Class Action Alleges Novartis Gleevec Patent Infringement Suit a Sham

Complaint seeks permanent injunctive relief to prevent overcharges and damages, and bring generic Gleevec to market

BOSTON – A class-action lawsuit filed against Novartis alleges that the pharma company's patent infringement suit against generic company Sun Pharma was a sham, and seeks a permanent injunction to prevent Novartis or Sun from enforcing the terms of a settlement agreement that, barring relief, will delay the launch of generic Gleevec for months, according to attorneys at Hagens Berman. 

According to Hagens Berman, the suit marks the first time purchasers of prescription drugs have sought injunctive relief to try to prevent antitrust overcharges or damages stemming from delayed launch of generic drugs.

The lawsuit, filed June 22, 2015 in the U.S. District Court for the district of Massachusetts, seeks to prevent Novartis' unlawful delay of generic Gleevec (imatinib mesylate), an FDA-approved prescription drug that radically improves the lives of the thousands of patients suffering chronic myeloid leukemia, a cancer of the blood and bone marrow. The drug's compound patent expires on July 4, 2015, but Novartis unlawfully barred generic maker Sun Pharma from releasing its generic version of Gleevec for at least an additional seven months, according to the suit. Two generic versions of the drug have already been tentatively approved by the FDA.

"If Novartis played by the rules, a generic version of Gleevec would be available for cancer patients this July, but Novartis wants to illegally reap benefits from of its sham of a patent infringement suit," said Hagens Berman partner, Thomas M. Sobol. "Gleevec costs about $9,000 a month and has appropriately grossed Novartis more than $13.5 billion in U.S. sales. Now it's time for it to fairly compete with generics."

The suit calls Novartis' efforts to delay generic Gleevec "patent gamesmanship and frivolous litigation."

The suit states that Novartis, "listed invalid follow-on patents in the FDA's Orange Book, frivolously sued (belatedly) first-inline generic Sun for infringing one of those patents, and extracted from Sun a promise not to launch its generic for seven extra months beyond the compound patent's expiration in the guise of settling the bogus infringement lawsuit."

The suit names two end payers as plaintiffs and has been filed on behalf of a class of all purchasers of Gleevec.