News & Analysis as of

Food and Drug Administration (FDA) Exclusivity Patents

Robins Kaplan LLP

Liquidia Techs., Inc. v. FDA - Updated 5.2.25

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: FDA refused to approve Liquidia’s drug product, Yutrepia because another company, UTC, maintained marketing exclusivity. Liquidia sued FDA, and UTC intervened. The court granted...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Proskauer Rose LLP

First Federal Appellate Court Holds a NonCash Reverse Payment Subject to Antitrust Scrutiny: Is the Third Circuit's Decision in...

Proskauer Rose LLP on

Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more

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