News & Analysis as of

Patent Infringement Patents Teva Pharmaceuticals

Fish & Richardson

Recent Decisions and FTC Challenges Dictate Caution When Listing Patents in the Orange Book

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In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.

Robins Kaplan LLP on

Invega Sustenna® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., Civ. Nos. 18-734, 19-16484, 2024 WL 5135666 (D.N.J. Dec. 17, 2024) (Cecchi, J.)  Drug Product and Patent(s)-in-Suit:...more

WilmerHale

Federal Circuit Patent Watch: Orange Book Patents Can Be Delisted If They Do Not Claim Active Ingredient

WilmerHale on

Precedential and Key Federal Circuit Opinions - TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC [OPINION] (2024-1936, 12/20/2024) (Prost, Taranto, Hughes) - Prost, J. The...more

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

Defining an Orange Book ‘Drug’

The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent infringement in response...more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S. - ProAir® HFA (albuterol sulfate)

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Case Name: Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., Civ. No. 24-4404 (SRC), 2024 WL 3966314 (D.N.J. Aug. 28, 2024) (Chesler, J.)....more

DLA Piper

Teva Ordered to Delist Inhaler Patents From FDA Orange Book

DLA Piper on

In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist five patents from the Food and Drug Administration (FDA)’s Approved Drug Products...more

Jones Day

FTC Weighs In on Orange Book Listing of Drug-Device Patents

Jones Day on

On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2024 #2

Janssen Pharms., Inc. et al. v. Teva Pharm. USA, Inc. et al., Appeal Nos. 2022-1258, -1307 (Fed. Cir. April 1, 2024) In this week’s Case of the Week, the Federal Circuit vacated-in-part a district court’s bench trial...more

Robins Kaplan LLP

Vanda Pharms. Inc. v. Teva Pharms. USA, Inc. Hetlioz® (Tasimelteon)

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Case Name: Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., No. 2023-1247, 2023 WL 3335538 (Fed. Cir. May 10, 2023)(Circuit Judges Dyk, Bryson, and Prost presiding; Opinion by Dyk, J.) (Appeal from D. Del., Connolly, J.)....more

Axinn, Veltrop & Harkrider LLP

Axinn IP Update: District of Delaware Magistrate Judge Recommends Dismissal of Claims of Induced Infringement in Skinny Label Case

In the first decision to issue following the Supreme Court’s denial of certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, Magistrate Judge Sherry R. Fallon of the United States District Court for the...more

A&O Shearman

SCOTUS denies cert in skinny label appeal from the Federal Circuit

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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

Foley Hoag LLP

The Fate of the Skinny Label: Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC

Foley Hoag LLP on

On May 15, 2023, the Supreme Court denied certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC et al., a case some argued had enormous implications for so-called “skinny labeling” practices amongst generic drug...more

Robins Kaplan LLP

Vanda Pharms. Inc. v. Teva Pharms. USA, Inc. Hetlioz® (Tasimelteon)

Robins Kaplan LLP on

Case Name: Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., Nos. 22-7528, 22-7529 (CCC), 2023 WL 1883357 (D.N.J. Feb. 10, 2023) (Cecchi, J.) - Drug Products and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No....more

Knobbe Martens

Teva v. GSK: The “Skinny” Label Case Pending Before the Supreme Court

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On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva...more

Knobbe Martens

When an Unmet Need May Not Be Enough

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ADAPT PHARMA OPERATIONS LTD. V. TEVA PHARMS. USA, INC. Before Newman, Prost, and Stoll. Appeal from the United States District Court for the District of New Jersey. Summary: Recent attempts by competitors to achieve...more

WilmerHale

Federal Circuit Patent Watch - December 2021 #2

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Precedential Federal Circuit Opinions - TEVA PHARMACEUTICALS USA v. CORCEPT THERAPEUTICS, INC. [OPINION] (2021-1360, 12/07/2021) (MOORE, NEWMAN, and REYNA) -   Moore, C.J. The Court affirmed the PTAB’s IPR decision...more

Knobbe Martens

Limitations in Claim Language Frame Reasonable Expectation of Success Analysis

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TEVA PHARMACEUTICALS USA, INC., v. CORCEPT THERAPEUTICS, INC. Before Moore, Newman, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Limitations, such as specific drug doses, in claim language can...more

Smart & Biggar

PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more

Knobbe Martens

Federal Circuit Review - August 2021

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It’s No Secret That a Related Company’s Physical Presence in a Jurisdiction May Not Be Enough For Proper Venue - In Andra Group, LP v. Victoria’s Secret Stores, LLC, Appeal No. 20-2009, The Federal Circuit held that an...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

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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

Knobbe Martens

The Obviousness of Preamble Limitations Can Be a Real Headache for Patent Challengers

Knobbe Martens on

ELI LILLY AND COMPANY v. TEVA PHARMACEUTICALS  - Before Lourie, Bryson and O’Malley.  Appeal from the Patent Trial and Appeal Board. Summary: In claims for methods of using apparatuses or compositions, statements of...more

Knobbe Martens

Presumption of Nexus Between Claims and Commercial Products May Not Apply When Unclaimed Features Are Critical

Knobbe Martens on

TEVA PHARMACEUTICALS v. ELI LILLY AND COMPANY - Before LOURIE, BRYSON, and O’MALLEY. Appeal from the Patent Trial and Appeal Board. Summary: The presumption of nexus analysis requires the fact finder to consider the...more

McDermott Will & Emery

The Skinny Label That Wasn’t—Federal Circuit Reinstates Induced Infringement Verdict

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The US Court of Appeals for the Federal Circuit vacated the district court’s grant of judgment as a matter of law (JMOL) of non-infringement where substantial evidence supported the jury’s verdict of induced infringement by...more

Knobbe Martens

Ineffective Skinny Label Leaves Generic Liable Despite Effort to Carve-Out the Patented Indication

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GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. [OPINION] – PRECEDENTIAL - Before Moore, Newman, Prost (dissent). Panel rehearing of an appeal from the U.S. District Court for the District of Delaware - Summary:...more

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