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  1. Directives pour l'examen des demandes de brevet relatives aux produits pharmaceutiques
    Author: Correa, Carlos María
    Published: [2023]
    Publisher:  South Centre, Genève, Suisse

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    Source: Union catalogues
    Language: French
    Media type: Book
    Format: Online
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    hdl: 10419/278403
    Series: Document de recherche / South Centre ; 171 (31 janvier 2023)
    Subjects: Arzneimittel; Patent; Patentrecht; Theorie; Access to Medicines; Intellectual Property; Patent; Pharmaceuticals; Public Health
    Scope: 1 Online-Ressource (circa 74 Seiten), Illustrationen
  2. Analysis of COVID-related patents for antibodies and vaccines
    Author: Santhanam, Kausalya
    Published: [2023]
    Publisher:  South Centre, Geneva, Switzerland

    This paper provides an analysis of patents covering selected antibodies and vaccines used in the treatment or prevention of COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with... more

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    This paper provides an analysis of patents covering selected antibodies and vaccines used in the treatment or prevention of COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications. The antibody combination considered for the patent analysis in this paper are Casirivimab and Imdevimab. The vaccines considered for the patent analysis are mRNA-1273, Sputnik, ChAdOx1 nCoV-19 vaccine (AZD1222). The analysis was completed in May 2022.

     
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    Source: Union catalogues
    Language: English
    Media type: Book
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    hdl: 10419/278404
    Series: Research paper / South Centre ; 173 (7 February 2023)
    Subjects: Access to Medicines; Antibodies; COVID-19; Global Health; Health; Intellectual Property; Pandemic; Patent; Patent Examination; Patent Law; Patent Offices; Patent Policy; Patent Protection; Public Health; Vaccines
    Scope: 1 Online-Ressource (circa 30 Seiten)
  3. Leading and coordinating global health
    strengthening the World Health Organization
    Author: Syam, Nirmalya
    Published: [2023]
    Publisher:  South Centre, Geneva, Switzerland

    The World Health Organization (WHO) should act as the directing and coordinating authority in global health but it has been steadily marginalized over time by design, through criticism as an inefficient organization, the reduction of assessed... more

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    The World Health Organization (WHO) should act as the directing and coordinating authority in global health but it has been steadily marginalized over time by design, through criticism as an inefficient organization, the reduction of assessed contributions and consequent impoverishment, and the proliferation of "new" international health agencies to which WHO has been compelled to cede operational space. This paper discusses how such marginalization of the WHO is in the interest of the dominant actors in global health, and leads to the neglect of health as a development issue. Today the global health system is more fragmented than it was when the WHO was established in 1948. Rich donor countries and corporations dominate multistakeholder governance structures in health partnerships, marginalizing most of the WHO membership and, notably, the Global South, in their decision-making. A consequence of this fragmentation in global health governance is that the space of the only multilateral organization where developing countries have an equal presence in terms of participation and decision-making as sovereign States -WHO- has been marginalized. Consequently, the development dimension of health is also marginalized and only the development assistance aspects of it receive major attention through vertical programmes and agencies addressing limited health needs without effectively addressing the basic need of strengthening health systems. Therefore, for developing countries it is imperative that WHO is effectively retooled to act as the leading and coordinating authority on global health with adequate legal powers, as well as institutional and financial capacities to do so without undue influence from donor countries and entities that have interests in the private sector. This would enable WHO to ensure that the interests of all countries are fairly addressed in its normative and operational activities. Such a transformation of WHO would require action both within and outside the organization. The paper proposes some suggestions in this regard.

     
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    Source: Union catalogues
    Language: English
    Media type: Book
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    hdl: 10419/278405
    Series: Research paper / South Centre ; 174 (7 February 2023)
    Subjects: Access to Medicines; COVID-19; Epidemics; Essential Drugs; Food Standards; Global Health; Health; Health Security; Health Systems; Intellectual Property; International Cooperation; Pandemic; Primary Health Care (PHC); World Health Organization (WHO)
    Scope: 1 Online-Ressource (circa 50 Seiten)
  4. Experiencias internacionales sobre la concesión de licencias obligatorias por razones de salud pública
    Author: Puente, Catalina de la; Palopoli, Gastón; Silvestrini, Constanza; Correa, Juan
    Published: [2023]
    Publisher:  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.... more

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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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    Source: Union catalogues
    Language: Spanish
    Media type: Book
    Format: Online
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    hdl: 10419/278410
    Series: Documento de investigación / South Centre ; 175 (22 de marzo de 2023)
    Subjects: 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
    Scope: 1 Online-Ressource (circa 62 Seiten), Illustrationen
  5. Promoting Jordan's use of compulsory licensing during the pandemic
    Author: Barqawi, Laila
    Published: [2023]
    Publisher:  South Centre, Geneva, Switzerland

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    Source: Union catalogues
    Language: English
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    hdl: 10419/278682
    Series: Research paper / South Centre ; 184 (15 September 2023)
    Subjects: 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
    Scope: 1 Online-Ressource (circa 44 Seiten)
  6. Neglected dimension of the inventive step as applied to pharmaceutical and biotechnological products
    the case of Sri Lanka's patent law
    Author: Fernando, Ruwan
    Published: [2023]
    Publisher:  South Centre, Geneva, Switzerland

    Apart from the basic statutory definition in section 65 of the Intellectual Property Act of Sri Lanka, there do not appear to be any detailed statutory guidelines or judicial decisions to provide any framework for the assessment of inventive step in... more

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    Apart from the basic statutory definition in section 65 of the Intellectual Property Act of Sri Lanka, there do not appear to be any detailed statutory guidelines or judicial decisions to provide any framework for the assessment of inventive step in Sri Lanka. The current statutory definition is highly insufficient to evaluate the standard of obviousness in relation to biotechnological and pharmaceutical claims based on a combination or modification of a prior art reference. The Courts in both developed and developing countries have adopted a variety of tests to evaluate the obviousness standard of a claimed invention based on a combination or modification of a prior art reference. Sri Lanka, as a developing country, should look at the development that has taken place in other jurisdictions and adapt the patent law to local conditions when developing tests or guidelines in a manner that is compatible with the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and its biotechnology/pharmaceutical policy guidelines. This approach that is appropriate to Sri Lanka is twofold. First, it is most likely to prevent the issuance of patents on trivial or incremental inventions that do not provide any technical advance to the existing prior art and are a mere extension of what is already known in the prior art. Second, it is most likely to protect genuine technical advances to the existing prior art while at the same time enhancing competition and promoting local innovations so that the local researchers will be able to draw on the existing knowledge for the purpose of follow-on innovations.

     
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    Language: English
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    hdl: 10419/278606
    Series: Research paper / South Centre ; 180 (9 August 2023)
    Subjects: Access to Medicines; Biotechnology; Health; Innovation; Intellectual Property; Inventive Step; Patent; Patent Law; Pharmaceuticals; Sri Lanka; TRIPS; TRIPS Agreement
    Scope: 1 Online-Ressource (circa 60 Seiten)
  7. An examination of selected public health exceptions in Asian patent laws
    Author: Adachi, Kiyoshi
    Published: [2022]
    Publisher:  South Centre, Geneva, Switzerland

    This study examines the variations within Asia of two exceptions to patent rights that are commonly justified under Article 30 of the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS... more

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    This study examines the variations within Asia of two exceptions to patent rights that are commonly justified under Article 30 of the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement), namely the research and experimentation exception and the regulatory review (or "Bolar") exception. Both these exceptions are important in the context of the 2001 Doha Declaration on the TRIPS Agreement and Public Health insofar as they are designed to provide flexibility to protect public health and support countries' overall scientific and technological aspirations. The study examines, from a comparative perspective, examples of these respective exceptions in patent legislation in South, Southeast and East Asia, and identifies peculiarities in the variations among countries in these sub-regions.

     
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    Source: Union catalogues
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    hdl: 10419/262127
    Series: Research paper / South Centre ; 152 (21 April 2022)
    Subjects: Access to Medicines; Article 30 TRIPS; Asia; Bolar; Doha Declaration on the TRIPS Agreement and Public Health; East Asia; Experimentation Exception; Flexibilities; Health; Intellectual Property; Patent; Public Health; Research Exception; South Asia; South East Asia; TRIPS; TRIPS Agreement
    Scope: 1 Online-Ressource (circa 32 Seiten)
  8. Patent analysis for medicines and biotherapeutics in trials to treat COVID-19
    Author: Ravi, Srividya
    Published: [2022]
    Publisher:  South Centre, Geneva, Switzerland

    This report provides an analysis of patents covering medicines in trials to treat COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the... more

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    This report provides an analysis of patents covering medicines in trials to treat COVID-19. The aim of the report is to support national patent offices and interested parties in developing countries with information that can serve as guidance for the examination of the claims contained in relevant patents or patent applications. The medicines considered for the patent analysis in this report are remdesivir, ruxolitinib, favipiravir, molnupiravir and nirmatrelvir, and the biotherapeutics tocilizumab, siltuximab and sarilumab.

     
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    Source: Union catalogues
    Language: English
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    hdl: 10419/262128
    Series: Research paper / South Centre ; 153 (26 April 2022)
    Subjects: Access to Medicines; Affordable Medicines; Biotherapeutics; Coronavirus; COVID-19; Favipiravir; Global Health; Health; Intellectual Property; Molnupiravir; Nirmatrelvir; Pandemic; Patent; Patent Offices; Public Health; Remdesivir; Ruxolitinib; Sarilumab; Siltuximab; Tocilizumab
    Scope: 1 Online-Ressource (circa 50 Seiten), Illustrationen
  9. TRIPS flexibilities and access to medicines
    an evaluation of barriers to employing compulsory licenses for patented pharmaceuticals at the WTO
    Author: Wong, Anna S. Y.; Cole, Clarke B.; Kohler, Jillian Clare
    Published: [2022]
    Publisher:  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... more

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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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    Source: Union catalogues
    Language: English
    Media type: Book
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    hdl: 10419/278265
    Series: Research paper / South Centre ; 168 (28 October 2022)
    Subjects: 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)
    Scope: 1 Online-Ressource (circa 34 Seiten), Illustrationen
  10. Left on our own
    COVID-19, TRIPS-Plus Free Trade Agreements, and the Doha Declaration on TRIPS and Public Health
    Author: Omino, Melissa; Kahumbu, Joanna
    Published: [2022]
    Publisher:  South Centre, Geneva, Switzerland

    The cusp of the twentieth anniversary of the WTO Doha Declaration on the TRIPS Agreement and Public Health (hereafter "the Declaration") was marked by a global pandemic. The Declaration and its iteration in the Agreement on Trade Related Aspects of... more

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    The cusp of the twentieth anniversary of the WTO Doha Declaration on the TRIPS Agreement and Public Health (hereafter "the Declaration") was marked by a global pandemic. The Declaration and its iteration in the Agreement on Trade Related Aspects of Intellectual Property Rights (hereafter "TRIPS") Article 31 bis, should have helped to contain the devastation in least developed and developing countries. The reality is that the pandemic is still ongoing, and the Global South led by South Africa and India are seeking a waiver of provisions to the TRIPS Agreement to ensure that COVID-19 therapeutics, diagnostics, and vaccines reach their citizens in order to contain the spread of the COVID-19 virus ("the TRIPS waiver"). These citizens are especially vulnerable because of their inability to access vaccines due to their prices and supply shortages caused by the refusal to share manufacturing technology. The Doha Declaration aimed at reaffirming the interpretation and implementation of the TRIPS Agreement to support WTO members' right to protect public health and promote access to medicines. However, the operationalization of the Declaration via Article 31bis of TRIPS has been cumbersome and procedurally difficult to navigate. This paper argues that the current iteration of the Doha Declaration within TRIPS fails to meet the objectives of the Declaration as demonstrated by the need for a further waiver of the TRIPS agreement. It also attempts to "reimagine" Article 31 bis in light of the TRIPS waiver from the position of the Global South to make it more equitable and practicable and maintain the spirit of the Declaration.

     
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    hdl: 10419/278267
    Series: Research paper / South Centre ; 170 (17 November 2022)
    Subjects: Access to Medicines; Article 31bis; COVID-19; Diagnostics; Doha Declaration on the TRIPS Agreement and Public Health; Flexibilities; Free Trade Agreements (FTAs); Intellectual Property; Kenya; Pandemic; Paragraph 6; Public Health; Therapeutics; TRIPS; TRIPS Agreement; TRIPS Flexibilities; TRIPS Plus; TRIPS Waiver; United States-Kenya Free Trade Agreement (USKEFTA); Vaccines
    Scope: 1 Online-Ressource (circa 36 Seiten)
  11. Pautas para el examen de solicitudes de patentes relacionadas con productos farmacéuticos
    Author: Correa, Carlos María
    Published: [2022]
    Publisher:  South Centre, Ginebra, Suiza

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    Source: Union catalogues
    Language: Spanish
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    hdl: 10419/278268
    Series: Documento de investigación / South Centre ; 171 (29 de noviembre de 2022)
    Subjects: Arzneimittel; Patent; Patentrecht; Theorie; Access to Medicines; Intellectual Property; Patent; Pharmaceuticals; Public Health
    Scope: 1 Online-Ressource (circa 72 Seiten), Illustrationen
  12. The intersection between intellectual property, public health and access to climate-related technologies
    Author: Batista, Lívia Regina
    Published: [2023]
    Publisher:  South Centre, Geneva, Switzerland

    On the 20th anniversary of the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health adopted by the World Trade Organization, we realize that its impact is beyond issues of... more

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    On the 20th anniversary of the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health adopted by the World Trade Organization, we realize that its impact is beyond issues of public health stricto sensu. The Doha Declaration has inspired discussions at the Council for TRIPS regarding access to climate-related technologies. Climate change is the main and most globalized environmental problem with adverse effects on public health, especially for the vulnerable communities in the Global-South. The main argument of the proponents of the discussion in the TRIPS Council is the need to rebalance public interests (such as public health and environmental/climate issues) with the private/economic interests of the most powerful countries and corporations. This debate addresses both the recognition of intellectual property rights as an important means for the promotion of technological innovation, and the required wider dissemination of technologies - be they medicines or climate-related technologies. This research paper explores the possibilities that the TRIPS Agreement and the Doha Declaration create for international transfer of climate-related technologies. Even though such discussions on climate-related technologies have initially failed in linking climate change and public health, as well as the rhetoric of human rights, the relevance of the topic remains. Besides that, the response to public health issues also must learn from the experience in climate change, such as the case studies evidencing the insufficiency and inefficiency of fast-tracking programs to provide for a wider dissemination of technologies - which have now been widely replicated to address the COVID-19 pandemic. Such comparison can also be an entrance point to discuss the public health implications for the international regime on climate change, highlighting that such issues are deeply intertwined, and need to be addressed jointly as well.

     
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    Source: Union catalogues
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    hdl: 10419/283481
    Series: Research paper / South Centre ; 188 (7 December 2023)
    Subjects: Access to Medicines; Climate Change; Climate-related Technologies; COVID-19; Doha Declaration on the TRIPS Agreement and Public Health; Health; Human Rights; Innovation; Intellectual Property; Intellectual Property Rights (IPRs); Pandemic; Public Health; Technology Transfer; TRIPS; TRIPS Agreement; TRIPS Council
    Scope: 1 Online-Ressource (circa 46 Seiten)
  13. Patentamiento de anticuerpos monoclonales
    el caso de Argentina
    Author: Correa, Juan; Puente, Catalina de la; Picasso, Ramiro; Silvestrini, Constanza
    Published: [2023]
    Publisher:  South Centre, Ginebra, Suiza

    This research paper aims to identify, describe and analyze the patents on monoclonal antibodies granted by the National Institute of Industrial Property (INPI) of Argentina, from 2010 to 2020 inclusive. The research includes the protected subject... more

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    This research paper aims to identify, describe and analyze the patents on monoclonal antibodies granted by the National Institute of Industrial Property (INPI) of Argentina, from 2010 to 2020 inclusive. The research includes the protected subject matter and the universe of applicants, among other aspects. To this end, a database of patents and applications was created, where the characteristics of the patent applications and granted patents, ownership and nationality of the applicants, status of the applications, the time it takes to process a patent application and divisional patents are examined. The document also presents recommendations on public policy applicable to the examination of patent applications on monoclonal antibodies.

     
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    hdl: 10419/283483
    Series: Documento de investigación / South Centre ; 186 (14 de noviembre de 2023)
    Subjects: Access to Medicines; Argentina; Biologicals; Biologics; Biopharmaceuticals; Biosimilars; Intellectual Property; Monoclonal Antibodies; Patent; Public Health
    Scope: 1 Online-Ressource (circa 50 Seiten), Illustrationen
  14. Can negotiations at the World Health Organization lead to a just framework for the prevention, preparedness and response to pandemics as global public goods?
    Author: Tellez, Viviana Muñoz
    Published: [2022]
    Publisher:  South Centre, Geneva

    This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO... more

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    This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO processes of: 1) review of recommendations under examination by the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, 2) consideration of potential amendments to the International Health Regulations (IHR) 2005, and 3) elaboration of a draft text for an international instrument on pandemic preparedness and response.

     
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  15. Manufacturing for export
    a TRIPS-consistent pro-competitive exception
    Author: Correa, Carlos María; Correa, Juan I.
    Published: [2022]
    Publisher:  South Centre, Geneva, Switzerland

    The paper discusses the flexibilization of the sui generis system of supplementary protection certificates (SPCs) under European law recently introduced to allow for the manufacturing, stockpiling and export of covered products. Against this... more

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    The paper discusses the flexibilization of the sui generis system of supplementary protection certificates (SPCs) under European law recently introduced to allow for the manufacturing, stockpiling and export of covered products. Against this background, it examines the viability under the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement) of an exception allowing for the manufacture and export of patent-protected products. It concludes that such an exception would promote competition and enhance access to medicines (including biologicals) for the general public while being consistent with Article 30 of the TRIPS Agreement if read in accordance with the principles of interpretation of customary international law.

     
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    Language: English
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    hdl: 10419/270380
    Series: Research paper / South Centre ; 155 (27 May 2022)
    Subjects: Access to Medicines; Biologicals; Competition; Customary International Law; European Law; Exclusive Rights; Export; Health; Intellectual Property; Manufacture; Patent; Sui Generis System; Supplementary Protection Certificates (SPCs); TRIPS; TRIPS Agreement; World Trade Organization (WTO)
    Scope: 1 Online-Ressource (circa 38 Seiten), Illustrationen
  16. Twenty years after Doha
    an analysis of the use of the TRIPS Agreement's public health flexibilities in India
    Author: Abbas, Muhammad Zaheer
    Published: [2022]
    Publisher:  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... more

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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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    Source: Union catalogues
    Language: English
    Media type: Book
    Format: Online
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    hdl: 10419/270383
    Series: Research paper / South Centre ; 158 (15 June 2022)
    Subjects: 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)
    Scope: 1 Online-Ressource (circa 38 Seiten)
  17. ¿Podrán las negociaciones en la organización mundial de la salud resultar en un marco justo para la prevención, la preparación y la respuesta ante pandemias como bienes públicos globales?
    Author: Tellez, Viviana Muñoz
    Published: [2022]
    Publisher:  South Centre, Ginebra, Suiza

    This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO... more

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    This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO processes of: 1) review of recommendations under examination by the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, 2) consideration of potential amendments to the International Health Regulations (IHR) 2005, and 3) elaboration of a draft text for an international instrument on pandemic preparedness and response.

     
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  18. Les négociations au sein de l'Organisation mondiale de la santé peuvent-elles aboutir à un cadre juste pour la prévention, la préparation et la riposte aux pandémies en tant que bien public mondial?
    Author: Tellez, Viviana Muñoz
    Published: [2022]
    Publisher:  South Centre, Genève, Suisse

    This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO... more

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    This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO processes of: 1) review of recommendations under examination by the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, 2) consideration of potential amendments to the International Health Regulations (IHR) 2005, and 3) elaboration of a draft text for an international instrument on pandemic preparedness and response.

     
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  19. Brazilian competition law and access to health in Brazil
    exploitative pricing in the pharmaceutical sector
    Author: Castro, Bruno Braz de
    Published: [2022]
    Publisher:  South Centre, Geneva

    This paper aims to analyze the interfaces between Brazilian Competition Law and the issue of access to medicines, with a special focus on abuse of industrial property rights and related exclusionary and exploitative effects. The paper analyzes the... more

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    This paper aims to analyze the interfaces between Brazilian Competition Law and the issue of access to medicines, with a special focus on abuse of industrial property rights and related exclusionary and exploitative effects. The paper analyzes the case law of Brazilian Administrative Council for Economic Defense (CADE) in the pharmaceutical sector and discusses abusive practices such as illegitimately imposing non-existent or invalid intellectual property rights with anticompetitive purposes. It then addresses abusive strategies in the exercise of industrial property rights which are, in essence, valid: i.e., exclusionary practices, aimed at artificially raising barriers to entry; and exploitative practices, directly translated as the exercise of market power to the detriment of the consumer. The latter ultimately result in exploitative excessive prices; contractual, quality or privacy degradation; and restrictions on supply, such as by hoarding/preventing the exploitation of industrial property rights. The paper concludes that the prohibition of exploitative pricing under the current competition law is legally valid and effective, with certain methodological concerns towards reducing the risk of wrongful convictions (for instance, by applying screening tests to determine the markets that are candidates for intervention). In view of such guidelines, the pharmaceutical industry appears to be an important candidate for antitrust attention, given the magnitude of the harm potentially derived from non-intervention against the practice. Remedies in this area, importantly, should focus on identifying and solving the sector's structural competitive problems. In the case of medicines subject to price regulation by the Drug Market Regulation Chamber (CMED), the technical expertise of the competition authority may be of great value in terms of competition advocacy, a fact that is demonstrated in light of recent discussions on extraordinary price adjustments because of competitive problems in certain markets.

     
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    Source: Union catalogues
    Language: English
    Media type: Book
    Format: Online
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    hdl: 10419/270388
    Series: Research paper / South Centre ; 143 (11 January 2022)
    Subjects: Access to Healthcare; Access to Medicines; Antitrust; Brazil; Competition; Competition Law; Competition Policy; Competition Regulation; COVID-19; Health; Industrial Property; Industrial Property Rights; Intellectual Property; Intellectual Property Rights (IPRs); Pandemic; Pharmaceuticals
    Scope: 1 Online-Ressource (circa 58 Seiten)
  20. Lessons from India's implementation of Doha Declaration on TRIPS and Public Health
    Author: Batra, Nanditta
    Published: [2022]
    Publisher:  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,... more

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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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    Source: Union catalogues
    Language: English
    Media type: Book
    Format: Online
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    hdl: 10419/270393
    Series: Research paper / South Centre ; 166 (6 October 2022)
    Subjects: 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)
    Scope: 1 Online-Ressource (circa 46 Seiten), Illustrationen
  21. The human right to science
    from fragmentation to comprehensive implementation?
    Author: Larsen, Peter Bille; Pamintuan, Marjorie
    Published: [2022]
    Publisher:  South Centre, Geneva, Switzerland

    In times when the role of science in society is more debated than ever in polarized, politicized and partial terms, what is the role for the human right to science and rights-based approaches? The right to science remains poorly understood and... more

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    In times when the role of science in society is more debated than ever in polarized, politicized and partial terms, what is the role for the human right to science and rights-based approaches? The right to science remains poorly understood and neglected in both national and global human rights processes. Beyond defending the freedom of scientific expression, upholding the right to science is arguably fundamental to resolving key sustainability challenges of our times from climate change and the biodiversity crisis to global health and pandemics. The global COVID-19 pandemic has revealed persistent global inequalities not least in terms of how the privatization of science and current intellectual property regimes hinder just and equitable responses to access science and its benefits. This prompts the need for a shift from single-issue approaches to comprehensive and systematic treatment of the right to science as a bundle of human rights across multiple arenas to counter fragmentation and silo-tendencies.

     
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    Media type: Book
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    hdl: 10419/270390
    Series: Research paper / South Centre ; 163 (19 August 2022)
    Subjects: 2030 Agenda for Sustainable Development; Access to Medicines; Access to Science; Biodiversity; Climate Change; COVID-19; Global Health; Human Rights; Inequalities; Innovation; Intellectual Property; Pandemic; Right to Science; Science; Sustainability; Sustainable Development Goals (SDGs); Swiss Commission for UNESCO; Technology; UNESCO
    Scope: 1 Online-Ressource (circa 40 Seiten)
  22. Non-violation and situation complaints under the TRIPS Agreement
    implications for developing countries
    Author: Syam, Nirmalya
    Published: 2020
    Publisher:  South Centre, Geneva

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  23. Guide for the granting of compulsory licenses and government use of pharmaceutical patents
    Author: Correa, Carlos María
    Published: 2020
    Publisher:  South Centre, Geneva

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  24. Guía para la concesión de licencias obligatorias y uso gubernamental de patentes farmacéuticas
    Author: Correa, Carlos María
    Published: 2020
    Publisher:  South Centre, Ginebra

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  25. The comprehensive and progressive agreement for the trans-pacific partnership
    data exclusivity and access to biologics
    Author: Boru, Zeleke Temesgen
    Published: 2020
    Publisher:  South Centre, Geneva

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