News & Analysis as of

Patents Teva Pharmaceuticals Abbreviated New Drug Application (ANDA)

Wolf, Greenfield & Sacks, P.C.

CAFC Decision on Orange Book Listings for Drug/Device Combination Patents

On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals that impacts Orange Book (OB) listings for patents...more

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

Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing

On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more

McCarter & English, LLP

Drug Delivery Device Patents Removed from Orange Book

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The listing of patents in the Orange Book has an important role in intellectual property protection for pharmaceuticals. Patents listed in the Orange Book can include, without question, patents covering compositions or...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

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

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 & 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

McDermott Will & Emery

The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

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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

Troutman Pepper Locke

Federal Circuit Places “Skinny Labels” in Danger

Troutman Pepper Locke on

Section viii of the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(A)(viii), allows a generic applicant to “carve out” indications and other use information from its labeling that are protected by patents listed in FDA’s Orange Book...more

McDermott Will & Emery

Federal Circuit Restores Induced Infringement Verdict Against Teva

McDermott Will & Emery 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...

Haug Partners LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)

What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...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.

Robins Kaplan LLP on

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., 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

McDermott Will & Emery

Determining Venue for ANDAs Containing Paragraph IV Certification

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The US District Court for the Northern District of Texas found that venue was not proper under 28 USC § 1400(b) because Teva Pharmaceuticals USA did not commit any act of infringement in the Northern District of Texas, nor...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

Morgan Lewis

District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation

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There have been two interpretations of the “acts of infringement” language in the patent venue statute regarding ANDA submissions in Hatch-Waxman litigation....more

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