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 legal expenses, not capital expenditures to obtain FDA approval. The Court of Appeals noted that legal defense costs for ANDA filers do not “facilitate” obtaining an intangible asset because “ultimate…
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.
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 priority from lacked sufficient written description under 35 U.S.C. § 112. Regents of University of MN v. Gilead Sciences, Inc., No. 2021-2168 (March 6, 2021). Because the patent could not…
Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware granting a motion for an injunction to delist Jazz Pharmaceuticals, Inc.’s (“Jazz”) REMS patent from the Orange Book, as the patent covers neither the drug itself nor a method of using it. Jazz Pharms., Inc., v. Avadel CNS…
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…
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…