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Investigational New Drug Application (IND) Appeals

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #2

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more

Cozen O'Connor

First Circuit Permits Antitrust Claims for Improperly Listing a Device Patent on the FDA’s Orange Book to Move Forward

Cozen O'Connor on

In a holding that could significantly broaden the antitrust inquiry in the context of the Hatch-Waxman regulatory scheme, on February 13, 2020, the U.S. Court of Appeals for the First Circuit issued an opinion that may have...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2019

PATENT CASE OF THE WEEK - BioDelivery Sciences Int’l, Inc. v. Aquestive Therapeutics, Inc., Appeal Nos. 2019-1643, -1644, -1645 (Fed. Cir. Aug. 29, 2019) - Our case of the week this week focuses on Section 314(d)—the...more

Knobbe Martens

Broad Description in Specification Defeats Patent Owner’s Bid for Narrow Construction

Knobbe Martens on

BTG INTERNATIONAL LIMITED v. AMNEAL PHARMACEUTICALS LLC - Before Wallach, Moore, and Chen. Consolidated appeals from the Patent Trial and Appeal Board and the U.S. District Court for the District of New Jersey. ...more

Knobbe Martens

Orexo AB, Orexo US Inc., v. Actavis Elizabeth LLC

Knobbe Martens on

Federal Circuit Summary - Before Newman, Hughes, and Stoll. Appeal from the United States District Court for the District of Delaware Summary: Objective indicia of nonobviousness cannot be dismissed merely because all...more

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