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 (paricalcitol) is a drug used for the prevention and treatment of secondary hyper-parathyroidism (excessive secretion of parathyroid hormone) 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 the District of Delaware.
When contacted, a DRL spokesperson declined to comment on the matter.
However, patent lawyers told FE 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 under paragraph IV with the US Food and Drug Administration. 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 into the market or block its entry, depending on the merits of the case.
According to AbbVie’s petition, on May 20, 2013, it received letters from DRL notifying that the Indian drug maker had filed an ANDA containing a paragraph IV certification for Zemplar. The letter also stated that, in DRL’s opinion, the patents-in-suit are invalid, unenforceable, or will not be infringed by the commercial manufacture, use, or sale of the generic Zemplar products.
The American drug manufacturer requested the US 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 prior to the expiration of the said patents.
DRL filed an ANDA with the USFDA seeking approval to sell a generic copy of US drug maker’s Zemplar injectable products in 2 microgram/ml and 5 microgram/ml formulations, prior to the expiration of the patents owned by