See Credit Details Below
When coupled with decisions in Vanda Pharmaceuticals v. West-Ward Pharmaceuticals and Roche Molecular Systems v. Cepheid last year, the Federal Circuit's recent decisions Cleveland Clinic Foundation v. True Health Diagnostics; Endo Pharmaceuticals v. Teva Pharmaceuticals; Natural Alternatives International v. Creative Compounds; and Athena Diagnostics v. Mayo Collaborative Services suggest that the court has drawn a distinction between diagnostic method claims and method of treatment claims. In particular, diagnostic method claims appear to be almost per se patent ineligible while method of treatment claims have been found by the Federal Circuit to be patent eligible in some cases. This distinction between diagnostic method claims and method of treatment claims was further highlighted by the Federal Circuit’s recent order denying rehearing en banc in Athena Diagnostics v. Mayo Collaborative Services, which was accompanied by eight opinions, four concurring in the denial of the petition for rehearing en banc and four dissenting in the denial of the petition. When the court's decisions are considered in the context of the U.S. Patent and Trademark Office’s May 2016 subject matter guidance update – and, in particular, Example 29 of the update – practitioners are starting to get a better idea of how to best obtain life sciences method claims. However, since the Supreme Court is currently entertaining a petition for certiorari in the Vanda Pharmaceuticals case, and has invited the Solicitor General to file a brief in this case expressing the views of the United States, there may be more change coming with respect to the patent eligibility of life sciences method claims.
Discussions will include:
- Recent Federal Circuit decisions regarding the patent eligibility of diagnostic method claims and method of treatment claims;
- What can be distilled from these decisions to better draft patent eligible life sciences method claims;
- How these decisions are impacting the examination of life sciences method claims at the USPTO;
- And what may lay ahead in view of the petition for certiorari in Vanda.
Donald L. Zuhn, Jr., Ph.D.: Partner, McDonnell Boehnen Hulbert & Berghoff LLP
Brian A. Cocca, Ph.D.: Senior Director, Assistant General Counsel, Patents, Regeneron Pharmaceuticals, Inc.
June E. Cohan: Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy; United States Patent and Trademark Office
Sarah E. Fendrick, Ph.D.: Partner, McDonnell Boehnen Hulbert & Berghoff LLP