Aurobindo Pharma Ltd has been sued by The Medicines Co in the United States district court of New Jersey for alleged infringement of patents of its heart drug, Angiomax, according to court documents on April 11. The drug had registered a sale of $608.6 million in 2013 and accounted for approximately 88% of the company?s net revenue.
Aurobindo had filed for the approval of 250 mg vial of generic Angiomax, chemically known as bivalirudin, with the US Food and Drug Administration. The lawsuit says the abbreviated new drug application (ANDA) infringes on two patents held by Medicines Co, 727 and 343. The 727 patent was issued on September 2009 and the 343 patent was allowed in October 2009.
Angiomax prevents creation of blood clots during angioplasty.
The principal US patents covering Angiomax include the patent 404, 727 and 343. The patent 404 covers the composition of matter of Angiomax. The patent 404 will expire in March 2010, but the term was extended to December 15, 2014, by the US Patent and Trademark Office.
The patent 727 and the patent 343 will expire in July 2028 and are entitled to a six-month period of pediatric exclusivity following expiration of the patents, Medicines Co said in an SEC filing.
This is not the first instance of a company challenging the ‘727 and ‘343 patents. In September 2011, the company settled a patent infringement lawsuit with Teva Pharmaceutical Industries while it settled another lawsuit with privately-held APP Pharmaceuticals in January 2012.
