After the Patent and Trademark Office (PTO) denied an application issued by the Medicines Company for a term extension for patent No. 5,196,404 (the ‘404 patent), the company filed a complaint against the FDA, the Department of Health and Human Services and the PTO on March 26 to derail the Hatch-Waxman patent application covering Angiomax (bivalirudin).
The Parsippany, N.J.-headquartered company filed the complaint through the U.S. District Court for the Eastern District of Virginia. According to the company, the most recent complaint is related to a prior case decision that took place on March 16, where the court set aside the PTO’s denial for a patent term extension application by the Medicines Company and readmitted the decision back to the PTO for reconsideration.
According to Medicines, the court ordered that the PTO take necessary action to ensure that the ‘404 patent didn’t expire pending resolutions of the proceedings.
On March 18, the PTO granted an interim extension of the ‘404 patent through May 23, but on March 19, the PTO denied Medicines' application for the extension. The company then confirmed that this extension remained in effect through May 23, 2010, and will not expire on that date.
The company has issued that the court set aside the PTO’s March 19 decision and has instructed that the PTO accept the company’s patent term extension application to extend the term of the Angiomax patent for the full period required under the Hatch-Waxman Act.
The company is now considering court challenges and efforts to extend the terms of the ‘404 patent. The interim extension is still in effect.