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Gleevec Antitrust Litigation -- United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund v. Novartis Pharmaceuticals Corp.

Court: United States District Court, District of Massachusetts
Case No.: 15-cv-12732

Gleevec is a drug used to treat certain types of leukemia, bone marrow disorders, and skin cancer, or certain tumors of the stomach and digestive system. It costs approximately $9,000 per month. The drug, manufactured by Novartis, should be available as a generic formulation on July 5, 2015. However, as alleged in the complaint filed by Wexler Wallace and others on behalf of plaintiffs, Novartis has unlawfully extracted an additional seven months of exclusivity to guarantee that this very expensive life-saving drug will continue to sell for an extended period without generic competition. Novartis has made more than $13.5 billion in U.S. sales from Gleevec and continues to make approximately $2 billion a year from the drug. 

The complaint, filed June 22, 2015, alleges that: Novartis unlawfully listed invalid follow-on patents in the FDA’s Orange Book; frivolously sued first-in-line generic maker Sun Pharmaceuticals for infringing one of those patents; and entered into an anticompetitive settlement with a potential generic competitor, Sun Pharmaceuticals, whereby Sun agreed not to launch its generic for seven months beyond the expiration date of Gleevec’s original patents. Plaintiffs are seeking a permanent injunction prohibiting Novartis from taking any steps to enforce the May 2014 Sun Pharmaceuticals settlement agreement. As stated in the complaint, “[P]atent gamesmanship and frivolous litigation undertaken solely for the purpose of extracting settlements that delay generic entry violate basic principles of antitrust law, and should be enjoined.”

Read Wexler Wallace’s Gleevec antitrust litigation complaint here.