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


Conducted on Wednesday, January 8, 2020

Recorded event now available

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Program Materials

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.

Description

Several recent Federal Circuit decisions have addressed the requirement for reasonable expectation of success in the obviousness context. Recent cases discuss the requirement and the degree of predictability required and demonstrate increased emphasis on a showing of obviousness increasingly relies on a showing of reasonable expectation of success.

The Federal Circuit's recent decision in OSI Pharmaceuticals v. Apotex (Fed. Cir. Oct. 4, 2019) highlighted the importance of a reasonable expectation of success in the obviousness analysis. In that case, the court held nonobvious a method of treating non-small cell lung cancer (NSCLC) using a known compound, where there was no efficacy data or other information regarding the compound’s effect on NSCLC and there was a high failure rate of other drugs for treatment of NSCLC. And, in Endo Pharmaceuticals Inc. v. Actavis L.L.C. (Fed. Cir. May 3, 2019), the Federal Circuit held that a prior art reference that discloses a goal but not an explanation of how to reach that goal does not provide a reasonable expectation of success. Moreover, in Allergan Sales L.L.C. v. Sandoz Inc., (Fed. Cir. Aug. 29, 2019), the Federal Circuit explained that a similar showing of expectation of success must be met for functional aspects of a claimed invention as well.

Listen as our authoritative panel of patent attorneys discusses recent Federal Circuit cases and potential implications of these cases. The panel will also examine the relationship between the requirement for reasonable expectation of success and enablement. The panel will offer best practices for patent drafting and patent prosecution in light of the recent case law.

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Outline

  1. History of the requirement for reasonable expectation of success
  2. Recent cases discussing the requirement, including
    1. OSI Pharmaceuticals v. Apotex (Fed. Cir. Oct. 4, 2019)
    2. Endo Pharmaceuticals Inc. v. Actavis L.L.C. (Fed. Cir. May 3, 2019)
    3. UCB v. Accord (Fed. Cir. 2018)
    4. Genzyme Corp. v. Dr. Reddy’s Labs. Ltd. (Fed. Cir. 2018)
    5. Allergan Sales L.L.C. v. Sandoz Inc. (Fed. Cir. Aug. 29, 2019)
  3. The requirement for reasonable expectation of success and enablement
  4. Best practices for patent drafting
  5. 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

Lipton, Alissa
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

MacAlpine, Jill
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

McDonell, Leslie
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

Leiman, Sara
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

Wang, Oulu
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

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