Tuesday, March 6, 4:30 p.m.
Lubar Center (Eckstein Hall Room 144)
1 CLE credit
Rebecca S. Eisenberg
Robert & Barbara Luciano Professor of Law
University of Michigan Law School
Opting for Regulation When Patentability Is In Doubt
New technologies have dramatically reduced the cost of DNA sequencing, making it feasible to use genetic testing to select the most appropriate treatment for each patient. But recent judicial decisions have cast doubt on the patentability of the DNA sequences and interpretive algorithms that make up these new diagnostic tests, threatening to undermine investment incentives for this promising field of research. On the other hand, FDA has so far allowed most laboratory-developed diagnostic tests to be sold without regulatory approval. Perhaps by avoiding this regulatory burden, test developers can survive without patents. Surprisingly, however, some test developers are forgoing this regulatory break and instead opting to pursue approval that the FDA does not require. This episode may illuminate the complex strategic considerations that innovators face in navigating the intersection of patents, regulatory approval, and insurance coverage for new health-related technologies.
Rebecca S. Eisenberg specializes in intellectual property and the regulation of biopharmaceutical innovation. Her teaching includes courses about patent law, trademark law, international intellectual property law, and FDA law. She has written and lectured extensively about the role of intellectual property in biopharmaceutical research, publishing in leading law reviews and scientific journals. Professor Eisenberg also has played an active role in public policy debates concerning the role of intellectual property in biopharmaceutical research, advising the National Institutes of Health and the National Academies of Science. She is a graduate of Stanford University and Boalt Hall School of Law at the University of California, Berkeley. In 1984, Professor Eisenberg joined the faculty at the University of Michigan, where she serves as the Robert & Barbara Luciano Professor of Law.