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Oliveira, Carlos Fernando Lopes de. "Patentes de fármacos: as tensões existentes entre os interesses da indústria farmacêutica e as necessidades das populações." Universidade Federal da Paraíba, 2010. http://tede.biblioteca.ufpb.br:8080/handle/tede/4363.
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Previous issue date: 2010-04-27<br>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior<br>It is a study focused on the medicament patent from the analysis of the existing tensions among the pharmaceutical industry and the population necessities regarding medicine access. It is well-known the inner nature of the fundamental rights the condition of its social function. In this context, reasoning regarding the protection limits conferred to human nature property is posed, the so-called intellectual property, particularly in the health field, in a concentrated pharmaceutical industry context in the hands of transnational economic conglomerates. Drug Patent-letters are industrial property titles of core application in this universe, as they confer the temporal exclusivity right of exploration in the registered invention. The exercise of the patent right confronts itself with the necessity of the drug access of the population. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Intellectual Property Act rise as rigid diplomas for protecting these rights. The tenet of intellectual property shows a path for a well limited protection, from its technical requisites. In the Mercosur context, a need for enhancement on the mechanisms of regional protection, and the political articulation maintenance is seen, in the sense of avoiding the adherence to bilateral instruments which foresees more rigid protective conditions than the existing ones at the TRIPS.
Data stress the importance of a severe protection for an innovation process, at the same time that it is questioned. The drug access becomes more important in situations for the AIDS and other epidemics treatment. At the same time, the sense of investments of the pharmaceutical industry points to the negligence of the P&D on tropical diseases, privileging researches on the high incident diseases of cold countries, or global diseases. The fall on the drug prices is shown, due to the introduction of the generics, and also the way the piracy implies into barrier towards the population access to the drugs. The necessity of a more objective legal mechanism definition is stated aiming to avoid the me-too drug patenting, with a consequent time gap lag on the temporal exclusivity patent right. The formation of the PPP for the realization of P&D of medicament in the industrial phase and the concession technology transferring definition in one of the requisites to form partnerships and international acquisitions, is also shown as relevant. The creation of a new useful capitalism to the reduction of the regional inaqualities passes for the process to endow with flexibility the rights on the pharmaceutical patents.<br>Trata-se de um estudo sobre as patentes de medicamentos a partir da análise de tensões existentes entre os interesses da indústria farmacêutica e as necessidades das populações no tocante ao acesso aos remédios. Sabe-se ser inerente ao direito de propriedade uma função social, devendo servir à promoção de justiça social. Neste contexto, são tecidos questionamentos sobre os limites de proteção conferidos à propriedade decorrente da criação humana, a chamada propriedade intelectual, particularmente na área da saúde, em um contexto de concentração da indústria farmacêutica nacional em poder de conglomerados econômicos transnacionais. Cartas-patentes de medicamentos são títulos de propriedade industrial de utilidade chave neste universo, pois conferem o direito de exclusividade temporal de exploração da invenção registrada. O exercício do direito patentário defronta-se com a necessidade de acesso das populações a medicamentos. O Tratado sobre os Direitos de Propriedade Intelectual Relacionados com o Comércio (TRIPS) e a Lei de Propriedade Industrial despontam como diplomas rígidos de proteção destes direitos. Os princípios da propriedade intelectual fornecem um caminho para uma proteção bem delimitada, a partir de requisitos técnicos. No contexto do Mercosul verifica-se a necessidade de aprimoramento dos mecanismos de proteção regional e da manutenção de uma articulação política no sentido de não ser realizada a adesão a instrumentos bilaterais que prevejam condições mais rígidas de proteção do que as previstas no TRIPS. Dados enaltecem a importância de uma severa proteção para um processo de inovação, ao mesmo tempo que a põe em dúvida. O acesso aos fármacos torna-se mais premente em situações de medicamentos para o trato de epidemias, como a AIDS. Ao mesmo tempo, o sentido dos investimentos da indústria farmacêutica indica a negligência de P&D sobre doenças tropicais, privilegiando pesquisas sobre doenças de maior incidência em países de clima temperado, ou doenças globais. Demonstra-se a queda de preços de medicamentos em função da introdução de genéricos e como a pirataria implica em uma barreira ao acesso da população aos fármacos. Constata-se a necessidade de definição de mecanismos jurídicos objetivos com a finalidade de evitar-se o patenteamento de drogas ―me-too‖, com o consequente prolongamento do lapso temporal do direito de exclusividade patentário. A formação de Parcerias Público-Privadas (PPPs) para a realização de P&D de medicamentos em fase industrial e a definição da concessão de transferência de tecnologia como um dos requisitos para a formatação de parcerias e aquisições internacionais, mostra-se igualmente relevante. A criação de um novo capitalismo útil à redução das desigualdades regionais passa pelo processo de flexibilização dos direitos sobre as patentes de medicamentos.
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Figueiredo, Luciano Lima. "A função social das patentes de medicamentos." Universidade Federal da Bahia, 2008. http://www.repositorio.ufba.br/ri/handle/ri/12373.
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Previous issue date: 2008<br>Este trabalho tem por objetivo analisar a aplicação do princípio da função social da propriedade às patentes de medicamentos. Verifica se o princípio da função social impõe aos titulares das cartas-patentes o dever de comercializar remédios a um preço razoável, o qual não gere lucros astronômicos e seja apto a tornar o bem industrial acessível à população mais pobre. Para tanto, foi dividido o trabalho em cinco temas principais, abordados em capítulos específicos: A Constitucionalização do Direito Civil; A(s) Propriedade(s); A Propriedade Industrial; As Patentes de Medicamentos; e a Função Social das Patentes de Medicamentos. Perpassa o trabalho pela migração das normas do direito civil para o bojo da Constituição Federal (constitucionalização); a existência de propriedades; o estudo da espécie propriedade industrial, com atenção às patentes; as patentes de medicamentos, seu custo e inserção da ciência para o pilar da produção; e a aplicação do princípio da função social às patentes de medicamentos. Há a análise de questões atuais, como os remédios genéricos, o patenteamento de genes e do genoma humano, as patentes de transgênicos, diversos acordos internacionais, “quebra” de patentes. Após a pesquisa realizada, concluiu-se que a função social da propriedade, núcleo duro e elemento unificador das propriedades, têm plena aplicação às patentes de medicamentos. Consiste a função social da propriedade em princípio constitucional, sendo sua maximização a observância da legalidade constitucional. Com esta premissa, parte o autor a traçar caminhos para a concretização nacional e global de acesso aos remédios, consignando no seu trabalho medidas funcionais. Devido ao caráter interdisciplinar, para a confecção do trabalho foram analisadas doutrina e legislação de direito constitucional, civil, internacional, comercial, bem como jurisprudência dos principais tribunais pátrios e de direito comparado. De igual maneira recorreu-se a referências relacionadas a questões ligadas a medicamentos e de direito alienígena, legitimando ao máximo a pesquisa realizada.<br>Salvador
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Basheer, Shamnad. "The invention of an investment incentive for pharmaceutical innovation." Thesis, University of Oxford, 2011. https://ora.ox.ac.uk/objects/uuid:b53d2ab0-dcdd-4adc-8728-cdf32e948df6.
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Pharmaceutical drugs are often hailed as the poster child for the proposition that patents foster accelerated rates of innovation. This sentiment stems, in large part, from the significantly high research and development (R&D) costs endemic to the pharmaceutical sector. I argue that if the role of the patent regime is one of fostering higher amounts of investment in the R&D process, it is better served by a direct investment protection regime, where the protection does not depend upon whether or not the underlying idea behind the drug is 'new' and 'inventive', the two central tenets of patent law. Rather, any drug that successfully makes it past the regulatory filter ought to be entitled to protection, since its discovery and development entail significant investment and risk. Owing to the inadequacy of the current patent regime in appropriately protecting intensive pharmaceutical R&D investments from free-riders, I propose a comprehensive investment protection regime that protects all the investment costs incurred during the drug discovery and development process. Though similar to existing data protection regimes in some respects, it differs in others. Firstly, it enables a recovery of all R&D costs, and not only costs associated with clinical trials. Secondly, unlike patents and data exclusivity which offer uniform periods of protection, it rewards investments in a proportionate manner, wherein drug originators are entitled to protection against free-riders only until such time as they recoup their specific investments and earn a rate of return on investment that is dependent on the health value of the drug. Given that a pure market exclusivity based investment protection regime is likely to foster excessive pricing and subject the market to the dictates of a single firm, I advocate a compensatory liability model based on a novel cost sharing methodology, where follow-on entrants are free to manufacture the drug, but must pay a reasonable amount of compensation to the originator.
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袁慶文. "基於引證網絡的藥品專利價值分析". Thesis, University of Macau, 2018. http://umaclib3.umac.mo/record=b3952162.
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胡元佳. "Pharmaceutical patent valuation based on technology innovation and applications in the industry." Thesis, University of Macau, 2009. http://umaclib3.umac.mo/record=b2150641.
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Harnisch, Sandy. "Die Zwangslizenz im südafrikanischen und deutschen Patentrecht : ein Rechtsvergleich unter besonderer Berücksichtigung der Arzneimittelerfindungen /." Berlin : BWV, Berliner Wiss.-Verl, 2006. http://deposit.ddb.de/cgi-bin/dokserv?id=2792408&prov=M&dok_var=1&dok_ext=htm.
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Rigestam, Björn. "Pharmaceutical patents and generic drugs : When may interim injunctions be issued against an attempt or preparation to offer generic drugs on the market?" Thesis, Internationella Handelshögskolan, Högskolan i Jönköping, IHH, Rättsvetenskap, 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-18933.
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Since the implementation of Directive 2004/48 EC on the Enforcement of Intellectual Property Rights in Sweden there is today a possibility for pharmaceutical companies holding a patent to issue interim injunctions against a generic company on the grounds of an attempt or preparation to a pharmaceutical patent infringement. It has been shown that one of the earliest steps in which a generic company may infringe a pharmaceutical patent is to offer the generic drugs onto the market. However, since the implementation of the attempt and preparation rule in the Swedish Patent Act questions have been raised as to in what stage interim injunctions may be issued against an attempt or preparation to offer generic drugs onto the market made by generic companies. This thesis has therefore intent to investigate at what stage interim injunctions may be applied for against a generic company on the grounds of an attempt or preparation to offer generic drugs. In the thesis the writer argues that in order for an attempt or preparation to offer generic drugs to exist an overall assessment must be made of the particular situation and that there is no specific principles to follow in order to determine either an attempt or a preparation to offer generic drugs. However, some guidance might be brought from Danish case law in order to establish a preparation to offer generic drugs in Sweden.
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Chan, Yuen Cheung. "Quality evaluation and anti-chronic glomerulonephritis properties of a patent herbal drug yi-shen-hua-shi granule." HKBU Institutional Repository, 2020. https://repository.hkbu.edu.hk/etd_oa/825.
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Yi-Shen-Hua-Shi (YSHS) granule is a Chinese patent drug for treating chronic glomerulonephritis (CGN). It was marketed in 2009. However, up to now, there is no report about the quality and pharmacological activities of this product. In this work，we evaluated the quality and anti-CGN effects of the drug. To evaluate the quality of the granule, a qualitative and quantitative HPLC-DAD analytical method was developed. For qualitative analysis, HPLC fingerprint of ten batches of YSHS granule was established. The fingerprints were analyzed using similarity evaluation, hierarchical cluster analysis (HCA), principal components analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) based on 15 characteristic fingerprint peaks. Similarity values of 10-batche samples were all above 0.960, indicating a stable quality. Minor differences were observed among batches by HCA and PCA. For quantification analysis, contents of six constituents in the granule were simultaneously measured. To establish the chemical profile of the granule, a HPLC-Q-TOF- MS/MS method was developed. A total of 105 peaks were detected using HPLC-Q-TOF-MS/MS in the granule, of which, 99 were tentatively identified as terpenoids, flavonoids, coumarins, alkaloids, phenols and other types of compounds, and 15 were further validated with reference substances. HPLC fingerprint chromatogram establishment, quantification analysis of 6 constituents and compound identification should improve the quality control of YSHS granule. To study the pharmacological activities of the granule, we investigated its anti-CGN effects and TGFβ signaling-related mechanism of action. A CGN rat model was established by injection of cationization-bovine serum albumin (C-BSA) for five weeks. After C-BSA injection, drugs were intragastrically administered to the rats once daily for four weeks. Clinical signs were recorded daily. Urine and serum biochemical parameters were analyzed using respective kits. Protein levels were examined by Western blotting. Pathological changes of renal tissues were evaluated using HE and Masson's trichrome staining. No significant differences in body weights and clinical signs were found among normal, model and drug treatment groups. Proteinuria; albuminuria; increased urine volume; elevated creatinine, urea nitrogen, triglyceride levels and total cholesterol in serum; decreased serum total protein and albumin; as well as renal pathological damages and fibrosis were observed in CGN model rats. YSHS granule ameliorated all the abnormal behavioral and biochemical changes in the model rats. Mechanistic investigations revealed that YSHS granule down-regulated proteins levels of TGFβ1, phospho-Smad2/3 (Thr 8) and Smad4 in rat renal tissues. These findings indicate that the drug has anti-CGN effects in rats, and inhibiting TGFβ signaling contributes to the underlying mechanisms. In summary, our chemical analytical studies will help in improving the quality control of YSHS granule. Our bioactivity and mechanistic studies provide a pharmacological basis for the clinical use of the granule in treating CGN.
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Hedner, Erik. "Implementering av "Life Cycle Management" i svensk läkemedelsindustri." Thesis, University of Gävle, Department of Business Administration and Economics, 2009. http://urn.kb.se/resolve?urn=urn:nbn:se:hig:diva-5169.
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<p>It generally takes 10 to 12 years for a new drug to hit the market. The pharmaceutical industry invests huge sums in these early stages of research and development. In spite of the rapidly rising research and development expenditures fewer and fewer blockbuster drugs are being developed. Longer lead times and aggressive generic post-patent competition have narrowed the timeframe for the pharmaceutical companies to profit on their investments.</p><p>In the face of these threats the pharmaceutical industry has developed a battery of strategies to prolong market exclusivity and to maximize return on investment. These emerging strategies are commonly known as Life cycle management (LCM), which actually is more of a concept than a method. A life cycle is a sequence that stretches all the way from early research and development, through marketing to finally end when the product is withdrawn from the market. By managing the product through these different stages the company can improve the commercial lifespan.</p><p>This thesis analyzes how Life cycle management is implemented in the Swedish pharmaceutical industry. The data is based on interviews from people who are active in the pharmaceutical business. Further, the thesis studies the strategies that AstraZeneca used for their gastrointestinal drugs Losec and Nexium.</p><p>Based on the collected data from the interviews a clear view of the role and involvement of LCM strategies appears. The value and importance of LCM have steadily increased during the last 10 years. LCM is heavily embedded in the decision processes of drugs today. Several strategies such as OTC switching and patent prolongation through pediatric indication application are common practice. The Swedish pharmaceutical industry has a prominent position in the advancement of LCM.</p><br><p>Idag lanseras mindre innovativa nya läkemedel än under 80- och 90-talet. Kostnaderna för att utveckla ett läkemedel har ökat och det tar dessutom längre tid från upptäckt till lansering. Läkemedel har endast en begränsad marknadsexklusivitet som styrs av patentskyddet. Vid patentutgång så utsätts läkemedlet för stenhård konkurrens från aggressiva generika tillverkare. De ställs hårdare krav på forskande farmaceutiska företag för att vara lönsamma i detta klimat.</p><p>Det finns en tydlig trend att läkemedelsföretag har blivit mer beroende av sina storsäljande läkemedel. Ett flertal offensiva strategier har utvecklats för att förlänga lönsamheten hos de mest framgångsrika läkemedlen, t.ex. genom att minska utvecklingstiden, utveckla nya formuleringar och expandera indikationerna. ”Life cycle management” (LCM) är ett samlingsbegrepp på dessa strategier, som används under en produkts livscykel för att förbättra den kommersiella livslängden. Försäljning och marknadsföring för innovativa läkemedel passerar distinkta faser och olika strategier krävs beroende på vilka fas en produkt befinner sig i.</p><p>I denna uppsats analyserar jag hur LCM är implementerat i den svenska läkemedelssektorn. Slutsatserna bygger på data från intervjuer av personer som är sysselsatta inom läkemedelsbranschen. Uppsatsen studerar dessutom de strategier som AstraZeneca har använt för sina två magtarmläkemedel Losec och Nexium.</p><p>Baserat på insamlad intervjudata så framkommer tydligt att LCM är starkt involverat i beslutsprocesserna runt ett läkemedel. Betydelsen av LCM har successivt ökat under de senaste 10 åren. Flera strategier för t.ex. patentförlängning är idag vanligt förekommande. Den svenska läkemedelsbranschen ligger relativt långt fram i denna utveckling.</p>
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譚偉民. "活血化瘀中成藥處方和製備工藝改進 : 雲南白藥劑型的質量比較分析". HKBU Institutional Repository, 2010. http://repository.hkbu.edu.hk/etd_ra/1132.
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Vargas, Chaves Iván Guillermo. "Balances, realidades y perspectivas de las patentes farmacéuticas." Doctoral thesis, Universitat de Barcelona, 2017. http://hdl.handle.net/10803/664063.
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Esta investigación explora la evolución de la patente farmacéutica en España desde su ordenamiento jurídico interno; el régimen aplicable en el Derecho comunitario europeo; y en el comercio internacional. Se realiza, siguiendo esta línea histórica, una aproximación crítica sobre la necesidad de repensar el equilibrio que debe existir entre la exclusividad que otorga la patente a sus titulares, y un acceso a los medicamentos en igualdad de condiciones. La investigación además sustenta, entre otras cuestiones relevantes en el panorama legislativo y jurisprudencial evolutivo, el contexto en el que se dio la protección de las patentes farmacéuticas a través del Acuerdo ADPIC, que marcó un antes y un después, suponiendo para el ordenamiento jurídico español importantes retos respecto a su implementación, aunque sin dejar a un lado el escenario favorable que supuso este Acuerdo para los laboratorios innovadores. Ello, con la problemática implícita para los laboratorios productores de genéricos, que no hacen parte de un sector que, como se señala en las conclusiones, necesariamente pretende aprovecharse del primero; siendo más bien eje cardinal del abastecimiento de los medicamentos en los países en desarrollo, dado los bajos costos que hacen que estos sean accesibles para la población en general. La investigación finaliza dando cuenta de las perspectivas de la patente farmacéutica, concluyendo que pese a todas las consideraciones que se despliegan a lo largo de la investigación, la patente sigue siendo la mejor vía para incentivar el desarrollo de nuevos medicamentos, dado el escaso interés del Estado en invertir en este ámbito.<br>This research explores the evolution of the pharmaceutical patent in Spain, in the European Community regime and in the international trade system. Following a historical line, a critical approach is made in order to rethink the balance that must exist between the exclusivity that the patent grants to its holders, and an access to the medicines in equal conditions. The research also presents the context in which the protection of pharmaceutical patents was given through the TRIPS Agreement, a historical event that meant for Spanish law important challenges regarding its implementation, and for innovative pharmaceutical laboratories a more than favorable situation. It is also evidenced the problem of this legal framework for the generics-producing laboratories, which are part of a sector that does not necessarily intend to take advantage of the pharmaceutical-innovative sector, but rather become part Key supply of medicines in developing countries, because of the low costs that make them affordable for patients in general. This research ends by giving an account of the prospects of the pharmaceutical patent in the public health, concluding that despite a discouraging context, the patent remains the best way to encourage the development of new medicines, as a result of the lack of interest of the States to invest in this scope.
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Karlsbakk, A. "Patents versus patients : global governance and the role of civil society in South Africa's quest for affordable drugs." Thesis, Stellenbosch : Stellenbosch University, 2005. http://hdl.handle.net/10019.1/50414.
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Thesis (MA)--Stellenbosch University, 2005.<br>ENGLISH ABSTRACT: This thesis is an explanatory study into civil society's increased influence in global
governance. More specifically this situation is examined by looking at the generic medicine
debate that came in the wake of the passing of the Medicines and Related Substances Act by
the South African government in 1997. This debate gained worldwide attention and touched
some of the prevailing inequalities between the developed world and the developing world in
our globalised society. The research question that is addressed here is to what extent did civil
society influence the signing of the Doha Declaration of the TRIPS Agreement and Public
Health by the members of the World Trade Organisation (WTO) in 2001? In doing so, this
thesis looks at the role of the US government, the South African government, the
pharmaceutical industry, the WTO's TRIPS Agreement and civil society in the form of nongovernmental
organisations like Treatment Action Campaign (TAC), Oxfam and Medecines
Sans Frontieres (MSF).
The study applies a constructivist approach in order to analyse how civil society used global
advocacy networks to inform and communicate the normative concerns regarding South
Africa and developing countries' lack of access to HIVand AIDS drugs. Moreover, it
examines how civil society's use of moral authority challenged the regulative power of the
WTO.
The study concludes that civil society played a vital role in influencing the WTO member
states' decision to sign the Doha Declaration on the TRIPS Agreement and Public Health.
However, it was not only civil society's ability to set the agenda concerning the HIV/AIDS
pandemic, but also the content of the normative concerns themselves that help explain its
success. Consequently, the study further concludes that civil society's success in this specific
case must be seen in light of its growing influence in challenging global governance.<br>AFRIKAANSE OPSOMMING: Hierdie tesis is 'n verduidelikende studie van die burgerlike samelewing se groeiende invloed
in globale regering. Hierdie situasie word meer spesifiek ondersoek deur te kyk na die
generiese medisyne debat wat gevoer is na die Suid-Afrikaanse Regering die Medisyne en
Verwante Stowwe Wet van 1997 goedgekeur het. Hierdie debat het wêreldwye aandag geniet
en het geraak aan sommige van die bestaande ongelykhede wat daar heers tussen die
ontwikkelde en ontwikkelende wêreld in die geglobaliseerde samelewing.
Die navorsingsvraag wat hier aangespreek word is tot watter mate die burgerlike samelewing
die ondertekening van die Doha Verklaring van die TRIPS Ooreenkoms en Publieke
Gesondheid deur lede van die Wêreld Handelsorganisasie (WHO) in 2001 beïnvloed het.
Deur dit te doen, sal hierdie tesis kyk na die rol van die Amerikaanse regering, die Suid-
Afrikaanse regering, die farmaseutiese bedryf, die WHO se TRIPS Ooreenkoms en die
burgerlike samelewing in die vorm van nie-regerings organisasies soos die Treatment Action
Campaign (TAC), Oxfam en Medecines Sans Frontieres (MSF).
Die studie maak gebruik van 'n konstruktiwistiese benadering om 'n analise te doen van hoe
die burgerlike samelewing globale ondersteunings netwerke gebruik het om die normatiewe
besorgdhede wat heers oor die tekorte in Suid-Afrika en die ontwikkelende lande ten opsigte
van toegang tot MIV en VIGS medisyne, toe te lig en te verkondig. Verder ondersoek die
studie hoe die gebruik deur die burgerlike samelewing van morele gesag die regulerende mag
van die WHO uitgedaag het.
Die studie kom tot die gevolgtrekking dat die bugerlike samelewing 'n uiters belangrike rol
gespeel het in die WHO lidlande se besluit om die Doha Verklaring van die TRIPS
Ooreenkoms en Publieke Gesondheid te onderteken. Dit was egter nie net die burgerlike
samelewing se vermoë om die agenda daar te stel ten opsigte van die MIV/VIGS pandemie
nie, maar ook die inhoud van die normatiewe besorgdhede self wat bygedra het om hierdie
sukses te verduidelik. Gevolglik kom die studie tot die verdere gevolgtrekking dat die
burgerlike samelewing se sukses in hierdie spesifieke geval gesien kan word in die lig van sy
groeiende invloed in die uitdaging van globale mag en gesag.
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Albanese, Christopher J. "Estimating The Size Of The Pharmaceutical Patent Cliff." Scholarship @ Claremont, 2014. http://scholarship.claremont.edu/cmc_theses/854.
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This paper attempts to estimate the change in sales associated with pharmaceutical patent expiration. Using data from the Medical Expenditure Panel Survey and patent expiration information from historical Orange Book publications, I estimated monthly sales associated with choice pharmaceutical patents. I then used a fixed-effects model to estimate the average change in sales before and after initial patent expiration, controlling for patent extension factors. My findings support that pharmaceutical patent expiration results in a statistically significant drop in sales by 38% on average within this sample, and further, that patent extensions had a negligible effect on this relationship. The question of patent expiration’s effect on sale is economically important for the sake of evaluating the efficacy of pharmaceutical patent law in protecting the interests of brand-name and generic drug manufacturers as well as paying consumers.
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Babin, Dominique. "The Canadian pharmaceutical patent regime in the world trading system /." Thesis, McGill University, 1999. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=29957.
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In 1994, the members of the World Trade Organisation (WTO) adopted the Agreement on Trade-Related Aspects of Intellectual Property (the "TRIPs Agreement") and thus committed themselves to respect certain standards for intellectual property protection. This thesis studies the scope of the standards for patent protection and their impact upon trade in medicines. The first part addresses the international dimension of the issue and explains how international trade in medicines can contribute to enhancing the level of global welfare. The first chapter argues that in order to fulfil this latter objective legislation relating to patents must be adapted to the economic and social situation of countries. The second chapter demonstrates that such adaptation is not only allowed, but is indeed encouraged by the provisions of the TRIPS Agreement. The second part of this thesis addresses the issue from a Canadian perspective, and discusses the way Canadian patent provisions applying to pharmaceuticals should be drafted so as to allow Canada to participate in---and to benefit from---international trade in medicines. Thus, I first analyse the factual, political, and legislative factors that influence the Canadian pharmaceutical industry. I then study the role of Canada as part of the integrated market for medicines, as well as the social, industrial and economic objectives underlying Canadian policies. I finally propose some modifications and adaptations to the Canadian Patent Act and suggest some orientations for future multilateral negotiations.
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Momodu, Rametu Omamegbe. "Knowledge and practices of patent medicine vendors in the use of artemisinin based combination therapy in the treatment of malaria in an urban community in Lagos." Thesis, University of the Western Cape, 2008. http://etd.uwc.ac.za/index.php?module=etd&action=viewtitle&id=gen8Srv25Nme4_2704_1271017667.
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<p>Malaria is a health, social and economic burden in Nigeria and consistently ranks amongst the four most common causes of childhood deaths. Treatment of malaria is usually started at home<br>care is only sought from the health facility when the treatment is ineffective (McCombie, 1996). Patent medicine vendors (PMVs) have been identified as a widely patronized source for drugs used in the home treatment of malaria (Breiger et al, 2001<br>Goodman, et al, 2007<br>Salako et al, 2001). Inadequate or poor knowledge and practices in the use of anti-malaria drugs (AMDs) increases morbidity and mortality, undermines therapeutic efficacy, and promotes the emergence and spread of drugresistant malaria. Aim: The aim of the study was to describe and quantify the knowledge and self-reported practices of PMVs in the use of antimalarials, particularly artemisinin-based combination therapies (ACTs), in a poor urban community in Lagos state, Nigeria.</p>
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Muhammad, Amran. "Patenting dyes and drugs in Britain, 1860-1960 : case studies on the role of patents in chemical science and industry." Thesis, University of Manchester, 2004. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.557622.
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A patent is a limited monopoly granted to an inventor by the state in return for the disclosure of new useful inventions. While the rights of patentees are protected and rewarded through royalties and licensing fees, for example, other enterprising bodies can develop new industries for the benefit of the public. Thus, the patent system has always been considered to be in a delicate position in serving both the rights of inventors and the interests of the public. However, in examining the relationship between scientists and the patent system in Britain between 1860 and 1960, it appears neither the rights of inventors nor the interests of the public were foremost in the actual operation of the patent system. On the contrary, the empirical evidence gathered in this thesis suggests that the British patent system had actually become a conservative and self-serving system, perpetuating the interests of its own practitioners - patent agents, lawyers, and judges. At the outset, the thesis questions a common perception that "British scientific tradition" discourages scientists from taking out patents, by showing that British chemists have a long and uninterrupted patenting tradition, and that it was often the British patent system itself that actually hindered scientists from taking out patents. Furthermore, the resistance to patenting generated by occupational conflict between the medical profession and chemists exacerbated the difficulty of patenting for British scientists. The thesis illustrates how British chemists experienced consistent difficulty with the British patent system. The chemists' patenting activity took place in the contexts of the emergence of the science-based chemical industry starting from the mid-nineteenth century characterised by the industrialisation and internationalisation of inventions, which consequently gave the patent system a key role in protecting the industry. While the rise of the new science-based chemical industry saw chemists play a crucial role in inventing new products and processes, the patent system, which was supposed to protect these new science-based chemical inventions, was slow to change in the face of entrenched legal interests and political and economic doctrine. It emerges from this study that patents and the patent system played at least as much of a role in the "decline" of the British chemical industry as the oft-cited lack of research, manufacturing, management and marketing investments in the British science-based chemical industry itself. The significance of these historical discussions for current patent reform in science is considered.
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Chandratre, Chaitanya. "Medicare drug plan formulary response to the patent expiration of atypical antipsychotics in the State of Washington for fiscal year 2010." Pullman, Wash. : Washington State University, 2010. http://www.dissertations.wsu.edu/Thesis/Spring2010/C_Chandratre_042310.pdf.
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Thesis (M.H.P.A.)--Washington State University, May 2010.<br>Title from PDF title page (viewed on July 20, 2010). "Department of Health Policy and Administration." Includes bibliographical references (p. 30-35).
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趙揚. "中國製藥企業的專利戰略 : 基於六家製藥企業的案例研究". Thesis, University of Macau, 2012. http://umaclib3.umac.mo/record=b2590327.
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Hoirisch, Cláudia. "Licença compulsória para medicamentos como política pública: o caso do anti-retroviral efavirenz." reponame:Repositório Institucional do FGV, 2010. http://hdl.handle.net/10438/6559.
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Previous issue date: 2010-03-24<br>The scope of this study is to evaluate the implementation process of the Compulsory License in the case of the antiretroviral efavirenz. This research is descriptive in nature and the medium of investigation was the case study. It was conducted during the months of October through December 2009 with semi-structured interviews containing open-ended questions with a group of Public Health policy makers and managers residing in the states of Rio de Janeiro, Sao Paulo and the Federal District who participated in the compulsory license process. These individuals were allowed to express themselves without any constraints in such a way that they could produce discourses. The Collective Subject Discourse (CSD) technique was then used for analysis of the discourses. The results revealed that Brazil has the technological capability to develop and produce antiretrovirals within a reasonably short period of time. The results further showed that the Compulsory License helped to curb spending on antiretrovirals and that the measure can be used to ensure access by the public to high-cost and strategic antiretroviral drugs for the Brazilian public health service (Unified Health System – SUS) in an environment with limited funds, whenever an impasse is reached in negotiations for price reductions with transnational pharmaceutical laboratories.<br>O objetivo deste estudo é avaliar o processo de implementação da Licença Compulsória no caso do anti-retroviral efavirenz. Esta pesquisa é de caráter descritivo, o meio de investigação foi o estudo de caso e foi conduzido com entrevistas semi-estruturadas contendo questões abertas para um conjunto de atores representativos da área da Saúde Pública que participaram do processo da licença compulsória residentes nos estados do Rio de Janeiro e São Paulo e no Distrito Federal durante os meses de outubro a dezembro de 2009. Permitiu-se que esses indivíduos se expressassem mais ou menos livremente de forma que eles produzissem discursos. Para a análise dos discursos, utilizou-se a técnica do Discurso do Sujeito Coletivo (DSC). Os resultados demonstraram que o Brasil possui capacitação tecnológica para desenvolver e produzir anti-retrovirais em um prazo relativamente curto. Os resultados mostram ainda que a Licença Compulsória ajudou a refrear os gastos com anti-retrovirais e que o instrumento pode ser utilizado para garantir o acesso da população a medicamentos anti-retrovirais de alto custo e estratégicos para o Sistema Único de Saúde em um ambiente de recursos limitados sempre que se chegar a um impasse na negociação para redução de preços com os laboratórios farmacêuticos transnacionais.
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Mbioh, Will Robinson. "Post-coloniality and the movements and readings of scientific and legal practices : the history of HIV/AIDS in Africa, patents, and the multilateral governance of generic drugs." Thesis, University of Kent, 2015. https://kar.kent.ac.uk/54170/.
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This thesis examines the history, political economy, and global response to HIV/AIDS in Africa. It is particularly interested in how Africa’s colonial past and postcolonial struggles with European science and law influenced these issues. It therefore explores the many ways that the colonial encounter coloured how scientific knowledge about HIV/AIDS travelled to and was read and contested in Africa. In addition, it sets out how this encounter informed the political economy of debates about access to and the global governance of generic HIV/AIDS drugs in the continent. It draws on an interdisciplinary and theoretically-informed scholarship to unpack these issues. However, it aims not to produce new theoretical insights or make original theoretical contributions to this scholarship. Rather, it seeks to contribute to and fill-in gaps in the historiography of HIV/AIDS in Africa and scholarship on the global governance of generic HIV/AIDS drugs. Accordingly, it examines two areas that have not received adequate, academic attention in these areas. Firstly, Project SIDA—the first major research project on HIV/AIDS in Africa; and, secondly, the World Health Organization Prequalification Programme for Generic HIV/AIDS drugs—the primary, regulatory regime that governs the production, certification, and importation of generic HIV/AIDS drugs in the continent. It situates these subjects within a wider discussion about the colonial encounter and postcolonial struggles in Africa around European science and law. It argues that the encounter influenced how Project SIDA, and the scientific knowledge that it produced, was read and contested in Africa. It also contends that postcolonial struggles, especially around the global patent regime, informed the political economy within which the Prequalification Programme emerged and, importantly, the technical capacity of African generic manufactured to certify their generic drugs for HIV/AID treatment programmes in the continent.
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Loff, Beatrice. "Health and human rights : case studies in the potential contribution of a human rights framework to the analysis of health questions." Monash University, Dept. of Epidemiology and Preventive Medicine, 2004. http://arrow.monash.edu.au/hdl/1959.1/5291.
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Djenna, Abdallah. "Brevet et développement : le cas de l'Algérie." Thesis, Grenoble, 2013. http://www.theses.fr/2013GREND004.
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La logique du nouveau système économique international s'appuie sur l'idée que le brevet est un mécanisme juridique d'incitation à la recherche et au développement. L'objet de notre étude est de savoir si les écarts de niveau de développement entre les pays pouvaient avoir des effets sur la fonction du brevet dans les pays en voie de développement. Dans cette perspective, nous avons consacré la première partie de notre recherche à l'étude du droit des brevets sur le plan international. Cette analyse est indispensable pour une meilleure compréhension des choix opérés par un pays en développement comme l'Algérie dans l'évolution de son propre système de protection des inventions. Ensuite, nous avons analysé le régime algérien des brevets et les changements qu'il a subi en vue de s'adapter au haut niveau de protection exigé par le système international, afin d'examiner les effets de telles exigences sur le développement. Il ressort de nos analyses, que pour remplir sa fonction universelle comme instrument d'incitation à l'innovation technologique et au développement, le système de brevet algérien doit connaitre plusieurs modifications sur le plan juridique, économique et institutionnel<br>The logic of the new international economic system is based on the idea that the patent is a legal mechanism to incentive research and development. The subject of our study is to know if the variations of the levels of development among between different countries could affect the function of the patent in the third world. In this perspective, we have to analyze the Algerian patent law and the changes they have undergone in order to adapt to the high level of protection required by the international system in order to examine the effects of the requirement of these conditions on reveal developments. Then we analyzed the Algerian regime of patents and the changes it has undergone in order to adapt to the level of protection required by the international system, to examine the effects of these requirements on you development. That the patent system in Algeria fulfills its universal function as an instrument for incentive technological innovation and development, several changes in the legal, institutional and economic should be performed
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高華. "中國制藥企業中的中成藥社會認同管理". Thesis, University of Macau, 2011. http://umaclib3.umac.mo/record=b2525100.
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Loum-Neeser, N'deye fatou. "Les pays en développement et la brevetabilité des médicaments en matière de lutte contre le VIH/SIDA : étude de droit comparé sur les controverses actuelles concernant le rôle des brevets pharmaceutiques dans l'accès aux médicaments de traitement du VIH/SIDA des pays en voie de développement." Thesis, Strasbourg, 2012. http://www.theses.fr/2012STRAA034/document.
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Dans les pays en développement (PED), les problèmes engendrés par le VIH/SIDA et l’inaccessibilité des antirétroviraux (ARV) s’avèrent être la cause de ravages extrêmement préoccupants à tous les niveaux (démographique, politique, social et économique). Dans le cadre de l’Organisation mondiale du commerce (OMC), et notamment de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce (« Accord sur les ADPIC »), un nombre croissant de PED ont ou sont en train d’intégrer un standard international de protection des brevets de produits et de procédés pharmaceutiques à leur législation nationale. Cette intégration a eu et continue de jouer un rôle majeur dans la problématique de l’accès aux médicaments dans les PED. Les conditions et les effets du régime de protection des innovations suscitent de vifs débats entre les partisans d’une protection accrue des brevets et les défenseurs de l’accès aux médicaments essentiels. Une des principales motivations de notre travail de recherche est de fournir une étude permettant de trouver des solutions à la fois favorables à l’amélioration de l’accès aux médicaments et à la préservation de l’innovation. Le problème complexe de l’accès aux médicaments ARV dans les PED est influencé par la pluridisciplinarité et l’interdépendance de nombreux facteurs. Le système des brevets ne constitue pas « l’unique » solution au problème. Toutefois, il doit être plus sérieusement considéré dans sa fonction d’équilibrage entre l’intérêt privé et l’intérêt collectif. C’est un outil juridique précieux pour le développement économique et technologique des PED et la réalisation de l’intérêt commun contre la pandémie<br>In developing countries, problems brought about by HIV/AIDS and inaccessibility of antiretrovirals (ARVs) are proving to be the cause of serious damages at all levels (demographic, political, social and economic). Within the context of the World Trade Organization, and in particular the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”), a growing number of developing countries have integrated or are in the process of integrating into their national law an international standard of patent protection for pharmaceutical products and processes. Such integration continues to play a major role in the issue of access to medicines in developing countries. The conditions and effects of the protection regime respecting innovations give rise to heated debates between supporters of an increased patent protection and defenders of the access to essential medicines. One of the main motivations for our research is to provide a study that helps to find solutions that are both in favour of improving access to medicines and protecting innovation. The complex problem of access to ARV drugs in developing countries is influenced by the multidisciplinarity and interdependence of many factors. The patent system does not solve the problem on its own. However, it should be seriously considered in its function of balancing the private and collective interests. It is a valuable legal tool for the economic and technological development of the developing countries and to achieve the common interest against the pandemic
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Bourassa, Forcier Mélanie. "Analyse des glissements juridiques de la politique canadienne en matière de brevets quant à son objectif d'équilibre entre la promotion des intérêts de l'industrie pharmaceutique novatrice et ceux de l'industrie du médicament générique." Thèse, 2003. http://hdl.handle.net/1866/2389.
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Les provinces canadiennes sont présentement aux prises avec des dépenses élevées en
matière de médicaments. Afin de contrôler ces dépenses, plusieurs d'entre elles ont
adopté différentes politiques visant à promouvoir et à accélérer la vente de
médicaments génériques, lesquels sont équivalents aux médicaments novateurs mais
de trente à quarante pourcents moins chers.
Le gouvernement canadien, en vertu de son pouvoir de réglementation en matière de
brevets, pourrait contribuer aux efforts des gouvernements provinciaux en
assouplissant les règles relatives aux brevets pharmaceutiques pour ainsi promouvoir
l'accélération de la mise en marché de médicaments génériques. Le gouvernement
hésite toutefois à le faire en raison de sa politique en matière de brevets
pharmaceutiques dont les effets se veulent équilibrés tant pour l'industrie
pharmaceutique novatrice que pour l'industrie du médicament generique.
Précisément, cette politique vise, d'une part, à encourager les investissements en
recherche et développement par l'industrie novatrice et, d'autre part, à garantir la
vente rapide de médicaments génériques au Canada pour que soient contrôlées les
dépenses en matière de médicaments.
Ce mémoire consiste en un examen du cadre juridique de la politique canadienne en
matière de brevets pharmaceutiques. Nous y soulevons et analysons particulièrement
ses glissements, quant à l'objectif d'équilibre recherché de la politique canadienne,
qui résultent de son application dans le contexte juridique, politique, scientifique et
économique actuel. Notre intention est de démontrer que, dans l'intérêt des Canadiens
à court et à long terme, la politique canadienne en matière de brevets
pharmaceutiques ne doit pas être assouplie en faveur de l'industrie du médicament
générique seulement, ceci malgré la croissance des dépenses en matière de
médicaments. En effet, l'intérêt des Canadiens ne peut être maximisé que si cette
politique est rééquilibrée en tenant compte de l'ensemble de ses glissements
juridiques observés.<br>All Canadian provinces are presently facing increasingly growing drug expenditures.
In order to control these expenditures the provinces have adopted different policies to
promote and accelerate the sale of generic drugs, these drugs being equivalent to
brand-name drugs but thirty to fourthly percent less expensive.
Considering its jurisdiction in the field of patents, the Canadian government could
contribute to the efforts of the provincial governments in making more flexible the
Canadian patent rules, thus promoting the marketing ofgeneric drugs in Canada. The
government is however hesitating to do so because of its policy on pharmaceutical
patents, which policy aims at balancing the interests of both the brand-name and
generic drug industries. Effectively, the purpose ofthe poltey is to promote, on the one
hand, the investments in research and development of new drugs in Canada and, on
the other hand, to guarantee the rapid marketing of generic drugs, thus controlling
drug expenditures. The purpose of this thesis is to examine the judicial framework of the Canadian policy
on pharmaceutical patents. Its weaknesses, with regard to the balanced objective of
the policy, resulting from its application in the present judicial, political, and
economical and scientific context are the focus of this analysis. Our goal is to
demonstrate that, to reach the Canadian social benefit, both in the short and long run,
the Canadian policy on pharmaceutical patents should not be relaxed for the sole
benefit of the generic drug industry, although the drug expenditures are growing.
Rather, the social Canadian benefit would only be maximised by re-balancing the
Canadian policy in the light of all its demonstrated weaknesses.<br>"Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de maîtrise en droit". Ce mémoire a été accepté à l'unanimité et classé parmi les 10% des mémoires de la discipline.
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Wilson, Kinsley Rose. "A Manufactured Solution? The Transfer of Technology for the Local Production of Affordable Antiretrovirals: Case Studies from Tanzania and South Africa." Thesis, 2009. http://hdl.handle.net/1807/17841.
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Statement of the issue: Facing large HIV-infected populations, Sub-Saharan African countries are producing antiretroviral (ARV) drugs under provisions of the World Trade Organization’s Agreement on the Trade-Related Aspects of Intellectual Property (TRIPS). Article 7 states that the protection of intellectual property should increase technology transfer to developing countries. This clause and the debate over domestic manufacturers’ ability to provide low-cost ARVs need examination.
Methods: Case studies from ARV manufacturing initiatives in Tanzania and South Africa analyzed conditions affecting two outcomes: the type of technology transfer arrangement entered (voluntary license or imitation) and the affordability of ARVs. Data were collected and analyzed from documents, key-informant interviews, and observation. Chi-squared and phi correlation statistics were then conducted across developing countries to test the association of voluntary ARV licensure with TRIPS-compliant patents and domestic firm ownership (state or private).
Results: Tanzania’s weak patent system and poorly-financed, partially state-owned firm dissuaded industry investment, but attracted a non-government organization to transfer technology through imitation. Donor-financed ARV tenders, however, restrict competition to international quality-accredited products not produced by the firm. Without large volumes and manufacturing capacity, it cannot achieve economies of scale to reduce prices below imported ARVs.
In South Africa, civil society challenged the strong patent system and poor government commitment that inhibited an ARV rollout. This and a well-financed, publicly-traded firm leveraged voluntary licenses. With international quality approval, the firm increased first-line ARV affordability; however, limited domestic competition keeps treatment prices above those of neighbouring countries.
A multi-country analysis found 321 generic ARV manufacturing initiatives in 86 firms across 25 developing countries. Voluntary ARV licenses had a strong positive association with TRIPS-patent compliance (ф=.56, p<.0001) and a weak negative association with state-ownership (ф=.19, p<.0001). Firms in South Africa and India were granted 77% of licenses and accounted for most quality accredited generic ARVs.
Conclusion: Despite positive association, technology transfer does not readily result from patent protection, particularly to state-owned firms. Developing countries must enact policies to enable affordable ARVs; yet, they must be cautious using local production to increase ARV access, as most initiatives cannot compete with high-volume generic manufacturers.
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Flynn, Matthew Brian. "Pharmaceutical governance in Brazil : globalization, institutions and AIDS." Thesis, 2010. http://hdl.handle.net/2152/ETD-UT-2010-12-2257.
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The Acquired Immune Deficiency Syndrome (AIDS) caused by the human immunodeficiency virus (HIV) represents one of the biggest challenges facing today's globalized world. Meanwhile, transnational drug companies have strengthened their market positions in developing countries as a result of the Agreement on Trade-Related Aspects of Intellectual Property (or TRIPS). Patent protection provided by TRIPS has led to higher prices and reduced access to essential medicines. Low- and middle-income countries are under increased pressure to provide expensive life-saving medicines to their citizens. Brazil's AIDS program is deemed successful in reducing morbidity and mortality rates through universal provision of free AIDS medicines. The program's sustainability came under threat as the result of TRIPS, pressures by transnational corporations, and trade threats by the US government. The research question that drove my dissertation centered on the impact of these threats on policy space available to Brazilian government to sustain its universal social program. How has the incorporation of patent protections for drugs affected the ability of local firms to develop pharmaceutical technology and challenged states like Brazil to fulfill social democratic obligations? Under what conditions can a developing country challenge the interests of transnational drug companies? I employed mixed methods for gathering and analyzing data. These included ethnographic field techniques, content analysis, and archival research. My findings are threefold. First, TRIPS has increased the power of foreign firms to secure monopoly positions in Brazil’s drug markets and weakened Brazil's labs to quickly make generic copies of essential medicines. Second, policy space, though curtailed due to external pressures and treaty obligations, expanded through the development of symbolic power, or what I call "reputational dividends," based on a successful social program. Third, by adroitly marketing its banner AIDS program by employing human rights principles, health officials constructed a triple alliance between the state, local private drug manufacturers, and domestic activists tied into transnational advocacy networks. I employ institutional and power analyses to examine the changing sources of power for transnational capital, social movements, and state actors, as well as analyze the impact patent protection has on the ability of Brazilian firms to produce medicines locally. I posit that globalization results in the formation of strong domestic coalitions who are capable of exploiting the "reputational dividends" of a successful social program in order to contest transnational corporate power. This symbolic form of power appears particularly well-disposed for "middle-income" countries that lack the material forms of power held by a global hegemon or transnational corporations.<br>text
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Volšanský, Petr. "Specifika patentového práva ve farmaceutickém průmyslu." Master's thesis, 2017. http://www.nusl.cz/ntk/nusl-266986.
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1 ABSTRACT SPECIFIC OF PATENT LAW IN PHARMACEUTICAL INDUSTRY This thesis scopes on particularities of patent law with regard to pharmaceuticals. It describes the basics of patent law while focusing mainly on international treaties, in particular on systems established by EPC and TRIPS. The patent system in USA and in the Czech Republic is also noted. This thesis is divided into seven chapters. In the first chapter named sources of law international institutions, treaties and situation in European union, USA and Czech Republic are described here. This chapter also deals with basic legal instruments such as patent, corporate invention or utility model. The next chapter is focused on individual conditions that need to be met in order to grant a certain patent - the most basic are novelty, inventive step and industrial applicability. The following chapter deals with problems associated with costly development of new drugs and the need of companies to get the longest possible protection for their inventions. A special chapter addresses exceptions to the stiff patent regulation. Described in the next chapter is the compulsory license, a legal instrument not very particular in the Czech Republic but relevant in some developing countries used in order to secure better availability of drugs to society. Other...
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Chen, Huang-Yu, and 陳皇宇. "Demand Forecasting for the Patent Expiration Drug." Thesis, 2019. http://ndltd.ncl.edu.tw/handle/n257q8.
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Hsu, Lucy, and 徐秀珠. "Branded Drug Manufacturer Business Strategy in Taiwan – based on New and Post Patent Drugs of X Company." Thesis, 2016. http://ndltd.ncl.edu.tw/handle/ac9977.
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碩士<br>國立政治大學<br>經營管理碩士學程(EMBA)<br>104<br>It is observed that the Taiwan health care environment, policies, payer’s attitude, tendency and patients’ expectations change over time and nothing has remained unchanged over the past years. To stay competitive over time, it is important to know what is learnt in the past and how to transform the learnings and make it be an aid in such a dynamic environment. This thesis focuses on how to maximize the product life cycle of a loss of exclusivity drug in Taiwan and how to leverage the time span between obtaining product license and gaining reimbursement for self-pay market development. The goal is to sort out all these learnings and experiences and make it a reference in the future.
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Esmail, Laura Caroline. "The Politics of Canada's Access to Medicines Regime: The Dogs that Didn't Bark." Thesis, 2012. http://hdl.handle.net/1807/33807.
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Decisions to reform pharmaceutical policy often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a reform that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only one order of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda for one year, has been exported. Future use of the regime appears unlikely.
This research aimed to examine the politics underlying the formation of CAMR. Parliamentary committee hearing transcripts from CAMR's legislative development (2004) and from CAMR's legislative review (2007) were analyzed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analyzed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR's final policy design.
In 2004, policy debates were dominated by two themes: intellectual property rights and TRIPS compliance. Promoting human rights and the impact of CAMR on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by a greater representation of the interests of potential beneficiary country governments.
While the Government attempted to strike a balance between drug affordability and intellectual property protection, it designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access.
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Wu, Tung-Che, and 吳東哲. "Pre-Approval Patent Resolution Process of Drug Product－ Lessons From U.S. Patent Linkage." Thesis, 2015. http://ndltd.ncl.edu.tw/handle/2bx5ms.
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碩士<br>國立政治大學<br>法律科際整合研究所<br>104<br>As the phamaceutical industry’s market leader, the United States continues to call for strengthening patent protection for pharmaceutical products during every trade negotiation, to preserve its national profit and leadership. Taiwan, being highly interested in joining “Trans-Pacific Partnership Agreement” (TPP) and signing “Trade and Investment Framework Agreement” (TIFA) with the United States, Taiwan's government is actively promoting the “patent linkage” since 2014. Althougn the effort done by Taiwan's government is extremely welcomed by American Chamber of Commerce, the domestic industry, which is mainly organized with generic drug manufactors, has expressed their opposition resolutely.
Patent linkage, as a kind of “pre-approval patent resolution process”, considers the possibility of patent infringement as a factor when issuing market approval. Such process are normally found in those countries that are trade partners of the United States, and espetially during the approval prosses of human-use drug products, animal drug products, which permits persons to rely on evidence or information concerning the safety and efficacy of a product that was previously approved.
Our current knowledge of pre-approval patent resolution process is limited, especially on how it was oranginally created in the United States. This research will focus on the purpose, enactment, amendment, court decisions, development, and issues of patent linkage, the first-of-its-kind which is established in 1984. On this basis, the reseach will then look back to what Taiwan has faced now, and provides recommendations on whether there is necessity of introdution, how to adjust the prosses, and how to enforce it, without serious abuse. This research propose “revised soft patent linkage”, which excludes automatic stay and re-date remedy, generally keeps the independence between drug approval and patent infringement, and at the same time meets TPP requirement. The research hopes to help Taiwan establishing its own pre-approval patent resolution, fair, clear and meet the need of domestic and public the industry.
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Huang, Chiu-jung, and 黃秋蓉. "The Patent Linkage Program of the U.S Drug Market Review." Thesis, 2013. http://ndltd.ncl.edu.tw/handle/98198773946196491541.
Full textAbstract:
碩士<br>國立雲林科技大學<br>科技法律研究所碩士班<br>101<br>The patent linkage program of the United States, means that the marketing approval of generic drugs are 「linked」to the judgment of whether the generics infringe a valid patent held by a brand-name pharmaceutical company on the same type of drugs or not.
In the drug for market, most high-profit drugs protected by patents, inexpensive generic drugs have the opportunity to enter the U.S. market in the patent expires. In 1984 through the 「Drug Price Competition and Patent Compensation Act」, Also known as the Hatch Waxman Act, jurisdiction by the U.S. Federal Food, Drug, and Cosmetic Act , provide a simplified application procedures for generics enter the market and for generics after the patent expires quickly enter the market. Focusing on this issue,
discuss about the U.S. patent system linked and discuss biological generic products applications listing regime.Further research of the patent litigation arising by the Hatch Waxman Act, the litigation about reverse payment settlement issues and counterclaim .Focusing on this issue, Taiwan has no patent linkage program differents from United States,comparison between the two countries and discuss the problems arising from different systems.
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WENG, SHENG-CHIEH, and 翁聖杰. "A Study on Patent Litigation Strategies of Generic Drug Company." Thesis, 2014. http://ndltd.ncl.edu.tw/handle/80622061114950821229.
Full textAbstract:
碩士<br>東吳大學<br>法律學系<br>102<br>The pharmaceutical expenditures have been increasing due to the use of patented new drugs and have caused heavy financial burdens for worldwide governments. Therefore, in recent years, to support the low-cost generics for saving health care expenditures has become the direction of pharmaceutical policies for worldwide governments. In 2009 the patented drugs market facing the competition from generics already reaches 24 billion US dollars. These generics competitors developed price war in each therapeutic category and diminished the profits of pharmaceutical companies of patented drug products. Each government endeavors in increasing the use of generics to lower the health care expenditure. There are 80 patent-protected pharmaceutical products become off-patented during 2008 and 2010. The market of these boosters, with a market value of 50 billion US dollars, has become the target of generics pharmaceutical companies. It is expected that the period within future will be declared as the golden age of generics.
The maximum public benefit of generics is providing the publics with the right to choose cheaper pharmaceutical products through the free mechanism of price competition in the market. Therefore each government encourages the prescription of generics, the correspondent regulations, and the complementary measures for generics. This is quite important for the vigorous development of pharmaceutical industry, and more influential on the public right on the use of pharmaceutical products and public health welfare.
The performance and potential of generics in prescription drug market demonstrates the threat of the sharp reduction in the profit of patented drugs manufacturers. Hence the patented drugs manufacturers have been continuously planned to utilize the intellectual property management strategies for those products which are going to be off-patented and threat by generics competition and tried to obstruct the launch of generics. This damages the right and benefit of consumers to purchase the medicines they need with reasonable pricing. In view of this, the generics regulations, correspondent policies of intellectual property right, and the reasonable regulations about complementary measures are quite important for the development of generics industries in each country, and also the public right on the use of pharmaceutical products and public health welfare.
In recent years the lawsuits charged against domestic generics manufacturers for infringement of the intellectual property rights of patented drug manufacturers are increasing. the correspondent domestic and international regulations and practical legislations of intellectual property are referenced and compared. The reference information of correspondent domestic/international cases and case studies about pharmaceutical related intellectual property lawsuits are provided. The intellectual property related topics which impact the development of generics industry are also studied. The necessity of legislation of generics law or specific chapter in the law of pharmaceutical affairs is also studied. This report also investigates the way to strengthen the developing circumstances of our pharmaceutical industry. On the circumstances that many domestic pharmaceutical manufacturers are charged of infringement lawsuits, it’s essential to study the legislation of the law of generics products as the reference of strategic planning for the development of future generics market in our country. And to solve the problems in our domestic pharmaceutical industry, it is recommended to revise the correspondent regulations which may be improper in practical before the legislation of generics law.
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Chien, Ting-Feng, and 簡庭鳳. "The Patent Analysis Studies of the Technology Strategy for Anticancer Drug." Thesis, 2002. http://ndltd.ncl.edu.tw/handle/62928187463821057670.
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碩士<br>國立東華大學<br>國際企業研究所<br>90<br>Through patent analysis technique, we explored the trend of the anticancer technology development in this study. We analyzed Taxol relevant patents by patent Guider 1.0 and American patent database USPTO. Also, several major Taxol patents-own companies were chosen for comparing their development trend. The patent analysis included technology life cycle analysis, patent citation, and the patent of the generic technology. The most of the anticancer patents are organic chemistry invention, and that are significantly progressing. Taiwan pharmaceutical manufactures should follow the trend to develop her own niche technology and do cross licensing with the international companies to speed up entering in the anticancer market.
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Liu, Ying-Hsiu, and 劉英秀. "Observing the Pharmaceutical Patents' Development and Portfolio of International Pharmaceutical Company by Patent Analysis - a Case Study of Anti-HER2 Targeted Drugs for Breast Cancer." Thesis, 2015. http://ndltd.ncl.edu.tw/handle/jf5ue7.
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碩士<br>國立臺灣科技大學<br>專利研究所<br>103<br>New drug research and innovation is a high-risk investment in the field of medicine, it has some characteristics, such as from R&D to launch a new drug to market is a time-consuming process and pharmaceutical companies still invest the great cost of capital during this period, pharmaceutical companies in order to improve cost recovery and return on investment, most of all will seek patent right to protect their products. The patent law offers the exclusive right to the inventors in a limited period of time, in this reason, brand name pharmaceutical companies could enjoy the exclusive right and avoid the competition of the generic drug manufacturers’ biosimilar medicine and affect the market return. Thus, the patent protective strategy of the pharmaceutical companies and the follow-up research of the drugs is significantly important.
In view of this, this paper were choose the targeted drugs, especially toward to HER2 positive breast cancer which genotype is HER2 overexpression, through the case study of the main patentee, we compare three analytical modes of patent value, such as highly cited patents, patent family size and main path analysis, and select the best model which could demonstrate pharmaceutical companies’ business model, then, take a detailed analysis of this models to understand International pharmaceutical companies were adopt which strategies to protect its pharmaceutical patents.
Finally, this thesis is of the view that the key patents summarized by the main path analysis methods, it can be seen not only within the international pharmaceutical company towards to a particular drug which its technology research and development Track, it may also understand how the international pharmaceutical company pay great attention to a drug through its patent application strategies and international deployment strategies, and the policy considerations in different development stages. The analytical methods we suggested and the results we obtained in this paper may provide a reference with patent protection and international deployment strategies to Taiwanese pharmaceutical Companies who decide to innovate a new drug.
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Hubálková, Pavla. "Competitive intelligence ve farmaceutickém průmyslu." Master's thesis, 2016. http://www.nusl.cz/ntk/nusl-350502.
Full textAbstract:
This diploma thesis describes and analyzes an area of competitive intelligence in the pharmaceutical industry. The work is divided into five parts. The first part deals with competitive intelligence and related aspects, the second part is dedicated to the pharmaceutical industry, with all specifics. The third part deals with competitive intelligence in the intersection with the pharmaceutical industry, the fourth part contains the classification and description of information resources appropriate for the activities of CI and a fifth part presents research, which consists of a questionnaire survey among pharmaceutical companies on the state of competitive intelligence and semi-structured interview with an expert in the area of CI in pharmaceutical company. The survey results represent a certain sub-probe, which demonstrates the strong position of CI as a common standard of pharmaceutical companies. Keywords competitive intelligence, pharmaceutical industry, information needs, drugs, pharmacovigilance, patents, information resources
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Cheng, Yao-Cheng, and 鄭耀誠. "Regulations and Intellectual Property Rights Protection Related to Drug Development and Marketing Approval- Focus on Patent Linkage, Data Exclusivity and Patent." Thesis, 2009. http://ndltd.ncl.edu.tw/handle/91809514167384777743.
Full textAbstract:
碩士<br>輔仁大學<br>財經法律學系<br>97<br>Drug development is a high cost, technology intensive industry. However, once there is a successful blockbuster drug, it will bring huge revenue. Intellectual property protection of pharmaceutical industry is mainly through patents which cover theorems and preparation methods of drugs that are derived from. Once such patents expire, those drugs usually become generic drugs that everyone can produce them freely. Even patents are expired, revenue derived from a blockbuster drug may still great. In order to enjoy monopoly power of the market, originators or agents of such drugs have to delay marketing of generic drugs to reduce competitors. On the other hand, generic drugs usually play important roles in lowering drug price, and promote access of drugs. To balance between revenue of originators and public welfare that the public can access useful drugs at lower price, there come many relevant systems.
This thesis mainly covers three drug related systems: patent linkage, data exclusivity and experimental use exemption. I researched and compared related regulations of international treaties, of Taiwan and of other countries, in order to find out a better solution that can balance industry development and public health and welfare in Taiwan.
On the side of patent linkage, Taiwan can take an eclectic solution. With current certificate based procedure as working in Australia, and work along with current patent reports. The most advantage of this eclectic solution is there won’t be great changes of current application and reviewing procedure. What we need to add are punishment to applicants that issue false certificates , notification to patent holders, certificate requirement when patent holders are willing to file a suit, and mechanism for governmental power to intervene into the suits. For generic drug manufactures, there will be a more clear range of patents that need to survey when they are going to produce a drug or file a marketing approval application.
On the side of data exclusivity, we have integrated this system in Pharmaceutical Affairs Act. Comparing with regulations in other countries, wording of the Taiwanese statute is fuzzier, and grants shorter term of protection. At this moment, pharmaceutical industry in Taiwan take development of non-NCE drugs as a breaking point, such fuzzier wording may be a chance and incentive to the industry; it may be acceptable therefore. However, current legislation did not correspond with compulsory license. In this amendment of The Patent Act, there is an exemption clause from Pharmaceutical Affairs Act article 40-2, which excludes compulsory licensed drugs which are exporting for humanitarian aid from data exclusivity protection of the originator, and is able to obtain marketing approval. In my opinion, if we wish to exclude compulsory licensed drugs from data exclusivity protection, we should include all kinds of reasons of granting a compulsory license as exemption of data exclusivity protection, no matter such compulsory license is for domestic use or for abroad aid, to elaborate full function of compulsory license system.
As to experimental use exemption, it is divided into general experimental use exemption and experimental use for drug development. In my opinion, ideal criteria of general experimental use exemption system are ”use of patents is for experiments that are for confirming effectiveness of such patents, evaluating such patents, advancing the same technology art or trying to solve same technology issue through another way; no matter such use contains commercial purpose or not.” On the side of experimental use for drug development, in cases of new drug development, it should apply general experimental use exemption if there are advanced researches conducted. If patent users use patents as research tool, they should obtain license from patent holder and pay reasonable royalty, and are unable to claim experimental use exemption for drug development. Experimental use exemptions for generic drug development, which is also known as “Bolar Clause” should strictly limited to use for research or experiments related to marketing approval purpose for generic drugs or medical devices that have legally marketed, use for new drug developments are unable to apply Bolar clause. As to promote access to key patents, I think this should not be solved in broadening experimental use exemption. What we may do is to establish statutory licensing mechanism that grant proper royalty to patent holders, in order to protect labor and investment of patent holders, and avoid possible blockage to scientific development.
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Zheng, Han-Sheng, and 鄭涵升. "Combined with the Industrial Patent Classification, Patent Information, and Knowledge Redundancy to Explore Firm M&A Intent：Evidence from drug-eluting stent." Thesis, 2014. http://ndltd.ncl.edu.tw/handle/43bzfn.
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碩士<br>國立雲林科技大學<br>企業管理系<br>102<br>Over the past decade, with the increasing population with cardiovascular diseases, the demand for medical treatment has sharply escalated, and it also generated profitable market for medical devices manufacturers. Nowadays, the competition in the market of medical devices related to chronic and degenerative diseases became extremely fierce. Lead companies, such as Johnson& Johnson、Boston Scientific、Guidant、Medtronic、Abbott, were engaged in strategic alliances and acquisitions for obtaining competitive advantage, key and basic patents. In 2005, Boston Scientific paid $27 billion to acquire Guidant, and it became one of the largest merger and acquisition in medical equipment industry. The patent portfolio behind the series of acquisitions and strategic behavior is something worth to think about.
In order to acquire a more precise industry classification, this research using patent co-citation approach to classify the industry technologies. Meanwhile, this research also using social network and technology network to analyze the position and role of firms to improve decision making.
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Lin, Chien-Hsing, and 林建興. "A Study for Review of Drug Registration and Patent Infringement Litigation of Drug-Focus on the Reverse of the Burden of Proof." Thesis, 2012. http://ndltd.ncl.edu.tw/handle/27570049255776430246.
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碩士<br>東吳大學<br>法律學系<br>100<br>Drug can help people to maintain healthy and plays an important role in the public health. Every country has specific law and regulations to manage the application, permission, sell, manufacture and change of the drug to ensure its safety and efficacy. Pharmaceuticals invest more in research and test for new medicine in order to acquire the permission of new drug. With this phenomenon, it is said that new drug business is an industry with high investment, high technology and high risk. Therefore, they always pay much more attentions on intellectual property. In contrast, generic drug has the same active ingredient, dosage form, dose and indication as the new drug or brand name drug. Generic drug costs lower than brand name drug to cause the use of generic drug in the society more popular than that of brand name drug. Therefore, brand name drug and generic drug is conflicted in their role for profit so that litigation between these two parties is inevitable. However, if the company of new drug on purpose delays the commercialization of the generic drug by any mean to extend its profit, it is harmful to the people and society for high cost in paying for new drug. Domestic litigation in the drug industry was initiated due to package insert of drug from these ten years ago. It was followed by an issue between two parts about exemption from patent infringement for experimental use. Recently, it shows a trend to have more patent infringement litigation in pharmaceuticals and the subject of the litigation is much diverse.
Government has responsibility to grant drug permit based on its safety and efficacy. The applicant will submit all of the technology documents in a dossier for the permission of drug. Basically, the dossier which includes research relevant and manufacturing relevant is a trade secret of the applicant. The review for the dossier in the government or any organization authorized by government covers a broad of fields from preclinical study to clinical study. They have responsibility to assure the drug is safe and has efficacy in therapy in normal use. In addition, they also consider the use of drug for special population and the quality of the drug from manufacturing point to ensure its quality.
Technique invention can be granted as a patent once it can meet the requirement of the patent. The owner of the patent has the monopolistic right in its scope of the claim to prevent the infringement from others. The patent owner can initiate a patent litigation against the infringer with evidence to prove this infringement. However, process patent is different to substance patent. The owner of the former can reverse the burden of the proof to assume other people infringe his patent, if some conditions are met, so that the patent right is able to enforce under this situation. However, dug business has specific law and regulations to manage the application, permission, sell, manufacture and change of the drug. The assumption for process patent to reverse the burden of the proof will have different influence in pharmaceutical industry. To look over the domestic patent infringement litigation relevant to drug, it shows that the brand name company somehow maintain its profit by applying the assumption of reversing the burden of the poof to cause the generic drug company an inconvenience of litigation proceeding.
This study further explores the original intention of the provision about the assumption for reversing the burden of the proof and how protection is applied to brand name company in this country. The exploration shows that to apply the assumption for reversing the burden of the proof in pharmaceutical industry needs more consideration about the details of the case in order not to prejudice the judgment in any way. It is also found that a motion for pre-action perpetuation of evidence for pharmaceutical industry maybe is meaningless. In contrast, to reasonably and legally apply the information in the dossier for drug permit application can help to effectively resolve the litigation.
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LIN, SZU YU, and 林思宇. "A Study on Challenge and Strategy of Patent Linkage in Taiwan -- Focusing on Generic Drug." Thesis, 2019. http://ndltd.ncl.edu.tw/handle/22563b.
Full textAbstract:
碩士<br>東吳大學<br>法律學系<br>107<br>ABSTRACT
The Patent Linkage has been implemented in the United States for more than 30 years. It was pushed to countries around the world with trade negotiations recently Taiwan has officially taken the road. Under the pressure of strong diplomatic pressure, it is not purely legal or drug certification systems. There are some additional administrative levels added and may lead to changes in the pharmaceutical industry.
There are some countries tried to add some local variant condition to slow down the impact on local pharmaceutic industry. In this way, it strives time to give them time to change the bones. In South Korea, they modified the Patent Linkage to develop the generic pharmaceutical industry and also some biological agents. They transformed the domestic pharmaceutical industry successfully.
In Taiwan, we did not see clearly active strategy or equivalent exchange on this system to protect our medicine demand. The people did not feel any impact under the protection of good medical insurance system so far. The system is still an important tool to guide local pharmaceutical industry to develop. The bill is proposed by Ministry of Health and Welfare, but the principle and direction was leaded by the Intellectual Property Bureau of Ministry of Economic affairs. In this way, some public heath issues may be neglect in this system. On the other way, it may have a long term impact of our medicine safety and accessibility.
At this time, I hope we should not only focus this bill as a pharmaceutical industry items. The government should, after the deep analysis and discussion, set up the direction of this health issue and put some more compensatory items to complete this goal.
Keywords: Intellectual Property Rights, Patent Linkage, Pharmaceutical Industry
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Keele, Mothobi Godfrey. "Beyond patent expiry: development of a model for pricing generic drugs in South Africa." Thesis, 2017. https://hdl.handle.net/10539/25605.
Full textAbstract:
A thesis submitted to the Faculty of Health Sciences, University of the Witwatersrand, in fulfilment of the requirements for the degree
of
Doctor of Philosophy.
Johannesburg, 2017.<br>Background: Generic drugs provide a safe, effective and affordable alternative to medicines whose patent protection has expired. The affordability of generics improves access to medicines and thus improves health outcomes. The generic pharmaceutical industry is complex; profitability depends on the number of other generics on the market.
Objective: To develop a model that explains structural relationships in the off-patent market between the price of a generic drug and the characteristics of a drug, formulation market and regulatory processes in the South African pharmaceutical industry.
Sources of Data: Innovators’ drugs and their generic equivalents were selected from all the molecules whose patents expired between 1999 and 2012. Data were obtained from IMS Health (Total Private Market Report) and National Department of Health (Database of Medicine Prices) for the patents’ expiration dates, prices, sales, launch dates of generics, therapeutic groups, schedules, and dosage forms of drugs in the sample.
Principal Findings: Generic entry into the local pharmaceutical industry is low, slow and selective. The developed model for this study identified seven market variables that were found to have an influence on the prices of generic drugs in South Africa. The determinants of generic entry are the market size of the on-patent innovator product, and the complexity of manufacture of a dosage form. The introduction of the transparent pricing system has had a significant impact in reducing the average unit prices of generics in South Africa. However, there appears to be policy incoherencies between the public health and industrial policies of the South African government as it pertains to pharmaceuticals. The erosion of the manufacturing capacity in South Africa could potentially be attributed to the pharmaceutical pricing policy. The overreliance on pharmaceutical imports for satisfying local consumption poses a risk to the security of supply of medicines in a country that has a high burden of diseases.
Conclusion: The introduction of legislative reforms related to the pricing of medicines in South Africa has largely yielded positive results in making medicines to be more accessible. Policy-making requires monitoring and evaluation programmes and inclusivity across all the stake-holders.<br>LG2018
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Collins, Robert J. "Technology and public policy : patent protection for new drugs in Canada." Thesis, 1989. http://spectrum.library.concordia.ca/10/1/ML49084.pdf.
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Jhen-Hong, Yang, and 楊鎮鴻. "The Impact of US Patent Linkage on Marketing of Generic Drugs." Thesis, 2015. http://ndltd.ncl.edu.tw/handle/10912532232187830025.
Full textAbstract:
碩士<br>國立雲林科技大學<br>科技法律研究所<br>103<br>Patent linkage system involves linking generic drug marketing approval with the originator drug’s patent status and refusing marketing approval until the relevant patent expires. However, generic pharmaceutical marketing as main market in Taiwan, and there is no patent linkage system in Taiwan, so there are still doubts about bringing in patent linkage system. For solve these question, first we discuss the legislative history and Current status of patent linkage system in US and the regulation of Biomedical and pharmaceutical in Taiwan. And then we discuss the impact of patent linkage on marketing of Generic drugs through the case “Novo Nordisk A/S v. Caraco Pharm. Labs, Ltd.”. In the end, we analysis the impact of patent linkage on Taiwan’s marketing of Generic drugs and discuss our government whether can introduce patent linkage system into Taiwan or not.
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Santos, Letícia. "Patente farmacêutica e medicamento genérico: o risco de conflito entre o interesse privado e o interesse público." Master's thesis, 2019. http://hdl.handle.net/1822/71863.
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Dissertação de mestrado em Direito dos Contratos e da Empresa<br>O acesso ao medicamento é pilar fundamental do direito à saúde amparado pelas
legislações nacionais e pelas normas do direito internacional. Inúmeros são os desafios para a
garantia desse direito à sociedade, pois o setor farmacêutico é complexo e apresenta
especificidades de ordem jurídica, econômica e social.
Neste trabalho, sob a perspectiva do Direito da Propriedade Industrial, com foco nas
patentes farmacêuticas em contraponto à livre comercialização dos medicamentos genéricos,
analisamos o risco de conflito entre o interesse público e o interesse privado no âmbito do setor
farmacêutico. Para tanto, apresentamos como fundamento da análise, a regulação normativa
envolvida na proteção jurídica à patente e no direito da concorrência, através de pesquisa a
doutrinas e ao estudo dos principais tratados e acordos internacionais e a respectiva transposição
para as legislações nacionais portuguesa, espanhola e brasileira. Abordamos importantes
questões dos sistemas das patentes farmacêuticas, com ênfase nas estratégias empresariais
violadoras do direito da concorrência, para tentar atrasar a entrada dos medicamentos genéricos
no mercado e prolongar o tempo de monopólio legal. Entretanto, apresentamos o positivo papel
das indústrias farmacêuticas na garantia do direito à saúde, pela investigação e desenvolvimento
de medicamentos, que requer elevados investimentos. Assim, a proteção do direito de patente é
um incentivo à produção de medicamentos inovadores. A regulação do setor farmacêutico tem o
objetivo de garantir a segurança jurídica e de estabelecer o equilíbrio entre o interesse privado e o
interesse público no mercado farmacêutico. Por fim, a análise estendeu-se aos desafios do direito
fundamental do acesso ao medicamento.<br>Access to medicine is a fundamental pillar of the right to health supported by national laws
and the rules of international law. There are numerous challenges to guaranteeing this right to
society, as the pharmaceutical sector is complex and has legal, economic and social specificities.
In this academic work, from the perspective of Industrial Property Law, focusing on
pharmaceutical patents as opposed to the free commercialization of generic drugs, we analyze the
risk of conflict between the public interest and the private interest within the pharmaceutical sector.
To this end, we present as the basis of the analysis, the normative regulation involved in patent
protection and competition law, through research into doctrines and the study of the main
international treaties and agreements and their transposition into Portuguese, Spanish and
Brasilian national laws. We address important issues of pharmaceutical patent systems, with an
emphasis on competition law-violating business strategies, to try to delay the entry of generic drugs
into the market and prolong the time for legal monopoly. However, we present the positive role of
the pharmaceutical industries in guaranteeing the right to health, for the investigation and
development of medicines, which requires high investments. Thus, patent protection is an incentive
for the production of innovative medicines. Regulation of the pharmaceutical sector aims to ensure
legal certainty and to strike a balance between private and public interest in the pharmaceutical
market. Finally, the analysis extended to the challenges of the fundamental right of access to
medicine.
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WANG, CHUNG-YU, and 王崇宇. "A Research on the Influence of Patent Linkage on Taiwan's Regimes of Patent Protection, Drug Administration and Health Care Pricing - Towards the Legality of Reverse Payments." Thesis, 2017. http://ndltd.ncl.edu.tw/handle/689d2y.
Full textAbstract:
碩士<br>世新大學<br>智慧財產權研究所(含碩專班)<br>105<br>Even though MMA(the Medicare Prescription Drug, Improvement, and Modernization Act) has considerably improved the disadvantage of the Hatch-Waxman Act, the dynamic balance among brand-name, generic pharmaceuticals and customers is extremely hard to maintain.By observing the game of Prisoner's Dilemma in the characteristics and competition of the pharmaceutical industry, I found that the brand-name pharmaceuticals are in favor of the strategy of risk aversion. Based on the economic and legal context, the Supreme Court of the United States adopted "rule of reason" to deal with Reverse Payment Settlements, which is far from the counterpart in European Union.
Subsequently, the finding from the comparison of the regimes of Health Care Pricing in several countries is that the shortcomings of Taiwan's Health Care are evident. Massive consumption in the huge hospitals constitutes the business model of pharmaceutical manufacturers in Taiwan. It is supposed that the incentive of achieving Reverse Payment Settlements decreases for reasons of the generic drugs are struck by its low quality and Health Care Price, and the brand-name drugs make less profit compared with the foreign market. The influence of the amendments of Pharmaceutical Affairs Act is supposed that the brand-name pharmaceuticals prefer to continue the patent litigation or make their exit from relevant markets.
In this thesis, I take a compromising stance between "the scope of the patent" and "rule of reason" to deal with the legality of reverse payment. Furthermore, I recommend that some articles and legal orders shall be added for the use of administration penalty in order to fulfill the requirement of the principle of clarity and definiteness of law. Finally, I think we shall take advantage of certain patterns of Reverse Payment Settlements which have less anti-competitive effect to boost the pharmaceutical industry in Taiwan.
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Chang, Teng-Feng, and 張登封. "The patent searching analysis and products planning - The empirical study of anticancer drugs." Thesis, 2003. http://ndltd.ncl.edu.tw/handle/06888847260752845636.
Full textAbstract:
碩士<br>國立東華大學<br>國際企業研究所<br>91<br>In order to develop product strategy for anticancer drugs of liver cancer technology, the study uses patent analysis, software Patent Guider 1.0, to analyze product anticancer drugs — thalidomide and adrianycin through USPTO patent searching. The results indicated that the thalidomide and adriamycin were in the product decline stage. According to Industry Life Cycle Theory, an enterprise should adapt the transformation strategy. For managerial implication, an enterprise in Taiwan should adapt the technology-licensing to exploit emerging market. Due to, these two kind of anticancer drugs belongs to different patent strategy groups, this study addresses vertical diversity for reconstructing Industry Value Chain and technical disclosure in accordance with Taiwan biotechnology industry.
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TSAI, HSIN-PEI, and 蔡欣貝. "The Impact on Patent Linkage of Pharmaceutical Industry and Access of Drugs in Taiwan." Thesis, 2018. http://ndltd.ncl.edu.tw/handle/hy87u4.
Full textAbstract:
碩士<br>逢甲大學<br>財經法律研究所<br>106<br>Patent linkage is the system, which a competent authority adapt to the patent status of the originator product during the sale of generic drugs review process. Patent linkage is a common policy for government to manage the drug market. Besides safeguarding pa-tent rights, it provides invention incentives to achieve the goal of promoting economic growth.
In early years, there was a debate while establishing patent linkage system in Tai-wan. Recently, in order to coordinate U.S. policy and join the TPP and TIFA, the Ex-ecutive Yuan proposed a draft amendment to the Pharmaceutical Affairs Act in 2016 to establish the patent linkage system. Although, after the election, President Trump with-drew the U.S. from the Trans-Pacific Partnership, Taiwan government adjusted its na-tional policy direction and continued to promote the signing of TIFA and Taiwan-US FTA. According to this study, among the countries that signed the FTA with U.S., Israel is the only country that have not established patent linkage system. Other countries that signed the FTA with U.S. have established a patent linkage system. Therefore, as a rule of thumb, if Taiwan's government wants to sign the Taiwan-US FTA, preparing the law on patent linkage is essential.
The draft amendment of the Pharmaceutical Affairs Act, which was proposed by the Executive Yuan, generally refer to the U.S. patent linkage system. In order to help pharmaceutical industry in Taiwan compete in the international market, it is imperative that pharmaceutical-related laws, regulations, and the new drug approval process apply the international standards. However, many studies point out that patent linkage systems have aroused a considerable number of legal issues since 1984. Therefore, this article attempts to clarify the issuse that Taiwan will face once the patent linkage system has been formally introduced in Taiwan, based on the experience of the U.S. in the process of revision law, and the amending the law locally in various countries. Also, this article will discuss how to amend the law locally and establish complementary measures to reduce the impact on the pharmaceutical industry in Taiwan.
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Huang, Yu-Chun, and 黃鈺鈞. "The Application and the Challenge of the Pharmaceutical Drugs Patent Linkage System in Taiwan." Thesis, 2018. http://ndltd.ncl.edu.tw/handle/4k4tb9.
Full textAbstract:
碩士<br>國立臺灣科技大學<br>專利研究所<br>106<br>In recent years, in order to cooperate with the Free Trade Agreement (FTA), the Executive Yuan of Taiwan has announced the Pharmaceutical Affairs Law’s latest amendment and declared to establish the patent linkage system in 2016. The partial amendment of Pharmaceutical Affairs Law legislated on Dec. 29th, 2017 indicates that patent linkage system was established to strengthen the relation between the listed drugs and the disclosure of the patent information, so as to let the original branded drug companies and the generic drug companies to clarify the potential infringement arguments. However, the application of the patent linkage system has brought up to many discussions and arguments. Moreover, because of the controversy related to the abuse of the Patent Listing and the appropriation of the 30-Month Stay, there have been much consideration about the impact this would have brought to the drug industry of Taiwan, which mainly consists of generic drug companies.
This study explores the historical evolution and regulations of the patent linkage system in the United States and provides understandings of the background and the intentions of the legislation at the time, in order to compare the pros and cons before and after it. This study further analyzes Taiwan’s structure and current status of the pharmaceutical industry, observes the dynamics of the overall pharmaceutical market, compares the medical insurance system and pharmaceutical industry in Taiwan to that of the United States, and how we learn from the introduction of the patent linkage system in other countries. This study tries to integrate the factors and concludes with the possible impacts on Taiwan after the implementation and deduces the applicability of the patent linkage system in Taiwan.
This study further compares the current draft of the Patent Linkage amendments in Taiwan to the Pharmaceutical Affairs Law and the Patent Law with the U.S. Patent Linkage System, proposes amendments to the law and the implementation of the patent linking system in the future, and how Taiwanese manufacturers, both branded and generic drugs companies, can make responsive measures.
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Barron, Paul. "Management decisions regarding end patent strategies in the South African private pharmaceutical market." Diss., 2013. http://hdl.handle.net/2263/41894.
Full textAbstract:
The loss of patent protection for a pharmaceutical product is a significant event for
manufacturers. Although this phenomenon has been occurring in the industry for
decades, it has been of increased interest during the past few years due to the much
publicised “patent cliff” experienced by a number of major pharmaceutical
manufacturers. Recent developments in emerging economies such as India and South
Africa have brought the concept of intellectual property rights under review. The
traditional approach to extend market exclusivity through the use of secondary patents
is no longer valid. New product strategies are now required to transition from a patent
protected market to an open market. This study adds to the current literature by
investigating post-patent strategies pursued in the South African private
pharmaceutical market. The primary focus was to determine the rationale behind
choosing a particular strategy.
This study, exploratory in nature and structured around five propositions, investigated
strategies to manage the patent expiry and potential entry from generic competitors.
These included manipulating price, increasing promotion, developing value adding
product extensions or launching a clone. Information was gathered through 14
interviews with product managers responsible for implementing the chosen strategy.
The interviews were conducted using a structured questionnaire as well as open-ended
questions. Five companies were selected for the study using purposive sampling and
each company then self-selected which products would be discussed.
The most pursued strategy for the sample was to launch a clone. This allowed the
manufacturer to compete with lower priced generics using the clone as well as continue
to profit from the remaining brand loyal, price insensitive consumers with the original
product. The price of the original product was not used to deter entry or compete with
generic products. Profit-maximising behaviour was exhibited by the reduction in
advertising and promotional spend after patent expiry. When available, the use of
product extensions to extend market exclusivity continued to be a preferred strategy.<br>Dissertation (MBA)--University of Pretoria, 2013.<br>zkgibs2014<br>Gordon Institute of Business Science (GIBS)<br>MBA<br>Unrestricted