The time period has expired for the U.S. government to challenge a court's decision that The Medicines Company had filed a timely request for a patent extension for bivalirudin (Angiomax).
On Aug. 3, a district court ordered the U.S. Patent and Trademark Office (PTO) to consider that The Medicines Company had filed a timely application for patent term extension of Angiomax. On Aug. 6, the PTO granted the Parsippany, N.J.-based Medicines Company a one-year extension for the bivalirudin patent (Patent No. 5,196,404).
On Sept. 10, the U.S. Solicitor General said it would not appeal at this time the district court's decisions that ordered PTO to consider the extension for the drug. The deadline to appeal the decision expired Oct. 4 at midnight.
Additionally, The Medicines Company holds other U.S. patents that cover a more consistent and improved Angiomax product. Those patents expire in 2028 and are currently the subject of litigation with several generic drug companies that are seeking to market a generic version of bivalirudin.
APP Pharmaceuticals, one of those generic drug companies, has sought to intervene in the case decided by the U.S. District Court for the Eastern District of Virginia on the '404 patent. On September 10, the U.S. District Court for the Eastern District of Virginia denied APP's motion to intervene. APP has filed an appeal, according to The Medicines Company.