BPCIA TRIAL TRACKER: New Developments at the Federal Circuit District Courts and the PTAB

Satisfying the Statutory Requirements for Enablement and Written Description: §112(a) and the Future of Genus Claims

June 28, 2022 10:45am

Maureen A. Bresnahan
Assistant General Counsel, Legal Department
Eisai Inc.

Rachel J. Elsby

Rachel Elsby
Akin Gump Strauss Hauer & Feld LLP

Nicholas P. Groombridge
Paul, Weiss, Rifkind, Wharton & Garrison LLP

Ryan Hagglund
Loeb & Loeb LLP

Two recent Federal Circuit decisions, Amgen Inc. v. Sanofi and Juno Therapeutics, Inc. v. Kite Pharma, Inc., confirmed biopharma patents claiming a genus of antibodies may be especially susceptible to invalidation for lack of enablement or insufficient written description under 35 U.S.C. §112(a). Given that the scope of appropriate claims for antibodies is tightening, biopharmaceutical patent attorneys will need to consider:

  • Devising alternate strategies for drafting enforceable claims
    • Protecting newly-developed biopharma IP
  • Analyzing how these decisions (including further appeals to the U.S. Supreme Court) impact the enforcement of existing claims
  • Reconciling whether written description is met when the specification discloses formulas