The U.S. District Court for the District of New Jersey has ruled in United Therapeutics Corporation‘s favor in the company’s case against Sandoz, regarding United Therapeutics’ Remodulin product.
First approved in the United States in May 2002, Remodulin is a prostacyclin vasodilator used for the treatment of pulmonary arterial hypertension. The therapy is typically used to decrease symptoms associated with exercise. In patients with PAH, Remodulin is indicated to diminish the rate of clinical deterioration. Since it is considered a specialty medication for a rare, orphan disease, a 20 ml dose of Remodulin may cost over $6,000. The high price point of the drug has therefore made it an attractive target for generic drug manufacturers, who would like to produce a generic form of Remodulin and undercut United Therapeutics’ leading name-brand version of the drug — a gambit that Sandoz recently attempted, and that UT moved to block in the courts.
The court’s decision will now prevent Sandoz, Novartis’ generic pharmaceuticals division, from selling a generic version of United Therapeutics’ best-selling Remodulin hypertension drug, until the expiration of the drug’s patent, in October 2017.
Judge Peter Sheridan, who decided that U.S. Patent No. 6,765,117 is both valid and enforceable against Sandoz, considered the Novartis’ company did not sufficiently prove that this patent was invalid, adding that it was likely that generic sales by Sandoz would infringe on the patent.
On the other hand, the court ruled that Sandoz’s version of Remodulin did not infringe on another patent, no. 7,999,007, covering United Therapeutics’ Remodulin, which is set to expire in 2029. United Therapeutics may, however, appeal this ruling to the U.S. Court of Appeals for the Federal Circuit.