United Therapeutics, Novartis cardiovascular, generics news
The U.S. District Court for the District of New Jersey ruled that United Therapeutics’ process patent covering Remodulin treprostinil is valid and infringed by an ANDA submitted by Novartis’ Sandoz generic unit for a generic version of Remodulin for injection. The court enjoined Sandoz from marketing its generic until the expiration of U.S. Patent No. 6,765,117 on Oct. 24, 2017.
The court ruled that the ANDA does not infringe United Therapeutics’ U.S. Patent No. 7,999,007, which covers a certain buffer solution that lowers the risk of bloodstream infection when used to dilute Remodulin for IV injection. The court rejected United Therapeutics’ argument that Sandoz’ proposed ANDA label will “actively induce” physicians to infringe the ‘007 patent, saying that label does not instruct physicians to use the diluent covered by the patent. The ‘007 patent expires on March 29, 2029. United Therapeutics said it may appeal the ‘007 patent ruling in the U.S. Court of Appeals for the Federal Circuit. ...