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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

McDermott Will & Schulte

ANDA Applicant Has Standing to Appeal IPR Decision, Even with Only Paragraph III Certification

McDermott Will & Schulte on

The US Court of Appeals for the Federal Circuit found that a failed inter partes review (IPR) petitioner that maintained a Paragraph III certification had sufficient standing to appeal an adverse decision, but affirmed the...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

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