How Federal Circuit Is Applying Section 101 to Drug Patents

Between 2010 and 2014, the U.S. Supreme Court issued four decisions on patent subject matter eligibility under Title 35 of the U.S. Code, Section 101 —  Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Labs Inc., Association for Molecular Pathology v. Myriad Genetics Inc. and Alice Corp v. CLS Bank International — establishing its modern Section 101 jurisprudence.

In Mayo, the court in 2012 set forth a two-step test for determining eligibility, commonly known as the Mayo/Alice framework. Step one inquires whether the patent is "directed to" an ineligible subject matter: a law of nature, a natural phenomenon or an abstract idea. If so, step two evaluates whether the patent claims any "inventive concept" to transform the patent ineligible subject matter into patent eligible application of that subject matter.

In this Law360 article written by Mark E. Waddell, co-chair of the Life Sciences department and chair of the Patent Litigation & Counseling practice, Patent Litigation partner Ryan Hagglund and associate Dan Liu, the authors review the U.S. Court of Appeals for the Federal Circuit's recent applications of the Mayo, Myriad and Alice decisions to life sciences patents. In addition, they discusses practical implications for claim drafting and enforcement as practitioners and parties strategize when facing Section 101 issues.