Inducement in a Pharmaceutical, Post-Launch Non-Hatch-Waxman World

Evaluating the Effect of a Skinny Label, Implications of GSK v. Teva

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


Conducted on Thursday, December 17, 2020

Recorded event now available

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Program Materials

This CLE webinar will guide patent counsel on the Federal Circuit’s recent GSK v. Teva decision, and any other relevant post-launch non-Hatch Waxman pharmaceutical litigations. The panel will also discuss strategies and tactics regarding claim language and label language, as well as types of evidence to adduce to prove inducement of infringement.

Description

The pharma industry’s high interest in GlaxoSmithKline LLC v. Teva Pharms. USA Inc. (Fed. Cir. Oct. 2, 2020), is reflected in the amicus curiae briefs submitted before the Federal Circuit from three trade associations. In a 2-1 decision, over a spirited and lengthy dissent, the Federal Circuit reversed the district court’s grant of judgment of non-infringement as a matter of law (JMOL) and reinstated the jury verdict of induced infringement in a drug patent case that was post-launch and non-Hatch Waxman. The court accepted as evidence of inducement Teva’s press releases and promotional materials affirmatively promoting its carvedilol tablet as the AB generic equivalent of Coreg®.

The decision provides guidance regarding the use of skinny labels and other evidence such as press releases, promotional materials, and drug classification, such as AB, in a post-launch, non-Hatch Waxman pharmaceutical litigation, most notably that the carve out is not a guarantee of avoiding induced infringement under such circumstances. The Federal Circuit majority agreed with GSK that “precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met.” Id. at Slip Op. page 16.

Listen as our authoritative panel of patent attorneys examines the Federal Circuit’s recent GSK v. Teva decision, and any other relevant, post-launch, non-Hatch Waxman pharmaceutical litigations, and the implications for post-launch, non-Hatch Waxman induced infringement cases. The panel will also discuss strategies and tactics regarding claim language and label language, as well as types of evidence to adduce to prove inducement of infringement.

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Outline

  1. Skinny labels and inducement
  2. GSK v. Teva; A post-launch, non-Hatch Waxman pharmaceutical litigation
    1. Review of jury verdict and district court decision
    2. Dueling amici positions
    3. Federal Circuit majority decision
    4. Dissent
  3. Implications of GSK v. Teva
    1. Carve-out provisions of 21 U.S.C. § 355(j)(2)(A)(viii) for AB-rated―all―505(j) generics
    2. Use of “AB” ratings in the future
    3. Types of evidence to demonstrate inducement
    4. Pre-launch vs. post-launch
  4. Best practices

Benefits

The panel will review these and other noteworthy issues:

  • What impact will GSK v. Teva and other recent decisions have on proving induced infringement?
  • What impact will recent decisions have on claim drafting?
  • What strategic considerations should patent owners keep in mind when labeling FDA-approved drugs?

Faculty

Feldstein, Mark
Mark J. Feldstein, Ph.D.

Partner
Finnegan Henderson Farabow Garrett & Dunner

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and...  |  Read More

Holt, Cora
Cora R. Holt

Partner
Finnegan Henderson Farabow Garrett & Dunner

Ms. Holt is an experienced patent litigator at both the appellate and trial levels. A former clerk at the U.S. Court of...  |  Read More

Irving, Thomas
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

Kim, Kyu Yun
Kyu Yun Kim

Associate
Finnegan Henderson Farabow Garrett & Dunner

Ms. Kim focuses on patent litigation and patent prosecution in the chemical and pharmaceutical fields. Her litigation...  |  Read More

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