<p>For many years pharmaceutical patents and their impact on prices have been at the centre of the international debate over insufficient access to lifesaving HIV/AIDS medicines in developing countries. The conflict has largely revolved around the implementation of an intellectual property system in the developing world, subsequent the adaptation of the TRIPS Agreement, which has made a 20 year pharmaceutical patent protection mandatory for these countries and consequently contributed to high drug prices for patented medicines as well as limited the use of generic drugs.</p><p>Developing countries, where patents are already in place, have sought to reduce high drug prices by making use of compulsory licensing, a safeguarding practice allowing the production or importation of a generic medicine without the consent of the patent holder. Compulsory licences are allowed under the TRIPS Agreement, but disagreements about the conditions, under which compulsory licences are available for ‘essential medicines’, have restricted their use. A definition of the extent to which compulsory licensees can export generic drugs to developing countries unable to manufacture their own has been missing, but on 30 August 2003 the WTO announced that it had resolved this problem by lifting the TRIPS Agreement’s restrictions on exports and permitting exports of drugs produced under a compulsory license as an exception to a patent right. The main question is whether the compulsory licensing system as prescribed in the recent Decision is an ample means of improving access to patented AIDS medicines in the developing world.</p><p>By means of legal and economic reasoning this master thesis argues that the 30 August Decision on lifting TRIPS’ restrictions on exports of patented pharmaceuticals produced under compulsory licences provides complex and uncertain rules, rendering an unreliable employment of compulsory licensing. It is desirable that further recommendations are given on which generic producing companies should be awarded compulsory licences and also on which premises. In reality, the debate about compulsory licensing is part of a much wider structural problem in development policy. The solution to the inaccessibility problem requires a mix of courses of action with a functioning compulsory licensing system included. However, disagreements such as how necessary funding should be divided equitably between developed countries could protract the reaching of a pragmatic solution.</p>

The Canadian canola breeding sector met a transition from publicly funded breeding research to large private investments in research and development (R&D). The increasing use of biotechnology tools in the mid 1990s made the assignment of plant ownership technically possible while the legislative safeguards that were put in place during the same period enabled owners to take juristic actions against potential infringers. Today, canola breeding sector is dominated by large multinational firms. The generation of proprietary knowledge in the canola breeding sector has caused a freedom to operate issue. Private and public firms conducting canola R&D are seriously concerned about their ability to gain and preserve access to key technologies in an IPR world. <p>This thesis uses the tragedy of the anticommons framework to analyze the consequences of increased intellectual property protection in the canola breeding sector. Theory suggests that when a common resource is owned by multiple owners, each of the owners has the incentive to overcharge potential users, leading to the underuse of the resource. In R&D, different owners of complementary technologies may overcharge potential R&D firms that want to assemble different technological pieces to produce a new one. The result is forgoing research and development of new products.<p>The results of personal interviews with thirteen canola researchers and IP officers are presented and analyzed. The results suggest that the increase in the intellectual property protection in the last two decades in the canola breeding sector has led to difficulties with canola R&D. These difficulties take the form of reduced access to current, proprietary and public material. With hampered access to research input material, research output is not maximized and potential research may be forgone. Interviewees described how the increase in the intellectual property protection affects their personal and organizations ability to conduct research as well as some the implications of the new IP regime on the canola breeding sector. There is indication that canola breeding sector is moving towards a super-protectionism. Under these conditions, canola R&D firms, private and public, are in search for ways that will open access to enabling technologies and research areas. The creation of platform technologies and collaborations are the most prominent ones and are observed to increase in occurrence world wide.

University of Macau / Institute of Chinese Medical Sciences

The Canadian canola breeding sector met a transition from publicly funded breeding research to large private investments in research and development (R&D). The increasing use of biotechnology tools in the mid 1990s made the assignment of plant ownership technically possible while the legislative safeguards that were put in place during the same period enabled owners to take juristic actions against potential infringers. Today, canola breeding sector is dominated by large multinational firms. The generation of proprietary knowledge in the canola breeding sector has caused a freedom to operate issue. Private and public firms conducting canola R&D are seriously concerned about their ability to gain and preserve access to key technologies in an IPR world. <p>This thesis uses the tragedy of the anticommons framework to analyze the consequences of increased intellectual property protection in the canola breeding sector. Theory suggests that when a common resource is owned by multiple owners, each of the owners has the incentive to overcharge potential users, leading to the underuse of the resource. In R&D, different owners of complementary technologies may overcharge potential R&D firms that want to assemble different technological pieces to produce a new one. The result is forgoing research and development of new products.<p>The results of personal interviews with thirteen canola researchers and IP officers are presented and analyzed. The results suggest that the increase in the intellectual property protection in the last two decades in the canola breeding sector has led to difficulties with canola R&D. These difficulties take the form of reduced access to current, proprietary and public material. With hampered access to research input material, research output is not maximized and potential research may be forgone. Interviewees described how the increase in the intellectual property protection affects their personal and organizations ability to conduct research as well as some the implications of the new IP regime on the canola breeding sector. There is indication that canola breeding sector is moving towards a super-protectionism. Under these conditions, canola R&D firms, private and public, are in search for ways that will open access to enabling technologies and research areas. The creation of platform technologies and collaborations are the most prominent ones and are observed to increase in occurrence world wide.

Applied economists and strategy scholars have examined a variety of firm-level factors that may explain the level and direction of firms' innovative effort and performance, including firms' profit incentives. Innovation at the firm level, however, should also depend heavily on the nature of the pecuniary and non-pecuniary incentives driving the efforts of those individuals that are responsible for innovative activities within firms. Drawing on research in economics and social psychology, I examine three questions: 1. What are the motives of individuals engaged in firm innovation? 2. How do individuals' motives and incentives affect their innovative effort and performance? 3. How do individuals' motives and incentives differ between entrepreneurial and established firms, and are any such differences associated with differences in innovative effort and performance? My empirical analysis builds on the National Science Foundation's SESTAT data, which contain survey responses from over 10,000 scientists and engineers employed in U.S. firms. Among others, the data contain measures of individuals' extrinsic, intrinsic, and social motives (e.g., preferences for work benefits such as salary, intellectual challenge, and contribution to society), effort, and innovative performance. In chapter Two ("What makes them tick - Employee motives and firm innovation"), I develop a formal model of the relationships between individuals' motives and incentives, effort, and innovative performance. Econometric analyses using the SESTAT data suggest that individuals' motives have significant effects upon innovative effort, as well as on innovative performance, controlling for effort. Overall, intrinsic motives (in particular, intellectual challenge) appear to be more beneficial for innovation than extrinsic motives. In chapter Three ("Fire in the belly? Individuals' motives and innovative performance in startups and established firms"), I examine differences in motives, effort, and performance between startups and established firms. I find that individuals' extrinsic motives differ significantly between startups and established firms, while their intrinsic motives are surprisingly similar. Startup employees expend more effort and have higher patent application counts than individuals in established firms. Individuals' motives explain only a limited amount of these effort and performance differences across firm types, however, because the intrinsic motives that are most strongly associated with effort and performance differ little between startups and established firms. / Dissertation

This thesis attempts to analyze a part of the big and complex process of how intellectual property ownership and technological innovation influence the performance of firms and their revenues. Here I analyze a firm's stock market performance as a function of the quantity and quality of intellectual property (patents) owned by the firm in context of the three US high-technology sectors, Pharmaceuticals, Semiconductors and Wireless. In these sectors, value of a firm is predominantly driven by the technologies which a firm owns. I use citation based indicators and number of claims to measure the quality of patents. This research presents empirical evidence for the hypothesis that in high-tech sectors, companies which generate better quality intellectual property perform better than average in the stock market. I also posit that firms which are producing better quality technologies (good R&D) invest more in R&D regardless of their market performance. Furthermore, though smaller firms get relatively less returns on quality and quantity of innovation, they tend to invest a bigger fraction of their total assets in R&D when they are generating high quality patents. Larger firms enjoy the super-additivity effects in terms of market performance as the same intellectual property gives better returns to them. In addition, returns to R&D are relatively higher in the pharmaceutical industry than semiconductor or wireless industries.

No description available.

For many years pharmaceutical patents and their impact on prices have been at the centre of the international debate over insufficient access to lifesaving HIV/AIDS medicines in developing countries. The conflict has largely revolved around the implementation of an intellectual property system in the developing world, subsequent the adaptation of the TRIPS Agreement, which has made a 20 year pharmaceutical patent protection mandatory for these countries and consequently contributed to high drug prices for patented medicines as well as limited the use of generic drugs. Developing countries, where patents are already in place, have sought to reduce high drug prices by making use of compulsory licensing, a safeguarding practice allowing the production or importation of a generic medicine without the consent of the patent holder. Compulsory licences are allowed under the TRIPS Agreement, but disagreements about the conditions, under which compulsory licences are available for ‘essential medicines’, have restricted their use. A definition of the extent to which compulsory licensees can export generic drugs to developing countries unable to manufacture their own has been missing, but on 30 August 2003 the WTO announced that it had resolved this problem by lifting the TRIPS Agreement’s restrictions on exports and permitting exports of drugs produced under a compulsory license as an exception to a patent right. The main question is whether the compulsory licensing system as prescribed in the recent Decision is an ample means of improving access to patented AIDS medicines in the developing world. By means of legal and economic reasoning this master thesis argues that the 30 August Decision on lifting TRIPS’ restrictions on exports of patented pharmaceuticals produced under compulsory licences provides complex and uncertain rules, rendering an unreliable employment of compulsory licensing. It is desirable that further recommendations are given on which generic producing companies should be awarded compulsory licences and also on which premises. In reality, the debate about compulsory licensing is part of a much wider structural problem in development policy. The solution to the inaccessibility problem requires a mix of courses of action with a functioning compulsory licensing system included. However, disagreements such as how necessary funding should be divided equitably between developed countries could protract the reaching of a pragmatic solution.

Au cours de la dernière décennie, la pharmacogénomique est devenue le mantra révolutionnaire de nombreux chercheurs et de certains porte-paroles de l'industrie. L'intérêt que porteront les compagnies bio-pharmaceutiques du secteur privé à la recherche et au développement de nouveaux médicaments pharmacogénomiques sera déterminé par la facilité à obtenir du financement et les perspectives de retombées économiques. Dans cette perspective, le droit de la propriété intellectuelle (plus spécifiquement le droit des brevets) a toujours été l'instrument de prédilection pour motiver la recherche et le développement des produits pharmaceutiques. Cependant, l'extension de ce droit au domaine de la pharmacogénomique est controversé. Cette étude évalue l'applicabilité du système international des brevets au domaine de la pharmacogénomique. Suite à une analyse comparative du droit et des principaux textes normatifs, applicables aux brevets pharmaceutiques et biotechnologiques, ainsi qu'à une revue de la doctrine, l'étude soutient que le système de brevets reste une solution viable pour encourager la recherche et le développement dans le domaine de la pharmacogénomique. Cependant, certains ajustements sont nécessaires pour empêcher que des brevets trop larges, ayant des fondements juridiques douteux, ne soient octroyés sur des nouveaux tests de diagnostic pharmacogénomiques et sur des nouveaux outils de diagnostic pharmacogénomiques, ce qui serait néfaste à la recherche et limiterait l'accès aux soins de santé. Plusieurs stratégies sont proposées pour promouvoir un système de brevets applicable au domaine des biotechnologies qui, tout en donnant la motivation nécessaire aux inventeurs et à l'industrie, protégerait nos valeurs humaines fondamentales. / In the last decade, pharmacogenomics has become the "revolution" mantra for numerous researchers and industry representatives. The research interest of the industry for pharmacogenomics will be determined by financing possibilities and prospective economic benefits. In this perspective, the intellectual property system (more specifically patents), has always been the privileged tool to motivate research and development of pharmaceutical products. However, its application to pharmacogenomics is controversial. This study evaluates the applicability of the international patent system to the area of pharmacogenomics. A comparative review and analysis of international laws and guidelines applicable to biotechnology and pharmaceutical patents as well as a review of the literature was carried out. Our study found that the patent system remains a viable solution to promote research and development of pharmacogenomics. However, some adjustments are needed to ensure that overbroad patent having a weak legal basis are not granted on both new pharmacogenomic research tools and diagnostic tests since this could be detrimental to research and limit access to healthcare. Strategies are suggested to promote a patent system, applicable to the field of biotechnology, that will give the necessary incentive to inventors and industry while protecting our fundamental human values. / "Mémoire présenté à la Faculté des études supérieures en vue de l'obtention du grade de Maîtrise en droit (LL.M.) Option droit, Biotechnologies et société" / Texte du mémoire également publié dans Lex Electronica, vol. 10 n°2 (Été/Automne 2005)

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. / 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. / "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.