FDA Law

IRS Treatment of Litigation Costs in ANDA Cases Affirmed

August 25, 2023

The Third Circuit Court of Appeals affirmed on July 27, 2023, that infringement-suit defense costs for ANDA filers who file Paragraph IV certifications are deductible...

Supreme Court Upholds Federal Circuit’s Full-Scope Enablement Test in Amgen Inc. v. Sanofi

June 8, 2023

Recently, a unanimous Supreme Court issued its ruling in Amgen Inc. v. Sanofi, holding that Amgen’s challenged patents ran afoul of Section 112’s enablement requirement.

Recitation of Common Functional Groups for Genus Claims Fails Written Description Requirement

March 29, 2023

In an opinion issued on March 6, 2023, the Federal Circuit affirmed the PTAB’s holding of unpatentability because the applications from which the patent claimed...