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Lawsuit Says Novartis’ Gleevec Patent Infringement Suit a ‘Sham’

June 30, 2015

Two institutional buyers of Gleevec want to stop its manufacturer, Novartis, from delaying generic competition of the blockbuster leukemia drug, saying a patent litigation settlement between the brandmaker and generics maker Sun Pharma was construed solely for that purpose.

The lawsuit, filed on behalf of a class of all purchasers of Gleevec (imatinib mesylate), seeks a permanent injunction to prevent Novartis and Sun from enforcing the settlement agreement, which gives Gleevec seven extra months without competition.

Novartis spokeswoman Liz Power called the claims unsubstantiated and said Novartis will vigorously defend its patent rights.

In May 2014, Novartis settled litigation with Sun Pharmaceutical over what the plaintiffs allege were invalid follow-on patents on the use of certain polymorphic forms of Gleevec. Those patents are set to expire in 2019. The basic compound patent expires July 4, 2015.

The plaintiffs — the United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund and the Laborers Health and Welfare Trust Fund for Northern California—claim Novartis listed the follow-on patents in the FDA’s Orange Book and frivolously sued Sun for infringing one of those patents. To settle the “bogus” lawsuit, Sun agreed to delay launching a generic Gleevec until Feb. 1, 2015, the suit says.

Power disagrees, saying the settlement was a lawful agreement resolving the patent challenge by Sun.

Gleevec costs about $9,000 per month and has grossed Novartis more than $13.5 billion in U.S. sales, says Thomas Sobol, a partner with Hagens Berman, which represents the plaintiffs.

The suit, United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund, et al. v. Novartis Pharmaceuticals Corp., et al., was filed in U.S. District Court for the District of Massachusetts. The case is assigned to Judge Allison Burroughs. — Jonathon Shacat