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Pharmaceutical Industry › Injunctive Relief › Appeals

Robins Kaplan LLP

Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC

Robins Kaplan LLP on

Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Nos. 2024-2274, 2024-2277, 2024-2278, 2025 WL 1298920 (Fed. Cir. May 6, 2025) (Circuit Judges Lourie, Reyna, and Taranto presiding; Opinion by Lourie, J.) (Appeal from...more

Jenner & Block

A Secured Reversal of Preliminary Injunction in High-Stakes Pharmaceutical Battle

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In a significant victory for pharmaceutical competition and access to generic drugs, Jenner & Block secured a key litigation win on behalf of client MSN Pharmaceuticals. A federal judge denied a pharmaceutical company’s...more

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

District Circuit Denies Novartis’s Request for Injunctive Relief Against MSN’s Generic Version of Entresto®

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The District Court for the District of Delaware recently rejected Novartis’s effort to block MSN Pharmaceuticals from launching a generic version of Entresto® (sacubitril/valsartan), its top-selling heart failure medication....more

Knobbe Martens

A Patent Does Not Guarantee the Patent Owner Will Be First to Market

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INCYTE CORPORATION V. SUN PHARMACEUTICAL INDUSTRIES, LTD. - Before Moore, Prost and Hughes. Appeal from the United States District Court for the District of New Jersey. A district court erred in issuing a preliminary...more

Mintz - Health Care Viewpoints

PBMs Sue Arkansas Over Restrictive PBM Ownership Law

Mintz - Health Care Viewpoints on

On April 16, 2025, Arkansas enacted Act 624 (the Act), an unprecedented law prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state. As we discussed in our May 2025 blog post, the law’s...more

Haug Partners LLP

Federal Circuit Clarifies Safe Harbor from Injunctive Relief in Jazz v. Avadel

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On May 6, 2025, the U.S. Court of Appeals for the Federal Circuit refined the boundaries of injunctive relief under the Hatch-Waxman Act in its precedential opinion in Jazz Pharms., Inc. v. Avadel CNS Pharms. The decision...more

McDermott Will & Schulte

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

McDermott Will & Schulte on

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Pharmaceutical Patent Protections

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This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Third Circuit Holds FTC Must Show Defendants Are ‘About to Violate’ the Law for Injunctive Relief and Disgorgement

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On February 25, 2019, in FTC v. Shire ViroPharma, Inc., the U.S. Court of Appeals for the Third Circuit confirmed that the Federal Trade Commission (FTC) cannot plead its way into federal court via Section 13(b) of the FTC...more

Miles & Stockbridge P.C.

A Patent for Personalized Medicine Survives §101 Challenge at the Federal Circuit and Will Exclude Generic Drugs from the Market...

Miles & Stockbridge P.C. on

On April 13, 2018, the United States Court of Appeals for the Federal Circuit issued a decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd upholding the validity of U.S. Patent 8,586,610 (“the ’610...more

Goodwin

U.S. Argues Amgen’s State Law Claim Preempted by BPCIA, Supporting Sandoz

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Yesterday, in the remanded appeal in Amgen v. Sandoz, the United States submitted an amicus brief to the Federal Circuit that generally supports Sandoz’s position that Amgen’s state-law claim for an injunction under...more

Goodwin

Amgen v. Sandoz: Federal Circuit Vacates Opinion and Mandate, Reinstates Appeal, Orders Further Briefing on Remanded Issues

Goodwin on

As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the Supreme Court had remanded to the Federal Circuit,...more

Mintz

Second Circuit: “C” is for Comity; Price Fixing Judgement Against Chinese Vitamin C Sellers Reversed

Mintz on

Last week, in In re Vitamin C Antitrust Litigation, the US Court of Appeals for the Second Circuit (“Second Circuit”) vacated a $147 million jury award against Chinese vitamin C sellers Hebei Welcome Pharmaceutical Co. and...more

Proskauer Rose LLP

Third Circuit Rejects Presumption of Irreparable Harm for Injunctive Relief under Lanham Act

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Following a series of recent appellate decisions across the spectrum of intellectual property disciplines, including the fields of patent, copyright and trade secrets, the Court of Appeals for the Third Circuit has ruled that...more

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