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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

  • work Practice Area

    Patent

Date & Time
  • event Date

    Tuesday, March 8, 2022

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$347.00

This course is $0 with these passes:

CLE
ALL

This CLE course will guide patent counsel on patent claiming and the virtues of claiming precisely what the FDA approved. The panel will discuss the recent Teva Pharms. v. Corcept Therapeutics decision, the obvious to try requirements, and the lessons from the recent decision. The panel will also highlight a similarly successful claiming strategy employed in Sanofi v. Watson and will explore creative claim strategies that take advantage of 112(f)’s means-plus-function terminology. The panel will offer best practices for patent claiming and tethering the claims to an FDA-approved product.

Faculty

Amanda K. Murphy
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

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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Adriana L. Burgy
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

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. She has assisted clients in the early stages of development through due diligence and patent portfolio analysis.

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Thomas L. Irving
Partner
Marbury Law Group

Mr. Irving has 47 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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Janice Klunder
Vice President, Head of Global Intellectual Property
Ipsen Bioscience, Inc

Ms. Klunder is Vice President, Head of Global Intellectual Property at Ipsen. She and her team support the R&D, Business Development, and Commercial organizations in all IP matters, including patent and trademark strategies, prosecution, adversarial proceedings, due diligence, deal strategy, and negotiations. Prior to joining Ipsen, she was Associate General Counsel at Millennium Pharmaceuticals, Inc., and previously was an Associate at Hale and Dorr LLP. She began her career as a medicinal chemist at Boehringer Ingelheim and ProScript, Inc. She holds an undergraduate degree in Chemistry from Swarthmore College, a Ph.D. degree in Organic Chemistry from M.I.T., and a J.D. from Suffolk University Law School. 

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Description

The Federal Circuit’s recent decision in Teva Pharms. v. Corcept Therapeutics reminds practitioners of the importance of claiming what was approved by the FDA and also that showing obviousness requires both a motivation to modify/combine the prior art AND a reasonable expectation of success at arriving at the claimed invention. Moreover, that reasonable expectation of success must be tied to the claim limitations, which are optimally tied to an FDA-approved product or method of treatment.

In addition, the case reminds practitioners that an obvious to try argument, for example, by a petitioner in an IPR, may be a difficult one if the changes that are allegedly “obvious to try” are not predictable solutions or if there is not a reasonable expectation of success. In such circumstances, the petitioner’s argument of obviousness may fail.

This case also highlights the importance of claim construction. Corcept’s claims were construed to require safe administration, even though that was not recited in the claims. But the Board and the Federal Circuit focused on what the clinical trials showed and what Corcept claimed. Claim construction was an important underpinning of the conclusion that the success of the claimed invention could not have been reasonably expected.

The case also brings to mind other creative claiming strategies like those in Sanofi v. Watson, 875 F.3d 636 (Fed. Cir. 2017), as well as using means-plus-function terminology, as prescribed by 35 U.S.C. § 112(f). See, e.g,. Ex parte Gleave, Appeal 2012-004973 (P.T.A.B. Jan. 22, 2014).

Listen as our authoritative panel of patent attorneys as they examine patent claiming and the virtues of claiming precisely what the FDA approved. The panel will discuss the recent Teva v. Corcept decision, obvious to try arguments, and the practical lessons from the recent decision. In addition, the panel will highlight a similarly successful claiming strategy employed by Sanofi in Sanofi v. Watson, 875 F.3d 636 (Fed. Cir. 2017). Further, the panel will explore creative claim strategies that take advantage of 112(f)’s means-plus-function terminology, particularly as a way to link an FDA-approved formulation to patent claims describing the approved formulation and literal equivalents thereof. The panel will offer best practices for patent claiming and tethering the claims to an FDA-approved product.

Outline

  1. Designing patent claims to read on FDA approved active ingredients, formulations, and methods of treatment
  2. Formulating and defending against obvious-to-try attacks
  3. Court treatment
  4. Best practices

Benefits

The panel will review these and other key issues:

  • What guidance does the Federal Court's recent decision provide on obvious to try?
  • How do limitations in claim language frame the reasonable expectation of success analysis?
  • What best practices should patent counsel employ to minimize the risk of facing a challenge to the patent application?