News & Analysis as of

Patent Infringement Induced Infringement Food and Drug Administration (FDA)

Jones Day

U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"

Jones Day on

On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Mylan Labs. Ltd.

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Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more

WilmerHale

Federal Circuit Patent Watch: Pending, non-final litigation or IPR decision does not negate intent to infringe that is otherwise...

WilmerHale on

Precedential and Key Federal Circuit Opinions - UNITED THERAPEUTICS CORPORATION v. LIQUIDIA TECHNOLOGIES, INC. [OPINION] (22-2217, 7/24/23) (Lourie, Dyk, and Stoll) - Lourie, J. The Court affirmed the district...more

A&O Shearman

SCOTUS denies cert in skinny label appeal from the Federal Circuit

A&O Shearman on

On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

Robins Kaplan LLP

Salix Pharms., Ltd. v. Norwich Pharms., Inc. Xifaxan® (Rifaximin)

Robins Kaplan LLP on

Case Name: Salix Pharms., Ltd. v. Norwich Pharms., Inc., C.A. No. 20-cv-430-RGA, 2022 WL 3225381 (D. Del. Aug. 10, 2022) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199...more

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

Hogan Lovells

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

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Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more

Proskauer - The Patent Playbook

GSK v. Teva: Federal Circuit Issues New Opinion Analyzing Induced Infringement

On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more

Cooley LLP

Alert - GSK v. Teva: Federal Circuit Opinion After Rehearing Confirms Induced Infringement Liability Despite Skinny Label

Cooley LLP on

In October 2020, as reported in a previous Cooley alert, the US Court of Appeals for the Federal Circuit reinstated a jury’s verdict that Teva infringed GSK’s patented method of using its Coreg drug product, even though...more

McDonnell Boehnen Hulbert & Berghoff LLP

GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed. Cir. 2021)

Most judicial outcomes, particularly on appeal, are broadly based on varying combinations of process and outcome. The law is replete with process-based decisions (standing, jurisdiction, waiver, to name a few) and of course...more

Troutman Pepper Locke

Federal Circuit Places “Skinny Labels” Back in Danger

Troutman Pepper Locke on

On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more

Proskauer - The Patent Playbook

Induced Infringement of Method of Treatment Claims: Looking to the Label and Beyond

Reference product sponsors often obtain patents claiming methods of using a known drug to treat a condition or disease. Because generic and biosimilar developers typically do not treat patients, and thus do not directly...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Panel Rehears Skinny Label Case (GSK v. Teva)

On February 23, 2021, a Federal Circuit panel of Chief Judge Prost, Judge Newman, and Judge Moore reheard oral argument in GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. As discussed in our previous post, on February 9, 2021,...more

Troutman Pepper Locke

Federal Circuit Hints at Reversed Course on “Skinny Labels”

Troutman Pepper Locke on

On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Decision Raises Concern over Whether Skinny Labels are Sufficient to Avoid Induced Infringement

The Federal Circuit recently held in a 2-1 decision that there was substantial evidence supporting a jury finding that Teva was liable for induced infringement for an indication carved out of its skinny label for its generic...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

Robins Kaplan LLP

Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp.

Robins Kaplan LLP on

Case Name: Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp., Civ. No. 14-1268-SLR, 2016 U.S. Dist. LEXIS 65317 (D. Del. May 18, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine); U.S....more

Foley & Lardner LLP

The Promise And Pitfalls Of 3D Printing

Foley & Lardner LLP on

3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....more

McDermott Will & Emery

Supplier to ANDA Filer Is Not Liable for Induced Infringement Until After ANDA Approval - Shire LLC v. Amneal Pharms., LLC

McDermott Will & Emery on

Addressing the scope of the safe harbor provision of § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit reversed the district court, holding that supplying an active pharmaceutical ingredient (API) to the filer of...more

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