HYDERABAD: Japanese firm Shionogi Inc has dragged Aurobindo Pharma Ltd (APL) to the US District Court of Illionois allegedly for infringing its patent.
As per a petition filed by Shionogi, Aurobindo sought approval from the USFDA to sell a generic version of Shionogi’s doripenem for injection - marketed under brand name Doribax - in the US market prior to the expiration of the original patent.
Doribax is a prescription drug used as an antibacterial agent. According to Shionogi, in August, 2012, the US Patent and Trademark Office had legally issued patents entitled ‘Crystal Form of Pyrrolidylthiocarbapenem Derivative’, and continues to hold all substantial rights.
It also said Shionogi holds the New Drug Application approved by the FDA for the marketing and sale of doripenem for injection, 250 mg/vial and 500 mg/vial.
As per Aurobindo ANDA filing, it sought FDA approval to engage in the commercial manufacture, use, offer for sale, and sale of a generic version of doripenem for injection. “Aurobindo’s submission of the Aurobindo ANDA including a paragraph IV certification constitutes infringement of one or more claims of the ’402 patent, either literally or under the doctrine of equivalents”, it said.