Section 112(a) Enablement and Written Description Issues in Life Science Cases: Leveraging CCPA and Federal Circuit Decisions

Capitalizing on Past Precedent to Withstand 112(a) Rejections and Attacks on Patent Validity and Patentability

Recording of a 90-minute premium CLE webinar with Q&A

Conducted on Tuesday, September 29, 2020

Recorded event now available

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Course Materials

This CLE course will guide patent counsel on leveraging decisions by the PTAB, the CCPA, and the Federal Circuit regarding the application of Section 112 written description and enablement requirements in life science patent cases. The panel will examine lessons learned from these decisions and offer strategies to overcome challenges under Section 112(a).


Life science practitioners face 112(a) issues all the time, in examiner rejections during prosecution, patentability challenges in post-grant reviews (PGRs) before the PTAB, and validity challenges before the courts. Also, 112(a) written description support is required for entitlement to the priority date, so practitioners may find themselves facing 112(a) issues in inter partes reviews (IPRs) to either defend a priority date assertion of a patent claim or attack a priority date assertion of a reference raised by a petitioner. Furthermore, in motions to amend in post-grant proceedings, 37 CFR 42.121/42.221 requires patent owners to show support for any proposed substitute claims.

Potential written description issues include:

  • Result without means of achieving it (hope vs. plan);
  • Broad claim with little support in the specification, e.g., a genus claim with few or no species described in the specification;
  • Unsupported claim limitations;
  • Attempts to cherry-pick the original disclosure to claim narrow subject matter later discovered to be valuable;
  • Substantial claim amendments made during prosecution;
  • Priority chain support; and
  • Could a POSITA conclude with "reasonable certainty" that patentee had "possession" of claimed invention?

Potential enablement issues include:

  • Are claims objectively enabled?
  • Routine vs. undue experimentation;
  • Proper/improper use of post-filing evidence? (can only reflect state of the art at the time of filing);
  • Priority date assertions;
  • Claims enabled throughout scope?
  • Any incorporation by reference issues?

The CCPA developed a rich body of Sect. 112 jurisprudence, which the Federal Circuit adopted as binding precedent, providing a treasure trove of arguments for practitioners. Counsel can draw on these CCPA cases, as well as PTAB and Federal Circuit cases, for guidance in presenting evidence and arguments of written description and enablement.

Listen as our authoritative panel of U.S. patent attorneys examines the lessons from recent Federal Circuit and PTAB decisions and select CCPA decisions to avoid repeating past mistakes and to promote the progress of the useful arts and sciences as mandated by the Constitution.



  1. Recent life science Section 112(a) CAFC decisions
    1. Merck v. Microspherix, No. 2019-2197 (Fed. Cir. June 9, 2020) and Purdue Pharma L.P. v Iancu, 767 Fed. Appx. 918 (Fed. Cir. April 17, 2019): written description support of a provisional application
    2. Immunex Corp. v. Sandoz Inc., No. 2020-1037 (Fed. Cir. July 1, 2020): written description support of priority application
    3. Idenix Pharms. v. Gilead Sciences Inc., No. 2018-1691 (Fed. Cir. Oct. 30, 2019): no enablement or written description
    4. Nalproprion v. Actavix Labs., No. 2018-01221 (Fed. Cir. Aug. 15, 2019): "equivalent" disclosure
    5. Verinata Health v. Ariosa Diagnostics, No. 2018-2198 (Fed. Cir. April 24, 2020): enablement
  2. Recent life science PTAB 112(a) decisions
    1. Dr. Reddy's Labs. v. Indivior UK Ltd., IPR2019-00329, Paper 49 (P.T.A.B. June 2, 2020): Petitioner's priority claim attack successful
    2. Ex parte Ismagilov, Appeal No. 2019-004109 (P.T.A.B. May 13, 2020): Claim language in written description support analysis
    3. Grunenthal GmbH v. Antecip Bioventures, PGR2019-00003, Paper 22 (P.T.A.B. May 5, 2020): successful defense against 112(a) attack
    4. Genome & Co. v. Univ. of Chicago, PGR2019-00002, Paper 40 (P.T.A.B. April 14, 2020): Wands factors
    5. Hybrigenics SA v. Forma Therapeutics, PGR2018-00098, Paper 23 (P.T.A.B. Mar. 19, 2020): mixed outcome
  3. Lessons from the CCPA and early Federal Circuit decisions that reversed Sect. 112 rejections/invalidity holdings


The panel will review these and other essential issues:

  • What lessons can counsel for life science patentees apply to meet the written description and enablement requirements and withstand invalidity/unpatentability challenges based on written description and enablement?
  • What steps can fix written description and enablement problems?
  • What proactive steps should patent counsel take going forward to avoid repeating mistakes of the past?


Burgy, Adriana
Adriana L. Burgy

Finnegan Henderson Farabow Garrett & Dunner

Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the...  |  Read More

Irving, Thomas
Thomas L. Irving

Finnegan Henderson Farabow Garrett & Dunner

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

Murphy, Amanda
Amanda K. Murphy, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new...  |  Read More

O’Connor, Steven
Steven P. O'Connor, Ph.D.

Finnegan Henderson Farabow Garrett & Dunner

Dr. O’Connor leads the firm’s biotechnology and pharmaceutical practice group. He provides IP counseling...  |  Read More

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