The Medicines Company has filed a complaint against the U.S. Patent and Trademark Office (PTO), the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services seeking to set aside the PTO's denial last week of the company's Hatch-Waxman application to extend the principal U.S. patent covering Angiomax.
This complaint, filed in the U.S. District Court for the Eastern District of Virginia, is related to a case decided on March 16, where the same Court set aside PTO's prior denial of the Company's application. In its March 16 decision, the Court sent the matter back to the PTO for reconsideration. The PTO purported to undertake that consideration in 65 hours, issuing a new denial on the morning of March 19, 2010.
The Company is asking the Court to set aside the PTO's March 19 decision, instruct the PTO to accept the Company's patent term extension application as timely filed and order the PTO to extend the term of the Angiomax patent for the full period required under the Hatch-Waxman Act.