Intellectual Property Primer on Pharmaceutical Patents with a Special Emphasis on Prodrugs and Metabolites

Author(s):  
Eyal H. Barash
Author(s):  
Kenneth C. Shadlen

The chapter provides brief introductions to intellectual property, patents, and pharmaceuticals to help the reader understand the nature of the enduring conflicts in this area. Prior to the 1990s few developing countries granted patents on pharmaceutical products, but changes in the global politics of intellectual property made doing so obligatory – the starting point for the analyses in this book. The chapter reviews the policy challenges that countries addressed in deciding how to introduce pharmaceutical patents and then in revising their new patent systems, and then presents the explanatory framework to account for cross-national and longitudinal variation. National forms of compliance with global changes are iterative and path-dependent processes, in that there are successive episodes of conflict, and the policy choices of one period exert influence on the policy choices in subsequent periods. Degrees of over-compliance with the new global order are produced through resolution of these two sets of conflicts.


2017 ◽  
Vol 59 (3) ◽  
pp. 376-393 ◽  
Author(s):  
M. Monirul Azam

Purpose This paper aims to analyse the impacts of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) as adopted by the World Trade Organization (WTO) on the pharmaceutical regulation and pricing of drugs in Bangladesh. The purpose of this paper is to explore how Bangladesh could adjust obligations for patent and pharmaceutical law reforms in the context of TRIPS Agreement while maintaining societal goals to ensure access to medicines. Another prime objective of this study is to examine viability of arguments regarding pharmaceutical patents for affordability and accessibility of pharmaceuticals in Bangladesh. Design/methodology/approach This paper used doctrinal research and case study using surveys and interviews in Bangladesh to understand the perceptions of different stakeholders regarding TRIPS and possible impacts on the local pharmaceutical industry and also consequences as to access to pharmaceuticals in terms of pricing, availability and affordability. Findings This study suggests that in the case of Bangladesh, the main health bottleneck is not patents or any drugs, but the lack of proper healthcare service, health infrastructure and lack of efficient healthcare personnel. Again, most of the necessary drugs for the local market are off patent, but patented drugs, issues of price, availability and affordability could become a concern for Bangladesh in situation of multi-drug resistance and for diseases like HIV AIDS, cancer and cardio-vascular problems. Research limitations/implications This study was based on randomly selected interview and surveys. To get a broader picture of the impacts of TRIPS compliant patent law and pharmaceutical patents in a country like Bangladesh, more in-depth socio-legal studies need to be conducted. Due to shortage of time and resources, it was not possible to conduct broader socio-legal studies; therefore, this study may not reflect views of all related stakeholders. Practical/implications This paper will guide how countries like Bangladesh could adopt intellectual property policies for pharmaceuticals in a way not only adjusting societal goals for accessibility and affordability of pharmaceuticals but also promoting innovation and capability of local industries. Social/implications Countries like Bangladesh should adopt intellectual property policies balancing not only investment and innovation side but also societal goals to ensure access to medicines for the vast majority of poor populations. Originality/value This study is an original study based on primary sources as collected during field studies in Bangladesh. It also used doctrinal research, and related materials are duly referred.


2019 ◽  
Vol 3 (56) ◽  
pp. 57
Author(s):  
Marta Carolina Giménezi PEREIRA

RESUMENLas nuevas tendencias en propiedad intelectual nos remiten al primigenio ADPIC para el análisis necesario de temáticas de derecho a la competencia y propiedad intelectual en el sector farmacéutico y más tarde arribar a las implicancias del futuro de ADPIC, a saber, ADPIC PLUS, con la polémica específica de la “información no divulgada” y, en ella, la protección de la “exclusividad de datos” que ya se encontraba prevista en el artículo 39.3 de aquél. Empero, existen difíciles interpretaciones para esta debatida figura que no escapa a los intereses de los distintos sectores participantes de los variados países miembros de la OMC. El presente estudio abarca dos temáticas diferenciadas que se desarrollan después de la introducción, la cual tiene por objeto colocar al lector en contexto. En una primera parte, se aborda la relación de la propiedad intelectual con el derecho de la competencia, generando luego dos propuestas anticompetitivas. En la segunda parte, aparece la figura de la exclusividad de datos como parte integrante de las nuances de extensión patentaria gestadas en el escenario internacional y las estrategias resultantes, desde sus conceptos y requisitos, analizando sus interpretaciones, así como las sensibilidades en su aplicación. El método utilizado es el deductivo y la técnica de investigación bibliográfica. Se estructura en introducción, desarrollo, conclusiones y bibliografía.PALABRAS-CLAVE: Patentes farmacéuticas; Innovación; Propiedad Intelectual; Acceso a la salud; Derecho de la competencia; Acuerdo ADPIC Plus; Artículo 39.3 ADPIC.ABSTRACTThe new trends in intellectual property refer us to the original TRIPS agreement for the necessary analysis on topics in competition law and intellectual property in the pharmaceutical sector and later arrive at the implications of the future of TRIPS, that is, TRIPS PLUS, with the specific controversy of the “undisclosed information” and, in it, the protection of “data exclusivity” that was already foreseen in the former’s article 39.3. However, there are difficult interpretations for this debated figure that do not escape the interests of different participating sectors in the various countries that are members of the WTO. The present study covers two differentiated themes that are scrutinized after the introduction, which aims to put the reader in context. At the first part, relations between intellectual property and competition law are addressed, thus generating two anticompetitive proposals. At the second part, the figure of data exclusivity appears as an integrating part of the patented extension nuances conceived on international stage and the resulting strategies, from their concepts and requirements, analyzing their interpretations, as well as the sensitivities in their application. The method used is the deductive and the bibliographic research technique. It is structured in introduction, development, conclusions and bibliography.KEYWORDS: Pharmaceutical patents; Innovation; Intellectual property; Access to health; Competition law; TRIPS PLUS Agreement; Article 39.3 TRIPSRESUMOAs novas tendências na propriedade intelectual nos remetem ao primordial Acordo TRIPS para a necessária análise de temáticas do direito da concorrência e propriedade intelectual no setor farmacêutico e, mais tarde para se chegar às implicações do futuro do TRIPS, a saber, o TRIPS PLUS, com a específica polêmica da “informação não divulgada” e, nesta, sobre a proteção da “exclusividade de dados” que já se encontrava prevista no art. 39.3 daquele primeiro. No entanto, existem interpretações difíceis para esta figura debatida que não escapa aos interesses dos diferentes setores participantes dos vários países membros da OMC. O presente estudo abarca duas temáticas diferenciadas que se desenvolvem após a introdução, a qual tem por objetivo colocar o leitor em contexto. Na primeira parte, aborda-se a relação da propriedade intelectual com o direito da concorrência, gerando então duas propostas anticoncorrenciais. Na segunda parte, aparece a figura da exclusividade de dados como parte integrante das nuances de extensão patentária gestadas no cenário internacional e as estratégias resultantes, desde seus conceitos e requisitos, analisando suas interpretações, bem como as sensibilidades em sua aplicação. O método utilizado é o dedutivo e a técnica de investigação bibliográfica. Se estrutura em introdução, desenvolvimento, conclusões e bibliografia.PALAVRAS-CHAVE: Patentes farmacêuticas; Inovação; Propriedade intelectual; Acesso à saúde; Direito da concorrência; Acordo TRIPS PLUS; Artigo 39.3 TRIPS. 


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