Patents and the Expectation of Success Doctrine
What is Reasonable, Tension With Enablement, Best Practices for Patent Drafting and Patent Prosecution
Recording of a 90-minute premium CLE webinar with Q&A
This CLE webinar will provide patent counsel with guidance on the doctrine of expectation of success. The panel will examine how much is reasonably needed as well as the tension between the doctrine and enablement. The panel will discuss recent cases and will offer best practices for patent drafting and patent prosecution.
Outline
- History of the requirement for reasonable expectation of success
- Recent cases discussing the requirement, including
- OSI Pharmaceuticals v. Apotex (Fed. Cir. Oct. 4, 2019)
- Endo Pharmaceuticals Inc. v. Actavis L.L.C. (Fed. Cir. May 3, 2019)
- UCB v. Accord (Fed. Cir. 2018)
- Genzyme Corp. v. Dr. Reddy’s Labs. Ltd. (Fed. Cir. 2018)
- Allergan Sales L.L.C. v. Sandoz Inc. (Fed. Cir. Aug. 29, 2019)
- The requirement for reasonable expectation of success and enablement
- Best practices for patent drafting
- Best practices for patent prosecution
Benefits
The panel will review these and other key issues:
- Under what circumstances should the reasonable expectation of success be argued during prosecution at the PTAB? During litigation?
- What evidence is necessary to support a reasonable expectation of success argument?
- How can patents be drafted to establish that the claimed subject matter is enabled by the disclosure but that skilled persons would not have had a reasonable expectation of success based on the prior art?
Faculty

Alissa K. Lipton
Partner
Finnegan Henderson Farabow Garrett & Dunner
Ms. Lipton represents clients in patent proceedings in district courts, before the U.S. Court of Appeals for the... | Read More
Ms. Lipton represents clients in patent proceedings in district courts, before the U.S. Court of Appeals for the Federal Circuit, and before the U.S. Patent and Trademark Office (USPTO). Her practice also involves strategic client counseling, including due diligence and opinion work, and portfolio management. She also provides strategic counsel to clients in technologies including therapeutic antibodies, CRISPR, antisense technologies, diagnostics, and small molecules.
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Jill K. MacAlpine, Ph.D.
Partner
Finnegan Henderson Farabow Garrett & Dunner
Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling,... | Read More
Dr. MacAlpine practices patent procurement, due diligence investigations, opinion work, and client counseling, primarily in the chemical and pharmaceutical areas. She has extensive experience in handling patent matters before the U.S. Patent and Trademark Office (USPTO), including post-grant proceedings specifically IPRs, appeals, and oral hearings at the PTAB; drafting and prosecution of patent applications; reissue and reexamination proceedings; and interferences.
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Leslie A. McDonell
Partner
Finnegan Henderson Farabow Garrett & Dunner
Ms. McDonell provides strategic counseling on the procurement and protection of IP in the pharmaceutical,... | Read More
Ms. McDonell provides strategic counseling on the procurement and protection of IP in the pharmaceutical, biotechnology, and medical device industries. She coordinates worldwide patent portfolio strategies, evaluates and analyzes competitors' patent positions around the world, and advises and renders opinions on issues of patentability, inventorship, validity, claim scope, infringement, and freedom to operate.
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Sara A. Leiman, Ph.D.
Attorney
Finnegan Henderson Farabow Garrett & Dunner
Dr. Leiman prosecutes and provides strategic counseling on U.S. and foreign patent portfolios, provides validity and... | Read More
Dr. Leiman prosecutes and provides strategic counseling on U.S. and foreign patent portfolios, provides validity and patentability opinions, and manages and prepares landscape and freedom-to-operate analyses. She has developed global prosecution strategies and prosecuted patent applications in fields spanning the life sciences, including antibodies, complement inhibition, controlled-release formulations, diagnostics and in vitro detection assays, gene editing (e.g., CRISPR), gene therapy, immunology, immuno-oncology, metabolic disease, neuroscience, nucleotide sequencing, protein purification, and recombinant and fusion protein therapeutics. Her work also includes preparing invalidity and infringement contentions for district court litigations in the mechanical and electrical spaces.
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Oulu (Lulu) Wang, Ph.D.
Attorney
Finnegan Henderson Farabow Garrett & Dunner
Dr. Wang practices all aspects of patent-related work in the life sciences industry, including litigation, post-grant... | Read More
Dr. Wang practices all aspects of patent-related work in the life sciences industry, including litigation, post-grant proceedings, strategic counseling, and patent prosecution. She focuses on combining technical expertise and legal insight into compelling strategies tailored to client needs. Dr. Wang provides freedom-to-operate and patentability opinions, represents clients in appeals and post-grant proceedings such as inter partes reviews before the PTAB, and prepares and prosecutes patent applications. She represents innovative companies in various pre-litigation and litigation matters. Her experience includes litigating under the Biologics Price Competition and Innovation Act; developing infringement, validity, and claim construction positions; preparing for depositions; and working with experts.
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