Patent portfolios after myriad, how to fit in those new genes?

Abstract

The recent US Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. clarified what is considered patentable subject matter. Patent claims limited to the composition of isolated nucleic acid sequences are now considered a product of nature and not patent eligible, while man-made variants of nucleic acid sequences may still be patentable. The decision is consistent with an earlier ruling in Mayo Collaborative Services v. Prometheus Laboratories., Inc. related to diagnostic methods. In Prometheus, the Court held that a method simply reciting known steps used to observe a natural event is not patentable subject matter. Taken together, the Court's decisions provide guidance as to what constitutes a natural phenomenon outside patent protection and what is considered a man-made creation worthy of protection. Despite misgivings, both decisions will provide impetus for increased genetic research and development of new therapeutics and diagnostics, especially in genomic and personalized medicine.