A class-action lawsuit filed against Novartis alleges that the pharma company’s patent infringement suit against generic company Sun Pharma was a sham. The suit further alleges that the Novartis obtained patent at issue through fraud on the Patent and Trademark Office.
The lawsuit, filed June 22, 2015 in the U.S. District Court for the district of Massachusetts, seek recovery for 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 expired 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 had been tentatively approved by the FDA before July 4, 2015. Sun's generic launched in February 2016.
The suit calls Novartis’ efforts to delay generic Gleevec “patent gamesmanship and frivolous litigation.”
The suit names two end payers as plaintiffs and has been filed on behalf of a class of all purchasers of Gleevec.
Although the district court dismiss the suit in June 2017, and the First Circuit affirmed dismissal in August 2018, the plaintiffs are now seeking re-hearing.
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