News & Analysis as of

Administrative Procedure Act Pharmaceutical Patents Pharmaceutical Industry

McDonnell Boehnen Hulbert & Berghoff LLP

MSN Laboratories Private Ltd. v. Bausch Health Ireland Ltd. (Fed. Cir. 2025)

As has been noted recently (Agilent Technologies, Inc. v. Synthego Corp.), fact-based decisions from the U.S. Patent and Trademark Office (typically from the Patent Trial and Appeal Board) are reviewed under the substantial...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc. (Fed. Cir. 2024)

Ever since the Supreme Court's decision in Dickinson v. Zurko, federal courts (including the Federal Circuit) are compelled under the Administrative Procedures Act to review factual determinations by the U.S. Patent and...more

McDonnell Boehnen Hulbert & Berghoff LLP

United Therapeutics Corp. v. Liquidia Technologies Inc. (Fed. Cir. 2024)

Zealous advocacy is a hallmark of adversarial proceedings, whether in district court or before the USPTO, where the opportunities for such advocacy have multiplied with the establishment by the Leahy-Smith America Invents Act...more

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

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions (8th Edition): Elekta Limited v. Zap Surgical Systems, Inc. 81 F.4th...

Zap filed an IPR petition alleging obviousness of a patent owned by Elekta. The petition relied on a combination of two references. The Board found a reason to combine the references and ultimately found obviousness of the...more

Morrison & Foerster LLP - Federal Circuitry

Last Week in the Federal Circuit (July 27-31): Gambling on an APA Challenge

It was a moderately eventful week at the Federal Circuit as the judges geared up for their August argument session and perhaps returned from their summer vacations. The Court issued 13 opinions and 2 orders on petitions for a...more

Foley & Lardner LLP

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

McDermott Will & Emery

PTO Revival Rulings Are Not Subject to Collateral Attacks by Third Parties - Exela Pharma Sciences, LLC v. Lee

Addressing whether third parties have the right to challenge a patent revival ruling by the U.S. Patent and Trademark Office (PTO) under the Administrative Procedure Act (APA), the U.S. Court of Appeals for the Federal...more

Foley & Lardner LLP

District Court Upholds FTC Hart-Scott-Rodino Rules for Pharmaceutical Patent Transfers

Foley & Lardner LLP on

A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We...more

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