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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

$347.00

This course is $0 with these passes:

CLE
ALL
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Description

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.

Presented By

Mark J. Feldstein
Partner
Finnegan Henderson Farabow Garrett & Dunner LLP

Dr. Feldstein focuses on U.S. district court litigation, primarily concerning the enforcement of U.S. patent rights and trade secret issues, and post-grant trial proceedings at the USPTO, including inter partes review (IPR) and post grant review (PGR). He maintains an active patent prosecution practice, preparing and prosecuting U.S. patent applications on behalf of domestic and foreign clients. He also provides opinions and strategic guidance to clients on infringement, validity, enforceability, and clearance matters. His practice encompasses a range of technologies, including pharmaceuticals, biochemistry, polymers, small molecule chemistry, optics, and medical and analytic devices.

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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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Kyu Yun Kim
Associate
Finnegan Henderson Farabow Garrett & Dunner LLP

Ms. Kim focuses on patent litigation and patent prosecution in the chemical and pharmaceutical fields. Her litigation experience includes conducting discovery on Abbreviated New Drug Application (ANDA) litigation. She has also researched various legal matters in preparation of inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office.

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Michelle E. O'Brien
Partner, Head of Life Sciences
Marbury Law Group

Ms. O’Brien has more than 20 years of experience representing domestic and foreign clients of all sizes in patent procurement, litigation, and client counseling, with a particular emphasis on chemical, biochemical, and pharmaceutical technologies. Exemplary areas of her technical expertise include polymer chemistry; ceramics; glass; food chemistry; cosmetics; paper products; adhesives; and pharmaceutical products, including new chemical entities and formulations and novel solid forms, including polymorphs, cocrystals, and amorphous forms of compounds.

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Credit Information

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


  • Live Online


    On Demand

Date + Time

  • event

    Thursday, July 6, 2023

  • schedule

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

  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?