Monthly Archives: February 2023

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Amici Weigh in on Enablement in Amgen Inc. v. Sanofi

Enablement, Section 112, Supreme CourtBy R. Willets Ely February 20, 2023

On Friday, February 10, 2023, the latest round of amicus briefs in Amgen Inc. v. Sanofi poured in. The case, set to be argued on March 27 before the U.S. Supreme Court, asks the Court to wrestle with the enablement requirement of Section 112 of the Patent Act. Specifically, the Court has been asked to…

IRS Treatment of Litigation Costs in ANDA Cases

35 U.S.C. § 271(e)(2), ANDA Litigation, Hatch Waxman ActionBy Christopher Johnson February 6, 2023

The Third Circuit Court of Appeals will decide whether the IRS can force Mylan (and by extension other ANDA filers) to treat a) legal expenses to prepare notice letters and b) legal expenses to defend against infringement suits after paragraph IV certification both as capital expenditures that may not be deducted entirely in the year…