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Inducement Following GSK v. Teva

Evaluating the Effect of a Skinny Label, Implications of Recent Court Treatment

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

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Conducted on Wednesday, May 11, 2022

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This CLE course will guide patent counsel on issues of inducement in pharmaceutical patent litigation in light of the GSK v. Teva decision. 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 continuing saga of GlaxoSmithKline LLC v. Teva Pharms. USA Inc., 7 F.4th 1320 (Fed. Cir. 2021) marches on, now facing a likely petition for certiorari with the Supreme Court. Following (i) an original panel opinion, (ii) a second panel opinion on rehearing, and (iii) a denial of en banc review accompanied by four separate opinions, 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 pharmaceutical 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®.

Now, the District Court of Delaware has issued its decision in Amarin Pharma v. Hikma Pharms. United States, 2022 U.S. Dist. LEXIS 1937 (D. Del. Jan. 4, 2022), granting Hikma's motion to dismiss Amarin's lawsuit for induced infringement based on Hikma’s (skinny) label and public statements. The case is on-going only against Defendant Health Net.

So what is the current guidance regarding the use of skinny labels and other evidence such as press releases, promotional materials, and drug classification in pharmaceutical patent litigation?

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. Recent court treatment
  3. Implications of GSK v. Teva
    1. Carve-out 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

Benefits

The panel will review these and other noteworthy issues:

  • What impact have GSK v. Teva and Amarin v. Hikma had so far 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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