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  1. Designing pro-health competition policies in developing countries
    Autor*in: Ido, Vitor Henrique Pinto
    Erschienen: 2020
    Verlag:  South Centre, Geneva

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  2. TRIPS flexibilities on patent enforcement
    lessons from some developed countries relating to pharmaceutical patent protection
    Autor*in: Sarnoff, Joshua D.
    Erschienen: 2020
    Verlag:  South Centre, Geneva

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    Weitere Identifier:
    hdl: 10419/232243
    Schriftenreihe: Research paper / South Centre ; 119 (October 2020)
    Schlagworte: Access to Medicines; Affordable Medicines; Canada; Compulsory Licenses; COVID-19; Flexibilities; Generic Medicines; Health; Injunction; Innovation; Intellectual Property; Pandemic; Patent; Patent Linkage; Permanent Injunction; Pharmaceuticals; Preliminary Injunction; Public Health; TRIPS; United States (US)
    Umfang: 1 Online-Ressource (circa 56 Seiten)
  3. Interpreting the flexibilities under the TRIPS agreement
    Autor*in: Correa, Carlos María
    Erschienen: [2021]
    Verlag:  South Centre, Geneva

    While the TRIPS Agreement provides for minimum standards of protection of intellectual property, it leaves a certain degree of policy space for WTO members, whether developed or developing countries, to implement the Agreement's provisions in... mehr

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    While the TRIPS Agreement provides for minimum standards of protection of intellectual property, it leaves a certain degree of policy space for WTO members, whether developed or developing countries, to implement the Agreement's provisions in different manners, to legislate in areas not subject to the minimum standards under the Agreement, and to develop legal interpretations of such provisions to determine the scope and content of the applicable obligations. This paper focuses on some aspects of how panels and the Appellate Body of the WTO have interpreted said provisions. The paper also draws general conclusions for the implementation of TRIPS flexibilities, which are of crucial importance for the design of a pro-competitive intellectual property system and, in particular, for achieving public health objectives, as specifically recognized by the Doha Declaration on TRIPS and Public Health.

     
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  4. Special Section 301: US interference with the design and implementation of national patent laws
    Autor*in: Correa, Carlos M.
    Erschienen: 2020
    Verlag:  South Centre, Geneva

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  5. Non-violation and situation complaints under the TRIPS Agreement
    implications for developing countries
    Autor*in: Syam, Nirmalya
    Erschienen: 2020
    Verlag:  South Centre, Geneva

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  6. Guide for the granting of compulsory licenses and government use of pharmaceutical patents
    Autor*in: Correa, Carlos María
    Erschienen: 2020
    Verlag:  South Centre, Geneva

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  7. Guía para la concesión de licencias obligatorias y uso gubernamental de patentes farmacéuticas
    Autor*in: Correa, Carlos María
    Erschienen: 2020
    Verlag:  South Centre, Ginebra

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    Weitere Identifier:
    hdl: 10419/232228
    Schriftenreihe: Documento de investigación / South Centre ; 107 (Diciembre de 2020)
    Schlagworte: Access to Medicines; Affordable Medicines; Compulsory Licenses; COVID-19; Data Exclusivity; Diagnostics; Doha Declaration on the TRIPS Agreement and Public Health; Evergreening; Flexibilities; Global Health; Government Use; Health; Innovation; Intellectual Property; Least Developed Countries (LDCs); Patent; Pharmaceuticals; Public Health; Research and Development (R&D); TRIPS; Vaccines; Voluntary License; WHO; WHO Global Strategy (GSPOA); World Health Organization (WHO)
    Umfang: 1 Online-Ressource (circa 44 Seiten), Illustrationen
  8. Intersección entre competencia y patentes
    hacia un ejercicio pro-competitivo de los derechos de patente en el sector farmacéutico
    Autor*in: Rodríguez Gómez, María Juliana
    Erschienen: 2020
    Verlag:  South Centre, Ginebra

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    Weitere Identifier:
    hdl: 10419/232225
    Schriftenreihe: Documento de investigación / South Centre ; 105 (Marzo de 2020)
    Schlagworte: Access to Medicines; Affordable Medicines; Competition; Compulsory Licenses; Evergreening; Health; Industrial Property; Innovation; Intellectual Property; Patent; Pharmaceuticals; Public Health; Research and Development (R&D); Right to Health; Technology Transfer; TRIPS
    Umfang: 1 Online-Ressource (circa 54 Seiten), Illustrationen
  9. Eighteen years after Doha
    an analysis of the use of public health TRIPS flexibilities in Africa
    Autor*in: Vawda, Yousuf A.; Shozi, Bonginkosi
    Erschienen: 2020
    Verlag:  South Centre, Geneva

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  10. Twenty years after Doha
    an analysis of the use of the TRIPS Agreement's public health flexibilities in India
    Autor*in: Abbas, Muhammad Zaheer
    Erschienen: [2022]
    Verlag:  South Centre, Geneva, Switzerland

    The World Trade Organization (WTO) linked intellectual property protection with trade. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), however, included a number of public health flexibilities in order to... mehr

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    The World Trade Organization (WTO) linked intellectual property protection with trade. The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), however, included a number of public health flexibilities in order to provide latitude to the Member States to tailor their national patent laws to fit their individual needs. In 2001, the Doha Declaration further clarified and reaffirmed the existing TRIPS flexibilities. This paper argues that India has taken the lead role in enacting the TRIPS Agreement's substantive and procedural patent flexibilities by introducing unique legislative measures to deal with the problem of access to medicines. This article evaluates India's use of section 3(d) as a subject matter exclusivity provision. It examines constitutional validity and TRIPS compliance of section 3(d). It also evaluates India's use of the flexibility to define the term "inventive step". Moreover, this article evaluates India's use of compulsory licensing, the most notable exception to patent rights provided under the TRIPS Agreement. This empirical study is important in the context of the COVID-19 pandemic, which has once again highlighted the same public health issues that the Doha Declaration sought to address twenty years ago.

     
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    Weitere Identifier:
    hdl: 10419/270383
    Schriftenreihe: Research paper / South Centre ; 158 (15 June 2022)
    Schlagworte: Access to Medicines; Compulsory Licenses; COVID-19; Doha Declaration on the TRIPS Agreement and Public Health; Flexibilities; Health; India; Intellectual Property; Inventive Step; Pandemic; Patent; Patent Law; Public Health; Subject Matter Exclusions; TRIPS; TRIPS Agreement; TRIPS Flexibilities; World Trade Organization (WTO)
    Umfang: 1 Online-Ressource (circa 38 Seiten)
  11. Lessons from India's implementation of Doha Declaration on TRIPS and Public Health
    Autor*in: Batra, Nanditta
    Erschienen: [2022]
    Verlag:  South Centre, Geneva, Switzerland

    The major bone of contention between the developed and developing countries in the TRIPS negotiations was patents for pharmaceuticals. The US-led developed countries bloc argued in favour of patents for pharmaceuticals amidst opposition from Brazil,... mehr

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    The major bone of contention between the developed and developing countries in the TRIPS negotiations was patents for pharmaceuticals. The US-led developed countries bloc argued in favour of patents for pharmaceuticals amidst opposition from Brazil, India and other countries. Ample evidence, including patented AZT for HIV/AIDS treatment, showed that patents could make life saving drugs prohibitively expensive. Notwithstanding the effect of patents on access to medicines, Article 27 of the TRIPS Agreement ordained patents for inventions "in all fields of technology". While the genie was out of the bottle in the form of patents for pharmaceuticals, the developing countries were able to extract some procedural and substantive flexibilities like transition period, parallel importation and compulsory licensing to leverage the IP system to further public health. However, there was uncertainty with respect to the interpretation of TRIPS agreement, scope of the flexibilities and Member States' rights to use them. It is in this background that the historic Doha Declaration on the TRIPS Agreement and Public Health assumed importance as it reaffirmed the rights of the Member States to take measures to protect public health, reconciled the interpretative tensions in the text of TRIPS Agreement and clarified the scope of some of the flexibilities and attempts to find solutions to the problems faced by countries that do not have sufficient manufacturing facilities. The Declaration which was initially dismissed by some scholars as "non-binding," "soft law" has been held by WTO Dispute Settlement Body (DSB) to constitute a "subsequent agreement" which must be followed in interpreting the provisions of TRIPS Agreement (Australia-Tobacco Plain Packaging Case)

     
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    Weitere Identifier:
    hdl: 10419/270393
    Schriftenreihe: Research paper / South Centre ; 166 (6 October 2022)
    Schlagworte: Access to Medicines; Compulsory Licenses; Dispute Settlement; Doha Declaration on the TRIPS Agreement and Public Health; Flexibilities; Health; India; Intellectual Property; Intellectual Property Rights (IPRs); Parallel Importation; Patent; Patentability Criteria; Pharmaceuticals; Public Health; Transition Period; TRIPS; TRIPS Agreement; TRIPS Flexibilities; World Trade Organization (WTO)
    Umfang: 1 Online-Ressource (circa 46 Seiten), Illustrationen
  12. Experiencias internacionales sobre la concesión de licencias obligatorias por razones de salud pública
    Autor*in: Puente, Catalina de la; Palopoli, Gastón; Silvestrini, Constanza; Correa, Juan
    Erschienen: [2023]
    Verlag:  South Centre, Ginebra, Suiza

    The purpose of this study is to analyze the compulsory licensing (CL) regimes in selected countries, in particular the economic elements of the granting of Compulsory Licenses (CLs), the determination and negotiation of royalties to the right holder.... mehr

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    The purpose of this study is to analyze the compulsory licensing (CL) regimes in selected countries, in particular the economic elements of the granting of Compulsory Licenses (CLs), the determination and negotiation of royalties to the right holder. For this purpose, a descriptive and exploratory analysis of the experiences of granting CLs in selected countries was carried out, focusing on the experiences of developing countries considering their proximity to the Argentine case. In particular, examples of experiences of issuance of CLs or governmental use measures in developing countries are discussed. With a special focus on Latin America, where only two countries have made use of such measures for public health reasons (Ecuador and Brazil). In addition, the effectiveness of the use of CLs or governmental use measures in the reduction of prices is examined, where significant savings are evidenced. In conclusion, the paper proposes the elaboration of a methodology in relation to royalties for Argentina through a payment range that takes into consideration criteria of accessibility and affordability of the licensed technology, as well as the sustainability of the financing agents' budgets.

     
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    hdl: 10419/278410
    Schriftenreihe: Documento de investigación / South Centre ; 175 (22 de marzo de 2023)
    Schlagworte: Access to Medicines; Argentina; Compulsory Licenses; COVID-19; Doha Declaration on the TRIPS Agreement and Public Health; Flexibilities; Government Use; Health; Intellectual Property; Latin America; Pandemic; Patent; Pharmaceuticals; Public Health; TRIPS; TRIPS Agreement; TRIPS Flexibilities; WTO TRIPS Decision on COVID-19 Vaccines
    Umfang: 1 Online-Ressource (circa 62 Seiten), Illustrationen
  13. TRIPS flexibilities and access to medicines
    an evaluation of barriers to employing compulsory licenses for patented pharmaceuticals at the WTO
    Autor*in: Wong, Anna S. Y.; Cole, Clarke B.; Kohler, Jillian Clare
    Erschienen: [2022]
    Verlag:  South Centre, Geneva, Switzerland

    Under Articles 31 and 31bis of the TRIPS Agreement, WTO members may validly sanction the use of a patented invention without the patent owner's authorization by issuing a compulsory license (CL). In the pharmaceuticals space, governments have... mehr

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    Under Articles 31 and 31bis of the TRIPS Agreement, WTO members may validly sanction the use of a patented invention without the patent owner's authorization by issuing a compulsory license (CL). In the pharmaceuticals space, governments have historically employed compulsory licenses to compel originator manufacturers to license their patents to generic manufacturers before patent expiry, increasing the supply and reducing the price of patented pharmaceuticals domestically. This paper evaluates the three primary barriers to employing compulsory licenses for pharmaceuticals underscored by members during TRIPS waiver discussions at the WTO: (1) a lack of enabling domestic legislation, (2) a lack of domestic manufacturing capacity coupled with an unworkable Article 31bis importation system, and (3) consistent political pressure from other members to refrain from issuing compulsory licenses. A survey of members' domestic compulsory license legislation finds that virtually all members have enacted enabling legislation under Article 31 for the issuance of compulsory licenses to supply their local markets. However, implementation of Article 31bis is limited by a lack of enabling compulsory license export legislation, streamlined administrative processes, or both across all members, preventing members lacking domestic manufacturing capacity from importing pharmaceuticals. An analysis of USTR Special 301 Reports from 1994-2021 further reveals that countries have consistently been placed on the Special 301 Report Priority Watch List for issuing pharmaceutical compulsory licenses, with instances as recent as 2020. As such, general reluctance by members to issue compulsory licenses due to overt political pressure through the Special 301 Report is likely warranted. These results highlight a range of barriers preventing the full use of compulsory licenses for pharmaceuticals under the current Article 31 and 31bis framework, with the effects disproportionately borne by member states lacking domestic manufacturing capacity.

     
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    hdl: 10419/278265
    Schriftenreihe: Research paper / South Centre ; 168 (28 October 2022)
    Schlagworte: Access to Medicines; Article 31 TRIPS; Article 31bis; Compulsory Licenses; COVID-19; Flexibilities; Generic Medicines; Intellectual Property; Pandemic; Patent; Pharmaceuticals; Public Health; TRIPS; TRIPS Agreement; TRIPS Flexibilities; TRIPS Waiver; US Special Section 301; World Trade Organization (WTO)
    Umfang: 1 Online-Ressource (circa 34 Seiten), Illustrationen
  14. The WTO TRIPS decision on COVID-19 vaccines
    what is needed to implement it?
    Autor*in: Correa, Carlos María; Syam, Nirmalya
    Erschienen: [2022]
    Verlag:  South Centre, Geneva, Switzerland

    The 12th WTO Ministerial Conference adopted a Ministerial Decision on the TRIPS Agreement on 17 June 2022. This partially concluded almost two years of protracted discussions in response to a proposal by India and South Africa for a waiver from... mehr

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    The 12th WTO Ministerial Conference adopted a Ministerial Decision on the TRIPS Agreement on 17 June 2022. This partially concluded almost two years of protracted discussions in response to a proposal by India and South Africa for a waiver from certain obligations under the TRIPS Agreement for health products and technologies for the prevention, treatment and containment of COVID-19. The adopted Decision only waives the obligation under article 31 (f) of the TRIPS Agreement. Developing country WTO members are now allowed to export any proportion of vaccines, including ingredients and processes, necessary for the COVID-19 pandemic that are manufactured under a compulsory license or government use authorization to other developing countries. It also contains some clarifications of relevant TRIPS provisions, while introducing a number of conditionalities that are not present in the TRIPS Agreement. This paper examines the object and scope of the Decision, the requirements established for its use, and the required actions to be taken by WTO members to implement it.

     
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    hdl: 10419/278266
    Schriftenreihe: Research paper / South Centre ; 169 (8 November 2022)
    Schlagworte: Compulsory Licenses; COVID-19; Diagnostics; Dispute Settlement; Doha Declaration on the TRIPS Agreement and Public Health; Flexibilities; Government Use; MC12; Pandemic; Parallel Importation; Test Data; Therapeutics; TRIPS; TRIPS Agreement; TRIPS Flexibilities; TRIPS Waiver; Vaccines; Voluntary License; World Trade Organization (WTO); WTO TRIPS Decision on COVID-19 Vaccines
    Umfang: 1 Online-Ressource (circa 36 Seiten)
  15. Promoting Jordan's use of compulsory licensing during the pandemic
    Autor*in: Barqawi, Laila
    Erschienen: [2023]
    Verlag:  South Centre, Geneva, Switzerland

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    hdl: 10419/278682
    Schriftenreihe: Research paper / South Centre ; 184 (15 September 2023)
    Schlagworte: Access to Medicines; Article 31bis; Compulsory Licenses; Compulsory Licensing; COVID-19; Emergency Use Authorization (EUA); Health; Intellectual Property; Jordan; Jordanian - US Free Trade Agreement (JUSFTA); Pandemic; Pharmaceuticals; TRIPS; TRIPS Agreement
    Umfang: 1 Online-Ressource (circa 44 Seiten)
  16. Licencias obligatorias para exportación
    operacionalización en el orden jurídico argentino
    Autor*in: Delich, Valentina
    Erschienen: [2024]
    Verlag:  South Centre, Ginebra, Suiza

    In 2017, the amendment to the Agreement on Trade-Related Intellectual Property Rights (TRIPS) entered into force, whereby Article 31bis was included in its text. This provision allows compulsory licensing for exports to third countries with no or... mehr

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    In 2017, the amendment to the Agreement on Trade-Related Intellectual Property Rights (TRIPS) entered into force, whereby Article 31bis was included in its text. This provision allows compulsory licensing for exports to third countries with no or insufficient local production capacity. The aim is to alleviate the difficulties faced by countries without drug production infrastructure so that they can make effective use of compulsory licensing and thus strengthen access to medicines at a lower price. Argentina is a country that has drug production infrastructure and could potentially become an efficient exporter. This paper explores the possible implementation of art. 31 bis in Argentina's legislation, proposing to incorporate into the national patent law the concept of humanitarian compulsory licensing.

     
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    Schriftenreihe: Documento de investigación / South Centre ; 196 (19 de abril de 2024)
    Schlagworte: Access to Medicines; Argentina; Article 31bis; Compulsory Licenses; Compulsory Licensing; Export; Intellectual Property; Local Production; Patent; Patent Law; Public Health; TRIPS; TRIPS Agreement; TRIPS Flexibilities
    Umfang: 1 Online-Ressource