"August 2000" Includes bibliographical references (leaves 115-118) and index of inventors 1. Introduction, overview of years 1836-1886 -- 2. The Patent Act, no. 18, of 1859 -- 3. The Provisional Registration of Patents Act, no. 3, of 1875 -- 4. The Patent Act, no. 78, of 1877 -- 5. Numerical list of inventions

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.

Innovation comprises the processes of invention and commercialization. While the importance of innovation, especially commercialization, has been widely recognized, existing studies have largely overlooked the commercialization process. By examining the determinants of uses and nonuses of patented inventions from firms at the levels of technology, organization, and project/invention, this study attempts to help fill a critical gap in the literature. In doing so, it enriches theoretical understandings of innovation and, in particular, builds on the evolutionary explanation of technology development, the Teecian framework on profiting from innovation, Transaction Cost Economics (TCE), the Knowledge-Based View (KBV), and open innovation and innovation network perspectives. It also reveals an empirical reality of commercial use and strategic nonuse of patents. The study is based on a novel dataset constructed from multiple sources: inventor surveys, the United States Patent and Trademark Office online database, and COMPUSTAT, among others. After examining the factors affecting overall propensity to commercialize patented inventions, this study explores the factors that affect the organizational paths of commercialization. The empirical estimation indicates that technological uncertainty and a strong internal position of complementary assets raise the propensity for internal commercialization. The study argues that openness of innovation processes and network relationships should affect the choice of commercialization paths. Consistent with the hypotheses, empirical estimations show that external industrial knowledge increases the propensity of internal commercialization. The study also indicates that collaboration has diverging effects on the choice of commercialization paths. While collaboration with firms in vertical relationships tends to favor internal commercialization, collaboration with firms in horizontal relationships tends to favor external commercialization (licensing, start-up). Finally, the study reports findings on the strategic use of patents and then tests hypotheses about the factors driving strategic nonuse. It concludes that a significant portion of U.S. patents are indeed filed for strategic reasons. It also finds that characteristics of technology and firms are significantly associated with different strategies. In particular, firms are more likely to use a patent for strategic defensive purposes when they have larger amounts of assets. The study concludes with discussing managerial and policy implications.

Ongoing research in the fields of genetics and biotechnology hold the promise of improved diagnosis and treatment of genetic diseases, and potentially the development of individually tailored pharmaceuticals and gene therapies. Difficulty, however, arises in determining how these services are to be evaluated and integrated equitably into public health care systems such as Canada's. The current context is one of increasing fiscal restraint on the part of governments, limited financial resources being dedicated to health care, and rising costs for new health care services and technologies. This has led to increasing public debate in the last few years about how to reform public health care, and whether we should prohibit, permit or perhaps even encourage private purchase of health care services. In Canada, some of these concerns have crystallized around the issue of gene patents and commercial genetic testing, in particular as illustrated by the case of Myriad Genetics' patented BRACAnalysis test for hereditary breast and ovarian cancer. While most Canadians who currently access genetic services do so through the public health care system, for those with the means, private purchase is becoming an option. This situation raises serious concerns - about justice in access to health care; about continued access to safe and reliable genetic testing supported by unbiased patient information; and about the broader effects of commercialization for ongoing research and the Canadian public health care system. Commercial genetic testing presents a challenge to health care professionals, policy analysts, and academics concerned with the social, ethical and policy implications of new genetic technologies. Using the Myriad case as an exemplar, tools from moral philosophy, the social sciences, and health policy and law will be brought to bear on the larger issues of how as a society we should regulate commercial research and product development, and more coherently decide which services to cover under public health insurance and which to leave to private purchase. Generally, the thesis is concerned with the question of "how best to bring capital, morality, and knowledge into a productive and ethical relationship" (Rabinow 1999, 20).

L'Accord sur les Aspects des Droits de Propriété Intellectuelle qui touchent au commerce constitue l'un des principaux piliers des accords de l'Uruguay Round. C'est aussi l'un des plus controversés. Cet Accord renforce les droits de propriété intellectuelle, les associe au commerce et introduit une norme mondiale ayant force exécutoire. La mise en application de cet Accord, qui suppose notamment de reconnaître et de renforcer la protection des produits et procédés pharmaceutiques par des brevets, pose des problèmes particuliers aux pays en développement vu le manque de ressources professionnelles, financières et d'infrastructure. La manière dont se fait l'interprétation de cet Accord peut avoir d'importantes répercussions sur les politiques de santé publique et, en particulier, sur l'accès des populations aux médicaments. Soumis aux pressions des pays riches et des groupes pharmaceutiques, les gouvernements des pays en développement se retrouvent parfois pieds et poings liés et n'utilisent pas les flexibilités prévues à leur avantage dans l'Accord, ce qui rend la situation sanitaire de leur population encore plus précaire. Cette étude décrit les principaux acteurs et les étapes importantes de la négociation de l'Accord, ainsi que les différentes adaptations qui en ont été faites sous les pressions contradictoires des nombreux protagonistes. Elle donne des explications sur les mécanismes en place et les conséquences possibles de l'entrée en vigueur de l'Accord sur l'accessibilité des pays en développement aux médicaments. / The Agreement on Trade-Related Aspects of Intellectual Property Rights is one of the main pillars of the agreements of the Uruguay Round. It is also one of the most controversial. This agreement strengthens the intellectual property rights, ties them to trade regulation and introduces a global binding standard. The implementation of this Agreement, which includes the recognition and the strengthening of the protection of pharmaceutical products and processes by patents, raises particular problems for developing countries, given the in lack of professional over financial resources as well as their poor economics infrastructure. The interpretation of this Agreement can have important consequences on public health policies and in particular on people's access to medicines. Unless the pressure of rich countries and pharmaceutical companies, governments of developing countries sometimes find themselves bound hand and foot and do not use the flexibilities provided to them by the Agreement to improve their position, thus making the health situation of their people still more precarious. This study describes the main actors and the important stages of negotiating the Agreement, as well as the various adjustments that were made under the pressures of numerous actors. It provides explanations of the existing mechanisms and of the potential consequences of the implementation of the Agreement on the accessibility of developing countries to medicines.

Mémoire numérisé par la Division de la gestion de documents et des archives de l'Université de Montréal

Questa tesi analizza le determinanti e gli effetti dell'innovazione attraverso un'analisi empirica. Nel primo capitolo viene analizzato l'impatto delle leggi di proprietà intellettuale sull'innovazione domestica in campo farmaceutico. Nel secondo capitolo, in cui vengono usati dati a livello di impresa, si studia la correlazione tra innovazione, export, produttività e vincoli finanziari. Infine nell'ultimo capitolo si studia l'effetto dell'innovazione domestica nell'attrarre investimenti diretti esteri. Mentre nel primo e nell'ultimo capitolo l'innovazione viene misurata come output, usando il numero di brevetti attribuiti ad un determinato paese, nel secondo capitolo vengono usati dati di R&D, e quindi di input di innovazione. / This dissertation analyses the determinants and the effects of innovation using an empirical analysis. In the first chapter the impact of Intellectual Property Rights on domestic innovation in the pharmaceutical sector is estimated. In the second chapter the correlation between innovation, export, productivity and financial constraint is studied at the firm level. Finally, in the last chapter the role of domestic innovation in attracting Foreign Direct Investments is estimated. While in the first and in the last chapter innovation output is considered, and innovation is proxied by patent data, in the second chapter innovation input is taken into account, and R&D data are used.

美國最高法院於2013年6月13日，發佈自2010年起纏訟多年的 AMP v. USPTO & Myriad Genetics案判決，最高法院全體一致認為，與天然相同的DNA序列，即使經過單離（isolated）仍然不具有可專利性，但補償性的DNA（complementary DNA，簡稱cDNA），則為人為發明產物具有可專利性。 判決出來後，引發各界譁然，相關基因測試業者擔心，最高法院的見解，會使基因研發的投資意願大幅減少，反而會阻礙往後創新研發。但支持者認為基因本屬人類共有產物，且否准基因專利後，能夠讓其他更低價、更有效率的檢測方法進入市場，對社會有助益。在專利權人的私有利益與公共衛生利益激烈衝突下，各方都有鏗鏘有力的理由。 美國專利商標局（USPTO）從1980年代起，開始核發與基因有關之專利，並在2001年公布「實用性檢查指引」（Utility Examination Guidelines），認為單離的人類DNA或純化DNA分子，亦可賦予專利，透過賦予專利排他權，達鼓勵研發創新之目的。從過去三十年來，基因相關專利數量劇增，也因為專利排他的特性，對現有的科學研究產生阻礙，不僅如此，對於患者而言，因為專利權人積極行使權利，成為市場唯一壟斷者，使患者無法獲得其他醫療意見（second opinion）的權利，這也是Myriad案備受矚目的原因之一。 因此，本論文將藉由AMP v. USPTO & Myriad Genetics案，重新省思對於人體基因是否具有可專利性，並整理美國司法實務過往對於可專利標的、基因專利等重要判決進行分析，最後提出本文的見解，試圖提出一些可能的解決方案。

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.

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.