Raleigh, NC (February 16, 2011) – Robert Rehm, a partner in Smith Anderson’s Intellectual Property practice group, moderated a panel discussion among physicians and intellectual property law practitioners and academicians at Duke University School of Law's 10th Annual "Hot Topics in Intellectual Property" Symposium. The Symposium was held on Friday, February 11, 2011, at Duke University School of Law. The panel's discussion topic, "The Future of Biotech and Gene Patents," arose primarily out of recent federal court decisions in Prometheus Labs., Inc. v. Mayo Collaborative Servs. and Association for Molecular Pathology v. USPTO, both of which deal with whether certain subject matter is patentable under Section 101 of the U.S. Patent Statute.
In Prometheus Labs, the United States Court of Appeals for the Federal Circuit ("CAFC") held that certain patent claims directed to medical diagnostic correlations and corresponding treatment protocols constitute patentable subject matter under Section 101, thereby overturning a lower court decision and rejecting arguments that the claimed subject matter comprises "natural phenomena," which the U.S. Supreme Court has ruled are not patentable under Section 101.
In Association for Molecular Pathology, the federal district court for the Southern District of New York held that certain patent claims directed to isolated and purified DNA molecules do not constitute patentable subject matter under Section 101, thereby upholding arguments that such molecules are physical embodiments of "laws of nature," which the U.S. Supreme Court also has ruled are not patentable under Section 101. The district court's decision in this case is on appeal to the CAFC.
The panel discussed how the holdings in these two cases likely will impact existing and future patents and patent applications in the United States that claim subject matter directed to genetic materials and diagnosis-based disease treatment protocols, specifically, and biotechnology improvements and advancements, generally. Opponents of the patentability of such subject matter contend that protecting these items under the patent laws will have far-reaching adverse effects, including lower-quality health care resulting from precluding health care providers and the general public from freely using such materials and protocols while any such patents are in effect. Proponents of the patentability of such subject matter contend that patent protection in such cases is essential to stimulate innovative research and development of such materials and protocols and allow inventors to recoup the oftentimes substantial economic investments needed to fund such innovation.