Novartis sues Intas for patent infringement in US

Claims that Intas has sought US FDA's nod to sell generic version of immunosupressant drug before Novartis' patent expired

Swiss drugmaker Novartis AG has sued Ahmedabad-based Intas Pharmaceuticals Ltd for patent infringement over its immunosupressant drug Myfortic.

Novartis claimed that Intas has sought the US drug regulator's approval to sell the generic version of the drug before Novartis' patent expired.

In a filing before the federal court in Washington Novartis has sought to block Intas Pharma and its US unit Accord Healthcare Inc from importing and selling the generic version of Myfortic in the US until the former's patent expire in April 2017.

The drug is used to treat patients who have had kidney transplants.

An Intas Pharmaceutical official refused to comment on the case, but added that such legal battles are fought usually to gain the 180-day exclusivity period for sale of a patented drug which is nearing expiry.

An industry insider explained, "Any company wishing to sell the generic version of a patented drug has to file an abbreviated new drug application (ANDA) before the US Food and Drug Administration (USFDA) at the earliest possible date. Those first in the queue to gain approval receive a 180-day exclusivity period to sell their version of the drug." He added that any innovator company's first reaction to such a filing would be move court on grounds of patent infringement, and a legal battle follows.

In this particular case, Novartis has alleged that its patents were violated when Intas sought to manufacture and sell generic Myfortic in strengths of 180 mg delayed release tablets claiming that Novastis' patents are invalid.