HYDERABAD: Basel-headquartered Novartis Pharmaceuticals Corporation and Novartis AG dragged Dr Reddy’s Laboratories Ltd (DRL) and its US subsidiary Dr Reddy’s Laboratories Inc to the US court over alleged patent infringement.
As per Novartis’ petition filed on August 20 at the District Court of Delaware, DRL infringed its patents pertaining to the generic version of its anti-cancer drug -- Gleevec.
“DRL’s commercial manufacture, use, offer to sell or sale of its Imatinib Mesylate ANDA Tablets, prior to the expiration of the ’051 Patent and the RE932 Patent, would constitute infringement of the ’051 Patent and the RE932 Patent under 35 U.S.C. § 271,” Novartis said adding that the company will be substantially and irreparably damaged and harmed if DRL’s infringement is not enjoined.
According to Novartis, DRL sought the FDA’s approval to manufacture, use, offer to sell or sale of bioequivalents of Novartis’ 100 mg and 400 mg imatinib mesylate Gleevec® tablets prior to their expiration of patents.
It urged the Court to issue a judgment and decree that the ’051 Patent and the RE932 Patent are valid and enforceable and declare that DRL’s making, using, sell ing, offering to sell or importing its Imatinib Mesylate ANDA Tablets will infringe the ’051 Patent and the RE932 patent.
It also sought a judgment permanently enjoining DRL from making, using, selling, offering to sell, or importing its Imatinib Mesylate ANDA tablets until after expiration the said patents besides seeking damages resulting from such infringement.
It may be noted that early this year, Novartis filed a similar suit against DRL for submitting 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.