Sun Pharma loses generic challenge in US court

Sun Pharmaceutical Industries has lost an opportunity to launch the generic version of a schizophrenia drug that had generated revenue of $4 billion (Rs 18,150 crore) in the United States market in 2009. It, with some other generic drug majors, lost a patent battle against Japanese drug major Otsuka and its US business partner, Bristol Myers Squibb (BMS), last week.

A favourable decision in this regard would have seen the company launching a low-cost version of Abilify (aripiprazole), during the year. The district court of New Jersey had ruled last week that Abilify had patent protection and exclusive marketing rights till 2015.

A Sun Pharma spokesperson said the company was yet to decide if it should appeal to a higher court. It was among a handful of generic drug manufacturers, including Israel’s Teva Pharmaceuticals and Swiss drug maker Novartis’ generic arm, Sandoz, that had filed a patent suit on the drug in the US court.

For BMS, which holds marketing rights for the drug in US and Europe, the decision has been very positive. Abilify is the sixth-biggest selling drug in the US.

Sun Pharma said the setback would not have much impact on its US fortunes, given its significant win, the biggest legal one for any Indian pharma company, in invalidating the innovator patent in yet another product (gemcitabine) recently.

“We not only won in the lower court but also in the appeal court. Even the request for review of appeal by Eli Lilly was denied by the court...No Indian pharma company, except us, has invalidated an innovator patent at the appeal stage, fighting the litigation alone,” the spokesperson said.

Sun was expected to launch its version of gemcitabine, a cancer medicine, in the US market this month. Eli Lilly markets it under the Gemzar brand name. It is one of the largest selling drugs for that company.