US firm slaps patent suit on Dr Reddy's
US-based AbbVie Inc has slapped patent infringement suit against Dr Reddy's Laboratories Limited alleging...
US-based AbbVie Inc has slapped patent infringement suit against Dr Reddy's Laboratories Limited alleging that the city-based drug maker had infringed on three patents of its drug Zemplar on six counts. AbbVie along with Wisconsin Alumni Research Foundation filed a petition in this regard at the US District Court for the District of Delaware on June 6. Zemplar (Paricalcitol) is a drug used for the prevention and treatment of secondary hyperparathyroidism (excessive secretion of parathyroid hormone) associated with chronic renal failure.
"DRL committed an act of infringement by filing an Abbreviated New Drug Application with a Paragraph IV Certification that seeks FDA-marketing approval for DRL generic versions of AbbVie's paricalcitol injection products prior to expiration of the patents-in-suit," the company said in the petition.
The Chicago-based pharma firm has requested the court to pass an order to restrain DRL from commercially manufacturing, using, offering for sale, selling, marketing, distributing, or importing DRL's generic paricalcitol injectable products before the expiration of said patents. Dr Reddy's filed an ANDA with the US Food and Drug Administration, seeking approval to sell a generic copy of Zemplar injectable products in 2 microgram/ml and 5 microgram/ml formulations, prior to the expiration of the patents owned by and exclusively licensed to the complainants, the petition said.
AbbVie, in its annual report 2012, said it generated $383 million from Zemplar sales including $230 from the US. Two patents (799 and 758) will expire on April 8, 2018.Wisconsin Alumni research foundation holds the rights for patent no. 815, which will expire on July 13, 2015.
"DRL has committed and will commit acts of infringement of the patents-in-suit that create a justiciable case or controversy between plaintiffs and DRL," the petitioners alleged.