AVENTIS REFILES LAWSUIT AGAINST BAXTER'S ADVATE

Aventis Pharma has refiled a lawsuit claiming that Baxter's drug Advate infringes on a patent related to factor VIII:c, a protein that helps form blood clots.

The '427 patent covers solutions with factor VIII:c activity as well as methods of making the solutions. Advate uses factor VIII:c solutions to prevent and control bleeding episodes from classical hemophilia.

According to documents from the U.S. District Court for the District of Delaware, Aventis first filed a lawsuit for infringement of patent '427 against Baxter in April 2003. When Baxter revealed new information in court, the patent's owners called for a reexamination of the '427 patent. The parties agreed to dismiss the lawsuit, and to refile once the patent had been completely reviewed.

With the U.S. Patent and Trademark Office review now completed, Aventis has refiled the infringement litigation against Baxter as planned.

The FDA granted approval of Baxter's Advate in July 2003. Sales of the drug began in August 2003 and surpassed 1 billion units in January 2006, according to Baxter.

Advate is the world's only recombinant factor VIII:c therapy that does not have animal or human blood components, according to Baxter. It is the best-selling drug in Baxter's hemophilia division, the company said.