Inducement Following GSK v. Teva
Evaluating the Effect of a Skinny Label, Implications of Recent Court Treatment
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Patent
- event Date
Wednesday, May 11, 2022
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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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.
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.
Ms. Holt is an experienced patent litigator at both the appellate and trial levels. A former clerk at the U.S. Court of Appeals for the Federal Circuit, she represents clients in patent disputes before the Federal Circuit, the U.S. Supreme Court, and district courts across the country. She handles cases involving a variety of technologies, with an emphasis on the biotechnology, pharmaceutical, and life sciences industries. She also assists clients in portfolio counseling matters and proceedings before the U.S. Patent and Trademark Office (USPTO).
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.
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.
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.
- Skinny labels and inducement
- Recent court treatment
- Implications of GSK v. Teva
- Carve-out provisions of 21 U.S.C. § 355(j)(2)(A)(viii) for AB-ratedall505(j) generics
- Use of "AB" ratings in the future
- Types of evidence to demonstrate inducement
- Pre-launch vs. post-launch
- 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?
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