, background, negotiation: developed and developing countries stand during negotiations 65 a good initiation. 14 This followed by creating the Group of Expert on Trade on Counterfeit Goods by contracting parties at their Fourth Session in 1984. The Group was of the opinion that joint action was necessary, but some countries were against producing additional norms and standards and others were of the belief that WIPO was a better forum for dealing with these issues and not GATT. 15 However, there are other reasons that encouraged developed countries to push for GATT. One of the reasons was that they can incorporate all intellectual property rights into a single document and any country wants to benefit from WTO has to ratify this single document (the TRIPS Agreement) as well. 16 Even though the developing countries were aware that TRIPS was a loss but they were of the opinion that joining WTO will be beneficial overall. 17 GATT was considered to be a place where contracts and pacts were freely traded rather than concentration on free trades. 18 Another strong reason that led the developed countries to prefer GATT over WIPO was that the former had a well-established enforcement and dispute settlement mechanisms. 19 Another reason for chosen GATT by United States as a forum for intellectual property was that the GATT’s background and dealings with the developing countries was not perfect as supposed to be. The representatives of developing countries were not existed continuously during the process of creating the TRIPS Agreement and during drafting the (Framework of Understanding) and setting the foundations of the final agreement they were left out. 20 14 Graham Dutfield, Intellectual Property Rights and the Life Science Industries: A Twentieth Century History, Globalization and Law (Aldershot, Hampshire, England ; Burlington, VT: Ashgate, 2003), p. 197. 15 Daniel J. Gervais, The TRIPS Agreement: Drafting History and Analysis, 3rd ed (London: Sweet & Maxwell, 2008), pp. 8–9. 16 Crowne, pp. 79–80. 17 Dutfield, p. 197. 18 Drahos, ‘GLOBAL PROPERTY RIGHTS IN INFORMATION’, p. 13. 19 Dutfield, p. 199. 20 Drahos, ‘Developing Countries and International Intellectual Property Standard-Setting’, p. 770. SAMAN ABDULRAHMAN ALI 66 1.3 STEPS TAKEN BY DEVELOPED COUNTRIES (UNITED STATES OF AMERICA IN PARTICULAR): United States government had a great role in the actual existence of the TRIPS Agreement. Alone with all the powers it had could persuade more than 100 countries that they should pay more for the importation of information. 21 The United States government was backing up the interest groups especially those of pharmaceuticals and brand name goods on one side and other various high technology sectors on the other. Fears spread wide that the United States economy was declining and weakening. Base on this pessimism among political elites led the United States government think that this is highly due to intellectual property piracy by other countries. 22 Many American big corporations like IBM, Pfizer and Microsoft which largely relying on intellectual property assets, were worried about losing profits due to piracy. 23 Data collected by the United States International Trade Commission (hereinafter the “ITC”) showed that United States corporations losing some US$ 50 billion a year due to weak intellectual property protection abroad. 24 Furthermore, some developing countries were emerging as potential regional economic power such as Brazil and India. While United States looking at their developing as a threat and unfriendly economic rivals. 25 Long before the Punta del Este Ministerial Conference, both of the patent and copyright interest groups were of the opinion that strong and enforceable intellectual property protection is necessary. Patent industries wanted to achieve this through multilateral approach with the aim of globalizing United States standards of intellectual property protection. On the other hand, the copy right industries were concerned more with their level of enforcement. But before the 21 Drahos, ‘GLOBAL PROPERTY RIGHTS IN INFORMATION’,p. 7. 22 Dutfield, p. 199. 23 Drahos, ‘GLOBAL PROPERTY RIGHTS IN INFORMATION’, p. 7. 24 Adronico O Adede, ‘Origins and History of the TRIPS Negotiations’, in Trading in Knowledge: Development Perspectives on TRIPS, Trade, and Sustainability, ed. by Christophe Bellmann, Graham Dutfield, and Ricardo Meléndez-Ortiz (Earthscan, 2003), p. 24. 25 Drahos, ‘GLOBAL PROPERTY RIGHTS IN INFORMATION’, p. 7. Trips history, background, negotiation: developed and developing countries stand during negotiations 67 Conference both parties agreed that their approaches were complementary. 26 There are two main entities that had great influence on the United States government decision on preferring strong and high standard of intellectual property rights. The first and most important of these entities is the Office of the United States Trade Representative (hereinafter the “USTR”). USTR was created by Congress and placed in the Executive Office of the President to coordinate trade policy, but in reality, it was a means through which the Congress and interest groups put pressure on the Executive to incorporate their interests in the country’s international trade policy. The other entity was the United States ITC. ITC aimed at providing trade expertise to both branches of government (Legislative and Executive) by identifying the effects of imports on US industries and actions necessary to be taken against ‘unfair trade practice’ including intellectual property piracy. The interests of other developed countries were similar to those of United States. Therefore, it was easy for United States to acquire support of European Union, Japan, Canada and other developed countries. However, before receiving such support, United States through major multinational corporations established Intellectual Property Committee (hereinafter the “IPC”) in 1986. IPC did its best to gather supports of European and Japanese governments and businesses. IPC could with help from other local and international business and trade association turn the issue of intellectual property into a trade related issue in a package and eventually developed into the TRIPS agreement. 27 However, developing countries resisted this attempt and United States had to deal with opposition in its own way. Since the United States can be considered as a mastermind of existence of the TRIPS agreement and mostly will be beneficial for the United States, it was the United States that strongly opposed all the resistance. Dealing with sovereign states was not easy for the United States because they had rights under previous international conventions to regulate laws with lower protection from what United States wishes for. Some of these countries were not culturally ready to 26 Dutfield, p. 201. 27 Crowne, pp. 81–83. SAMAN ABDULRAHMAN ALI 68 accept intellectual property and some looked at it as a new form of decolonization or economic imperialism. 28 As has already been said, one of the main countries that contributed to the existence of TRIPS Agreement and strongly repulsed any resistance against creation of the TRIPS was United States of America. The United States had taken some measures to ensure that nations and in particular developing nations would follow the standards that USA prefers. IPC adopted a strategy of dialogue to divide between the developing countries. In 1988 a delegation from IPC visited newly industrialized countries like Korea, Hong Kong and Singapore, with the intention separate them from India and Brazil by persuading them that their issues and interests are not same as of India and Brazil. The IPC delegation also visited ASEANS with the intention to persuade them that India and Brazil are not suitable countries to represent you as they don’t care about investment climate. 29 The origin of the Office of the United States Trade Representative (USTR) goes back to the time of President Kennedy. During his time and under the Trade Expansion Act of 1962, Congress requested the President to create a Special Representative for Trade Negotiations to conduct United States trade negotiation, which up to that time it was the responsibility of the Department of State. 30 In the beginning the office was called Special Trade Representative (hereinafter the “STR”), but later on according to section 1 (a) of the Reorganization Plan No. 3 of 1979, the office renamed as the Office of the United States Trade Representative (USTR). Reorganization Plan No. 3 of 1979 broadened USTR responsibilities. The primary responsibilities of USTR as stated in Section 1 (b) (1) are developing and coordinating the implementation of United States international trade policy, including commodity matters and direct investment policy and overseeing negotiations with other countries. USTR serve as the principal advisor to the President on international trade policy and on 28 Drahos, ‘GLOBAL PROPERTY RIGHTS IN INFORMATION’, p. 9. 29 Peter Drahos and John Braithwaite, Information Feudalism: Who Owns the Knowledge Economy? (London: Earthscan, 2002), p. 129. 30 https://ustr.gov/about-us/history. Seen on 03/11/2016 Trips history, background, negotiation: developed and developing countries stand during negotiations 69 the impact of other policies of the United States Government on international trade. Even though there are other committees and groups such as Trade Policy Staff Committee (hereinafter the “TPSC”) and Trade policy Review Group (hereinafter the “TPRG”), however it is the USTR that dominates the bureaucratic process and it is all due to USTR’s primary responsibility for trade policy formation and implementation. Most of the actions by USTR, among others are under Section 301 of Trade Act 1974 regarding unfair foreign trade practices and Section 182 (which is called special 301 and introduced in 1988 amendments) on intellectual property rights. 31 These new laws were come into existing in order for United States prepare itself for world domination of intellectual property and enforce its own interests by coercing other sovereign states. 32 This is no different from what the British government had done when it had dominant power. For example, when its trade monopoly ended with china, the British government pressured by Lancashire manufacturers, ship owners and other commercial interests to extend the monopoly through whatever means is necessary. Eventually through using military power the monopoly further extended while the Chinese government agreed to more trade agreements. Then after a while further agreement enforced on china, but this time British government aided by the French. 33 Section 301 is the first section under Title III, Chapter 1 of the Trade Act of 1974. Title III specialised for relief from unfair trade practices and its chapter one dedicated to enforcement of rights of United States and responses to certain foreign trade practices. The first section which is Section 301 titled ‘Actions by United States Trade Representative’. Originally Section 301 enacted to give the President the huge flexible power to solve trade disputes and also enhanced the President’s authority to impose sanctions unilaterally without observing international obligations. However, currently this responsibility transferred to USTR and it has final decision in cases 31 Marcus Noland, ‘Chasing Phantoms: The Political Economy of USTR’, International Organization, 51.3 (1997), 365–87 (p. 367). 32 Drahos, ‘GLOBAL PROPERTY RIGHTS IN INFORMATION’, p. 9. 33 Edward Goldsmith, ‘The Uruguay Round: Gunboat Diplomacy by Another Name’, Ecologist, 1990, 202–4 (p. 202-203). SAMAN ABDULRAHMAN ALI 70 related to section 301 and it has authority of initiating investigations as well. 34 Section 301 is not directly related to intellectual property rights but gives great power to USTR to take actions, and in fact it is mandatory action when “the rights of the United States under any trade agreement are being denied or an act, policy, or practice of a foreign country (i) violates, or is inconsistent with, the provisions of, or otherwise denies benefits to the United States under, any trade agreement, or (ii) is unjustifiable and burdens or restricts United States commerce”. 35 Section 301 specified the authority that USTR has, which in reality is a very broad that includes suspension, withdrawal or prevention of benefits from trade agreements. Furthermore USTR has authority to impose duties or other import restrictions on the goods. 36 Also, USTR has the right to take discretionary action when (1) an act, policy, or practice of a foreign country is unreasonable or discriminatory and burdens or restricts United States commerce, and (2) action by the United States is appropriate. 37 Therefore, USTR has authority to take action and impose trade sanction and punish foreign countries and Section 301 has given United States unilateral power to punish any foreign countries that threaten American interests, whether United States has bilateral or multilateral agreements with these foreign countries or simply their actions considered unreasonable, unjustifiable or discriminatory that restrict or burden the United States trade. 38 Even though section 301 interpreted in such a way as to be applied to all kind of trade practice including trades related to intellectual property. However, to further strengthen the protection of United States intellectual property trades Special 301 added to the Trade Act of 1974 in 1988. Special 301 particularly designed to protect the intellectual property rights. 34 A. Lynne Puckett and William L. Reynolds, ‘Rules, Sanctions and Enforcement under Section 301: At Odds with the WTO?’, The American Journal of International Law, 90.4 (1996), 675–89 (pp. 676–77). 35 Section 301 (a)(1)(A) &(B) Trade Act of 1974 36 Section 301 (c)(1)(A) &(B) Trade Act of 1974 37 Section 301 (b) Trade Act of 1974 38 Puckett and Reynolds, p. 675. Trips history, background, negotiation: developed and developing countries stand during negotiations 71 The title of special 301 (section 182) of Trade Act of 1974 reads as “Identification of Countries That Deny Adequate Protection, Or Market Access, For Intellectual Property Rights”. The main purpose of the Special 301 as can be understood from the title is to promote the adequate and effective protection of intellectual property rights in foreign countries. This can be achieved by Special 301 (section 182) through using a foreseeable threat of unilateral retaliation by the United States to induce trading partners to reform their intellectual property practices. 39 This retaliation was the result of the reality as stated by the United States International Trade Commission that in 1986 alone United States companies lost between $43 and $61 billion due to the piracy practices abroad. The President and the Congress were firmly committed and ready to do everything to adequately protect intellectual property rights through international trade negotiations and revisions to the United States trade laws. 40 Protecting the United States businesses and interests and satisfying the policies of both the president and the Congress were the reasons of enacting and designing the Special 301 in its current form. Base on this determination, Special 301 requires the USTR that within 30 days after submission of a report of (National Trade Estimate) to the President, the Committee on Finance of the Senate, and appropriate committees of the House of Representative, 41 to identify those foreign countries that ‘deny adequate and effective protection of intellectual property rights, or deny fair and equitable market access to United States persons that rely upon intellectual property protection’. 42 Furthermore USTR can identify some foreign countries as ‘priority foreign countries’. However, some stipulations are stated in Special 301 (section 182 of the Trade Act 1974) in those countries in order USTR be able to list as priority foreign countries, such as if they ‘have the most onerous or egregious acts, policies, or practices that (i) deny adequate and effective intellectual property rights, or (ii) deny fair and equitable market access to United States persons that relay upon 39 Judith H. Bello and Alan F. Holmer, ‘Special 301: Its Requirements, Implementation, and Significance’, Fordham International Law Journal, 13 (1989), 259 (p. 259). 40 Bello and Holmer, p. 260. 41 Section 181(b)(1) Trade Act of 1974. 42 Special 301(Section 182) (a)(1)(A) & (B) Trade Act of 1974. SAMAN ABDULRAHMAN ALI 72 intellectual property protections. 43 Special 301 does not stop here but further authorised USTR to put any states in priority foreign countries ‘whose acts, policies or practices described in subparagraph (A) have the greatest adverse impact (actual or potential) on the relevant United States products, and that are not (i) entering into good faith negotiations, or (ii) making significant progress in bilateral or multilateral negotiations, to provide adequate and effective protection of intellectual property rights’. 44 Special 301 enacted exclusively to protect the intellectual property rights of United States companies and businesses in foreign countries. It gives a great authority to USTR to investigate in a very short time, much faster than investigation conducted according to normal section 301. 45 USTR admitted that Special 301 has great impact on changing acts and policies of intellectual property rights of foreign countries. For example, during 1989, People’s Republic of China and Taiwan committed and agreed to amend their copyright laws that bring them into line with what is acceptable intellectual property rights according to the United States. Colombia also changes its policy regarding permission problems of motion picture and Saudi Arabia enacted a new patent law entirely. USTR also admitted that both Chile and Indonesia yield to the proposed patent law amendments or anew patent law including increased protection for pharmaceuticals. But still USTR was not satisfied and believed that during Uruguay Round none of the United States trading partner happy with the intellectual property standards proposed by U.S. 46 USTR did not stop by targeting developing countries only, but rather USTR used section 301 to put pressure on a developed country such as Japan in order to direct its intellectual property protection standards to the same of those of United States. Japanese market in United States was blooming and creating bad image to the United States economic capabilities. Therefore, public was made to understand that it is the United States ideas and knowledge that have 43 Special 301(Section 182) (b)(1)(A) Trade Act of 1974 44 Special 301(Section 182) (b)(1)(B) & (C) Trade Act of 1974 45 Bello and Holmer, p. 263. 46 Bello and Holmer, pp. 265–66. Trips history, background, negotiation: developed and developing countries stand during negotiations 73 been stolen by the Japanese. 47 Eventually, the United States government worked on this point and in 1984 the United States trade officials put pressure on Japan’s Ministry of International Trade and Industry to give up its proposals for a sui generis form of protection for computer software. 48 This may be the reasons why Japan stayed away from targeting developing countries bilaterally in intellectual property issues. 49 Even though section 301 and special 301 had a great role in assisting USTR in performing its task, but without reports and data from intellectual property lobbies such as International Intellectual Property Alliance (hereinafter the “IIPA”) and Business Software Alliance (hereinafter the “BSA”), USTR could not perform its duty. Thousands of companies are gathered to create these associations and they were active in countries all over the world and continuously feeding information to USTR. With the help of all these big corporations, USTR was capable of persuading ample number of countries, majority of them were developing countries, to enact or amend their intellectual property laws so that satisfy United States needs. 50 This clearly helped and put United States in advantageous position comparing to other countries while negotiating and submitting its idea at GATT. But this was not enough as some developed countries priority was not inclusion of intellectual property into the trade domain, i.e. to be part of GATT. Therefore, United States had to do its best to influence its alliance within the developed countries and started with the most distinct group which was Quad group. Quad group was one of the essential groups which had great influence on TRIPS negotiations. Quad consisted of the United States, the European Community (hereinafter the “EC”), Japan and Canada. Sometimes the group extended to include Switzerland and Australia, 47 Drahos, ‘GLOBAL PROPERTY RIGHTS IN INFORMATION’, p. 8. 48 Drahos, ‘Developing Countries and International Intellectual Property Standard-Setting’, p. 773. 49 Crowne, p. 85. 50 Drahos, ‘GLOBAL PROPERTY RIGHTS IN INFORMATION’, pp. 10–12. SAMAN ABDULRAHMAN ALI 80 countries negotiators call the process the Black Room consultations. Eventually, by 1990 onwards the discussions and negotiations were focused on how far the final draft of TRIPS agreement deviate from the original proposal submitted in 1988 by Pfizer, IBM, DuPont and other members of the international business community. Then the battle on the language of the TRIPS agreement starts as every country wanted the language to be construed in the way that describe the deals favours by the country. If a particular issue is not in their favour, the negotiators try to construct the article in an ambiguous language so that to be able to open a backdoor exit and be able to run away from responsibility of that particular issue. But it was a difficult task for negotiators as they all entangled in a complex web of relationships. Every negotiator was considered insider for some groups and outsider for others. Furthermore, some negotiators were fulfilling the wish of their countries, which they have other ambitions. For example, South Korea did not support India and Brazil fully because South Korea was trying to join the Organization for Economic Co-operation and Development (hereinafter the “OECD”) and finally in 1996 became a member. 71 1.5 CONCLUSION From the historical perspective and negotiation process of creating the TRIPS Agreement, it can be concluded that the TRIPS Agreement as an international agreement did not come into existence for the benefits of all countries equally. During the process many coercion mechanisms implemented by developed countries and in particular the United States of America. The developing countries were aware of this fact but accepted the agreement partially because they did not have any choice but submit to the will of developed and industrialized countries, and also hoping to gain some advantages from joining the WTO. 71 Drahos and Braithwaite, pp. 133–40. 81 2 NATURE, SCOPE, OBJECTIVES AND PRINCIPLES OF THE TRIPS AGREEMENT 2.1 INTRODUCTION The TRIPS Agreement like many other international conventions and agreements established for certain purpose and has its own specific nature and scope of obligations, objectives and principles. In order to understand the nature, purposes, scopes, objectives and principles of the TRIPS Agreement, one has to look at the provisions and articles of the TRIPS Agreement as they create obligations upon the member countries to implement them. Even though there is one particular provision in the TRIPS Agreement that dedicated for clarifying the objectives of the Agreement, but still there is a debate in regard to what is the main objective of the TRIPS Agreement. Critics believe that the main objective of the TRIPS Agreement is to enhance the protection of intellectual property, however this is considered as a common misunderstanding by Nuno Pires de Carvalho. NP de Carvalho believes that “the main - if not the only - objective of the TRIPS Agreement as well as that of the whole WTO Agreement is to promote free international trade”. 72 Principle of an agreement is considered to be a central part of the system by being the spirit of the whole agreement and represent the different rules that create one single agreement. If not for the principles of the TRIPS Agreement the social, environmental and economic aims of the WTO and TRIPS Agreement may be jeopardised by the scope of the intellectual 72 Nuno Pires de Carvalho, The TRIPS Regime of Patents and Test Data, Fourth edition (Alphen aan den Rijn, The Netherlands: Kluwer Law International, 2014), p. 46. SAMAN ABDULRAHMAN ALI 82 property rights. 73 In this part the objectives and principles of the TRIPS Agreement will be discussed after looking at the purpose, nature and scope of the obligations of the Agreement. 2.2 PURPOSE, NATURE AND SCOPE OF THE TRIPS AGREEMENT The TRIPS Agreement states minimum standard of intellectual property rights through rules and principles in order to ensure protection of the rights. It is considered to be the most comprehensive agreement in the international level compare to other agreement in the area of intellectual property rights. 74 The scope of such rights defined through the articles of the agreement by conferring rights to the title holders. Rights in the TRIPS Agreement considered to be negative rights in the sense that it is required from others not to deal with the protected subject matters without permission from the right holders. 75 2.2.1 Purposes and Objectives of the TRIPS Agreement According to the Preamble There are two main purposes and objectives that can be deduced from the Preamble which are consistent with the foundation of the WTO. First; presenting the intellectual property protection in a better way that reduce distortions and impediments to international trade. And second; recognition of intellectual property rights as private rights which can be protected against any arbitrary and unjust acts of governments. 76 It is not necessary that all international agreements and conventions relating to intellectual property have a preamble, for example some of those agreements tabled by the United States of America and the European Community. Before 1990 having Preamble 73 Rodrigues Jr and Edson Beas, The General Exception Clauses of the TRIPS Agreement: Promoting Sustainable Development (Cambridge, U.K.: Cambridge University Press, 2015), pp. 44–45. 74 Carvalho, The TRIPS Regime of Patents and Test Data, p. 32. 75 Carlos María Correa, Trade Related Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement, Oxford Commentaries on International Law (Oxford ; New York: Oxford University Press, 2007), p. 7. 76 Carvalho, The TRIPS Regime of Patents and Test Data, p. 39. Nature, scope, objectives and principles of the trips agreement 83 in the current form was not considered to be useful. 77 The Preamble does not have same legal power as those of the Articles and it is not considered to be creating specific rights and obligations. However, it can be referred to while interpreting the provisions of the TRIPS Agreement. 78 Not all the Article of the TRIPS Agreement are clear enough to avoid interpretation. Some of the articles may carry more than one meaning and can be interpreted in more than one ways, therefore the Preamble can be referred to in many interpretative contexts. 79 The TRIPS Agreement in the first sentence of the Preamble states that members ‘Desiring to reduce distortions and impediments to international trade’ and this is directly connected to the intellectual property when the next part of the paragraph of the Preamble states that ‘taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade’. This proves that according to the TRIPS Agreement there is a strong connection between intellectual property rights and international trade. The existence of such connection was due to the attempts by the United States of America and United States’ big corporations to include the trade-related aspects of intellectual property rights as one part of negotiation in the Uruguay Trade Round which was launched by Ministerial Declaration in 1986. 80 Despite the efforts of developing countries or less developed countries to stop this attempt but still made it to the Uruguay Round. Even though some analysts are of the opinion that the TRIPS Agreement was discussed in wrong place as it is not about the free trade but rather creating new domestic rules and 77 Peter-Tobias Stoll, Jan Busche, and Katrin Arend, WTO: Trade-Related Aspects of Intellectual Property Rights (BRILL, 2009), p. 65. 78 Stoll, Busche, and Arend, p. 67. 79 Resource Book on TRIPS and Development, ed. by United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development (Cambridge; New York: Cambridge University Press, 2005), p. 10. 80 Drahos, ‘Developing Countries and International Intellectual Property Standard-Setting’, p. 769. SAMAN ABDULRAHMAN ALI 84 regulations, and legal regimes. 81 However, by relating intellectual property rights to free trades, the TRIPS Agreement is recognizing the same purpose that stated in the Preamble of the WTO Agreement ‘substantial reduction of tariffs and other barriers to trade and to the elimination of discriminatory treatment in international trade relations’. It was the same interest that the GATT of 1947 was founded on, which was ‘liberalization of international trade’. 82 Trade in this context refer to both areas of trade of the WTO which they are trade in goods and in services. 83 The TRIPS Agreement is part of the WTO (GATT) and therefore it is concentrated only on those parts of intellectual property rights that their protections considered to be distortions and barrier to trade. Those areas that the parties to the GATT considered were trade related aspects of intellectual property rights such as copyright and trade related parts, with some other areas of industrial property that have independent Articles within the TRIPS Agreement which are; trademarks, geographical indications, industrial designs, patents, and layout designs (topographies) of integrated circuits. Some other areas that related to industrial protection but not given an independent Articles but joint with other areas, and they are protection of undisclosed information and plant varieties. Protection of undisclosed information though mentioned in Section 7 of Part II of the TRIPS Agreement but in Article 39.1 of the TRIPS Agreement it is stated that undisclosed information is merely to give ‘effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967)’. Plant varieties also mentioned in Article 27.3 (b) within Section 5 of Part II of the TRIPS Agreement which dedicated for patents. According to the said article plant varieties shall be protected by the member countries through patent or an effective sui generis system as an alternative patent protection or sui generis 81 Correa, Trade Related Aspects of Intellectual Property Rights, p. 3. 82 Paul Katzenberger and Annette Kur, ‘TRIPS and Intellectual Property’, in From GATT to TRIPs: The Agreement on Trade-Related Aspects of Intellectual Property Rights, ed. by Friedrich-Karl Beier and Gerhard Schricker, IIC Studies, v. 18 (Weinheim; New York: VCH, 1996), pp. 2–3. 83 Stoll, Busche, and Arend, p. 66. Nature, scope, objectives and principles of the trips agreement 85 system can be combined with patent protection. 84 Therefore, it becomes clear that the reason behind the words of the first paragraph of the Preamble of the TRIPS Agreement that international trade considered as an important element in the TRIPS Agreement and concentration will be on those intellectual property rights that their measures and procedures of enforcement will not lead to barrier to international trade. The first paragraph of the Preamble did not neglect the requirement in which the TRIPS Agreement established for essentially, in the first paragraph of the Preamble while concentrating on trade the members should take ‘into account the need to promote effective and adequate protection of intellectual property rights’. This is an acknowledgement that effective and adequate protection of intellectual property rights is necessary in every individual country in order to have free international trade with reduced distortions and impediments. In case these effective and adequate protection is absent, then it is believed that distortions and impediments subsequently occur in international trade and achievements of individuals and corporates will be abused as well, while investments will lead astray. Therefore, it is not the high standard of intellectual property right or its effective and adequate protection that threatens the international trade, but the abuse of such rights will do. This is an opinion that harmonization of strong intellectual property protection is necessary and should be an important objective of the TRIPS Agreement. Other abuses of intellectual property rights can be found in other places in the TRIPS Agreement such as Article 8.2 and Article 40. Article 8.2 states that it is necessary to prevent any abuse of intellectual property rights by right holders through needed measures by the TRIPS Agreement member countries. Such measures can be adopted ‘to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology’. Article 40 of the TRIPS Agreement concentrates on anti-competitive practices that relate to intellectual property rights. Therefore, any abuse in practice of intellectual property rights that have adverse effect on competition 84 Carvalho, The TRIPS Regime of Patents and Test Data, p. 33. SAMAN ABDULRAHMAN ALI 86 in the relevant market can be dealt with by the member countries in their legislation. 85 As Article 31.1 of the Vienna Convention in regard of interpretation of treaties stated that ‘A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose’, therefore the Preamble serves as a purpose of interpretation since the Preamble identifies the object and purpose of the TRIPS Agreement. This further strengthened by the Doha Declaration on the TRIPS Agreement and public health, 86 as in paragraph 5 (a) states that the provisions of the TRIPS Agreement shall be read with the purpose and object of the TRIPS Agreement and especially objectives and principles. This clearly refers to the Preamble and Articles of 7 and 8 of the TRIPS Agreement. Even though its believed that the provisions of the TRIPS Agreement cannot be further broadened or narrowed in the light of the Preamble and Article 7 and 8, because any alterations would mean a new negotiation on what have already agreed on. 87 2.2.2 Need for New Rules and Disciplines The second paragraph of the Preamble is concerned with passing new rules and disciplines that are needed to accomplish the objectives of the first paragraph. In the second paragraph five subparagraphs numbered in which the new rules and disciplines should be regulated for accordingly. The first one is Subparagraph (a) that states ‘the applicability of the basic principles of GATT 1994 and of relevant international intellectual property agreements or conventions’. There are some important principles in the GATT 1994 which they are national treatment, most favoured nation, transparency and sovereignty, 88 which the TRIPS Agreement needs to abide by. Since 85 Katzenberger and Kur, p. 5-7. 86 ‘WT/MIN(01)/DEC/2 -WTO | Ministerial Conferences - Doha 4th Ministerial - Declaration on the TRIPS Agreement and Public Health - Adopted 14 November 2001’, 2001 <https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm> [accessed 22 December 2017]. 87 Carvalho, The TRIPS Regime of Patents and Test Data, pp. 37–38. 88 Correa, Trade Related Aspects of Intellectual Property Rights, p. 5; Stoll, Busche, and Arend, p. 68. Nature, scope, objectives and principles of the trips agreement 87 the TRIPS Agreement is integral part of the GATT/WTO, therefore it’s understandable that comply with the GATT’s principles. In many situations the Panels and Appellate Body have referred to the principles and previous GATT jurisprudence in cases of the TRIPS Agreement. 89 Nonetheless, the question to what extent the GATT principles apply in the TRIPS Agreement is not clear yet, though these principles should not undermine the TRIPS Agreement. However, subparagraph (a) goes further than the GATT principles and requires the integrity to the applicability of other intellectual property agreements and conventions, such as Berne Convention, 90 Paris Convention and the Washington Treaty. 91 In subparagraph (b) new rules and disciplines should be regulated concerning ‘the provision of adequate standards and principles concerning the availability, scope and use of trade-related intellectual property rights’. The requirement of adequate standards and principles is necessary in order to balance the protection rights of the right holders and the interest of public and users in general. It was not the intention of the negotiators to impose highly standards form of protections, but it was the adequate standards and principles that are enough to achieve the objective of the TRIPS Agreement as stated in the first paragraph of the Preamble, which is to reduce distortions and impediments of international trade. 92 Then what constitutes adequate standards and principles is a matter of opinion, as what may be an adequate standards and principles for the developed countries many not be the same for less developed countries, and this may change through times as well. The developed countries have changed their standard of protection through times and during their development stages. However, the TRIPS Agreement states minimum standard of protection and requires from the member countries to incorporate these minimum standards that put forth in the Agreement into their national legal system. This has been considered as the highly criticised 89 Correa, Trade Related Aspects of Intellectual Property Rights, p. 6. 90 Stoll, Busche, and Arend, pp. 68–69. 91 Gervais, p. 155. 92 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, pp. 10–11. SAMAN ABDULRAHMAN ALI 88 aspect of the TRIPS Agreement because ‘one size does not fit all’ notwithstanding some limited period of transition given by part VI of the TRIPS Agreement. 93 Subparagraph (c) emphasis on ‘the enforcement of trade-related intellectual property rights, taking into account differences in national legal systems’. The Preamble wanted to stress on another important point as well which is the element of enforcement of the TRIPS Agreement that cannot be found in the previous conventions on intellectual property rights. This was one of the important point that United States of America and other developed countries emphasised on during the negotiation because according to them the previous conventions such as Paris Convention and Berne Convention lacked effective binding enforcement method to deal with non-compliance member countries. For this reason, these conventions were called teeth less convention by the developed countries. 94 However, the second part of this subparagraph added an important element to the enforcement measure which is considering the differences in national legal systems. This brings flexibility to the enforcement measure. 95 Because this gives an opportunity to the member countries as to how implement the obligations required by the TRIPS Agreement. 96 In fact, subparagraphs (d) and (e) mention two important and necessary points to the developed and developing countries respectively. Developed countries were supporting the high standards of minimum protection and enforcement provisions, therefore in the case of any disputes arising from non-compliance should be resolved according to the multilateral procedures of the WTO. 97 Article 64 of the TRIPS Agreement states that ‘The provisions of Articles XXII and XXIII of GATT 1994 as elaborated and applied by the Dispute Settlement Understanding shall apply to consultations and the 93 Correa, Trade Related Aspects of Intellectual Property Rights, pp. 7–8. 94 Crowne, p. 78. 95 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 11. 96 Correa, Trade Related Aspects of Intellectual Property Rights, p. 9. 97 Correa, Trade Related Aspects of Intellectual Property Rights, p. 9. Nature, scope, objectives and principles of the trips agreement 89 settlement of disputes under this Agreement except as otherwise specifically provided herein’. Since the provisions of the TRIPS Agreement require very extensive legislative and administrative measures that are above the capacity of less developed countries, hence, it provides for transitional arrangements in subparagraph (e) to help those countries in order to be able to implement the minimum standard protections of the TRIPS Agreement. In two occasions the transitional period extended. The first time was on 27 June 2002 when the Council for the TRIPS Agreement extended the transitional period until 2016 for least developed country members in regard pharmaceutical products. The second time was on 19 November 2005 in the same way the transitional period was extended for least developed countries until 1 July 2013 in regard the applicability of the whole TRIPS Agreement. 98 There are four more paragraphs in the Preamble that recognize important points, such as dealing of international trade in counterfeit in paragraph three, as this was the wishes of United States of America with the support of EC. Then, the Preamble recognizes the intellectual property rights as private rights in the fourth paragraph. This was included in order to reaffirm that the matters of intellectual property rights should be left for private parties to deal with, though the TRIPS Agreement in some occasion allowed the interference of states particularly in cases of criminal sanction or balancing the public rights and rights of intellectual property right holders. 99 The importance of this paragraph is that it gives rights holders to take burden of their rights and be able to defend their rights without necessity of states interference and taken action of ex officio. 100 The fifth paragraph recognizes an important element which is ‘Recognizing the underlying public policy objectives of national systems for the protection of intellectual property, including developmental and technological objectives’. Implementation of high standard of intellectual property rights may cause great changes to the national systems and policies especially to the less developed 98 Stoll, Busche, and Arend, p. 70. 99 Gervais, p. 156. 100 Correa, Trade Related Aspects of Intellectual Property Rights, p. 10. SAMAN ABDULRAHMAN ALI 96 provision are the Paris Convention (1967), the Berne Convention (1971), the Rome Convention and the Treaty on Intellectual property in Respect of Integrated Circuits. It can be concluded that the word ‘nationals’ has been given very wide meaning in order to protect intellectual property rights as private rights of very wide ranges of persons, whether at international or domestic levels, or natural or legal persons as long as they hold intellectual property rights in those areas mentioned in the TRIPS Agreement. 2.3 OBJECTIVES OF THE TRIPS AGREEMENT The TRIPS Agreement contain one article which is titled the ‘Objectives’ (Article 7 of the TRIPS Agreement) and ordinarily should represent the objectives of the whole Agreement. The content of the Article was proposed by twelve developing countries to the Uruguay Round Negotiating Group, however, the original proposal was under the title ‘Article 2 Principles’ of the Anell Draft. 122 Paragraphs 1 and 3 of the original proposal of Article 2 of the Anell Draft summarised into Article 7 of the TRIPS Agreement. Main purpose for the insertion of Article 7 of the TRIPS Agreement was the concerns of the developing countries that the TRIPS Agreement and in particular the standard protections of patents should be in a manner to have positive effect on advancing their technological and economic development, and social welfare. 123 The developing countries were worried that the objectives of the TRIPS agreement are directed only toward the strong protection of the intellectual property rights by developed countries. 124 To the developing countries the wordings of Article 7 of the TRIPS Agreement will balance between rights and obligations and their interests will be taking into account, even though 122 During the negotiations on the standard of intellectual property protection between the developed and less developed countries, a draft prepared by the GATT Secretariat and Chairman Anell in order to bring their opinion closer to each other on the matter, the draft is known as Anell Draft. See Peter K. Yu, ‘The Objectives and Principles of the Trips Agreement’, Houston Law Review, 46 (2009), 979–1046 (p. 990). 123 Carvalho, The TRIPS Regime of Patents and Test Data, pp. 164–65. 124 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 119. Nature, scope, objectives and principles of the trips agreement 97 it’s mainly concentrated on technology related intellectual property rights. 125 However, the majority of the developed countries’ proposals were mainly concentrated on general statement of intent and do not coincide with the spirit of the Articles of the TRIPS Agreement. Nevertheless, articles of the TRIPS (including Articles 7 and 8) should be given greater importance during implementations and interpretations. 126 Even though the heading of Article 7 particularly states ‘Objectives’ but the objectives of the TRIPS Agreement cannot be limited to Article 7 alone, but rather has to be read with Article 8 and the Preamble of the Agreement. For this reason, some scholars such as NP de Carvalho are of the opinion that Article 7 is misplaced as it’s more accurately related to Patent. Therefore, it should have placed in Section 5 (Patents) of the Part II or in the Preamble with the Paragraphs 5 and 6 (development objectives). 127 Article 7 can strongly be associated with Patent because the wordings of the Article which has some phrases such as ‘technological innovation’, ‘technological knowledge’, and the word ‘technology’. All these words indicating that the developing countries were mostly concerned with the Patents and its impact on their countries. 128 Even though the wordings of the Article 7 start with ‘The protection and enforcement of intellectual property’ but since it’s linked with technical innovation, therefore it applies to those provisions of intellectual property rights that involve technical innovations only. This means that Article 7 only applies to patents and trade secrets as in wider sense may involve technical innovation and knowledge even though they cannot be patented. Other areas of intellectual property rights such as copyrights and related rights, trademarks, geographical indications and industrial designs cannot be placed under the umbrella of Article 7 as titled the objectives of the TRIPS Agreement. However, it can be argued that the phrase of 125 Stoll, Busche, and Arend, p. 180. 126 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 124. 127 Carvalho, The TRIPS Regime of Patents and Test Data, p. 165. 128 Stoll, Busche, and Arend, p. 181. SAMAN ABDULRAHMAN ALI 98 ‘promotion of technical innovation’ is very wide and not necessarily limited to the area of patentable inventions. Technical invention is considered as only one early stage of the innovation. The innovation process may lead to enhancement of existing or creation of new product or service, even though it may not include every area of intellectual property. 129 Other commentators also are of the opinion that the last two phrases of Article 7 of the TRIPS Agreement that read ‘in a manner conducive to social and economic welfare’ and ‘to a balance of rights and obligations’ have emphasis on wider areas and can apply almost to all types of intellectual property rights. Developing countries gave up on resisting insertion of protection and enforcement of high standards of intellectual property rights in the GATT, which apparently all were in favour of developed countries. However, the developing countries wanted to make sure that in return the high standard of protection, especially in the area of Patent, has some advantage on their social, economic and technological development. 130 This idea of creating link between intellectual property rights’ protection and their promotion of social and economic and technological development that exist in Article 7, with other ideas in the Preamble and Article 8 are originally taken or inspired by those of the Draft International Code of Conduct on the Transfer of Technology which was negotiated under the umbrella of UNCTAD but never became an international instrument. 131 The wording of Article 7 and 8 (objectives and principles) cannot be found in other intellectual property international instruments such as Paris Convention and Berne Convention. 132 This becomes clear that this idea is not new and the developing countries always wanted some benefits in exchange for their compliance to the high standards of 129 Stoll, Busche, and Arend, p. 181. 130 Yu, pp. 1000–1001. 131 Yusuf, p. 10. 132 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 119. Nature, scope, objectives and principles of the trips agreement 99 protection of intellectual property rights and they wanted this to be presented in an international instrument. 2.3.1 Balance Between Rights and Obligation of Intellectual Property Holder According to the last part of Article 7, developing countries have the right to object the exclusive rights of the right holders if failed to use their innovation actively to benefit the social and economic welfare of the country or failed to perform their obligations while enjoying their rights. However, the developing countries have to be careful in balancing between intellectual property right holders’ interests in form of fair returning of compensation for their innovations and those of the users and public in general. The reason is that if the balance tilted towards the interest of users and public, the inventors are not spending much efforts of time and money in their innovations and this counterproductive process will not be in favour of the developing countries and their public. 133 It is also well established that enforcement and protection of intellectual property rights has a higher purpose of benefiting society as a whole and not just protecting the interests of specific individual or group rights. Article 7 of the TRIPS Agreement clearly stated that ‘the protection and enforcement of intellectual property rights should contribute…to the mutual advantage of producers and users of technological knowledge’, which means that the protection and enforcement should have equal impact and benefit to both of the users and producers. All the privileges that contributed to the individuals and groups were with the purpose of providing further benefits to society in general. This apply to both developed and developing societies, but specifically in less developed societies as they are considered mostly users of technology and not producers of technology. Even though Article 7 of the TRIPS Agreement requested and supported by less developed countries, but it fits the spirit of the 133 Gervais, pp. 203–4. SAMAN ABDULRAHMAN ALI 100 WTO, as balancing between rights and obligations considered superseding objective of the WTO system. 134 Even in the previous Intellectual Property conventions (for example Article 5A of the Paris Convention) the principle of balance of rights and obligations existed between the governments on behalf of public interests and intellectual property right holders’ interests. 135 This will help the interpreters of the TRIPS Agreement and assist courts as well. Usually courts are interested in reasons behind creating particular intellectual property rights by national legislators, and in this regard, courts can rely on Article 7 that the TRIPS Agreement intended to keep balance between interests of right holders and society in general. TRIPS negotiators never wanted to abandon the interests of user of intellectual property assets and by keeping this balance a harmonized atmosphere will be created that promote both social and economic welfare. 136 GATT’s approach in Intellectual property rights which apparent in the TRIPS agreement is permissive approach rather than prescriptive approach, in which GATT gives wide freedom to member countries to adopt regulations which best suits their unique situation with the condition that these regulations should not be inconsistent with GATT and their application be far from discriminatory and arbitrary manner. Permissive approach to Intellectual Property norms comes from the stand that GATT believes intellectual property rights may cause trade barriers. This is a special treatment of Intellectual Property rights by GATT as the normal approach by GATT to achieve trade liberalization was prescriptive approach. 137 134 Yu, pp. 104–8. 135 Rajan Dhanjee and Laurence Boisson de Chazournes, ‘Trade Related Aspects of Intellectual Property Rights (Trips): Objectives, Approaches and Basic Principles of the GATT and of Intellectual Property Conventions’, Journal of World Trade, 24.5 (1990), 5–15 (p. 10). 136 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 126. 137 Dhanjee and de Chazournes, p. 6. Nature, scope, objectives and principles of the trips agreement 101 2.4 PRINCIPLES OF THE TRIPS AGREEMENT Article 8 of the TRIPS Agreement allocated for specifying the principles of the TRIPS Agreement. The origin of Article 8 can be traced back to the Anell Draft. In Anell Draft a group of developing countries suggested some principles under Article 2 of the B text of the Draft. B text is part of the Draft that suggested and supported by developing countries. Clause 2 and 4 of Article 2 of the Draft made it to the TRIPS Agreement as Article 8 and titled Principles. 138 . Article 8 of the TRIPS Agreement consists of two paragraphs. Article 8.1 gives great powers to member countries in adopting ‘measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development’. However, Article 2 of the B text contained two extra measures which they were to protect public morality and national security, but they did not make it to Article 8. Yet still these measures can be found within the other Articles of the TRIPS Agreement. Article 27.2 allows members countries to prevent patenting inventions if they believe such prevention is necessary to protect ordre public and morality, and in the same way Article 73 provides for security exceptions. 139 As we have seen before while discussing Article 7 of the TRIPS Agreement, NP de Carvalho believes that Article 8 does not set any new principles and exceptions. The important public policies and exceptions are already regulated in other articles of the agreement, such as exhaustion, compulsory licences, and exclusions from patentability or registrability. According to NP de Carvalho, Article 8 cannot set any new exception or limitation to the rights conferred in the TRIPS agreement. However, Article 8 simply offers exceptions and limitations to the use of the rights and not on the rights. This Article shows how the process of concession of the TRIPS Agreement was managed and cleared some doubts that the developing countries 138 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, pp. 122–23. 139 Yu, p. 1010. SAMAN ABDULRAHMAN ALI 102 had, that they will not be able to adopt measures to stop the effect of some of the intellectual property rights on their most important areas of public health, nutrition and matters of vital socio-economic importance. Hence, Article 8 allows the adoption of some measures by member countries with the condition that such measures are consistent with the provisions of the TRIPS Agreement. 140 These measures can be intellectual property rights measures that naturally allowed by the TRIPS agreement for example exceptions to exclusive rights (Article 30), compulsory licences (Articles 31 and 31bis) and the disclosure to the public of test data (39.3), or other measures like marketing approval and price control of medicines, which is considered as a nonintellectual property rights measures as stated by Correa. 141 Carlos M. Correa gave an example of Canada that as one of the developed country put prices of drugs under permanent examination. This practice is common in many developing and developed countries including many European countries as well. 142 The process of such measures can be taken while the member countries ‘formulating or amending their laws and regulations’. If the term ‘measures’ alone existed in the provision, then it could include any rules and decision whether from national authorities or from courts. However, since it is stated and encompassed with the terms of ‘in formulating or amending their laws and regulations’, therefore it refers only to ‘binding legislative measures’. 143 Originally the developing countries proposed this provision that had the words of intellectual property rights to the national laws and regulations, however later on it was omitted to include any national laws and regulations without been limited to laws and regulations related to intellectual property rights. It has to be an official published law or regulation; if the measure is stated in an administrative practice then it will not be justified under the TRIPS Agreement. 144 However, when it comes to measures by Members to promote public interest, it is not necessary that those measures in future will 140 Carvalho, The TRIPS Regime of Patents and Test Data, pp. 193–94. 141 Correa, Trade Related Aspects of Intellectual Property Rights, p. 104. 142 Correa, Trade Related Aspects of Intellectual Property Rights, p. 104 Footnote 60. 143 Stoll, Busche, and Arend, p. 192. 144 Carvalho, The TRIPS Regime of Patents and Test Data, p. 195. Nature, scope, objectives and principles of the trips agreement 103 achieve their goals, but it’s enough to show that the measure taken is suitable for that particular situation. Public interest has a wider concept than the ordre public of the Article 27.2. The term ‘public interest’ is considered to be more subjective than that of the ‘ordre public’ and cannot be measured by any other objective tests. When interest of public and an individual collides and face each other, the individual should relinquish his rights in favour of that of public, as it will benefit the society and common good as a whole. 145 Public interest is a domestic issue which covers anything that affects the interest of public in general. It cannot be contested by other Members with their own view because every country has its own priorities and interests base on circumstances of the country in question. The word ‘sector’ also has a wide meaning which can include any type of sector of economic activities with different sizes even it may include small enterprises. The phrase ‘vital importance to their socio-economic and technological development’ may seem to limit the scope of the provision, but what constitute an important sector is for the Member state to determine within its socio-economic and technological development. Furthermore, the phrase ‘socioeconomic and technological development’ is broad enough to include any type of activities in different sectors, not limited to matters related to economic or technology, but social matters are included as well as long as considered socially important. 146 Economies of developing countries like Brazil, China, India, and South Africa are complex due to their rapid development and cannot be compared to that of the European countries and United States of America. Sectors of vital importance in China, for example, are very different compare to other countries. China may prefer stronger intellectual property protection in some specific areas such as entertainment, software, semiconductors and certain areas of biotechnology. However, in other areas like pharmaceutical, chemicals, fertilizers, seeds and foodstuff that China heavily relies on due to its massive population for the purpose of agriculture and public 145 Yu, p. 1011. 146 Correa, Trade Related Aspects of Intellectual Property Rights, p. 105. SAMAN ABDULRAHMAN ALI 104 health, therefore, in these areas China does not want and resist increasing intellectual property protections. 147 On the other hand, despite the fact that the origin of this provision is from B text of the Anell Draft that included the opinion of the developing countries, yet, the current Article 8.1 of the TRIPS Agreement contains two phrases that limit the benefits of this provision for the developing countries. These phrases in fact were added by the developed countries. The first one is the phrase of ‘adopt measures necessary’ which allow the member countries to adopt only those measures that are necessary and not what they consider necessary. In fact, this phrase has affected the abilities of the developing countries to adopt any measures which they consider necessary. The second phrase that further limit the flexibilities of this Article is the requirement that the measures to be ‘consistent with the provisions of this Agreement’. Unaware and inexperience of the developing countries were the cause of adding these phrases by the developed countries during the negotiation process. However, even if the developing countries were aware of the side effect of these phrases, the belief is that they would not be able to stop the modification due to the political pressures of the developed countries. 148 However, this should also be addressed in the light of Article 7 and the Preamble, in other words, in the light of the balance of rights and obligations, and the social and economic account. 149 When a measure taken by a developing country and found out that the measure is inconsistent with one particular standard would not automatically be rejected, because it’s the consistency of the measure with the overall of the TRIPS Agreement should be taken into account. 150 Correa is of the believe that paragraph four of the Doha Declaration on the TRIPS Agreement and Public Health of 2001, 151 can be understood that when 147 Yu, p. 1013. 148 Yu, pp. 1013–15. 149 Correa, Trade Related Aspects of Intellectual Property Rights, p. 104. 150 Yu, p. 1014. 151 ‘WT/MIN(01)/DEC/2 -WTO | Ministerial Conferences - Doha 4th Ministerial - Declaration on the TRIPS Agreement and Public Health - Adopted 14 November 2001’, Paragraph 4 We agree that the TRIPS Agreement does not and should not prevent Nature, scope, objectives and principles of the trips agreement 105 there is a conflict between intellectual property rights and rights to protect public health or to promote access to medicines for all, intellectual property rights should not be a hindrance to arrive to that objective. 152 2.4.1 Appropriate Measures to be Taken by Member Countries Again, while NP de Carvalho analysing this provision, he stated that this provision does not add any principles to the TRIPS Agreement even though the Article named and titled Principles. It merely states some conditions that can be taken by member states to prevent anticompetitive and abuse practices. 153 Others believe that Article 8.2 is only having a historical and symbolical effects and only shows what the developing countries were trying to emphasize during the negotiations. 154 The structure and content of this provision is very close to the previous one, as they both provide for measures that can be taken by member countries and they also require the consistency and necessity as well, though the word necessary is not used in this provision but the word ‘’needed’ is used. 155 In many places the TRIPS Agreement used the concept of necessity before one member country be able to use measures to limit the intellectual property rights or depart from obligations stated in the Agreement. The terms are used include ‘necessary, unnecessarily, need and needed’, however these terms are synonymous and considered to be requiring same level of precaution before a measure to be implemented. 156 members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose’. 152 Correa, Trade Related Aspects of Intellectual Property Rights, p. 105. 153 Carvalho, The TRIPS Regime of Patents and Test Data, p. 213. 154 Yu, p. 1017. 155 Carvalho, The TRIPS Regime of Patents and Test Data, p. 214; Yu, p. 1016. 156 For more detail see Carvalho, The TRIPS Regime of Patents and Test Data, pp. 113–17. SAMAN ABDULRAHMAN ALI 112 Republic of Iraq, stating that ‘The Republic of Iraq is a single federal, independent and fully sovereign state in which the system of government is republican, representative, parliamentary, and democratic, and this Constitution is a guarantor of the unity of Iraq’. After the change of political system from monarchy to republic, in 1970 the first patent law during the Republic enacted under the title of (Patent and Industrial Design) Law No. 65 of 1970, 170 and replaced the old patent law of monarchy reign Law No. 61 of 1935. The Law No. 65 of 1970 followed by some instructions, regulations and amendments. The most important amendments were through ‘Law No. 28 of 1999 First Amendment to Law No. 65 of 1970 on Patents and Industrial Designs’, 171 and Coalition Provisional Authority (CPA) Order No. 81 of Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law “CPA/ORD/26 April 2004/81”. 172 3.2 PATENT LAW NO. 61 OF 1935 AND ITS AMENDMENTS Patent Law No. 61 of 1935 was a simple and basic law which was enacted in a time that invention and industrial development cannot be compared to those of current time. The judicial system and capability of government in handling and protecting the intellectual property rights was at minimal level. For example, in this law the word invention under section one defined as ‘producing new thing (matter) through information or creating new method and medium for producing knowing things or creating new method and medium for producing new result in industrial area and that include discovery or just improving in the mentioned areas’. 173 170 ‘Law No. 65 of 1970 on Patent and Industrial Designs’ <http://www.wipo.int/wipolex/en/text.jsp?file_id=238400> [accessed 10 October 2017]. 171 ‘Iraq: Law No. 28 of 1999 First Amendment to Law No. 65 of 1970 on Patents and Industrial Designs’ <http://www.wipo.int/wipolex/en/details.jsp?id=10515> [accessed 17 January 2018]. 172 ‘Order No. 81 Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law.’ <http://www.wipo.int/wipolex/en/text.jsp?file_id=181090> [accessed 10 October 2017]. 173 ‘Iraq: Law No. 61 of 1935 on Patents’, Section 1. History of Iraqi patent law and its amendments 113 However, despite the low expectation of outcome of inventions, even in this law some important areas were excluded from patentability which they were considered vital matters for needs of society in general which they were pharmaceutical formulations, medicines, and methods used in financial and banking matters. 174 All these exclusions made it to the Law of Patent and Industrial Design No. 65 of 1970. Under this law (Patent Law No. 61 of 1935) period of protection was only 15 years from the filing date, which is considered short period by the current standard and without making any differentiating among types of inventions. On the other hand, if the patent registered outside Iraq, then period of protection would have been same as period of protection of that foreign country with the condition that the granted period of protection does not exceed 15 years. 175 This means that the law accepted shorter period of protection from foreign countries but did not recognize protection longer than 15 years of other countries. It is also stated under section 21 that the patent will be revoked in three circumstances: (A) if the invention was not new, it was granted contrary to this law or any other laws, granted by fraud or due to infringement of rights of others; (B) the subject of the patent breaches public security and its contrary to morality and ethics; and (C) the presented information about the invention is not sufficiently explaining the subject or essence of the invention or method of application not included in a complete and precise manner. 176 Patent Law No. 61 of 1935 clearly stated in section 14 that patent will be granted by the registrar according to the provisions of this law without making any investigation to the usefulness, correctness, truthfulness or correctness of its data or compare it with the invention that submitted for patent to make sure it matches the invention, and government will not guarantee any of these matters. 177 Certainly, with rules and regulations like this no government in the world will be able 174 ‘Iraq: Law No. 61 of 1935 on Patents’, Section 4. 175 ‘Iraq: Law No. 61 of 1935 on Patents’, Section 7. 176 ‘Iraq: Law No. 61 of 1935 on Patents’, Section 21.1. 177 ‘Iraq: Law No. 61 of 1935 on Patents’, Section 14. SAMAN ABDULRAHMAN ALI 114 to protect intellectual property rights of inventors and right holders in a proper way. This certainly will not guarantee the safety of ideas and inventions from stealing and copying by others. Even though section 23 provides for penalties in forms of imprisonment for not more than two years or financial penalty and fine not exceeding one thousand Iraqi Dinar for those who intentionally deceive, attempt, assist, or encourage of doing any of the following acts; (A) manufacture or the method of producing which is the subject of the granted patent is violating the rights of the original right holder; (B) import, sale, store for the purpose of selling or display for selling any manufactured product that produced in violation to the rights of the rights holder; (C) publish in an announcement, plate (board), stamp or cover that a certain thing (invention) was granted a patent but in reality no patent was granted or the period of patent has expired or the patent was already revoked. 178 From the outset, Patent Law No. 61 of 1935 had undergone three amendments prior to its replacement by Patent and Industrial Design Law No. 65 of 1970. All these amendments show that the Iraqi Government, since its establishment, had tried to provide a patent law that best serves the interest of both Iraqi people in general and the interest of intellectual property right holders. The first amendment was passed by Law No. 64 of 1940 which is titled as ‘Amendment to Law No. 61 of 1935 on Patents’. 179 In this amendment two provisions were added to section 22 which is about the revocation of patent and all the rights that attached to that patent. The original section 22 under subsection 1 provided three situations that causes the revocation of the patent; (A) if fees were not paid on stipulated time; (B) if the patent holder, without legitimate reasons, did not put the invention into work in Iraq within two years of granting the patent; (C) if the patent holder brought a foreign product similar to the one that he was granted patent for. However, under subsection 2 one exception is provided for the above situations, which 178 ‘Iraq: Law No. 61 of 1935 on Patents’, Section 23. 179 ‘Law No. 64 of 1940 Amendment to Law No. 61 of 1935 on Patents’ <http://www.iraqld.iq/LoadLawBook.aspx?page=1&SC=&BookID=2005> [accessed 16 January 2018]. History of Iraqi patent law and its amendments 115 is the absence of sufficient facilities to industrialize the invention or establish a trade base on the invention inside Iraq. But still the inventor has to publish the invention to public. In addition to this exception, the amendment provided for another two exceptions; (A) in case of section 22.1 (A) if the unpaid fee on stipulated time was due to war; (B) in case of subsection 2, if patent holder or his representative could not publish the invention to public or industrialize and put to work the invention was due to war. These exceptions show that the amendment to the Patent Law No. 61 of 1935 was in favour of the right holders and protecting their rights in better way. Another amendment was followed in 1949 by Law No. 27 of 1949 Second Amendment to Law No. 61 of 1935 on Patents. 180 This amendment added another section that include 2 subsections to Patent Law No. 61 of 1935 and according to the new provisions, new patent shall not be granted after expiration period of the patent. In another word, after expiration of 15 years there will be no extension. According to the second provision, after revocation of patent according to sections 21 and 22, new patent shall not be granted to the invention in which it was subject of the revoked patent. The last amendment was during the Republic by the Law No. 210 of 1968 Amendment to Law No. 61 of 1935 on Patents. 181 This amendment converted the provision of section 14 into section 14.1 and added section 14.2 and 14.3 as well. According to subsection 2 the registrar has authority to reject a patent application, transfer its ownership, amendment or renew it and eras it from the register if found to be contrary to public interest. Subsection 3 gives right of appeal to the right holder to the Minister of Economic of the decision of the registrar within 30 days, and both party has right to appeal to the Council of Ministers and the decision of the Council will be final. This amendment is clearly in favour of public in which the interest of public is considered to be higher to the interest of the right 180 ‘Law No. 27 of 1949 Second Amendment to Law No. 61 of 1935 on Patents’ <http://www.iraqld.iq/LoadLawBook.aspx?page=1&SC=&BookID=3302> [accessed 16 January 2018]. 181 ‘Law No. 210 of 1968 Amendment to Law No. 61 of 1935 on Patents’ <http://www.iraqld.iq/LoadLawBook.aspx?page=1&SC=&BookID=24416> [accessed 16 January 2018]. SAMAN ABDULRAHMAN ALI 116 holders. Right to appeal can be considered as an improvement, but not to Minister and Council of Ministers because their decisions are tamed by nature because they are executive branch of government in the same way of registrar. Therefore, their decisions will be biased toward the right holders and they cannot be considered partial. However, the perfect place to acquire justice are courts as they are exercising judiciary which have judicial power to decide the cases between the registrars and the right holders. 3.3 PATENT AND INDUSTRIAL DESIGN LAW NO. 65 OF 1970 AND ITS AMENDMENTS Law No. 61 of 1935 was considered to be an outdated law and was necessary to be replaced by a new law in order for the Republic of Iraq be able to trade with industrialized and developed countries and benefit from their technologies and be able to protect the intellectual property rights of the inventors and right holders in a better way. This can be noticed as explained at the end of the Patent and Industrial Design Law No. 65 of 1970 which repealed the Patent Law No. 61 of 1935, a paragraph written without having any section number and titled (Mandating Reasons) which states reasons for replacing the old patent law. Under the Mandating Reasons, it is stated that due to the economic, industrial and social development of the country that makes Patent Law No. 61 of 1935 unable to respond to them in a proper way, and for insuring the protection of intellectual property and encouraging the inventors and widening the relationship with developed countries this law has been enacted. Law No. 65 of 1970 on Patent and Industrial Design repealed the Law No. 61 of 1935 on Patents along with all its amendments and regulations (systems) issued thereunder. 182 Law No. 65 of 1970 has also undergone four amendments which two of them are minor amendments and the other two are considered major amendments. The first amendment was through ‘Law No. 28 of 1999 First Amendment to Law No. 65 of 1970 on Patents and 182 ‘Law No. 65 of 1970 on Patent and Industrial Designs’, Section 52. History of Iraqi patent law and its amendments 117 Industrial Designs’. 183 This first amendment includes 13 sections out of which the first 12 sections are amendments to the original law No. 65 of 1970, and the last section simply dedicated for the date of enforcement which from date of publishing it in the official Gazette, and it include place of writing it down which is Baghdad. Out of these 12 amendments some of them are minor amendments such as changing one word, or one single subsection and others are major amendments by changing the whole section, such as section 1, 5, 9, 13, 29 and 51. The first amendment of Law No. 28 of 1999 is considered a huge amendment to the original law. However, the second amendment which is implemented according to ‘Law No. 5 of 2002 Second Amendment to Law No. 65 of 1970 on Patents and Industrial Designs’, 184 has amended only one section. The second amendment law includes two sections only and the second section dedicated to enforcement date which is from publishing it in the official Gazette. The amendment in the first section is about section 22 of the original law and replacing it with new section that includes six subsections. The original section 22 is about inventions that relate to military and defence system in which the registrar has to inform ministry of defence. After the amendment section 22 includes more detail on this matter and requests forming a special committee that include representatives from ministry of defence, military industrialization corporation and security services. The third amendment can be considered as a major amendment because it changes the nature and scope of the original law of Law No. 65 of 1970 on Patents and Industrial Designs. This amendment occurred after the invasion of Iraq by the United States of America and its Coalition Partners in 2003 and was made through the Coalition Provisional Authority (CPA) Order No. 81 of Patent, Industrial 183 ‘Iraq: Law No. 28 of 1999 First Amendment to Law No. 65 of 1970 on Patents and Industrial Designs’ <http://www.wipo.int/wipolex/en/details.jsp?id=10515> [accessed 17 January 2018]. 184 ‘Iraq: Law No. 5 of 2002 Second Amendment to Law No. 65 of 1970 on Patents and Industrial Designs’ <http://www.wipo.int/wipolex/en/details.jsp?id=10347> [accessed 17 January 2018]. SAMAN ABDULRAHMAN ALI 118 Design, Undisclosed Information, Integrated Circuits and Plant Variety Law ‘CPA/ORD/26 April 2004/81’. Shortly after the invasion of Iraq, the Coalition Provisional Authority (hereinafter the “CPA”) was established in order to govern the country. On May 6, 2003 Lewis Paul Bremer III named as the new director of the CPA, and on May 12 officially took the office. Paul Bremer had held many positions in the United States governments before taking such position in Iraq, such as assistant to Secretaries of State Henry Kissinger and Alexander Haig, ambassador to the Netherlands, managing director of Kissinger Associates and Homeland Security Advisor Board. On June 28, 2004 the CPA ruling ended and Paul Bremer handed the authority to the Iraqi provisional government. 185 Paul Bremer during his directorship and presidency of the CPA expected to rebuild a strong Iraq economically and bring justice after long run of dictatorship. One of his major work was de-Ba’athification program through removing all the Ba’ath party members from their ruling authority and prevent them from taking public position ever again. In his capacity as chief administrator of the CPA he also created the Iraqi Special Tribunal for Crimes against Humanity (Special Tribunal) for trying against genocide, crimes against humanity and war crimes. He established a property claims commission, a central criminal court and a new Iraqi army and civil defence corps. 186 He also issued a series of regulations, orders, memoranda and public notices. In his first regulation which named as Coalition Provisional Authority Regulation No. 1, he stated that all the laws that were in force before the occupation will continue to be in force unless they contradict the regulations and orders issued by the CPA and until they will be suspended or replaced by the CPA or by legislation of any other Iraqi democratic institutions. In section 3 of the same Regulation No. 1, it is stated that the regulations and orders issued by the CPA will remain enforce unless ‘repealed by the 185 ‘L. Paul Bremer III | American Statesman’, Encyclopedia Britannica <https://www.britannica.com/biography/L-Paul-Bremer-III> [accessed 18 January 2018]. 186 Eric Stover, Hanny Megally, and Hania Mufti, ‘Bremer’s “Gordian Knot”: Transitional Justice and the US Occupation of Iraq’, Human Rights Quarterly, 27.3 (2005), 830–57 (pp. 832–33). History of Iraqi patent law and its amendments 119 Administrator or superseded by legislation issued by democratic institutions of Iraq’, it further stated that ‘Regulations and Orders issued by the Administrator shall take precedence over all other laws and publications to the extent such other laws and publications are inconsistent’. 187 The preamble of the CPA Order No. 81 clearly stated that the economy of Iraq needs to be changed and modernized in order to benefit the whole people of Iraq. For that reason, one of the big change to be occurred is by changing the Iraqi intellectual property system because the Iraqi Patent and Industrial Design Law No. 65 of 1970 and other related laws does not meet the international standard of protection. It further stated that its necessary to have fair, efficient and predictable environment for protection of right holder’s interests and privileges whether be a company, lender, entrepreneurs. It also refers to the necessity of improving people’s life condition, technical skills and fighting unemployment. It is the interest of the Iraqi Governing Council to join the World Trade Organization (WTO) therefore its necessary to adopt modern intellectual property standards. Also based on the report of Secretary General to the Security Council of July 17, 2003, the Preamble states that it is necessary to change the economic system from ‘non-transparent centrally planned economy to a free market economy characterized by sustainable economic growth through the establishment of a dynamic private sector, and the need to enact institutional and legal reforms to give it effect’. 188 Therefore, Paul Bremer gave the right to himself to amend the original Patent and Industrial Design Law No. 65 of 1970 through Coalition Provisional Authority Order No. 81 of Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant 187 ‘Coalition Provisional Authority Regulation Number 1’, 2003, p. Section 2 <http://govinfo.library.unt.edu/cpairaq/regulations/20030516_CPAREG_1_The_Coalition_Provisional_Authority_.pdf> [accessed 18 January 2018]; Sean D. Murphy, ‘Coalition Laws and Transition Arrangements during Occupation of Iraq’, The American Journal of International Law, 98.3 (2004), 601–6 (p. 602) <https://doi.org/10.2307/3181659>. 188 ‘Order No. 81 Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law.’, The Preamble <http://www.wipo.int/wipolex/en/text.jsp?file_id=181090> [accessed 10 October 2017]. SAMAN ABDULRAHMAN ALI 120 Variety Law “CPA/ORD/26 April 2004/81”. 189 Order No. 81 of the CPA made 79 amendments to the Law NO. 65 of 1970, out of which the first 22 amendments were on Chapter One ‘Patent’ with the first amendment dedicated to changing the name of the whole law to ‘Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law’. The rest of the amendments from number 2 to 22 dedicated to amendments of the patent part of the original law No. 65 of 1970. The Order No. 81 of CPA added some new parts to the original law No. 65 of 1970 as well, such as chapter Threebis which titled ‘Protection of Undisclosed Information’, chapter Threeter with the title of ‘Protection of Integrated Circuits’, and chapter Threequater for the ‘Protection of New Varieties of Plants’. However, on 12 May 2013 a new law was enacted under the name of Registration, Accreditation and Protection of Agricultural Varieties Law No. 15 of 2013 in which repealed chapter Threequater for the Protection of New Varieties of Plants. Under this law, section 18 states that ‘Repeal section 51 to 79 of the CPA Order No. 81 of 2004 of Law Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law’. 190 Though this is a mistake by the new Law No. 15 of 2013, because CPA had authority to promulgate Order No.81 according to the laws and usages of war and Resolution 1483 and 1511 (2003) of the Security Council, 191 therefore an amendment to the original law becomes part of the law. In its capacity, the CPA amended some parts and added some new chapter to Law No. 65 of 1970, therefore, the section 18 of Law 15 of 2013 should have written as follows ‘Repeal chapter Threequater including all sections thereunder of the Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law No. 65 of 1970 Amended’, without any necessity of referring to the CPA Order No. 189 ‘Order No. 81 Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law.’ 190 ‘Law No. 15 of 2013 on Registration, Release and Protection of Agricultural Varieties’, Section 18 <http://www.iraq-lg-law.org/ar/webfm_send/1447> [accessed 8 October 2017]. 191 ‘United Nations Official Document - Resolution 1511 (2003) - Adopted by the Security Council at Its 4844th Meeting, on 16 October 2003’ <http://www.un.org/en/ga/search/view_doc.asp?symbol=S/RES/1511(2003)> [accessed 20 January 2018]. History of Iraqi patent law and its amendments 121 81. This fault can be noticed in Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law No. 65 of 1970 Amended, under chapter Threequater by referring to the sections of the CPA Order No. 81. Lastly and for the fourth time Law No. 65 of 1970 on Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety Law was amended through Law No. 58 of 2015. 192 However, the Fourth Amendment did not change much from Law No. 65 of 1970, because it includes only one minor amendment in Section 1 which changes the definition of The Ministry from Minister of Industry to Minister of Planning, and by this amendment all the powers and authorities in the Law No. 65 of 1970 will be shifted from the Minister of Industry to the Ministry of Planning. This was the third time that the definition of ‘The Ministry’ was amended. The first time it was repealed by Law No. 28 of 1999 First Amendment, which replaced the word Minister of Economy by The Secretariat and defined to mean ‘Secretariat for the Council of Ministers’, then the second time this definition repealed by the CPA Order No. 81 and the word Minister added again and to be defined as the Minister of Industrial. 3.4 CONCLUSION Since the establishment of the first government in the Kingdom of Iraq, patent law was enacted as part of encouraging inventions in the Kingdom. However, the Patent Law No. 61 of 1935 was unpretentiously drafted, and its definition of invention was wide enough to include even a simple improvement or a discovery. In this law it was clearly stated that the government could not make any investigation in the nature of the invention or its data, whether it is useful invention or not. It can be perceived that newly established country in the Middle East like Iraq a century ago, had little resources 192 ‘Law No. 58 of 2015 Fourth Amendment to Law 65 of 1970 on Patent, Industrial Design, Undisclosed Information, Integrated Circuits and Plant Variety - (Qanun altaedil alrrabie liqanun bira’at alaikhtirae walnamadhij alsinaeiat walmelwmat ghyr almufasih eanha waldawayir almutakamilat wal’asnaf alnabatiat raqm (65) lisanat 1970)’ <http://ar.parliament.iq.> [accessed 20 January 2018]. SAMAN ABDULRAHMAN ALI 128 information or creating new method and medium for producing knowing things or creating new method and medium for producing new result in industrial area and that include discovery or just improving in the mentioned areas’. 199 This definition shows that the word invention had been given the simplest definition because according to this definition even discoveries were considered to be within the sphere of an invention. According to the basic principle of patent laws ‘discovery’ is not patentable. This is because ‘A “discovery” is commonly considered to mean the mere recognition of what already exists; it is the finding of casual relationships, properties on phenomena that objectively existed in nature’. 200 One of the important step was taken by the Law No. 65 of 1970 in which the term invention in section 1.4 defined is to remove the discoveries from the definition. This law defined the invention as ‘every new innovation that industrially exploitable whether relates to new industrial products or innovative methods and means or both of them together’. In the first amendment Law No. 28 of 1999 this subsection was amended by adding an extra sentence at the end of the subsection to be red as ‘every new innovation that industrially exploitable whether relates to new industrial products or innovative methods and means or both of them together or achieve some specific development in order to be outside of traditional framework’. The definition of invention of the original Law No. 65 of 1970 and including its additional part by the Law No. 28 of 1999 have some important elements. Firstly, it has to be a new innovation, secondly, industrially exploitable, and third, relates to new industrial products or innovative methods and means or both of them, or achieve some specific development. The last part (achieve some specific development) is the new element which added by Law No. 28 of 1999 that broaden the concept of invention in the way that even if the new innovation which industrially exploitable does not relate to new industrial products or methods, still can be considered invention if 199 ‘Iraq: Law No. 61 of 1935 on Patents’, Section 1. 200 Carlos María Correa, ‘Implementing the Trips Agreement in the Patents Field’, The Journal of World Intellectual Property, 1.1 (1998), 75–99 (p. 77) <https://doi.org/10.1111/j.1747-1796.1998.tb00004.x>. Inventions, criteria of patentability and sufficient description 129 achieve some specific development in order to be outside the traditional circle. However, the CPA Order No. 81 amended the whole subsection and introduced a new definition of the term invention as it is ‘Any innovative idea, in any of the fields of technology, which relates to a product or a manufacturing process, or both, and practically solves a specific problem in any of those fields’. The CPA Order No. 81 presented some of the elements and criterion of the term invention in a clear and more precise form. It exchanged the words of ‘new innovation’ to ‘innovative idea’, ‘industrially exploitable’ to ‘field of technology’, and ‘achieve some specific development’ to ‘practically solves a specific problem in any of those fields’. Even though exchanged the words of ‘relates to new industrial products or innovative methods and means or both of them’ to ‘relates to a product or a manufacturing process, or both’ but both phrases imply introduce same conditions. As for the rest will be discussed further in the next section. On the other hand, the TRIPS Agreement does not define the term invention, even though in Article 27.1 clearly states that ‘patents shall be available for any inventions’. This will leave the member countries to define the term invention in such a way that best suits their legal systems. The dominant trend of the member countries is to avoid defining the term ‘invention’, because this will give them ‘a certain degree of flexibilities in a changing scientific and technological context’. Most of the countries simply stating the traditional criteria of patentability, in which they are (novelty, inventive step and industrial applicability). 201 However, reference to the word invention has to be done in a good face and subject to method of interpretation of the Vienna Convention. 202 201 Correa, ‘Implementing the Trips Agreement in the Patents Field’, p. 77. 202 Correa, Trade Related Aspects of Intellectual Property Rights, p. 272. SAMAN ABDULRAHMAN ALI 130 1.3 CRITERIA OF PATENTABILITY UNDER THE IRAQI PATENT LAWS AND TRIPS AGREEMENT Criteria of patentability under the Iraqi patent laws has gone through some changes. The original Patent and Industrial Design Law No. 65 of 1970 provided for some criteria, and later on the first amendment of Law No. 28 of 1999 added some changes. Finally, the CPA Order No. 81 changed some of these criteria. In this section, the general criteria of patentability of the Iraqi Patent laws will be analysed and compared to those of the TRIPS Agreement. While section 1.4 of the original law No. 65 of 1970 defined the term invention, it provides some important elements which can be considered as bases and criteria for granting the patent, because nowhere else in the Law No. 65 of 1970 any formal criteria are mentioned which can be used as bases of patentability. Section 2 of the original Law No. 65 of 1970, however, simply stated that ‘Patents of invention shall be granted according to the provisions of this Law’, without referring to any criteria of patentability. 1.3.1 New invention and Novelty The invention will be considered new and novel if it is bestowed upon the public by the inventor for the first time. However, if the invention was taken or created based on the information and knowledge that was available in public domain, then the inventor did not offer anything to society and his invention cannot be considered new and novel. 203 The term new invention was used in section 1.4 of the original law No. 65 of 1970 without determining what is meant by new. However, section 4 stated two situations in which invention cannot be considered new, therefore except for these two situations, every invention would have considered to be new invention. This means that Iraq has taken restrictive view as to what shall be considered novel 203 Sean B. Seymore, ‘RETHINKING NOVELTY IN PATENT LAW’, Duke Law Journal, 60.4 (2011), 919–76 (p. 930). Inventions, criteria of patentability and sufficient description 131 and what kind of disclosure affect the criterion of novelty 204 . From both of the provisions of section 4.1 205 and 4.2 206 , it can be observed that the Iraqi Legislature gave general ruling to the term ‘New’ and restricted novelty to the period of 50 years prior to the patent application date. Therefore, any invention that has been practically utilised and available for public to benefit from products of the invention, prior to the date of the application for patent, then that invention considered part of the prior art and cannot be patented because it lacks the novelty criterion. Here the priority is given to first to file. Even after the amendment by the CPA Order No. 81, priority stayed same. May be this is due to the fact the United States of America in 2011 amended the US Patent Act and changed the priority date from first to invent to first to file. 207 However, in Germany the priority is given to first to invent, the original principle was first to file, however this was changed due to the reform in 1936 and replaced by first to invent principle. 208 Even though first to file system is considered more efficient and less costly to settle a conflict. In the other hand first to invent system is more just and fair, because the patent will be given to the person who invented it first. 209 Also, even if the invention not utilised but publicized in such a way that an expert of the field who is a ‘person having ordinary skill in the art (hereinafter the “PHOSITA”)’ 210 can exploit such invention 204 Nabeel Mahdi Althabhawi and Zinatul Ashiqin Zainol, ‘Patentable Novelty in Nanotechnology Inventions: A Legal Study in Iraq and Malaysia’, NanoEthics, 7.2 (2013), 121–33 (p. 123). 205 ‘Law No. 65 of 1970 on Patent and Industrial Designs’, Section 4.1 (If the invention, in the 50 years prior to the date of the application for a patent, has been publicly worked out in or outside Iraq, or if the description or drawing of the invention has been publicized in periodicals within Iraq or outside it in such a clear way that enables experts to exploit). 206 ‘Law No. 65 of 1970 on Patent and Industrial Designs’, Section 4.2 (If, in the 50 years prior to the date of the application for a patent, letters patent had been granted to the invention or part thereof to a person other than the inventor or to whom the rights of the invention have been assigned, or that others had already applied for the same patent, or part thereof). 207 Althabhawi and Zainol, p. 126. 208 Patent Law: A Handbook on European and German Patent Law, ed. by Maximilian Wilhelm Haedicke and Henrik Timmann (München: C.H. Beck, 2014), p. 8. 209 Gervais, p. 338. 210 Jonathan J. Darrow, ‘The Neglected Dimension of Patent Law’s PHOSITA Standard’, Harvard Journal of Law & Technology, 23.1 (2009), 227–58 (p. 227). SAMAN ABDULRAHMAN ALI 132 into a practical use, then the invention will not be considered as new invention and cannot be granted a patent. However, if the subject matter of the invention has been kept secret, then the next invention in the same area will be considered novel and the new inventor has right to apply for patent as the subject matter invented without relying on previous work or publicised information. But according to the United States Patent system, secret information considered as part of the broader class of prior art, even though it was kept secret from public. 211 However, if an invention was granted a patent or applied for a patent by others, then will not be considered a new invention. Same principle can be found in Article 87-89 of the European Patent Convention (hereinafter the “EPC”). Even prior use by the applicant or his predecessor (own publication) also can be considered that it has become part of the state of art. If the information has reached the public through written or oral sources, I will become part of the state of art. Because technical teaching can be described orally, through a presentation, lecture, speech … etc. However, only that part of the information will become start of art which has been disclosed. 212 This means that if another person applied for patenting the same invention or part of it just one day before the new applicant, then the new applicant’s invention will not be considered new. It does not matter whether all these situations have occurred in Iraq or outside Iraq, because section 4 covers inventions whether be inside Iraq or abroad. However, section 4 did not refer to verbal disclosure in any way. Therefore, if the oral information regarding the subject matter of the invention is spread out within community, it will not bar the invention from the patentability and the invention will be considered new and novel. On the contrary, in United States of America, both forms of disclosure whether oral or written will prevent next invention from the element of novelty. Though if oral disclosure has occurred outside the territory of the United States, then such disclosure will not bar the patentability of the subject matter. But this will not apply to written disclosure, as like rest of the world if written disclosure has occurred inside or outside of the United States, then it will prevent the 211 Althabhawi and Zainol, p. 125. 212 Haedicke and Timmann, pp. 141–45. Inventions, criteria of patentability and sufficient description 133 patentability of the invention on the basis of novelty. However, the form of disclosure should not be matter as much as whether the information has become part of public domain or not. 213 The amendment by the CPA Order No. 81 was considered one of the major amendments as it added, suspended and amended many provisions of the Original Law No. 65 of 1970. The order amended the definition of the Invention and in the new definition the words ‘every new innovation’ replaced by ‘any innovative idea’. However, the CPA Order No. 81 amended section 2 as well by adding some more elements and criteria, which states ‘Patents of invention shall be granted pursuant to the provisions of this Law for each invention that is industrially applicable, novel and involves an inventive step, either concerning new industrial products, new industrial methods, or new application of known industrial methods’. This new section can be seen as positive amendment which states the requirement of patentability since it states three criteria of patentability which are internationally known and considered to be standard requirements. These criteria are: new (novelty), inventiveness (involves an inventive step and non-obvious) and industrial applicability (useful) and these are the same criteria which is required by the TRIPS Agreement in Article 27.1 214 . The CPA Order No. 81 also amended section 4 of the Patent and Industrial Design Law No. 65 of 1970. First the Order changed the numerical of both subsections of 4.1 and 4.2 to subsections 4.a and 4.b. This is a small technical amendment and does not affect the content of the Law and it is unnecessary change. Then it deleted the condition of 50 years period in both subsections. Which in fact it will bring more legal sense to the subsections, because limiting novelty of the inventions to 50 years prior to the date of the application for a patent has no logical basis, as to what logic the inventions of 60 years prior to the date of the application have not became public knowledge and part of public domain but the inventions of past 50 years have become part of public domain. The only logic that one may think of is that the legislatures were trying to give another chance to inventors to 213 Althabhawi and Zainol, p. 123. 214 Gervais, p. 338. SAMAN ABDULRAHMAN ALI 134 use the old information and produce something out of it, but still more provisions should had been included to make this encouragement workable in a way that did not affect the legal rights of the owners of the original idea and those of their predecessors. However, in general time should not matter but the important element is whether the information has been available within the community or not, therefore by deleting the period restriction, the CPA Order improved the original law. Furthermore, the CPA Order No. 81 added another provision to section 4, 215 of the Law No. 65 of 1970 which is an exception to the previous subsection in which if the disclosure of the information is the applicant himself or his predecessor by an action taken in the last twelve months before the filing date or priority date, or the disclosure occurred due to an abuse by third parties, then such disclosure will not bar the element of novelty of the invention. Similar provision can be found in the patent acts of other countries, for example in The Patents Act 1977 (as amended up to and including 28 January 2018) of the United Kingdom 216 , in section 2(4) states the same situations and included extras. The United Kingdom Patents Act is very detailed act and states all the elements patentability in great detail, and in section 2 novelty criterion regulated in a satisfactory manner. In section 2(4) states that disclosure of subject matter of the patent in six months before filing date of the application will not bar the novelty of the invention in these situations; disclosure occurred due to the obtaining information unlawfully or in breach of confidence or displayed at an international exhibition. 215 ‘Order No. 81 Patent, Industrial Design, Undisclosed Information, Integrated Circuits And Plant Variety Law.’ Number 7, which can be found also in ‘Law No. 65 of 1970 on Patent, Industrial Design, Undisclosed Information, Integrated Circuits And Plant Variety (Amended).’ Section 4.c 'Notwithstanding subparagraphs (a) and (b), the disclosure of the invention to the public shall not be taken into account if it occurred twelve months before the filing date of the application or its priority date, if any, and it occurred by actions taken by the applicant or applicant’s predecessor or due to an abuse by third parties against the applicant or predecessor’ < http://www.iraq-lg-law.org/ar/content/ [accessed 10 October 2017]. 216 Expert Participation, ‘Patents Act 1977’, Section 4 <https://www.legislation.gov.uk/ukpga/1977/37/contents> [accessed 28 January 2018]. Inventions, criteria of patentability and sufficient description 135 1.3.2 Inventiveness (involves an inventive step and nonobvious) The primary evidence as to what constitute an inventive step is the opinion of a person having ordinary skill and expert as to whether the invention is obvious or not and determining such task will ‘involve questions of fact and degree’ as well. 217 This is what the United Kingdom Patent Act 1977 confirmed in section 3 by stating ‘An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art’. The same regulation and interpretation exists in section 103 of the United States Code 35 Patents, as the question would be whether there is a difference between the subject matter and the prior art by a person who have ordinary skill in the art. However, there is an overlapping between the term invention and its criteria of non-obviousness because there is no obvious invention, but there can be a degree of inventiveness. For this reason, some has suggested that the provision of patentability in the patent laws should be read a ‘patents shall be available for any invention provided that it is new, involves a sufficient inventive step and is useful’. Also, it is a fact that both novelty and inventive step has to be determined through comparison with the prior art. 218 The Iraqi original Patent and Industrial Design Law No. 65 of 1970 does not provide for criteria of patentability in a proper form as has been explained previously. However, after the first amendment by Law No. 28 of 1999 the definition of invention in section 1.4 provided for as ‘every new innovation that industrially exploitable whether relates to new industrial products or innovative methods and means or both of them together or achieve some specific development in order to be outside of traditional framework’. From this definition it can be asserted that by the term of ‘new innovation’ the legislature wanted to make sure that the invention must have some innovation in it. The last sentence of the definition which was added by the first amendment 217 Terrell and others, pp. 242–43. 218 Carvalho, The TRIPS Regime of Patents and Test Data, pp. 257–58. SAMAN ABDULRAHMAN ALI 136 make this objective more perceivable by pointing out that even if the invention is not totally new still can be patented if the invention has added at least some specific development and addition so that it be outside of traditional framework and circle. If the innovation is outside the traditional framework, then the invention has added something which cannot be found in the prior art. This process can be done by comparing the new subject matter to the whole of the prior art. But the law failed to mention in a direct manner that it is in the perspective of the person with normal skill and expertise that the new innovation has been achieved is new to the prior art. Because in section 18 of the original Patent and Industrial Design Law No. 65 of 1970 it is stated that: ‘The Directorate examine the application and its annexes to check the following: 1. The application is submitted in accordance with section 16 of this Law. 2. The specification and drawing illustrate (demonstrate) the invention in a manner that allows the owners (employers) of the industry (field) to implement it. 3. The innovative elements that the concerned person seeks to protect, should be mentioned in the application in a clear and specific manner’. Section 16 of the original law also requires that the application for a patent should include the detail description of the invention and its new elements. Therefore section 18 wants to make sure that the directorate will check for these matters in order the owners and employers of the industry in that particular field be able to implement them. However, Instruction No. 1 of 1990 on implementing Law No. 65 of 1970 in section 1.1, and Regulation No. 3 of 2001 on the classification of Patents and Industrial Designs in section 2(a), state that ‘the invention will be considered innovative if it does not look obvious (self-evident) to an expert person while taking into consideration technical development prior to the application’. 219 Indirectly sections 18 and 16 require the invention to have new and innovative element in order to be granted a patent and be protected. In the other hand, Instruction No. 1of 1990 on 219 ‘Iraq: Instructions No. 1 of 1990 Implementing Law No. 65 of 1970 on Patents, Industrial Designs’, Section 1.1 <http://www.wipo.int/wipolex/en/details.jsp?id=10511> [accessed 10 February 2018]; ‘Iraq: Regulation No. 3 of 2001 on the Classification of Patents and Industrial Designs’, Section 2(a) <http://www.wipo.int/wipolex/en/details.jsp?id=10546> [accessed 14 February 2018]. Inventions, criteria of patentability and sufficient description 137 implementing Law No. 65 of 1970 and Regulation No. 3 of 2001 on the classification of Patents and Industrial Designs clearly stated the new invention should have an inventive step. According to section 1.1 of the instruction and section 2(a) of the regulation if the new invention appeared obvious and self-evident to a person skilled in the art, then the invention will not be considered innovative. And base on section 1.4 of the Law No. 65 of 1970 an invention has considered to be a ‘new innovation’. Consequently, an invention according to Patent and Industrial Design Law No. 65 of 1970, has to include an inventive step in order to be accepted within the definition of invention. However, the CPA Order 81 amended section 18.2 in order to clear some uncertainties. Section 18.2 as amended by the Order states ‘That the specification and drawing disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art.’ The wordings of this subsection are very close to that of section 16.2 as amended. The difference is that section 16 demands applicant for a patent to comply with certain conditions and section 18 demands the Central Organization for Standardization and Quality Control 220 to make sure the condition has been fulfilled. Both of the subsections require the content of the application for patent disclose and include enough clear and complete information so that can be carried out by a person skilled in the art. And as for the inventiveness and non-obviousness of the invention, the CPA Order No. 81 when amended section 2 clearly states that the invention in order to be patentable should involve an inventive step. Therefore, the new Law after all the amendments clearly and undoubtedly include the criterion of inventiveness, by requiring that every invention should involve an inventive step to a person skilled in the art by comparing to the prior art. This is a positive development by enhancing the patent law of Iraq to the international standard and clearing some ambiguous provisions of the original Law No. 65 of 1970 which did not state the 220 Section 1.3 the definition of The Directorate: Directorate of registration and monitoring public companies (enterprises) of the original Law No. 65 of 1970 repealed by the first amendment of Law No. 28 of 1999 and replaced by The Central: The Central Organization for Standardization and Quality Control. And in section 2 of the Law No. 28 of 1999 states that the word (The Central) replace the word (The Directorate) wherever mention in the Law. SAMAN ABDULRAHMAN ALI 144 States of American’s patent law as it states, in section 35 U.S.C. 112 Specification, that ‘shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention’. 234 Section 16.2bis which is added by the CPA Order 81 provides that ‘An applicant for a patent shall provide information concerning the applicant’s corresponding foreign applications and grants’. The exact same provision can be found in the TRIPS Agreement as well but as an optional provision in which member countries are allowed to include it in their local laws or opt it out. However, having such provision will help the developing countries as they have limited human resources and infrastructure, therefore this provision will facilitate their examination and decision in regard of the application by contacting foreign patent offices and coordinate as to their process of examinations and decisions. 235 This shows that the CPA Order No. 81 has included some good provisions for Iraq as a developing country and to bring up the regulation standard to that of the international communities and TRIPS Agreement. But failed in some situations to include provisions like second part of Article 29.1, which would have been very helpful for Iraqi patent law, especially Iraq could have benefited from such provisions in regard to the foreign technological invention which they want to apply for patent in Iraq, and it is part of international standard and TRIPS Agreement also provided for as an optional provision. 1.5 CONCLUSION In the definition of the term invention and criteria of patentability, the CPA Order No. 81 had altered the original law No. 65 of 1970 to a great extent. Since TRIPS Agreement does not provide for definition of invention, therefore it has been left for member countries to define the term in their best interest. However, CPA Order No. 81 changes the definition to include every kind of technical invention. As for the requirement of new invention, the CPA Order No. 81 has improved 234 ‘United States Code Title 35 - Patents’, p. Section 112 (a) <https://www.uspto.gov/web/offices/pac/mpep/mpep-9015-appx-l.html#d0e302824912> [accessed 30 January 2018]. 235 Stoll, Busche, and Arend, p. 527. Inventions, criteria of patentability and sufficient description 145 both section of 1.4 and 2 by clearly presenting and requesting that the invention has to be new and novel in order to be patentable. It has also improved the Iraqi patent law so that it could reach the same level of that of international communities and TRIPS Agreement. However, failed to include optional requirement of the TRIPS Agreement in Article 29.1 of requesting the inventor to reveal the best mode for carrying out the invention. The CPA Order No. 81 enhanced the original law by clearing the doubt and ambiguity of the criterion that the invention should ‘involve an inventive step’, as its required by the TRIPS Agreement. Because the original law did not mention the inventive step requirement in an obvious way. Since it is the one of the essential and important criteria of patentability in the modern patent system, therefore the amendment in this regard by the CPA Order No. 81 is positive improvement. The CPA Order No. 81 has successfully aligned the ‘industrial applicability’ requirement with that of the TRIPS Agreement like the previous two requirements. Choosing the ‘industrial applicability’ instead of ‘usefulness’, will be much better for Iraq as a developing country that want to receive all technology to develop itself as the term usefulness is much wider and allows patenting of broader fields. However, the CPA Order No. 81 by asserting ‘in any of the fields of technology’ and suspending the exception of ‘medical and pharmaceutical formulation’, has burdened Iraq to a responsibility which is not obliged to take while still not a WTO member. This step is not in favour of Iraq because it has not yet recovered from the severe aftereffect of the invasion and still in war with terror. Many Iraqi people still living in shelter and not have access to basic living requirements including medicine. Therefore, this amendment can be considered as a premature move by the CPA and the Iraqi interest was not in mind while the original law amended as much as trying to higher the standard of intellectual property protection to that of the TRIPS Agreement. 147 2 EXCLUSIONS FROM PATENTABILITY 2.1 INTRODUCTION Article 27.1 of the TRIPS Agreement generalized granting patent for all types of inventions in all the fields of technology without excluding any areas and without discrimination as to the place of invention. However, Article 27.2 and 27.3 of the TRIPS Agreement limited the first provision by excluding some types of invention from patentability. For example, Article 27.2 gives freedom and choice to member countries to exclude from patentability of invention if the commercial exploitation of such invention in the territory of a member country goes against ordre public and morality. Hence, this chapter discusses Article 27.2 of the TRIPS Agreement first, then will be followed by the position of Iraqi patent law. Similarly, Article 27.3 provides for two different types of exclusions which are also optional for member countries to implement or not. The first type is related to methods of treatment of humans or animals whether be a diagnostic, therapeutic and surgical. In this chapter detail of this provision is discussed with reference to those countries that provide for protection of method of treatment through patent such as United States of America, New Zealand and Australia. Then the position of Iraqi patent law and its amendments will be discussed. The second part of Article 27.3 provides for exclusions from patentability of plants and animal. However, this provision requests the member countries to provide for protection whether be in a form of patent or sui generis system or combination of both of them. Due to the significance of this provision, it will not be discussed in this chapter, but will be analysed in a broader context independently in the next chapter. SAMAN ABDULRAHMAN ALI 148 Lastly, this chapter will examine the access to medicines and public health. Due to importance of this topic, this chapter will focus on the Doha Declaration on the TRIPS Agreement and Public Health as well. Some of the paragraphs of the Doha Declaration deal with flexibilities and options of the member countries to handle their domestic issues concerning public health. The position of developing countries and how they can access to medicines to fulfil their public needs will be discussed. Then the position of Iraqi patent law and its amendments will be discussed. 2.2 ORDRE PUBLIC AND MORALITY 2.2.1 Ordre public and Morality Under TRIPS Agreement Article 27.2 of the TRIPS Agreement allows member countries to exclude inventions from patentability if the commercial exploitation of the inventions endanger ordre public and morality in territory of the country concerned. 236 This is based on the proposals submitted by (the European Economic Community (hereinafter the “EEC”), 237 Japan 238 and developing countries 239 ). 240 The concept of ordre public and morality is not new as many countries used these concepts to prevent inventions from patenting long time even before the TRIPS Agreement was born. For example, in the United States of America, these concepts referred to in 1817 as ‘frivolous or injurious to the well-being, good policy, or sound morals of a society’. In European countries’ laws and many other civil law countries the practice of exclusion from patentability similar to the wordings of Article 27.2 of 236 Article 27.2 of the TRIPS Agreement states that ‘Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law’. 237 ‘GATT Document No. MTN.GNG/NG11/W/68 of 29 March 1990’, 1990 <https://docs.wto.org/gattdocs/q/UR/GNGNG11/W68.PDF> [accessed 22 April 2018]. 238 ‘GATT Document No. MTN.GNG/NG11/W/74 of 15 May 1990’, 1990 <https://docs.wto.org/gattdocs/q/UR/GNGNG11/W74.PDF> [accessed 22 April 2018]. 239 ‘GATT Document No. MTN.GNG/NG11/W/71 of 14 May 1990’, 1990 <https://docs.wto.org/gattdocs/q/UR/GNGNG11/W71.PDF> [accessed 22 April 2018]. 240 Correa, Trade Related Aspects of Intellectual Property Rights, p. 287. Exclusions from patentability 149 the TRIPS Agreement, were provided for. Such as Article 53(a) 241 of the European Patent Convention. 242 The notion of ‘ordre public’ is taken from the French word of public order and it is used because it gives much narrower meaning than the English notions of ‘public order’ and ‘public interest’. The European Patent Office has related ordre public to cases such as riots and public disorder, or those inventions that leads to criminal or offensive behaviour. Every invention has to be taken individually in order to be decided whether it is against ordre public. However, since there are no exact cases and situations that can be limited to ordre public, therefore, member countries are free to apply the ordre public to those situations that have no prior cases nor well known at international level. This in fact gives a flexibility to member countries to evaluate their conditions and decide on those principles if are breached will tantamount breaching ordre public. 243 Ordre public can be related to public policy, which is directly affecting the institutions of a particular society. Without such ordre public, society will tear apart, and the structure of civil society will be endangered. 244 It is also related to the notion of security, whether collective or individual, such as physical damage or anything can put the normal life of society in general into risk, or simply disharmonize the livelihood of individuals to live in peace and security. 245 In the same way of the ordre public, the term morality is not defined in the TRIPS Agreement. Likewise, a unanimous definition of the term morality was not achieved so far at the international law. 246 241 European Patent Office, ‘The European Patent Convention’, Article 53. European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States. <http://www.epo.org/law-practice/legaltexts/html/epc/2016/e/ar53.html> [accessed 13 February 2018]. 242 Resource Book on TRIPS and Development, ed. by United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development (Cambridge; New York: Cambridge University Press, 2005), p. 376. 243 Correa, Trade Related Aspects of Intellectual Property Rights, pp. 287–88. 244 Gervais, p. 343. 245 Carvalho, The TRIPS Regime of Patents and Test Data, p. 312. 246 Stoll, Busche, and Arend, p. 493. SAMAN ABDULRAHMAN ALI 150 However, Article XX(a) of GATT of 1947 247 which appeared also in GATT of 1994 was dedicated for the ‘General Exceptions’ in which ‘public morals’ which was considered as one of the bases of excluding invention from patentability. Here, the law clearly states that its public morals and not individual morals or private morals that leads to exceptions. 248 Therefore, if the commercial exploitation of the invention in the territory of a member country caused collective immorality or has negative effect on the morality of the community at large, then this member country is allowed to exclude such invention from patentability. Though originally there is a jurisprudential debate as the positivist school of law believes that law should be based on logic and reason only without considering morality. On the other hand, the school of natural law believes that law should reflect the morals of society. 249 In line with this principle, the majority of countries in the world considered morality in regulating their laws. For this reason, the draftsmen of TRIPS Agreement and GATT were cogitating on this principle. That is why we can clearly see that the TRIPS Agreement did not ignore the issue of morality in intellectual property protection. Furthermore, what constitutes a morality is dependent on the understanding of a country or cultural group to a particular conduct. Because some conducts and behaviours are considered normal and correct in some countries and societies, while in some other societies and countries the same conducts and behaviours are seen utterly different. Hence, the evaluation has to be done on case by case basis. In this regard religious, social and moral values of every society have to be considered. Therefore, in evaluating the outcome of industrial exploitation of an invention, whether it will affect the morality of the society, it has to be looked at from the realizations of fair and 247 ‘The General Agreement on Tariffs and Trade (GATT 1947)’ <https://www.wto.org/english/docs_e/legal_e/gatt47_02_e.htm#articleXX> [accessed 12 February 2018]. 248 Carvalho, The TRIPS Regime of Patents and Test Data, p. 312 (Footnote 712). 249 Kathleen Liddell, ‘Immorality and Patents: The Exclusion of Inventions Contrary to Ordre public and Morality’, in New Frontiers in the Philosophy of Intellectual Property, ed. by Annabelle Lever, University of Cambridge Faculty of Law Research Paper No. 55/2016 (Rochester, NY: Cambridge University Press, 2012), p. 12 <https://papers.ssrn.com/abstract=2865820> [accessed 15 February 2018]. Exclusions from patentability 151 reasonable persons. Needless to mention that the principle of good faith has to be observed as well. 250 Article 27.2 of the TRIPS Agreement includes the term ‘necessary’ and this looked at as requirement from the member countries. It has to be proven that it is necessary to exclude the invention from patentability because its commercial exploitation endangers the ordre public and morality of the member country. This needs to be shown that there is a real connection between the safeguarding of the ordre public and morality and the outcome of the measure that has been taken by the member country. 251 The member country also has to prove that other measures were not available that are consistent with the principles of the WTO, in order to be taken by them to protect ordre public and morality. This means that the member country has to use this measure as the last resort, after ensuring that there was no other justifiable and reasonable alternative that is less consistent with the WTO. 252 To elaborate more on ordre public, Article 27.2 of the TRIPS Agreement provides some examples that may be considered as a basis for ordre public and morality which they are protection of ‘human, animal or plant life or health or to avoid serious prejudice to the environment’. However, ordre public and morality are not limited to these situations or cases related to these situations. But still the focus is on the commercial exploitation of the invention and not the invention itself. The TRIPS Agreement allows member countries to exclude from patentability the invention that its commercial exploitation goes against the principles of ordre public. Therefore, if the invention is not applied in the member country, then the member country cannot exclude its patentability. The TRIPS Agreement clearly states that such exploitation has to be practically occurred in specific territory of the member country. In other words, the invention has to be industrially applied and exploited in territory of a particular 250 Stoll, Busche, and Arend, pp. 493–94. 251 Stoll, Busche, and Arend, pp. 494-95. 252 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 378. SAMAN ABDULRAHMAN ALI 152 member country, and then this member country will be allowed to exclude its patentability base on the principles of ordre public. The last proviso of Article 27.2 states that it’s not allowed for a member country to exclude patentability merely because the industrial exploitation of the invention is prohibited by domestic law. Therefore, in order for any invention to be excluded from patentability has to be based on real grounds as mentioned in Article 27.2. 253 This is influenced by Article 4quater of the Paris Convention for the Protection of Industrial Property, in which the Article states that ‘The grant of a patent shall not be refused and a patent shall not be invalidated on the ground that the sale of the patented product or of a product obtained by means of a patented process is subject to restrictions or limitations resulting from the domestic law’. 254 According to this Article of the Paris Convention restrictions and limitations by domestic laws and regulations that are not part of the patent system, should not be imported into the system. 255 However, Article 27.2 of the TRIPS Agreement goes further than sale of products or products itself, by generalizing the concept of exclusion to every kind of commercial exploitations that the right holder obtained by the TRIPS Agreement. Since commercial exploitation is not defined in the TRIPS Agreement, therefore, one can apply the definition of The Panel in the case of Canada-Pharmaceutical Patents, which states that exploitation include every commercial activity that the patent holder performing on his patent in order to gain economic benefits. 256 253 Carlos María Correa, ‘Patent Rights’, in Intellectual Property and International Trade: The TRIPS Agreement, ed. by Carlos María Correa and Abdulqawi A. Yusuf, 2nd ed (Austin: Alphen aan den Rijn, Netherlands: Wolters Kluwer Law & Business; Kluwer Law International, 2008), p. 231. 254 ‘WIPO-Administered Treaties: Paris Convention for the Protection of Industrial Property’. 255 Sam Ricketson, The Paris Convention for the Protection of Industrial Property: A Commentary (Oxford: Oxford University Press, 2015), p. 390. 256 Canada – patent protection of pharmaceutical products - Report of the panel, WT/DS114/R ON 17 MARCH 2000, para. 7.54 <https://www.wto.org/english/tratop_e/dispu_e/7428d.pdf>. Exclusions from patentability 153 2.2.2 Ordre public and Morality Under Iraqi Patent Law Section 3 of the Patent and Industrial Designs Law No. 65 of 1970 states that ‘Patent shall not be granted in the following circumstances; 1. Inventions in which their exploitations cause breaches of public moral or ordre public or contradict the public interest’. Here the law clearly refers to the exploitation of an invention. In fact, the Law No. 65 of 1970 is different from Article 27.2 of the TRIPS Agreement because the word commercial does not exist within section 3.1 of the Law No. 65 of 1970. However, the explanation in section 1.2 of the Instruction No. 1 of 1990 on implementing Law No. 65 of 1970 and Regulation No. 3 of 2001 on the classification of Patents and Industrial Designs in section 2(b), made it clear that the word exploitation or industrial exploitation (application) ‘can be applied or used in any fields of work related to industry, agriculture, profession, and services in broader understanding’. 257 Therefore, the term exploitation has general meaning and can be referred to any kind of commercial use, in which the patent holder uses his patent to gain benefits. When it comes to the issue of morality, under the Iraqi Patent Law the word public moral is used, hence, clearly eliminate any doubts that may arise whether morality is meant to be public or individual moral as in the case of Article 27.2 of the TRIPS Agreement as has been discussed in the previous section. Iraq is one of the most multicultural and socially diverse countries in the Middle East. Therefore, the meaning of the term public moral needs to carry the broadest sense as much possible. Because what is moral according to Iraqi Muslims may not be the same for Iraqi Christians, Yazidis or Sabians )Mandaean) or other minority religions, and vice versa. Iraq has some ethnics as well, apart from Arab, such as 257 ‘Iraq: Instructions No. 1 of 1990 Implementing Law No. 65 of 1970 on Patents, Industrial Designs’, Section 1.2 <http://www.wipo.int/wipolex/en/details.jsp?id=10511> [accessed 10 February 2018]; ‘Iraq: Regulation No. 3 of 2001 on the Classification of Patents and Industrial Designs’, Section 2(b) <http://www.wipo.int/wipolex/en/details.jsp?id=10546> [accessed 14 February 2018] ‘the invention will be considered industrially applicable if it can be applied or used in any fields of work related to industry, agriculture, profession, and services in broader understanding’. SAMAN ABDULRAHMAN ALI 256 the compulsory licence is in the form of goodwill, then it can be assigned and transferred as part of the market transaction. 556 2.3.2.6 Predominantly for The Supply of The Domestic Market Article 31 lit. (f) of the TRIPS Agreement states that ‘any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use’. This means that the compulsory licence should be ‘predominantly’ used for the domestic market. This indicate that the intention of the granting such licence should be for fulfilling the domestic market and not for exporting. Even though the term ‘predominantly’ may carry the meaning that small part of the subject matter of the compulsory licence can be exported but should not exceed more than fifty percent of the total production. Prior to the existence of the TRIPS Agreement, many countries legislated the principle of compulsory licence with the intention of exporting it to foreign markets. The Paris Convention did not prevent such practices. However, once the TRIPS Agreement implemented such practice should not be allowed. Because the principle of compulsory licence under Article 31 is considered as an exception to the general rule of exclusive rights of the patent owner, therefore, it should be kept as an exception. Thus, this subparagraph is introducing another limitation to the Paris Union Members that are member of the WTO (TRIPS Agreement) in the same time. 557 This subparagraph, according to the previous argument, prevents a country that have no technological capabilities to produce under the patented invention, to be able to buy such products for lesser money from another country that produce them under compulsory licence. 558 For this reason, some other authors claim that if the intention of a 556 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 473. 557 Carvalho, The TRIPS Regime of Patents and Test Data, pp. 415–16; United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 474. 558 Bartelt Sandra, p. 284. Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 257 member country of granting the compulsory licence is principally to fulfil the need of domestic market, then it has complied with the term ‘predominantly’. 559 Thus it does not make any different how many percentage of the compulsory licence’s products will be exported to foreign market. However, under Article 31 lit. (k) when the compulsory licence granted by judicial or administrative process of a member country to remedy an anti-competitive practice, then that member country is not obliged to comply with Article 31 lit. (f). In another word, in this situation the member country is allowed to export majority of the products to foreign market. 560 Furthermore, recent developments have added some more exceptions to this subparagraph. At the Doha Ministerial Conference in 2001, the Doha Declaration on the TRIPS Agreement and Public Health was adopted. On the recommendation of Paragraph 6 of the Doha Declaration 561 which was intended to create a path to the member countries so that they can easily access to medicines. 562 Eventually this followed by a Decision of the General Council of 30 August 2003. Part of this decision became Article 31bis and other became an Annex to the TRIPS Agreement. This was adopted by the General Council under the name of Amendment of the TRIPS Agreement (Decision of 6 December 2005) 563 and submitted to the member countries in order to be accepted. 564 Article 31bis 1 provides an exception to Article 31 lit. (f) when the products in question are pharmaceutical products. 565 559 Stoll, Busche, and Arend, p. 574. 560 Stoll, Busche, and Arend, p. 573. 561 Declaration on the TRIPS Agreement and Public Health, Paragraph 6 states ‘We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.’‘WT/MIN(01)/DEC/2 -WTO | Ministerial Conferences - Doha 4th Ministerial - Declaration on the TRIPS Agreement and Public Health - Adopted 14 November 2001’. 562 Abbott and Puymbroeck, p. v. 563 ‘WTO | Intellectual Property (TRIPS) - Amendment of the TRIPS Agreement - Decision of 6 December 2005’. 564 Gervais, pp. 396–97. 565 Stoll, Busche, and Arend, p. 581 and 584. SAMAN ABDULRAHMAN ALI 258 2.3.2.7 Termination Article 31 lit. (g) of the TRIPS Agreement states that ‘authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances’. This subparagraph provides for termination of the compulsory licence while the legitimate interest of the licensee is not prejudiced and gives authority that the licence be reviewed by the competent authority. 566 This subparagraph requires that the compulsory licence formally be terminated by the authority (executive or judicial) after taking all circumstances into consideration. Automatic termination is not allowed in this situation though the situations that causes its grant disappear, because it create a great risk to the licensee and this will cause injustice. 567 Some mechanism can be adopted in order to terminate the compulsory licence in such a way that the legitimate interest of the licensee is adequately protected. For example, in the terms of granting the compulsory licence a sufficient time can be stipulated so that the licensee recover the costs he has spent and earn reasonable profit. Also, during the normal period of the compulsory licence, it cannot be terminated so that to protect the licensee’s interest. However, if the patent holder requested such termination, then he has to compensate the licensee for rest of the licence’s value and in the same time he has to fulfil the needs of the market instead of the licensee. 568 Therefore, in deciding to terminate the compulsory licence balance has to be kept between the legitimate interest of the licensee and that of the patent owner. 569 566 Blakeney, Trade Related Aspects of Intellectual Property Rights, p. 92. 567 Carvalho, The TRIPS Regime of Patents and Test Data, p. 458. 568 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 475. 569 Carvalho, The TRIPS Regime of Patents and Test Data, p. 457. Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 259 When a member country legislates rules of compulsory licence into their laws, it has to be bear in mind to include some mechanism in order the patent owner be able to petition for a review to prove that the circumstance lead to granting the licence are not existence anymore and are unlikely to recur, as stated by this subparagraph. Nonetheless, the licensee has the right to appeal and present its own justification and evidence so that the licence be continued or renewed. 570 2.3.2.8 Adequate Remuneration Article 31 lit. (h) of the TRIPS Agreement states that ‘the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization’. This is an improvement by the TRIPS Agreement as the Paris Convention does not provide for any regulations as to adequate compensation of the patent owner, whether the licensee is a government or private party. 571 This is because TRIPS Agreement in its preamble 572 has considered intellectual property rights as private rights, hence any acquiring of such rights should be adequately compensated. 573 During the negotiation process in Brussels, the negotiators were hesitating whether to choose the term ‘adequate’ as it was proposed by the United States of America, or ‘fair and equitable’ which was supported by several members. This subparagraph is considered to be one of the most controversial provisions of the TRIPS Agreement. 574 However, this subparagraph does not illustrate the meaning of ‘adequate remuneration’. Nevertheless, one can get a hint of the meaning of this term by looking at Article 44 and 45 of the TRIPS 570 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 475. 571 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 475. 572 TRIPS Agreement, the Preamble in its fourth paragraph states that ‘Recognizing that intellectual property rights are private rights’ 573 Stoll, Busche, and Arend, p. 575. 574 Gervais, pp. 393–94. SAMAN ABDULRAHMAN ALI 260 Agreement. Article 44 provides for injunctions, but the second paragraph 575 states that when the use is by government or third parties authorised by government, then the only remedy is the one provided by subparagraph (h) Article 31 instead of damage according to Article 45 576 . Since the judicial authority is the one which has to assess the adequate damage and in the above cases the adequate damage is replaced by adequate remuneration, therefore, the same criteria can be used to assess the ‘adequate remuneration’. Which can be determined in the same way as damage, by calculating the amount that the patent owner would have made if he was the one utilising the patented invention instead of the licensee. 577 Adequate remuneration is different from one case to another according to their circumstances as it is stated in the subparagraph. Therefore, adequate remuneration cannot be standardized in which a uniform fee to be paid by the compulsory licensee in the same sector of industry. A uniform and average fee can be taken into consideration and used only as one of the factors of determining the adequate remuneration. Also, when trying to determine the adequate remuneration, the subparagraph requires that the economic value of the authorization has to be taken into account. But the provision is unclear whether it refer to the economic value according to the 575 Article 44.2 of the TRIPS Agreement states that ‘Notwithstanding the other provisions of this Part and provided that the provisions of Part II specifically addressing use by governments, or by third parties authorized by a government, without the authorization of the right holder are complied with, Members may limit the remedies available against such use to payment of remuneration in accordance with subparagraph (h) of Article 31.In other cases, the remedies under this Part shall apply or, where these remedies are inconsistent with a Member's law, declaratory judgments and adequate compensation shall be available’. 576 Article 45 of the TRIPS Agreement states ‘1. The judicial authorities shall have the authority to order the infringer to pay the right holder damages adequate to compensate for the injury the right holder has suffered because of an infringement of that person’s intellectual property right by an infringer who knowingly, or with reasonable grounds to know, engaged in infringing activity. 2. The judicial authorities shall also have the authority to order the infringer to pay the right holder expenses, which may include appropriate attorney's fees. In appropriate cases, Members may authorize the judicial authorities to order recovery of profits and/or payment of pre-established damages even where the infringer did not knowingly, or with reasonable grounds to know, engage in infringing activity’. 577 Carvalho, The TRIPS Regime of Patents and Test Data, p. 458. Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 261 patentee or the licensee. Economic value according to the authorization of the patentee would be the fee that he asks for licencing his patented invention in a voluntary licence. On the other hand, according the licensee the economic value of the compulsory licence would be the potential profit that the licensee is expecting. 578 Therefore, member countries are free to select factors that may determine the adequate remuneration, but they have to be careful because if they enforce inadequate remuneration, then they will violate Article 31 lit. (h). 579 2.3.2.9 Judicial Review Article 31 in both subparagraphs of (i) and (j) provides for judicial review or independent review by a distinct higher authority in that member country. However, in the first subparagraph of (i) it is states that ‘the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member’, which is requesting review of a decision of granting compulsory licence. This refers to legal validity of the decision only, without dealing with any other interlocutory issues. On the other hand, subparagraph (j) states that ‘any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member’, which is requesting review of a decision relating to the remuneration. Here the review is not limited to validity of the decision, but all other decisions that have influence the decision should be reviewed. Beside the amount of the remuneration, other issues such as methods of payment, currency, liquidity and insurance can be subject to review. 580 Due to the fact that the legal systems of the member countries are different from one another, therefore, these subparagraphs are only stating general terms and give some discretion during 578 Stoll, Busche, and Arend, p. 576. 579 Carvalho, The TRIPS Regime of Patents and Test Data, p. 459. 580 Carvalho, The TRIPS Regime of Patents and Test Data, p. 460. SAMAN ABDULRAHMAN ALI 262 implementations. Both of the subparagraphs state that the review can be carried out by the judicial review, which is clear enough by the patentee and the licensee to follow the procedures. However, the second part which is an independent review by a distinct higher authority in that member country, is not clear enough as the subparagraphs do not define the nature of that authority. But the word ‘independent’ means that the reviewing person or body should not be under control the authority that granted the licence or determined the remuneration. The term ‘distinct’ indicates that there should be adequate separation between the person or body reviewing and the one granting or determining the remuneration in function even though they are under same agency. This is reinforcing the idea of independent review. The term ‘higher authority’ refers to the notion that the reviewing authority should be higher in raking and level than the one granted the licence or determined the remuneration, so that be out of their influence in making the decision. 581 This option of ‘independent review by a distinct higher authority’ was added to these subparagraphs by Australia during the negotiations. 582 This seems to be a good choice as usually the judicial process may consume very long time and cost a lot, however, the process of administrative review is faster and less costly. If the procedures laid down in this provision followed carefully, the decision will be as just as the one reviewed by judicial authority. 2.3.2.10 Remedies for Anticompetitive practices Anti-competitive practice was one of the main concerns of TRIPS Agreement negotiators, which had increased due to the monopolies arise from the exclusive rights granted to patent owners by the intellectual property rights. Other articles and provisions of the TRIPS Agreement has allowed member countries to take measures and control such practices, such as Article 8.1 and 40 of the TRIPS 581 United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, pp. 477–78. 582 Stoll, Busche, and Arend, p. 576. Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 263 Agreement. 583 Beside these provisions, also Article 31 lit. (k) states that ‘Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anticompetitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur’. This provision gives authority to member countries to bypass the conditions in Article 31 lits. (b) and (f), which are notifying and prior negotiation with the patent owner, and the licence should be predominantly used for supplying the domestic market, when the compulsory licence granted in order ‘to remedy a practice determined after judicial or administrative process to be anti-competitive’. However, in this situation the government should not deprive the patent owner from receiving adequate remuneration, nevertheless this situation can be taken into consideration while determining the adequate remuneration. This provision can be interpreted as allowing the national authorities to reduce the remuneration or even a ‘royalty free’ licence. The final sentence gives further authority to the member countries’ competent authority to refuse termination of the compulsory licence if and when the anti-competitive conditions which led to granting the licence are likely to recur. 584 2.3.2.11 Dependent Patents Article 31 lit. (l) of the TRIPS Agreement, 585 provides for three more conditions beside other conditions of this Article, in cases that 583 Blakeney, Trade Related Aspects of Intellectual Property Rights, p. 92. 584 Stoll, Busche, and Arend, p. 577; United Nations Conference on Trade and Development, International Centre for Trade and Sustainable Development, and UNCTAD-ICTSD Project on IPRs and Sustainable Development, p. 479. 585 Article 31 lit. (l) of the TRIPS Agreement states that ‘where such use is authorized to permit the exploitation of a patent ("the second patent") which cannot be exploited without infringing another patent ("the first patent"), the following additional conditions shall apply: SAMAN ABDULRAHMAN ALI 264 concern the dependent patents. The dependent patent (second patent) is a patented invention which cannot be worked without exploiting the original patent (first patent). Generally, the dependent patent owner requests a voluntary licence over the original patent. However, if it is not granted, the dependent patent owner may apply for authorisation of using the original patent through a compulsory licence. 586 In Article 31 lit. (l) of the TRIPS Agreement it is stated that when compulsory licence granted in order to permit the second patent which cannot be exploited without infringing the first patent, three additional conditions has to be followed. Firstly; it is required that the second patent involve an important technical advancement, and such technical advancement should have considerable economic significance. However, the term ‘economic significance’ is not precise concept and may carry many interpretations. It is possible that the second patent have technically advanced the original patent but may have little application with great economic significance and vice versa. 587 Determining important technical advancement of an invention is matter of subjective judgment that carry a wide range of discretion. 588 However, this condition introduced by the TRIPS Agreement because some countries had very generous policy in granting compulsory licence in these cases. Therefore, it was introduced in order to limit granting such licences only after following this stringent condition. 589 Secondly, the first patent owner, shall be given a cross-licence on reasonable terms so that to be able to benefit from the invention of the (i) the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent; (ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and (iii) the use authorized in respect of the first patent shall be non-assignable except with the assignment of the second patent’. 586 Anonymous, ‘Genes and Ingenuity: Gene Patenting and Human Health (ALRC Report 99), 27. Compulsory Licensing, Dependent Patents’, 2010 <https://www.alrc.gov.au/publications/27-compulsory-licensing/dependent-patents> [accessed 5 April 2018]. 587 Carvalho, The TRIPS Regime of Patents and Test Data, p. 471. 588 Stoll, Busche, and Arend, p. 578. 589 Gervais, p. 394. Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 265 second patent. This condition stipulated here in order to keep balance and both patent owners benefit from each other’s inventions and not one of them only. However, it is required that there should be a negotiation process on reasonable terms. This indicate there the crosslicence will not be without compensation. It is presumed that the first patent owner already received adequate compensation after the compulsory licence granted to the second patent owner. Therefore, when the first patent owner acquires the cross-licence, it is logic that he should compensate the second patent owner as well. Or the economic value of both patented inventions can be evaluated and the most valuable receive an adequate compensation. 590 The final and third condition is related to non-assignability of the first patent except with the assignment of the second patent. However, the condition of non-assignment already covered by Article 31 lit. (e). Therefore, one can perceive that the third condition of Article 31 lit. (l) replacing Article 31 lit. (e), with one addition which is the exception of non-assignability to the second patent only. For this reason, it has been suggested by Nuno Pires de Carvalho, that this condition should read as ‘the compulsory licence granted under subparagraph (l) shall be assigned only with the patent that enjoys such use’. 591 2.4 ARTICLE 31BIS AND COMPULSORY LICENCE FOR PUBLIC HEALTH Article 31bis is the first amendment to the TRIPS Agreement. It was amended by the General Council’s Decision of 6 December 2005, 592 and submitted to member countries to be accepted. However, in order for any amendment to take effect, two thirds of the member countries have to accept it. Paragraph 3 of Article X of the WTO Agreement states that an amendment ‘shall take effect for the 590 Carvalho, The TRIPS Regime of Patents and Test Data, p. 471; Stoll, Busche, and Arend, p. 578. 591 Carvalho, The TRIPS Regime of Patents and Test Data, p. 472; Stoll, Busche, and Arend, p. 578. 592 ‘WTO | Intellectual Property (TRIPS) - Amendment of the TRIPS Agreement - Decision of 6 December 2005’. SAMAN ABDULRAHMAN ALI 272 31 lit. (f) in regard of granting compulsory licence predominantly for supplying the domestic market. Article 31bis 3 allows for re-export of imported pharmaceutical products. 613 However, this waiver applies when the member countries of the TRIPS Agreement are least developed and developing countries that they are members of the same regional trade agreement. Furthermore, the member countries of that regional trade agreement are at least half of them are from the list of United Nations least developed countries. Therefore, this condition only applies on the African regional groupings, as it was their specific request, nevertheless during negotiations some other member countries showed interest. 614 The main advantage of this exemption which created by Article 31bis 3 is that it applies to all the member countries of the regional trade agreement and notification to the TRIPS Council is not necessary whenever an exportation is made. However, this provision does not allow the same exporter to supply to all or some of the member countries of the same regional trade agreement, but rather the waiver is in regard of re-exporting from the importing member country of the trade agreement to other members. 615 Nevertheless, the last sentence of this provision provides for the principle of territoriality as it states that ‘It is understood that this will not prejudice the territorial nature of the patent rights in question’. Therefore, according to this principle when the pharmaceutical production of, pharmaceutical products: where a developing or least-developed country WTO Member is a party to a regional trade agreement within the meaning of Article XXIV of the GATT 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L/4903), at least half of the current membership of which is made up of countries presently on the United Nations list of least-developed countries, the obligation of that Member under Article 31(f) shall not apply to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that Member to be exported to the markets of those other developing or least-developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question’. 613 Abbott and Reichman, pp. 944–45. 614 Vandoren Paul and Eeckhaute Jean Charles, p. 790. 615 Correa, ‘Implementation of the WTO General Council Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health’, p. 25. Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 273 product is patented in an importing member country, such patent is valid and has legal effect only in that member country. It is independent from any other patent granted for the same product in other member countries. Thus, a compulsory licence granted for a patent in one-member country does not have any effect on another patent granted for the same product in other member countries. This principle of territoriality obliges every member wishes to import from the original exporter or from another importing member country, it has to apply for compulsory licence. 616 The purpose of this waiver as stated by both Article 31bis 3 and paragraph 5 of the Annex, is to promote economies of scale as it was an existing concern during the negotiation on the Decision of 30 August 2003, especially for the developing countries. 617 Therefore, paragraph 5 of the Annex states that this kind of exporting and importing should be promoted. Further this paragraph provides that the developed member countries should take responsibility to provide technical cooperation in accordance with Article 67 of the TRIPS Agreement and also with other intergovernmental organization. 618 Paragraph four of Article 31bis of the TRIPS Agreement states that ‘Members shall not challenge any measures taken in conformity with the provisions of this Article and the Annex to this Agreement under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994’. This paragraph expressly prevents nonviolation nullification or impairment under subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994. 619 Therefore, member countries are not allowed to bring 616 Vandoren Paul and Eeckhaute Jean Charles, p. 790. 617 Stoll, Busche, and Arend, p. 588. 618 Article 67 of the TRIPS Agreement, under the title ‘Technical Cooperation’ states that ‘In order to facilitate the implementation of this Agreement, developed country Members shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in favour of developing and least-developed country Members. Such cooperation shall include assistance in the preparation of laws and regulations on the protection and enforcement of intellectual property rights as well as on the prevention of their abuse, and shall include support regarding the establishment or reinforcement of domestic offices and agencies relevant to these matters, including the training of personnel’. 619 ‘WTO | Disputes - Dispute Settlement CBT - Legal Basis for a Dispute - Types of Complaints and Required Allegations in GATT 1994 - Article XXIII of GATT 1994 Subparagraph 1 Lits (B) and (C). ‘If any contracting party should consider that any benefit SAMAN ABDULRAHMAN ALI 274 actions under these two subparagraphs which relates to dispute settlement in cases of nonviolation and situation. This prohibition is important because it will bring substantial insecurity to those countries that are ready to use the system. 620 The last paragraph is Article 31bis 5 of the TRIPS Agreement which states that ‘This Article and the Annex to this Agreement are without prejudice to the rights, obligations and flexibilities that Members have under the provisions of this Agreement other than paragraphs (f) and (h) of Article 31, including those reaffirmed by the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2), and to their interpretation. They are also without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under the provisions of Article 31(f)’. In the first sentence this provision confirms that Article 31bis and the Annex do not interfere with the rights, flexibilities and obligations of the member countries under the TRIPS Agreement and the Doha Declaration the TRIPS Agreement and Public Health. However, Article 31bis 5 reaffirms the exceptions that provided by this Article under paragraphs of Article 31bis 1 and 3, which they are exceptions to obligations under Article 31 lits. (f) and (h). 621 Therefore, during implementation of this provision the member countries still can benefit from the flexibilities and limitations to the principle of exclusivity of rights of the patent owner. In the same time, implementation of this provision should not permit the member accruing to it directly or indirectly under this Agreement is being nullified or impaired or that the attainment of any objective of the Agreement is being impeded as the result of, (b) the application by another contracting party of any measure, whether or not it conflicts with the provisions of this Agreement, or (c) the existence of any other situation’.’ <https://www.wto.org/english/tratop_e/dispu_e/disp_settlement_cbt_e/c4s2p1_e.htm> [accessed 14 April 2018]. 620 Abbott and Reichman, p. 945. 621 Article 31 lits. (f) and (h) of the TRIPS Agreement, ‘(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use; (h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization’. Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 275 countries to escape from the obligations provided for in the TRIPS Agreement and Doha Declaration. The EC Regulation No. 816/2006 also provides for compulsory licence for the purpose of manufacturing pharmaceuticals and exporting them to countries with public health issues. This regulation is considered to be an action by the EU in order to solve public health problems especially in the least developed and developing countries that do not have access to safe and affordable medicines. Nevertheless, even the developed countries that informed the WTO about their intention to import such medicines, can be eligible to benefit from this scheme. 622 The term ‘their interpretation’ refers to the interpretation of the TRIPS Agreement and Doha Declaration. Paragraph 5 lit. (a) of the Doha Declaration, 623 states while interpreting the provisions of the TRIPS Agreement according to Article 31 of the Vienna Convention, the objectives and principles of the TRIPS Agreement have to be taken into consideration. Those objectives and principles stated in Article 7 and 8 of the TRIPS Agreement with other principles that are laid down in the Preamble and Part I of the TRIPS Agreement. 624 The last sentence of Article 31bis 5 of the TRIPS Agreement emphasizes that Article 31bis and the Annex shall not affect the rights of the member countries to export pharmaceutical products in which produced under compulsory licence and fulfilled the requirement of Article 31 lit. (f). Basically, Article 31 lit. (f) requires the member countries to grant the compulsory licence predominantly for supplying the domestic market. Therefore, the non-predominant portion can be exported to another member country. 625 622 ‘Regulation (EC) No. 816/2006 - Export of Generic Medicines to Developing Countries: Compulsory Licences’ <http://eur-lex.europa.eu/legalcontent/EN/TXT/HTML/?uri=LEGISSUM:l21172&from=ES> [accessed 4 May 2018]. 623 ‘WT/MIN(01)/DEC/2 -WTO | Ministerial Conferences - Doha 4th Ministerial - Declaration on the TRIPS Agreement and Public Health - Adopted 14 November 2001’, ‘In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles’. 624 Stoll, Busche, and Arend, p. 590. 625 Abbott, ‘The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO’, p. 495. SAMAN ABDULRAHMAN ALI 276 2.5 IRAQ’S POSITION TO COMPULSORY LICENCE One of the important principles of patent is granting exclusive right to the patent owner. However, countries around the world specify some circumstances in which they limit the exclusive right of the patent owner. These limitations are called exceptions as it is stated in Article 30 of the TRIPS Agreement as ‘Exceptions to Rights Conferred’. Different countries have stated different exceptions, however, in the previous part some examples have been discussed that can be allowed under Article 30 of the TRIPS Agreement, such as Research and Experimentation Exception, Early Working, Regulatory Review or Bolar Exception, Individual Prescriptions Exception, Prior Use Exception and Parallel Imports. However, the patent law No. 65 of 1970 does not state any such exceptions and neither the CPA Order No. 81. The CPA was well aware of the provisions of the TRIPS Agreement, therefore, should have taken advantage of Article 30 of the TRIPS Agreement and included some of these exceptions in the amendment. As these exceptions are important for the fulfilment of the needs of society and its development. 2.5.1 Compulsory Licence Under the Original Law No. 65 of 1970 There is another type of exception which limit the exclusive rights of the patent owners, which is called compulsory licence exception. However, this exception has to be applied for and granted by executive or judicial authority. The Iraqi patent law No. 65 of 1970 provides regulation in regard of compulsory licence in sections of 27, 28 and 29. 626 Nevertheless, all these Section were amended by CPA Order No. 81. 627 However, before the amendment Section 27 was consisted of two provisions. In the first provision the patent owner was required to inform the Registrar of the exploitation date of the invention within 30 days of the commencement of the exploitation. The second provision provided for three circumstances in which the 626 ‘Law No. 65 of 1970 on Patent and Industrial Designs’. 627 ‘Order No. 81 Patent, Industrial Design, Undisclosed Information, Integrated Circuits And Plant Variety Law.’ Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 277 Registrar authorised to grant compulsory licence to whom applied for it. According to this provision the Registrar was the executive authority that empowered to grant compulsory licences in the following circumstances. First, if the right holder did not exploit the invention in Iraq within three years of granting the patent. Second, if the exploitation by the patent owner did not correspond to the needs of the country. Three, if the patent owner stopped exploiting the invention for at least two years. However, the provision stated a condition on the applicant that he should be able to exploit the invention in a serious manner. The provision also stated that the patent owner has legal right to apply in the registry in order to receiving an adequate remuneration within ninety days of granting the compulsory licence. This suggest that if the patent owner did not apply for remuneration within specified period he will loss his legal right to receive remuneration. The provision also provided that the patent owner has right appeal against the decision of the Registrar before the Minister within thirty days of receiving notification of the grant of the compulsory licence, and the decision of the Minister is final and irreversible. According to Section 1.1 of the original patent law No. 65 of 1970 the Minister is Minister of Industry. Section 28 of the original patent law No. 65 of 1970 before the amendment provided for another circumstance in which the compulsory licence can be granted accordingly. In this case compulsory licence can be granted to a dependent patent. Section 28 stated that when the exploitation of the patented invention (second patent/dependent patent) has great industrial significance and its exploitation require using another previously patented invention (first patent), then the Registrar has the authority to grant compulsory licence to the second patent owner. However, the provision of this Article required that the second patent owner approached the first patent owner to obtain voluntarily licence on reasonable conditions and the first patent owner refused to grant him the voluntarily licence. According to this provision what constitute reasonable conditions in this context can be determined by the Registrar. Section 28 provided for granting compulsory licence in the vice versa situation as well. In circumstances when the first patent is a SAMAN ABDULRAHMAN ALI 278 dependent patent, and it has great importance that requires using subsequent patented invention (second patent). In the same condition the first patent owner has to request voluntarily licence from the second patent owner on reasonable conditions. If his request is refused, then the Registrar will be allowed to grant compulsory licence. In both circumstances adequate remuneration should be provided according to the stipulations stated in Section 27. Section 29 of the original law No. 65 of 1970 stated that ‘the Registrar may revoke the patent granted and anyone who has interest may request the Registrar to revoke it if the invention was not exploited in Iraq within two years of granting the compulsory licence’. This Section obviously did not make any sense as to why the patent would be revoked if the invention was not exploited during granting the compulsory licence. But Iraqi legislature spotted the mistake and amended this Section through the Law No. 28 of 1999 First Amendment to Law No. 65 of 1970. 628 Therefore, Section 29 to be read as ‘the Registrar may revoke the compulsory licence granted and anyone who has interest may request the Registrar to revoke it if the invention was not exploited in Iraq within two years of granting the compulsory licence’. In all the previous circumstances of granting compulsory licences according to Section 27 and 28, the Registrar was authorised to revoke the compulsory licence pursuant to Section 29. According to Section 29 everyone who had an interest could request for revocation of the compulsory licence if the invention was not exploited in Iraq within two years of granting the compulsory licence. 2.5.2 Compulsory Licence After the Amendment made by the CPA Order No. 81. The CPA Order No. 81 amended all the three sections that regulated the compulsory licence under the Iraqi patent law No. 65 of 1970. The amended Section 27 consists of three paragraphs in which they provide for different circumstances in which the compulsory 628 ‘Iraq: Law No. 28 of 1999 First Amendment to Law No. 65 of 1970 on Patents and Industrial Designs’. Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 279 licence can be provided for exclusively. First, Section 27. A. states that when the use of the subject matter of the patent necessary for national defence or emergency or for non-commercial public good. In these circumstances the compulsory licence can be granted to states authorities or third parties. The only condition stated in the paragraph A. is that the patentee has to be notified as soon as possible. Circumstances referred in this paragraph are close to Article 31 lit. (b) of the TRIPS Agreement. In the TRIPS Agreement the terms of ‘national emergency or other circumstances of extreme urgency or in cases of public non-commercial use’ are used. The term emergency in Section 27. A clearly refers to national emergency, which obviously include necessities in circumstances of national defences. Therefore, it was not necessary to include this circumstance within Section 27. A. On the other hand, the original patent law No. 65 of 1970 before the amendments, in its Section 30 stated that the Minister may issue an order to confiscate (expropriate) the ownership of the invention if public interest of the country or national defence requires it. This expropriation includes all rights gained through the patent. Nevertheless, Section 30 provided for adequate remuneration and right to appeal to the President of the Republic of Iraq. However, this Section has nothing to do with compulsory licence, because in compulsory licence the patent owner is not deprived totally from his right over the invention, it is simply an authorisation of using his invention without his consent. Meanwhile, according to this section, the patent owner permanently loses right over the invention and not allowed to exploit it any more. Hence the CPA Order No. 81 amended Section 30 to be read as ‘The Registrar's compulsory license decision shall be appealable to the Minister within 60 days of its notification’. Therefore, it seems that the CPA wanted to replace this total deprivation of the rights of the patent owner to granting licence over the invention without his consent in circumstances of necessity for national defence. However, it would have been more beneficial for Iraq, if the CPA had copied the three circumstances of Article 31 lit. (b) of the TRIPS Agreement ‘national emergency or other circumstances of extreme urgency or in cases of public noncommercial use’. The term ‘other circumstances of extreme urgency’ SAMAN ABDULRAHMAN ALI 280 would have been much more beneficial instead of national defence, as will include wider range of circumstances that can be determined by Iraq to grant compulsory licence. Next, Section 27. B. 1 provides for another circumstance in which the Registrar can grant a compulsory licence; that is if the patent owner does not exploit the invention or exploits insufficiently. However, some durations have been stipulated before the compulsory licence granted. Either four years have passed from the application date or three years from granting date, and the applied date is the one that elapses later. Therefore, the Registrar cannot grant licence even though the invention has not been exploited unless the latest date of these two periods has elapsed. The Section has authorised the registrar to extend this period if found out that reasons beyond control of the patent owner, prevented him to exploit the invention. The new amended Section 27. B. 1 has restricted granting compulsory licence compared to the old Section 27. In the old Section 27. 2 compulsory licence could be granted in three situations related to exploitation. Firstly, patented invention was not exploited within three years of granting the licence. Secondly, exploitation did not correspond to the needs of Iraq. Thirdly, stopped exploitation at any time for two years. However, the new Section 27. B. 1 removed the second and third circumstances and extended the period of the first one. This is clearly being in the benefit of patent owners, and while considered as a great disadvantage for a developing country like Iraq, because having variety of options to grant compulsory licence certainly help the country to fulfil its needs of products and technologies in considerable low prices. Furthermore, according to the new Section 27. B. 2 any importation of subject matter of the patent to Iraq will be considered an exploitation of the patent. The last circumstance of granting compulsory licence according to Section 27. C. is to remedy unfair competition. This is a new circumstance that was not existed in the original Iraqi patent law. Therefore, it benefits the country to balance between exclusive right of the patent owner and fair competition. This provision is inspired by Article 31 lit. (k) of the TRIPS Agreement. However, it is failed to Exceptions and limitations to patent rights in the trips agreement and Iraqi patent law 281 include all the exceptions that stated in Article 31 lit. (k) such as exception to prior negotiation and notification. Section 28 of the original patent law before amendment provided compulsory licence in cases of dependent patents. However, this type of compulsory licence is removed after the amendment by the CPA Order No. 81. The current section 28 provides for conditions and requirements of granting compulsory licence. The conditions are, A. Each application shall be considered on its merits, B. Prior negotiation on reasonable remuneration and conditions failed during a reasonable period of time between the parties, C. ‘The scope and duration of the license shall be limited to the purpose for which it is granted. If the license application relates to semiconductor technology, then it shall only be granted for non-commercial public good or to rectify practices deemed by the competent judicial or administrative authority to be anticompetitive’, D. Shall not be exclusive, E, shall not be assignable, F. should be for meeting the demand of the domestic market except in cases of anticompetitive, and G. patent owner shall receive equitable remuneration. All these conditions can be found in Article 31 of the TRIPS Agreement, some of them rephrased and others exactly copied. However, some conditions such as judicial review of the licence was not included within Section 28, instead an independent section was added which is Section 30bis that states ‘The Registrar's compulsory license decision shall be appealable to the Minister within 60 days of its notification’. But this section does not include judicial review of adequate remuneration as it is the case in Article 31 lit. (j) of the TRIPS Agreement. Also, the CPA Order No. 81 did not include in its amendment any special provisions in regard of ‘Remedies for Anticompetitive practices’ like Article 31 lit. (k) and ‘Dependent Patent’ like Article 31 lit. (l). Since the CPA Order No. 81 was ordered to inline the Iraqi patent law with the TRIPS Agreement, it should have included all the conditions and paragraphs of Article 31 of the TRIPS Agreement, including compulsory licence in cases of dependent patents. Section 29 also amended to read as ‘The Registrar may cancel the compulsory license sua sponte or on the strength of an application SAMAN ABDULRAHMAN ALI 288 1935 on Patents. This law amended few times until finally repealed by Patent and Industrial Design Law No. 65 of 1970 during the republic era because it was considered to be an outdated law. Law No. 65 of 1970 has also undergone four amendments, in which only two of them have made significant amendments, which they are first amendment by Law No. 28 of 1999 and third amendment by CPA Order No. 81. IV In section one of chapter two the definition of the term ‘invention’ was discussed, in which under Law No. 61 of 1935 the term had a simple definition i.e. considered discovery as invention that can be patentable. However, this term was changed from such a simple definition to a more modern definition by Law No. 65 of 1970, and even further developed by the amendment under Law No. 28 of 1999. Nevertheless, this definition was repealed and replaced by another one which was introduced by the amendment provided by the CPA Order No. 81. Even though the latest definition is included with the precise criteria of patentability, but the TRIPS Agreement does not define the term ‘invention’ as it is left for member countries to define according to their own legal systems. All the criteria of patentability could be found within the definition of the term ‘invention’ in the Law No. 65 of 1970 before the amendment by the CPA Order No. 81. However, after the amendment the same criteria can be found in the definition, and the CPA Order No. 81 also specified another section for including all the criteria of patentability that are mentioned in the TRIPS Agreement. This way the CPA Order NO. 81 has improved the Iraqi patent law by clearly and precisely introduced the criteria of patentability. V In section two and three it has been established that the member countries of the TRIPS Agreement are allowed to exclude some areas from patentability. Therefore, according to the TRIPS Agreement Conclusion 289 right of granting patent is limited base on some principles. Article 27.2 states that if the commercial exploitation of an invention endanger ordre public and morality. None of these terms are defined by the TRIPS Agreement, which is in favour of the member countries to define them according to their domestic understanding. However, generally speaking any invention jeopardises the structure of civil society and institutions of the society, then will be excluded from patentability base on breaching ordre public and morality. Interestingly, section 3.1 of the Iraqi patent law No. 65 of 1970 provides that if exploitation of an invention breaches the principle of ordre public, public moral and public interest, will be excluded from patentability. All the amendments including the CPA Order No. 81 did not amend this provision. Therefore, this provision is in compliance with the TRIPS Agreement even though the term public interest is not mentioned in Article 27.2 of the TRIPS Agreement, but member countries are allowed to protect their public interest according to Article 8 of the TRIPS Agreement. Article 27.3 (a) of the TRIPS Agreement also provides for another important exclusion from patentability which is ‘diagnostic, therapeutic and surgical methods for the treatment of humans or animals’. This provision is optional provision as all the exclusion provisions in the TRIPS Agreement are optional. Therefore, some member countries do not exclude method of treatment form patentability such as Australia, New Zealand and United States of America. Nonetheless, majority of member countries are excluding method of treatment from patentability. It is noticeable that such provision cannot be found in the Iraqi patent law No. 65 of 1970 and none of the amendments added any provision in this regard. Since Iraq is one of the developing countries and in need of exclusion from patentability as much as possible to cope with the current situation that Iraq is going through sectarian wars and war with terror. Iraq is underdeveloped country in many areas especially in the areas that related to medicines and method of treatments. Therefore, this thesis is recommending adding a provision similar to that of the TRIPS Agreement to the Law No. 65 of 1970 in section 3.2 to be read as ‘patent shall not be granted in diagnostic, SAMAN ABDULRAHMAN ALI 290 therapeutic and surgical methods for the treatment of humans or animals’. Furthermore, the Doha Declaration on the TRIPS Agreement and Public Health admitted that there is massive public health problem that affects the developing counties. In this regard the ministers, through the Doha Declaration emphasized that the TRIPS Agreement should not be an obstacle in solving the public health issues of the developing countries but instead should be part of the solution. In addition, the it has been admitted that high standard of protection is having negative impact on drug prices. Therefore, the provisions of the TRIPS Agreement should be interpreted in a manner supportive to member countries to protect their public health and access medicines through flexibilities that available within the TRIPS Agreement. Doha Declaration further stated that the member countries should have right to determine ground of granting compulsory licence in this regard and determine what constitutes the national emergency and other circumstances of emergency. The original Iraqi patent law No. 65 of 1970 had a provision that excluded medical and pharmaceutical formulations from patentability. However, this provision repealed and suspended by both amendments of No. 28 of 1999 and CPA Order No. 81 without substituting it with another provision related to access to medicine. The CPA Order No. 81 ordered in 2004 which is 3 years after endorsement of the Doha Declaration, therefore the CPA Order No. 81 should have taken advantage of the Doha Declaration and added a new provision to make easy for Iraq to access to medicines for needs of the public health, like other member countries have done it. This shows that the CPA Order No. 81 was legislated within the intention of solving the problems of Iraqi people. Therefore, the law No. 65 of 1970 should be amended in this regard to include some situations that Iraq can access medicines without authorisation of the patent holders as an exception to their exclusive rights, such as in cases of ‘preparation of a medicine in accordance with a medical prescription for individual cases, carried out by a qualified professional, as well as to the medicine so prepared’. Conclusion 291 VI Article 27.3 (b) of the TRIPS Agreement excludes from patentability of plants and animals, however, it requires that member countries to provide for protection of plant varieties through a patent or an effective sui generis system or a combination of both of them. The original Iraqi patent law No. 65 of 1970 does not have any regulation in this regard. However, the CPA Order No. 81 added a new chapter for the protection of plant varieties. All the essential provisions of this chapter such as the definition of plant varieties and requirement of registration and protection, have been taken from the UPOV Convention of 1991. However, the CPA Order No. 81 failed to take the optional exception from the UPOV Convention of 1991 which gives limited right of re-using seed. But instead in this regard the CPA Order No. 81 has followed the United States of America’s style of prohibiting saving, re-suing or resale protected seed. This showed that the CPA Order No. 81 was not regulated in best interest of Iraq, as the CPA was well aware of the bad situation of Iraqi fields and seed bank. However, Law No. 15 of 2013 on Registration, Accreditation and Protection of Agricultural Varieties has replaced the CPA Order No. 81. The new law regulated the protection of new varieties in different way and provides for breeder’s rights and in the same time provides for some extra exceptions than the CPA Order No. 81. Nevertheless, Law No. 15 of 2013 reduced the period of protection. Therefore, this thesis recommends this law to be amended so that Iraq can have a better sui generis system for protection of plant varieties that comply with the TRIPS Agreement and in the same time take advantage of the UPOV Convention that offered better rights to farmers in regard of saving seeds. VII In section one of chapter three, it has been concluded that Article 28 of the TRIPS Agreement has conferred certain exclusive rights to the patent owners in a form of negative rights. Some of these rights SAMAN ABDULRAHMAN ALI 292 are over the patented products, patented processes and direct products of patented processes, and other rights are related to rights to assign, transfer by succession and conclude licensing contracts. Nevertheless, these exclusive rights are subject to some exceptions that referred to in Articles of 30, 31 and 31bis the TRIPS Agreement. The TRIPS Agreement in Article 34 also provides for reversing the burden of proof in civil proceeding of cases involve identical products of the patented process. The original Iraqi patent law No. 65 of 1970 referred to these rights in section 12 in a general term that the patent owner has exclusive right to exploit the invention by all legal means. However, the CPA Order NO. 81 repealed this section and replaced with the new one while it failed to follow the Article 28 of the TRIPS Agreement by not stating the rights to assign, transfer and concluding licensing contracts. Even though section 25 of the original law No. 65 of 1970 states some of them but not similar to the TRIPS Agreement especially in the rights to conclude licensing contracts. Therefore, this thesis recommends that an amendment in section 12 in order to include all the exclusive rights that are stated by the TRIPS Agreement will be necessary. Since the original Iraqi patent law does not contain any provision similar to Article 34 of the TRIPS Agreement, and none of the amendments including the CPA Order No. 81 added any similar provision, therefore, this thesis also recommends that similar provision should be inserted to the Iraqi patent law so that the patent owners enjoy better protection. VIII Section two was dedicated to the exceptions to exclusive rights of patent owners. It has been concluded that Article 30 of the TRIPS Agreement can be used to grant many types of exceptions to the exclusive rights of the patent owners by following the criteria in Article 30. There are three general criteria, the exception must be limited, the exception should not unreasonably conflict with a normal exploitation of the patent, and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the Conclusion 293 legitimate interests of third parties. Therefore, the member countries are allowed to place exceptions to exclusive rights as long as they follow the criteria. Next this section has discussed and analysed the compulsory licence. compulsory licence is another important tool that keeps balance between patent owner’s rights and need of society for patented products, through limiting the exclusive rights of the patent owners. Article 31 of the TRIPS Agreement provides for ‘other use without authorization of the right holder’, and the term ‘other use’ refers to other exceptions to the exclusive rights of the patent holders than what allowed under Article 30. Grounds of granting compulsory licence is left for the member countries to determine according to their circumstances. Nevertheless, some conditions and requirements are stated in other for member countries to follow before granting the compulsory licence either to government or third parties authorised by government. The thesis has discussed in detail these conditions and requirements and concluded despite the importance of the compulsory licence exception to the member countries so that use it for fulfilling their needs, however, some of the conditions have created obstacles in front of least developed and developing countries to use this exception. Article 31 lit. (f) is one of the major obstacles for the least developed and developing countries, as it requires the compulsory licence should be granted predominantly for the supply of the domestic market. The fact is that many of those countries do not possess enough technology to produce most of the patented products locally. This eventually lead to amendment of the TRIPS Agreement and Article 31bis was added. Article 31bis submitted to member countries to be accepted by the General Council on 6 December 2005 and entered into force only on 23 January 2017 in addition to an Annex and Appendix. This article was added to remedy the obstacles that Article 31 caused to the least developed and developing countries. Therefore, Article 31bis permits the member countries to grant compulsory licence so that majority of the pharmaceutical products under the licence can be exported to other member countries. Furthermore, Article 31bis exempts the importing SAMAN ABDULRAHMAN ALI 294 member country from adequate remuneration. This thesis has concluded that this Article can help the member countries to fulfil their needs of medicines for their public health. Following the above discussion, the thesis has discussed and analysed the position of Iraqi patent law to exception to exclusive rights of the patent owners. In fact, neither the original law No. 65 of 1970 nor the CPA Order No. 81 contain any regulations allowing exceptions within the scope of Article 30 of the TRIPS Agreement. Since the CPA Order No. 81 ordered with the intention of inline the Iraqi intellectual property laws with that of the TRIPS Agreement, and if the CPA acted in favour of Iraq should have included some important exceptions that are allowed with the scope of Article 30 such as parallel imports. Nevertheless, the original law No. 65 of 1970 provided for compulsory licence in a few cases such as, if the right holder did not exploit the invention in Iraq within three years of granting the patent, if the exploitation by the patent owner did not correspond to the needs of the country, if the patent owner stopped exploiting the invention for at least two years and in cases of dependent patent. However, the CPA Order No. 81 amended all the provisions that related to compulsory licence by extending the period of not exploiting the invention in Iraq in the first situation and removing all the other three situations, even though compulsory licence in cases of dependent patent is provided for by the TRIPS Agreement. The CPA Order No. 81 added some new provisions to the Law No. 65 of 1970 in regard of compulsory licence that have taken them from Article 31 of the TRIPS Agreement. In this the CPA Order NO. 81 has brought the original law closer to the TRIPS Agreement but failed to mention any circumstances that stated in Article 31bis of the TRIPS Agreement. Last but not least, Article 31bis took effect only in 2017 but the Doha Declaration and Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health took place between 2001 and 2003, therefore, the CPA was well aware of the problem of developing countries in regard of supplying medicines for their public health crises. For this reason, the CPA should have added the exceptions in Article 31bis, which basically has been taken from Conclusion 295 provisions of the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. Again, in this regard the CPA did not acted in interest of Iraq. 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