News & Analysis as of

Patent Infringement Injunctive Relief Pharmaceutical Industry

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

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

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

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

Knobbe Martens on

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

Goodwin

Regeneron Files Another Complaint Against Amgen in Aflibercept BPCIA Litigation

Goodwin on

On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099...more

Haug Partners LLP

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

Haug Partners LLP on

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 & Emery

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

McDermott Will & Emery 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

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

Eversheds Sutherland (US) LLP

US-China Trade Agreement - Pharma impacts

President Trump has signed Phase I of a much anticipated multi-part trade agreement between the United States and China with provisions that will aid the branded pharmaceutical industry. One of the main goals of the agreement...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...

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

Hogan Lovells

Hogan Lovells Moscow Life Sciences team secures major win in a precedent patent case for Novartis against a generic producer in...

Hogan Lovells on

Led by partner Natalia Gulyaeva, the Hogan Lovells Moscow team represented Novartis in a precedent case for pharma business proving that one can obtain an injunction using patent rights against a generic in Russia before the...more

Foley & Lardner LLP

Janssen Seeks Injunction Against Remicade Biosimilar Based On Cell Culture Patent

Foley & Lardner LLP on

In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more

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