Ten Lawsuits Filed Over Tentative Settlement To Delay Generic Version of Plavix

Health plans, unions and businesses have filed ten lawsuits over a tentative settlement that would delay the sale of a generic version of the blood thinner Plavix, the AP/Fort Worth Star-Telegram reports (Agovino, AP/Fort Worth Star-Telegram, 5/26). The settlement, announced in March, would resolve a patent infringement lawsuit filed against generic pharmaceutical company Apotex by Sanofi-Aventis and Bristol-Myers Squibb, which co-market Plavix. BMS and Sanofi had filed the lawsuit against Apotex in federal court over allegations that the generic version of Plavix manufactured by the company violated a U.S. patent on the medication. Under the settlement, BMS and Sanofi would pay an undisclosed amount to Apotex, which could begin to sell the generic version of Plavix in September 2011, eight months before the U.S. patent expires (Saul, New York Times, 3/22). The settlement requires Federal Trade Commission approval. According to the ten lawsuits, the settlement would violate federal antitrust laws. FTC Commissioner Jon Leibowitz last month said his staff would examine the settlement and raised concerns about the increased number of similar agreements. BMS and Sanofi representatives declined to comment on the ten lawsuits, and Apotex did not return a call.

Comments
Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, said, "Brand-name companies face a product drought, so they are going after every possible tool to delay generic competition." Alex Sugerman-Brozan, director of the Prescription Access Litigation Project, said, "The generic companies are complicit" with brand-name pharmaceutical companies because they agree to such settlements. Pharmaceutical Research and Manufacturers of America spokesperson Ken Johnson said that such settlements allow brand-name pharmaceutical companies to focus on the development of new medications (AP/Fort Worth Star-Telegram, 5/26).