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 AbbVies 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 AbbVies 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 DRLs 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 DRLs 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 makers 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.
Indian companies have developed a paragraph IV pipeline in order to be part of the large expiring product basket In fact, DRL has filed about 38 paragraph IV applications with the US regulator and eight first-to-file as on March 31, 2013.
According to AbbVies annual report for 2012, it has clocked $383 million from Zemplar sales including $230 million from the US.
Two patents (numbers 799 and 758) that originally belonged to Abbott were subsequently transferred to AbbVie. These two patents will expire on April 8, 2018. Wisconsin Alumni Research Foundation holds the rights for patent number 815, which will expire on July 13, 2015, AbbVie informed the court in the petition.