Sandoz barred from making Remodulin generic until 2017

Novartis’s generic arm Sandoz may not market a generic version of Maryland-based United Therapeutics’ Remodulin (treprostinil) hypertension drug, the US District Court for the District of New Jersey ruled on Friday (August 29).

Judge Peter Sheridan said that the 6,765,117 patent, which covers a process for preparing certain compounds, is both valid and enforceable, and that Sandoz may not make a generic version of Remodulin until the patent expires in October 2017.

He also upheld United’s 7,999,007 patent, another patent that covers Remodulin and is due to expire in 2029, but found that Sandoz’s proposed generic product would not infringe it.

Reuters reported that Sheridan found Sandoz did not prove sufficiently that the ’117 patent was invalid, and added that it was more likely than not that generic sales by Sandoz would infringe the patent.

United Therapeutics’ chief executive Martine Rothblatt said on Friday: “We are pleased with the court’s ruling today confirming the validity and enforceability of the ’117 patent.

“We have always emphasised our investment in scientific advances and the resulting intellectual property that allows us to bring our products to patients, and this decision is a validation of that emphasis.”

United Therapeutics said that it is analysing the court opinion and assessing its steps with respect to the ’007 patent, which may include an appeal to the US Court of Appeals for the Federal Circuit.

Remodulin is an injection used to treat pulmonary arterial hypertension. In the six months to June 30, it generated net sales of $605 million.

Sandoz filed for an Abbreviated New Drug Application with the US Food and Drug Administration for approval to make and sell a generic version of Remodulin in 2011. In the same year it filed for summary judgment from the court that the ’117 patent was invalid, arguing that it had allegedly been previously disclosed in another patent application that was filed in 1985.