MMD FILES LAWSUIT OVER SELDANE PATENT

Marion Merrell Dow has filed a suit in the United States District Court for the Southern District of Florida alleging that Baker Norton Pharmaceuticals is infringing one of the company's patents relating to the antihistamine Seldane (terfenadine).

The suit alleges that Baker is infringing MMD's US patent which covers the carboxylic acid metabolite of terfenadine as well as the use of the product. Baker notified MMD that it had submitted an Abbreviated New Drug Application to the US Food and Drug Administration to obtain approval to market terfenadine before the expiration of the patent on March 3, 1998.

The notice by Baker falls under a provision of the Waxman Hatch Act, which provides that Baker's ANDA cannot be approved by the FDA for a period of up to 30 months from the filing of this lawsuit, pending the outcome of litigation in Federal District Court.