In yet another patent infringment suit, Dr Reddy’s Laboratories Ltd was dragged to court, by Purdue Pharma LP, which filed a petition in New Jersey Federal Court for alleged infringement of its insomnia drug — Intermezzo.
Stanford, Conn-based Purdue’s Intermezzo consists of tablets containing 1.75 mg and 3.5 mg of zolpidem tartrate. The US Food and Drug Administration (US FDA) gave its approval for the drug in November, 2011.
As per the complaint, DRL in February filed its abbreviated new drug application with the US FDA that includes Paragraph IV certifications saying that its product wouldn’t violate Purdue’s patents or that those patents are invalid.
The suit involves three patents held by Transcept Pharmaceuticals Inc and exclusively licensed to Purdue for an under-the-tongue sleep aid that targets middle-of-the-night awakenings.
“Dr. Reddy’s has infringed the ’809 Patent under 35 U.S.C. 271(e)(2)(A) by virtue of submitting ANDA No. 204503 with a paragraph IV certification and seeking FDA approval of ANDA No. 204503 to market a generic version of Intermezzo® prior to the expiration of the ’809 Patent,” Purdue said in its complaint dated April 7.
Last year, DRL was dragged to court by US-based Bristol-Myers over its cancer drug Ixempra. Besides it also contested multiple suits including those filed by Pozen regarding a generic version of arthritic drug Vimovo, Takeda of Japan over patent infringement of its gastrointestinal drug Dexilant and Roche Palo ALTO LLC and Helsinn Healthcare SA’s patent litigation suit for anti-nausea drug Aloxi.
In August, 2012, DRL lost a litigation suit for migrane drug Treximet filed by North Carolina-based Pozen Inc, way back in 2009.