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 […]
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 […]
A district court judge in New Jersey recently granted an API supplier’s motion to dismiss claims filed against the supplier in an ANDA suit, raising questions about whether an API supplier belongs as a defendant in these litigations. United Therapeutics Corp. v. Sandoz, Inc., No. 12-CV-1617 (March 10, 2014). The Court concluded that a declaratory […]