The 2018 Nies Lecture in Intellectual Property will take place Tuesday, March 6, from 4:30 p.m. to 5:30 p.m. in Eckstein Hall.
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, the 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. Some test developers are forgoing this regulatory break and instead opting to pursue approval that the FDA does not require. This lecture 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.
The event is presented by Rebecca S. Eisenberg, and Robert & Barbara Luciano, professors of Law at the University of Michigan. Registration is required by Monday, March 5.
This annual lecture remembers the honorable Helen Wilson Nies, who served as a judge of the U.S. Court of Appeals for the Federal Circuit from 1982 until 1996 (chief judge 1990 –1994).