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The past two decades have witnessed a growing debate in the United States over patenting genetic products and processes. At the heart of the debate are two interrelated questions – first, whether granting patents on the results of “upstream” genetic research undermines the norms of the biological research community, and second, whether such patenting promotes or retards biomedical innovation, technology transfer, and/or the development of downstream commercial products and processes. Much of this debate has focused on the impact of a 1980 piece of legislation codified as a chapter of the U.S. patent statute and commonly known as the Bayh-Dole Act.
The Bayh-Dole Act effected a major change in U.S. policy with respect to the ownership of intellectual property rights in federally funded research. It was designed to promote technology transfer by allowing universities, small businesses, and other research institutions, in the absence of special circumstances, to retain ownership of the patent rights resulting from federally funded research, subject to a number of obligations, including an obligation on the part of universities and other nonprofit institutions to share royalties with the actual inventor. Prior to the Bayh-Dole Act, patent rights were in principle retained by the federal funding agencies themselves, though the actual patent policies of federal funding agencies varied considerably, with some agencies allowing universities to patent publicly funded research discoveries under certain circumstances. Although the Bayh-Dole Act governs the patenting of federally funded research in all fields of technology, university patenting and licensing pursuant to the act have thus far overwhelmingly involved the life sciences.
One of the great questions of our time is how to promote global economic development, while preserving the biological and cultural diversity of “this fragile earth, our island home.” The international debate over how to reconcile these two seemingly conflicting goals has increasingly focused on the interplay among three international agreements that have entered into force during the past 15 years. An examination of the moral foundations of those three agreements can greatly illuminate the Rawlsian notion of “procedural justice,” and the “fair and equitable” objectives of the Convention on Biological Diversity (CBD), as already cited by Manuel Ruiz (Chapter 3) and Tomme Young (Chapter 4).
The CBD was opened for signature at the Earth Summit in Rio de Janeiro in June 1992. As elaborated elsewhere in this volume, it seeks to promote the conservation, sustainable use, facilitated access to, and the equitable sharing of benefits arising out of the utilization of genetic resources. As a part of this overarching objective, Article 8(j) specifically calls upon its members to “respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity, and to promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the sharing of benefits arising from the utilization of such knowledge, innovations and practices.”
This chapter proceeds on the assumption that the ultimate goal of intellectual property law teaching – and legal education generally – is not simply to impart knowledge of the law, but rather to inculcate in students the necessary analytical skills to apply the law to new factual situations. Thus, one of the most important, and challenging, tasks for the intellectual property law teacher is helping law students develop the ability to identify emerging legal issues and predict future legal developments in intellectual property law and policy.
The challenge has become particularly daunting for intellectual property law teachers because of the increasingly dynamic nature of the subject matter. This dynamism is the product of rapid global developments in three overlapping fields: international law, technology, and commerce.
Until 1994, for example, the field of international intellectual property law was largely governed, as it had been for the past century, by the Paris Convention for the Protection of Industrial Property (“Paris Convention”) and the Berne Convention for the Protection of Literary and Artistic Works (“Berne Convention”). The modest goals of these two conventions were (1) to ensure that foreign nationals were provided “national [i.e. non-discriminatory] treatment” with respect to whatever intellectual property protection a member chose to grant its own nationals; (2) to establish an international priority system for industry property; and (3) to establish some initially modest international minimum standards for the prevention of unfair competition and the protection of literary and artistic works.
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