News & Analysis as of

Pharmaceutical Industry Abbreviated New Drug Application (ANDA) Teva Pharmaceuticals

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

Fitch, Even, Tabin & Flannery LLP

Federal Circuit Declines to Revive Opioid Overdose Remedy

On February 10, in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed a district court’s holding that Adapt’s methods of treatment of opioid overdose is invalid as obvious. 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

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

Locke Lord LLP

Federal Circuit Places “Skinny Labels” in Danger

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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

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

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

Morrison & Foerster LLP

Hatch-Waxman and BPCIA Developments in June 2018

This month, we highlight significant developments in June 2018, including a Supreme Court decision regarding the PTAB, a federal court affirmation in Impax Laboratories Inc. v. Lannett Holdings Inc., and new legislation...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

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

McDermott Will & Emery

Supply and Purchase Agreement Triggers On-Sale Bar Provision of 35 USC § 102(b)

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The US Court of Appeals for the Federal Circuit reversed the district court and found that a Supply and Purchase Agreement between Helsinn and third-party MGI Pharma, Inc. (MGI) before the critical date of the asserted...more

Troutman Pepper

Deuterated Drugs Are New Chemical Entities

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FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more

Troutman Pepper

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...

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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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