DRL sued in US over kidney drug patents

US-based drug maker AbbVie,the biopharmaceutical entity spun out from Abbott Laboratories,has dragged the Hyderabad-based Dr Reddy’s Laboratories (DRL) to a US court for allegedly infringing on its patented drug Zemplar on six counts concerning three patents. Zemplar is a drug used for the prevention and treatment of secondary hyper-parathyroidism associated with chronic renal failure.

“DRL committed an act of infringement by filing an ANDA (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,” said a petition filed by AbbVie along with Wisconsin Alumni Research Foundation in the US District Court for Delaware.

When contacted,a DRL spokesperson declined to comment on the matter.

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However,patent lawyers said that this is a routine process under US laws. When a generic company wants to launch a copycat version of a patented drug in the US market,it has to file an ANDA with the US FDA. It also has to claim that the generic drug does not infringe on the patent or the patent is invalid.

The generic player then informs the innovator company about its ANDA filing and gives the patent holder 45 days to sue the copycat company with an infringement lawsuit. This triggers a 30-month stay on US FDA action on the ANDA. The court then decides whether to allow the copycat version or block its entry.