Medicines Co. cardiovascular news
The U.S. District Court for the Eastern District of Virginia ordered the U.S. Patent and Trademark Office to reconsider The Medicines Co.'s application to extend the term of its patent for anticoagulant Angiomax bivalirudin under the Hatch-Waxman Act. The court also directed the agency to ensure that U.S. Patent No. 5,196,404 does not expire pending further resolution of the proceedings.
District Judge Claude Hilton said in his decision that the PTO erred in using FDA's approval date of Friday, Dec. 15, 2000, as the first day of the company's 60-day period to submit the application because the company received FDA's notice of approval of Angiomax after normal business hours. In making its submission to the PTO, Medicines Co. used the next business day, Monday, Dec. 18, 2000, as the first day in calculating the 60-day window. As a result, the PTO rejected the company's submission on Feb. 14, 2001, because it fell outside of what the PTO considered to be the 60-day period by one day. The company is seeking to extend the patent's term to December 2014 from March 23, 2010 (see BioCentury, Feb. 8). ...