News & Analysis as of

Patent Litigation Teva Pharmaceuticals Abbreviated New Drug Application (ANDA)

Sheppard Mullin Richter & Hampton LLP

Claiming A Range, Watch Out For The Presumption Of Obviousness

This Federal Circuit opinion analyzes the presumption of obviousness and the obviousness challenge based on prior art that describes a wider range of doses than what is claimed....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

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

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

McDermott Will & Schulte

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

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

McDermott Will & Schulte

The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

The US Court of Appeals for the Federal Circuit has now vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA...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

McDermott Will & Schulte

Federal Circuit Restores Induced Infringement Verdict Against Teva

McDermott Will & Schulte on

Addressing the issue of whether a generic pharmaceutical company can be found to induce infringement even when all patented uses have been “carved out” of the label (resulting in a so-called “skinny label”), the US Court of...more

Haug Partners LLP

Induced Infringement: The Federal Circuit Addresses the Role of Skinny Labels in the Determination of Induced Infringement for...

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On October 2, 2020, the Federal Circuit issued a decision in GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.1 that addressed whether a generic drug manufacturer induced infringement of a method of use patent when its product...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

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - January 2020

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation. ...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

Foley & Lardner LLP

Federal Circuit Finds Endo Method Of Treatment Claims Satisfy 35 USC 101

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In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in Mayo v. Prometheus, and found them...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., Fed. Cir. Nos. 2015-2021, -2022, -2023, -2024, -2025, -2026, -2028, -2031, -2033, -2034, -2035, -2041, -2042, -2046, -2047, -2049, -2059, -2060, 2016-1025, -1060, -1117,...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., Civ. No. 3:17-cv-01076-M (N.D. Tex. Nov. 11, 2017) (Lynn, J.). Drug Product and Patent(s)-in-Suit: Soolantra® (ivermectin); U.S. Patents Nos. 8,815,816 (“the ’816...more

Robins Kaplan LLP

Allergan Sales, LLC v. Teva Pharms. USA, Inc.

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Case Name: Allergan Sales, LLC v. Teva Pharms. USA, Inc., Civ. No. 2:15-cv-01471-FRG-RSP, 2017 U.S. Dist. LEXIS 127886 (E.D. Tex. July 25, 2017) (Payne, M.J.). Drug Product and U.S. Patent: Delzicol® (mesalamine); U.S....more

Robins Kaplan LLP

Teva Pharms. USA, Inc. v. Sandoz Inc.

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Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc., Civ. No. 17-275(FLW), 2017 U.S. Dist. LEXIS 78002 (D.N.J. May 23, 2017) (Wolfson, J.)....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., 855 F.3d 1356, 2017 U.S. App. LEXIS 7650 (Fed. Cir. May 1, 2017) (Circuit Judges Dyk, Mayer, and O’Malley presiding; Opinion by Dyk, J.) (appeal from D.N.J.,...more

Troutman Pepper Locke

AIA On-Sale Bar Applies to Publicized Sales, Even When Knowledge of Sale Did Not Disclose the Underlying Invention

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The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes...more

Robins Kaplan LLP

Allergan, Inc. v. Teva Pharms. USA, Inc.

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Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., 15-1455-WCB, 2017 U.S. Dist. LEXIS 4545 (E.D. Tex. Jan. 12, 2017) (Bryson, J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic solution); U.S....more

Dickinson Wright

Federal Circuit Clarifies Post-America Invents Act “On-Sale” Bar Based on Publicly Announced Sale Agreements: Invalidates Four...

Dickinson Wright on

On May 1st, the Federal Circuit ruled that the America Invents Act (AIA) did not change the statutory meaning of “on sale” where the existence of a sale was publicly announced prior to patenting, even if the sale did not...more

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