News & Analysis as of

Statutory Interpretation Generic Drugs

Robins Kaplan LLP

Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc

Robins Kaplan LLP on

Bridion® (sugammadex) - Case Name: Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 2023-2254, 2025 WL 795317 (Fed. Cir. Mar. 13, 2025) (Circuit Judges Dyk, Mayer, and Reyna presiding; Opinion by Dyk, C.J.) (Appeal...more

Irwin IP LLP

Federal Circuit Finds Against Generics Where Hatch-Waxman's Full Five-Year Extension Fixes Delay For Pharmaceutical FDA-Review  

Irwin IP LLP on

Merck Sharp & Dohm B.V. v. Aurobindo Pharma USA, Inc. et al (Fed. Cir. March 13, 2025) - The Hatch-Waxman Act seeks to strike a balance in the pharmaceutical industry by incentivizing drugs makers to develop innovative...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing

On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more

Proskauer - Minding Your Business

Generic Competition for Withdrawn Drug Products

When a pharmaceutical company withdraws a product from the market, the basis for the withdrawal can affect whether a competitor can commercialize a generic version of that product. A generic cannot be approved if, in the...more

Hogan Lovells

Federal Circuit Acetris Decision Changes Procurement Country of Origin Landscape

Hogan Lovells on

On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more

Troutman Pepper Locke

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper Locke on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

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