Novartis statement on Gleevec patent lawsuit

"We believe these claims are unsubstantiated.  The patents covering Gleevec remain legally in force and are covered by a statutory presumption of validity. The patents are clearly directed to our marketed product and are properly listed in the FDA's Orange Book and the settlement with Sun is a lawful settlement agreement resolving the declaratory judgement action filed by Sun challenging the validity of one of the Gleevec patents. We will vigorously defend our patent rights and litigate these improper allegations.

In May 2014, Novartis Pharmaceuticals Corporation settled its litigation with the United States subsidiary of Sun Pharmaceutical Industries Ltd. relating to Novartis patents covering the use of certain polymorphic forms of Gleevec® (imatinib mesylate), which expire in 2019 (including pediatric exclusivity). The basic compound patent for Gleevec expires in the U.S. on July 4, 2015.  As a result of the settlement, Novartis will permit Sun Pharma's subsidiary to market a generic version of Gleevec in the United States on February 1, 2016.

Patents are vital to the ability of innovative companies like Novartis to invest in high-risk research to advance breakthrough treatments for patients without treatment options. This settlement validates the Novartis patents while allowing Sun Pharma's subsidiary to enter the market with its generic product."

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