IRS Treatment of Litigation Costs in ANDA Cases

Posted at 21:01h February 6, 2023 in 35 U.S.C. § 271(e)(2), ANDA Litigation, Hatch Waxman Action by Christopher Johnson
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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 […]

API Manufacturers Are Not Proper Defendants In Hatch-Waxman Actions

Posted at 15:30h April 11, 2014 in Hatch Waxman Action by Carlson Caspers
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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 […]