June 16, 2015 Articles

Facing Section 101 Challenges in the Biological and Chemical Arts

Recent USPTO guidance and court decisions provide strategies for current and future litigants

By Leslie T. Grab and Cynthia B. Rothschild

The patent landscape with respect to patentable subject matter for the biological and chemical arts is in a state of flux. After the Supreme Court's decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), holding that claims directed to natural phenomena, coupled with known techniques, do not claim patent-eligible subject matter, and Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad I), 133 S. Ct. 2107 (2013), holding that claims directed to isolated DNA that is naturally occurring do not claim patent-eligible subject matter but that claims directed to cDNA may be patentable, many lawyers began to question whether patents directed to diagnostic applications and genetic discoveries are directed to non-patent-eligible subject matter. This article briefly summarizes the current state of the law under 35 U.S.C. section 101 and provides tips and strategies for patent owners to successfully defend against challenges under section 101.

Premium Content For:
  • Litigation Section
Join - Now