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…
In a recently unsealed opinion from the District of Delaware, Judge Dyk of the Federal Circuit sitting by designation, held a patent in the “inherently unpredictable” field of antibodies invalid on summary judgment for failing to satisfy the enablement requirement. Baxalta Inc. v. Genentech Inc. Delaware Opinion, Case No. 17-cv-509-TBD (D. Del. Jan. 13, 2022). …