In 2001, The Medicines Company failed to file a patent term extension application for its anticoagulant drug Angiomax® (bivalirudin) within the 60-day time limit set forth under 35 U.S.C. § 156(d)(1); the application was filed one day late. Since that time, there have been efforts to remedy this deficiency by legislation (including H.R. 5120; S. 1785; and provisions of S. 1145, the patent "reform" act; as well as an earlier "stand alone" version of the bill introduced as H.R. 1178 earlier in this Congress). Last Monday, the House finally passed a bill containing the necessary provisions.
The bill, H.R. 6344, sets forth the changes in patent term extension law in Section 4:
The details can be read here.
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