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76 N.Y.U. L. Rev. 1623 (2001)
International Conflicts over Patenting Human DNA Sequences in the United States and the European Union: An Argument for Compulsory Licensing and a Fair-Use Exemption

handle is hein.journals/nylr76 and id is 1643 raw text is: ARTICLES INTERNATIONAL CONFLICTS OVER PATENTING HUMAN DNA SEQUENCES IN THE UNITED STATES AND THE EUROPEAN UNION: AN ARGUMENT FOR COMIPULSORY LICENSING AND A FAIR-USE EXEMPTION DONNA M. GrrrER The thought of a large biotech company holding an exclusive right to research and manipulate human genetic material provokes many reactions-from moral revul- sion to enthusiasm about the possibilities for therapeutic advancement. While most agree that such a right must exist, debate continues over te appropriate extent of its entitlements and preclusive effects. In this Article Professor Donna Gitter ad- dresses this multidinensional problem of patents on huntman dcoxyribonucleic acid (DNA) sequences in the United States and the European Union. Professor Gitter chronicles not only the development of the lai in this area, but also tie arrany of policy and moral arguments that proponents and detractors of such patents raise. She emphasizes the specific issue of patents on DNA sequences whose fincdon has not fully been identified, and the cilling effect these patents may have on beneficial researdcL From this discussion emerges a troubling realization: While the legal framework governing life patents may be similar in the United States and tie European Union, the public perceptions and attitudes toward them are not. Profes- sor Gitter thus proposes a dual reforn: a compulsory licensing regime requiring holders of DNA sequence patents to license them to conmmercial researchers, in return for a royalty keyed to the financial success of the product that tie licensee develops; and an experimental-use exemption from this regime for government and nonprofit researchers. INTRODUCTION In February 2000, the United States Patent and Trademark Office (PTO)' granted to Human Genome Sciences Incorporated (HGS), a publicly traded biotechnology company based in Rockville, Mary- * Assistant Professor of Legal and Ethical Studies, Fordham University Schools o Business. B.A., 1989, Cornell University, J.D., 1994, University of Pennsylvania. I wish to express my boundless gratitude to Jordan L Dentz, my husband, for his advice and encouragement throughout the process of researching and writing this Article. I also appreciate the able research assistance of Dorota Gilewicz, John Halpin, and Dean Kim, as well as the generous support provided by the Fordham University Schools of Business. 1 The PTO is the federal administrative agency charged with the review and grant of patents. 35 U.S.C. § 1 (Supp. V 2000). PTO patent examiners review patent applications 1623 Imaged with the Permission of N.Y.U. Law Review

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