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Pharmaceutical Industry › Administrative Procedure Act › Appeals

Mayer Brown

In Neurelis v. Brenner, The FDA’s “Indication-Specific” View of Orphan Exclusivity is (Again) Struck Down

Mayer Brown on

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the Orphan Drug Act (“ODA”)....more

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Goodwin

Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

Goodwin on

On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

Mintz - Health Care Viewpoints on

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

Jones Day on

No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

Morrison & Foerster LLP - Federal Circuitry

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

Morrison & Foerster LLP - Federal Circuitry on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Skadden, Arps, Slate, Meagher & Flom LLP on

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Akin Gump Strauss Hauer & Feld LLP on

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...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

McDonnell Boehnen Hulbert & Berghoff LLP

Genzyme Petitions Federal Circuit for Rehearing in Genzyme Therapeutic Products, Inc. v. Biomarin Pharmaceutical, Inc.

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Many of the complaints from patent holders over the PTO's inter partes review process under the Leahy-Smith America Invents Act (codified in pertinent part at 35 U.S.C. §§ 311-319) stem from how the Office has implemented...more

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