Dr Ron A. Bouchard is an intellectual property lawyer and scholar, specializing in the innovation, regulation, and litigation of biomedical products. His career has focused on the science, law, policy, regulation, and commercialization of medical technologies. He began his career as a medical scientist, completing a PhD and Postdoctoral Fellowship in the field of ion channel biophysics and Ca2+ imaging. He shifted focus to obtain a law degree specializing in pharmaceutical and biotechnology law and has been involved in the prosecution, acquisition, financing, distribution, and litigation of intellectual property rights. Dr Bouchard has appeared before the Federal Court of Canada and the Supreme Court of Canada. He has consulted with firms, universities, governments, and international organizations on legal, regulatory, and policy issues. He worked with the Government of Canada on its platforms for drug regulation and public private partnerships in technology commercialization. His research has been funded by federal and provincial funding agencies and private endowments. His scholarly expertise is focused on the intellectual property and regulatory aspects of therapeutic product development, including global aspects of technology commercialization, patenting, licensing, and regulatory approval, and empirical assessment of the impact of government stimulus packages and regulation on technology innovation. Dr Bouchard currently is involved with a new global consortium of scholars, physicians and economists studying the impact of emerging forms of patent law on the availability and costs of essential medications in developed and developing nations: the Consortium Study of Global Pharmaceutical Linkage.

• DedicationAcknowledgementsList of figures and tablesList of abbreviationsAbout the authorChapter 1: IntroductionAbstract:1.1 The emergence of global pharmaceutical linkage1.2 Canadian pharmaceutical linkage regulations1.3 OrganizationChapter 2: Background: drug approval, drug patenting, pharmaceutical linkage, and public health policyAbstract:2.1 Drug approval2.2 Patents2.3 Linkage regulations2.4 IPR rights and innovation policyChapter 3: Empirical analysis of drug approvalAbstract:3.1 Introduction3.2 Analysis3.3 Results3.4 Discussion3.5 Interpretation of data3.6 Study limitations3.7 Assessing the lifecycle approach: the long view3.8 Government as representative public agent3.9 Summary and conclusionsChapter 4: Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkageAbstract:4.1 Introduction4.2 Methods4.3 Results4.4 DiscussionChapter 5: Empirical analysis of drug patenting in multiple high-value cohortsAbstract:5.1 Introduction5.2 Methods5.3 Results5.4 Discussion5.5 Summary and conclusionsChapter 6: Implications of empirical data: are pharmaceutical linkage regulations a success?Abstract:6.1 Introduction6.2 Debate preceding Bill C-916.3 ‘Original policy intent’6.4 ‘Patent-specific’ analysis6.5 Statutory interpretation6.6 Revisiting the empirical data6.7 Summary and conclusionsChapter 7: Future directions: testable hypotheses and evolution toward global pharmaceutical linkageAbstract:7.1 Hypotheses regarding cluster-based drug development7.2 Globalization of pharmaceutical linkageIndex