News & Analysis as of

Hatch-Waxman Injunctive Relief

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...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

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