The Medicines Company announced today that the period for the government to appeal the Aug. 3 court decision ordering the Patent and Trademark Office to consider a 2001 Angiomax (bivalirudin) patent term extension application timely filed has expired.
The company applied for a standard patent extension back in 2001 on the '404 patent, but it missed the deadline by two days. So instead of getting the routine extension--which would have covered Angiomax until 2014--the company's patent was set to expire this year.
But in August, a U.S. judge ordered the PTO to consider the company's application for an extension. "Congress intended for the applicant to have 60 days," Judge Claude Hilton writes. "The PTO interpreted the statute in a manner that deprives the applicant the 60 days that Congress intended for them to receive." At issue was whether those 60 days were calendar days--which would have made the app late, as PTO contended--or business days, as Medicines Co. maintained. Hilton sided with the company.
The ongoing dispute did give rise to some interesting congressional actions. Legislation was introduced--dubbed the "Dog Ate My Homework Act"--that would amend 35 U.S.C. § 156 to permit the PTO to accept the late filing of a PTE application, and in particular, The Medicines Company's PTE application for the '404 patent, the FDA Law Blog notes. In the last session of Congress, H.R. 6344, passed the House but stalled in the Senate.
In a statement, Medicines notes that it 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.
- see the Medicines Co. release
- get more from the FDA Law Blog