• videocam On-Demand Webinar
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  • schedule 90 minutes

Inducement Following GSK v. Teva

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

$347.00

This course is $0 with these passes:

CLE
ALL
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About the Course

Introduction

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.

Credit Information

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


  • Live Online


    On Demand

Date + Time

  • event

    Wednesday, May 11, 2022

  • schedule

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

  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

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?