The Intellectual Property–Regulatory Complex

Emily Marden is counsel at Sidley Austin LLP in the food and drug regulatory practice in Palo Alto, California, and research associate in law at the University of British Columbia, where she teaches and directs research on genomics and innovation in agriculture and the life sciences. R. Nelson Godfrey is an associate in the Vancouver office of an intellectual property and technology law firm whose practice includes advising clients on litigation, compliance and regulatory matters, and licencing transactions. He has written extensively on issues relating to intellectual property and regulatory regimes and their interaction with research and knowledge translation, with particular emphasis on topics relating to genomics research and living modified organisms. Rachael Manion is a senior associate at a public policy consulting firm based in Ottawa that serves the health and life sciences sectors. She draws on her work as a regulatory lawyer for the federal Department of Justice, where she advised Health Canada on the application of existing statutory regimes to novel technologies and the development of science policy. Contributors: Vernon Bachor, Hannes Dempewolf, Rochelle Cooper Dreyfuss, Regiane Garcia, Gregory Graff, Jeremy Hall, Sarah Hartley, Ronald J. Herring, Stelvia Matos, Chidi Oguamanam, Loren H. Rieseberg, Matthew R. Voell, and David Zilberman

Foreword / Hannes Dempewolf

Introduction / Emily Marden, R. Nelson Godfrey, and Rachael Manion

Part 1: Perspectives On Regulatory Regimes

1 Biosafety and Intellectual Property Regimes as Elements of the IP–Regulatory Complex: The Case of Canadian Sunflower Genomics / Emily Marden, R. Nelson Godfrey, Matthew R. Voell, and Loren H. Rieseberg

2 The Treatment of Social and Ethical Concerns in Regulatory Responses to Agricultural Biotechnology: A Historical Analysis / Sarah Hartley

3 How the IP–Regulatory Complex Affects Incentives to Develop Socially Beneficial Products from Agricultural Genomics / Gregory Graff and David Zilberman

4 Stealth Seeds: Bioproperty, Biosafety, Biopolitics / Ronald J. Herring

Part 2: Intellectual Property Mechanisms And Counter-Movements

5 Implementing the International Treaty on Plant Genetic Resources for Food and Agriculture: A Regulatory and Intellectual Property Outlook / Chidi Oguamanam

6 Intellectual Property Management and Legitimization Processes in International and Controversial Environments / Jeremy Hall, Stelvia Matos, and Vernon Bachor

Part 3: Future Directions

7 A Governance Approach to the Agricultural Genomics Intellectual Property–Regulatory Complex / Regiane Garcia

8 Constructing an International Intellectual Property Acquis for the Agricultural Sciences / Rochelle Cooper Dreyfuss

Index