News & Analysis as of

Intellectual Property Protection Patent Litigation 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

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

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

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: Supreme Court Denies Cert. in Skinny Label Case, but the Impacts from GSK v. Teva Continue

Yesterday, the Supreme Court denied certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, locking in the Federal Circuit’s second panel decision (hereafter “GSK v. Teva”), which held that Teva’s attempted...more

Foley Hoag LLP

Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition

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The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...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., 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

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

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

Kilpatrick

Federal Circuit Decides Teva-Lilly Spat for Antibody Compositions and Methods

Kilpatrick on

On August 16, 2021, the Federal Circuit handed down two rulings related to patents issued to Teva, which involve therapeutic antibodies targeting a calcitonin gene-related peptide (“CGRP”). In both cases, the Federal Circuit...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

Knobbe Martens

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

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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

Knobbe Martens

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

Knobbe Martens on

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

Herbert Smith Freehills Kramer

DC District Court Provides Guidance as to the Meaning of ‘Protein’ Under the BPCIA

In December 2020, the U.S. District Court for the District of Columbia issued a decision in Teva v. FDA, reviewing FDA’s definition of “protein” in connection with the agency’s determination that Teva’s Copaxone®, a...more

Robins Kaplan LLP

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

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Coreg® (carvedilol) - Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Circuit Judges Prost, Newman, and Moore presiding; Opinion by Newman, J.; Dissent by Prost, C.J.)...more

Fish & Richardson

[Webinar] Life Sciences | 2020 Year in Review - January 27th, 1:30 pm - 2:30 pm ET

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2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more

Robins Kaplan LLP

IBSA Institut Biochimique, S.A. v. Teva Pharms. USA, Inc.

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Tirosint®/levothyroxine sodium - Case Name: IBSA Institut Biochimique, S.A. v. Teva Pharms. USA, Inc., No. 2019-2400 (Fed. Cir. July 31, 2020) (Circuit Judges Prost, Reyna, and Hughes presiding; Opinion by Prost, C.J.)...more

Robins Kaplan LLP

Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc.

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BECAUSE A SKILLED ARTISAN WOULD HAVE RECOGNIZED THE LIMITATIONS OF ONE PRIOR-ART REFERENCE AND WOULD HAVE BEEN MOTIVATED TO SELECT THE TEACHINGS OF ANOTHER REFERENCE TO OVERCOME THEM, THE PATENTS-IN-SUIT WERE OBVIOUS. Case...more

Robins Kaplan LLP

Galderma Labs., L.P. v. Teva Pharms. USA, Inc.

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Case Name: Galderma Labs., L.P. v. Teva Pharms. USA, Inc., No. 2019-2396 (Fed. Cir. Jan. 29, 2020) (Circuit Judges Moore, O’Malley, and Stoll presiding; Opinion by O’Malley, J.) (Appeal from D. Del., Andrews, J.). ...more

Robins Kaplan LLP

Galderma Labs L.P. v. Teva Pharms. USA, Inc.

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THE ASSERTED CLAIMS OF 1% IVERMECTIN FORMULATION ARE INVALID ON THE BASIS OF ANTICIPATION IN LIGHT OF A PRIOR ART REFERENCE THAT TEACHES APPLICATION OF 1-5% IVERMECTIN FORMULATION FOR TREATMENT OF THE SAME INDICATION. Case...more

Robins Kaplan LLP

Amgen Inc. v. Amneal Pharms. LLC

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The Court Denied Defendant’s Motion To Enforce Its Settlement Agreement With Plaintiff After The At-risk Launch And Subsequent Settlement Of Another Defendant. ...more

Robins Kaplan LLP

Teva Pharms. U.S.A., Inc. v. Azar

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Case Name: Teva Pharms. U.S.A., Inc. v. Azar, C.A. No. 18-2394 (RDM), 2019 U.S. Dist. LEXIS 30346 (D.D.C. Feb 26, 2019) (Moss, J.)....more

Robins Kaplan LLP

Endo Pharms. Inc. v. Teva Pharms. USA, Inc.

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Case Name: Endo Pharms. Inc. v. Teva Pharms. USA, Inc., C.A. No. 17-1240, 1455, 1887, 2019 U.S. App. LEXIS 9189 (Fed. Cir. Mar. 28, 2019)....more

Robins Kaplan LLP

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

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Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229, 139 S. Ct. 628 (Jan. 22, 2019) (Thomas, J. delivered the opinion for a unanimous Court), on cert. from the Federal Circuit, 855 F.3d 1356. ...more

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