Japanese pharma major Teijin Ltd and Takeda Pharmaceutical USA Inc together dragged city-based Dr Reddy’s Laboratories Ltd (DRL) to a US court allegedly for infringing their patent.
According to a suit filed with the District Court of Delaware, US, DRL infringed the ’474 patent — febuxostat — submitting an ANDA with the FDA seeking its approval to engage in the commercial manufacture, use, sale, or offer for sale of tablets containing 40 and 80 mg of febuxostat prior to patent expiration. Febuxostat is used for chronic management of hyperuricemia in patients with gout.
Takeda holds a new drug application for oral tablets containing 40 or 80 mg of febuxostat and also markets and sells these tablets in the US under the brand name — Uloric.
“...Pursuant to 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act, DRL certified in ANDA No. 205374 that the claims of the ’474 patent are invalid, unenforceable, or would not be infringed by the commercial manufacture, use, sale, or offer for sale of the DRL Generic Product,” the court report said.
It added that DRL was aware of the existence of the ’474 patent and was aware that the filing of its ANDA and a related certification constitutes an act of infringement. “...The effective date of any approval of DRL’s ANDA shall not be earlier than the expiration of the 474 patent including any applicable exclusivities or extensions,” it said.
“...DRL’s submission of ANDA No. 205374 to the FDA, including its 505(j)(2)(A)(vii)(IV) certification, constituted infringement of the ’474 patent under 35 U.S.C. 271(e)(2)(A),” it said adding that the commercial manufacture, use, offer to sell, sale or import of the DRL generic, if approved by the FDA, prior to the expiration of the 474 patent, would amount to infringement.
“...The effective date of the approval of DRL’s ANDA...be a date that is not earlier than the expiration of the patent term including any extension granted by the USPTO...” it said.
It may be mentioned that in 2011, Takeda had earlier filed a patent infringement suit against DRL over the latter’s efforts to manufacture a generic version of acid reflux treatment drug Dexilant (Dexlansoprazole).