Novartis Pharmaceuticals Corporation moved the District Court of Delaware, US against city-based Dr Reddy’s Laboratories Ltd (DRL) for alleged infringement of its patents.
According to Novartis, DRL filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for approval to market generic versions of Novartis’ Gleevec 100 mg imatinib mesylate capsules.
Novartis said, DRL in a letter on February 24, notified Novartis that it had submitted an ANDA seeking FDA’s approval to engage in the commercial manufacture, use and sale of oral capsules containing 100 mg of imatinib mesylate, imatinib mesylate oral capsules and EQ 100 mg Base, prior to the expiration of its patents.
DRL also notified Novartis that its ANDA contained a “paragraph IV certification” that in DRL’s opinion, the RE932 patent is invalid, unenforceable or will not be infringed by the manufacture, use, sale, or offer to sell of DRL’s Imatinib Mesylate ANDA capsules.
Novartis holds an approved New Drug Application for Gleevec oral capsules containing 50 mg and 100 mg imatinib mesylate, which was approved by the FDA on May 10, 2001. The 50 mg Gleevec capsules were discontinued in 2003 and the 100 mg capsules were discontinued in 2005.
Novarits also holds approved NDA for Gleevec tablets containing 100 mg and 400 mg imatinib mesylate, which was approved by the FDA on April 18, 2003.
“Novartis will be substantially and irreparably damaged and harmed if DRL’s infringement is not enjoined. Novartis does not have an adequate remedy at law,” Novartis said in the suit filed on March 26.
It added that an approval to engage DRL in the commercial manufacture, use, offer to sell or sale of its imatinib mesylate ANDA capsules, prior to the expiration of the patents, constitutes infringement of one or more of the claims of that patents.