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Wilson Sonsini Goodrich & Rosati

FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

Wilson Sonsini Goodrich & Rosati on

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

Goodwin

Federal Circuit Affirms Injunction Against Celltrion in Aflibercept BPCIA Litigation

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On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from...more

Orrick, Herrington & Sutcliffe LLP

Personal Jurisdiction/Forum Non Conveniens - The World in U.S. Courts: Winter 2019

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Taiwanese Manufacturer of Smartphones Subject to Personal Jurisdiction in Texas in Patent Infringement Case Because of its Allegedly Purposeful Efforts to Serve the US Market Even Though all US Distribution was Orchestrated...more

Polsinelli

New Guidance on Mandatory Notice in the Biosimilar ‘Patent Dance’

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The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing. The ruling weighed in on a key...more

Goodwin

Amgen v. Apotex: Analysis of the Fed. Cir. Opinion

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As we posted on July 5, 2016, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of...more

Jackson Walker

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs: Part Two

Jackson Walker on

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

Foley Hoag LLP

A Fractured Federal Circuit Panel Interprets The Biosimilars Patent Resolution Procedures

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On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more

Knobbe Martens

Alert: Fractured Federal Circuit Provides Guidance on Biosimilars Patent Dance

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Both Sides Come Away with Wins in Amgen v. Sandoz - Yesterday, in Amgen, Inc. v. Sandoz, Inc., the Federal Circuit construed multiple provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz Update -- Amgen's Continuing Efforts to Obtain Preliminary Injunction

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Amgen is once again seeking a preliminary injunction in the Amgen v. Sandoz case, this time at the Federal Circuit while that Court resolves the issues on appeal from the District Court. Sandoz has only agreed to stay off...more

Patterson Belknap Webb & Tyler LLP

Preliminary Injunction Order in Actavis Casts a Skeptical Eye Toward the “Hard Switch”

Patterson Belknap Webb & Tyler LLP on

Last week, we briefly reported on the injunction granted by the U.S. District Court for the Southern District of New York in the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest...more

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