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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 video webinar with Q&A

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Conducted on Thursday, July 6, 2023

Recorded event now available

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This CLE course will guide patent counsel on the Federal Circuit's recent GSK v. Teva decision, and any other relevant post-launch non-Hatch Waxman pharmaceutical litigation. 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.


On May 15, 2023, the U.S. Supreme Court denied certiorari in Teva Pharms. USA Inc. v. GlaxoSmithKline L.L.C., which brought attention to alleged skinny labels for generics. The Federal Circuit had twice reinstated the jury verdict of induced infringement in a drug patent case that was post-launch and non-Hatch Waxman [GlaxoSmithKline L.L.C. v. Teva Pharms. USA Inc. (Fed. Cir. Oct. 2, 2020)]. The appeals court found to be substantial evidence of inducement Teva's press releases and promotional materials affirmatively, inter alia, promoting its carvedilol tablet as the AB generic equivalent of Coreg®.

The decisions provide guidance regarding what is a skinny label and other evidence such as press releases, promotional materials, and drug classification, such as AB rating, in a post-launch, non-Hatch Waxman pharmaceutical litigation, most notably that the carveout is not a guarantee of avoiding induced infringement under circumstances where the generic label is not truly a skinny label. 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."

Listen as our authoritative panel of patent attorneys examines the recent decision in Teva v. GSK and 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.



  1. Skinny labels and inducement
  2. Teva v. GSK/GSK v. Teva; A post-launch, non-Hatch Waxman pharmaceutical litigation
    1. Review of jury verdict and district court decision
    2. Federal Circuit majority decision
    3. Dissent
    4. Supreme Court cert. denial
  3. Implications of Teva v. GSK/ GSK v. Teva
    1. Carveout provisions of 21 U.S.C. § 355(j)(2)(A)(viii) for AB-ratedall505(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


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 and label drafting?
  • What strategic considerations should patent owners keep in mind when labeling FDA-approved drugs?


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

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

Irving, Thomas
Thomas L. Irving

The Marbury Law Group

Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

O’Brien, Michelle
Michelle E. O'Brien

The Marbury Law Group

Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in...  |  Read More

Kim, Kyu Yun
Kyu Yun Kim

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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