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
This CLE webinar 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).
Outline
- Recent life science Section 112(a) CAFC decisions
- 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
- Immunex Corp. v. Sandoz Inc., No. 2020-1037 (Fed. Cir. July 1, 2020): written description support of priority application
- Idenix Pharms. v. Gilead Sciences Inc., No. 2018-1691 (Fed. Cir. Oct. 30, 2019): no enablement or written description
- Nalproprion v. Actavix Labs., No. 2018-01221 (Fed. Cir. Aug. 15, 2019): "equivalent" disclosure
- Verinata Health v. Ariosa Diagnostics, No. 2018-2198 (Fed. Cir. April 24, 2020): enablement
- Recent life science PTAB 112(a) decisions
- 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
- Ex parte Ismagilov, Appeal No. 2019-004109 (P.T.A.B. May 13, 2020): Claim language in written description support analysis
- Grunenthal GmbH v. Antecip Bioventures, PGR2019-00003, Paper 22 (P.T.A.B. May 5, 2020): successful defense against 112(a) attack
- Genome & Co. v. Univ. of Chicago, PGR2019-00002, Paper 40 (P.T.A.B. April 14, 2020): Wands factors
- Hybrigenics SA v. Forma Therapeutics, PGR2018-00098, Paper 23 (P.T.A.B. Mar. 19, 2020): mixed outcome
- Lessons from the CCPA and early Federal Circuit decisions that reversed Sect. 112 rejections/invalidity holdings
Benefits
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?
Faculty

Adriana L. Burgy
Partner
Finnegan Henderson Farabow Garrett & Dunner
Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the... | Read More
Ms. Burgy focuses on opinion work, client counseling, patent prosecution and management, and litigation in the chemical, pharmaceutical, and biotechnology arts. She counsels her clients on a diverse range of patent issues. She assists clients on single-patent issues as well as complex matters involving multiple patents and applications requiring ongoing advice on patent portfolio strategy and development, with an eye towards litigation. From a patent prosecution perspective, she has drafted and prosecuted numerous patent applications domestically and internationally, guided and advised clients on complex procedural and legal issues surrounding clients' patent portfolios, developed and implemented strategic prosecution in support of ongoing litigation, generated strategies for maximizing investment in patent portfolios, and facilitated the identification of high-priority applications within patent portfolios.
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Thomas L. Irving
Partner
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
Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.
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Amanda K. Murphy, Ph.D.
Partner
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
Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new patent applications, prosecutes U.S. and foreign applications, and represents applicants at appeals and oral hearings before the PTAB. She has experience in prosecuting inter partes and ex partes reexamination applications, reissue applications, and patent term extension applications for approved pharmaceuticals, including obtaining supplemental protection certificates in Europe.
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Steven P. O'Connor, Ph.D.
Partner
Finnegan Henderson Farabow Garrett & Dunner
Dr. O’Connor leads the firm’s biotechnology and pharmaceutical practice group. He provides IP counseling... | Read More
Dr. O’Connor leads the firm’s biotechnology and pharmaceutical practice group. He provides IP counseling for domestic and foreign clients, from startups to Fortune 100 companies, primarily in the biotechnology and pharmaceutical areas. Dr. O’Connor’s practice currently focuses on due diligence investigations, and the preparation of infringement, validity and freedom-to-operate opinions. He also assists clients with the preparation and prosecution of U.S. and foreign patent applications, ex parte appeals, and provides advice on global portfolio management. Additionally, Dr. O’Connor represents clients in interferences before the PTAB.
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