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Patents and the Expectation of Success Doctrine

What is Reasonable, Tension With Enablement, Best Practices for Patent Drafting and Prosecution

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

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Conducted on Tuesday, January 31, 2023

Recorded event now available

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This CLE course will provide patent counsel with guidance on the doctrine of expectation of success. The panel will examine how much is reasonably needed and 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 decision in OSI Pharmaceuticals v. Apotex (Fed. Cir. 2019) highlighted the importance of a reasonable expectation of success in the obviousness analysis. In OSI, the court ruled nonobvious a method of treating non-small cell lung cancer (NSCLC) that used a known compound, but there was no data on the compound's efficacy with NSCLC.

In Endo Pharmaceuticals Inc. v. Actavis L.L.C. (Fed. Cir. 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. 2019), the Federal Circuit explained that a showing of expectation of success must be met for functional aspects of a claimed invention as well.

Nor is the reasonable expectation of success limited to chem/bio technologies, in University of Strathclyde v. Clear-Vue Lighting (Fed. Cir. 2021), the Federal Circuit emphasized that a reasonable expectation of success requires more than the mere possibility of the claimed result. The court relied on studies that had shown the likely impossibility of the claimed result. These studies, which predated the cited references, showed that blue light would not inactivate antibiotic-resistant bacteria without a photosensitizing chemical, as claimed.

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 a reasonable expectation of success and enablement. The panel will offer best practices for patent drafting and patent prosecution in light of recent case law.

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Outline

  1. History of the requirement for a reasonable expectation of success
  2. The requirement for a reasonable expectation of success and enablement
  3. Best practices for patent drafting
  4. 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 disclosure enables the claimed subject matter but that skilled persons would not have had a reasonable expectation of success based on the prior art?

Faculty

Gosse, David
David A. Gosse

Partner
Fitch Even Tabin & Flannery

Mr. Gosse helps clients protect their intellectual property rights through litigation, working on all phases of...  |  Read More

Pereira, Daniel
Dr. Daniel J. Pereira, Ph.D.

Partner; Co-Head of the Chemical Practice Group
Oblon McClelland Maier & Neustadt

Dr. Pereira’s practice focuses on client counseling, portfolio management, patent prosecution, litigation and...  |  Read More

Wheelock, Bryan
Bryan K. Wheelock

Principal
Harness Dickey & Pierce

Mr. Wheelock’s practice includes the preparation and prosecution of patent and trademark applications and...  |  Read More

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