HYDERABAD: Tokyo-based Otsuka Pharmaceutical Co., Ltd dragged Aurobindo Pharma Ltd (APL) and its two subsidiaries — Aurobindo Pharma USA, INC. and Aurolife Pharma LLC — to the US District Court of New Jersey over alleged infringement of patents.
According to Otsuka’s petition, Aurobindo infringed patents pertaining to aripiprazole tablets, which it sells under the brand Abilify in the US.
Aurobindo allegedly infringed patents on three counts filing ANDAs with the US FDA to manufacture, use, sale, offer to sell and import generic low hygroscopic aripiprazole drug substance and processes of patent numbers 615, 796 and 760 before their expiration.
“This is an action for patent infringement under the US patent laws,” Otsuka said in its petition filed on May 26.
While patent 615 is set to expire on December 16, 2024 (including pediatric exclusivity), both patent 796 and 790 are set to expire on March 25, 2023 (including pediatric exclusivity).
Otsuka urged the Court to enjoin Aurobindo from seeking, obtaining or maintaining approval for patents 615, 796 and 760.
It also requested the court to enter into a judgement that Aurobindo has infringed at least one claim of each of the patents 615, 796 and 760 by submitting respective ANDAs to the FDA to obtain approval to manufacture, use, sale, offer to sell and import Aurobindo’s generic products in the US before the expiry of the patents.