A U.S. Supreme Court justice refused to block a ruling that would open Teva Pharmaceutical Industries Ltd.’s Copaxone multiple-sclerosis drug to generic competition in May.
The lower court ruling invalidated one of the company’s patents and shaved more than a year off the legal protection for Copaxone, a treatment that generated $2.25 billion in U.S. sales for Teva in 2011. Chief Justice John Roberts today rejected Teva’s request to put that ruling on hold while the court decides whether to take up Teva’s appeal.
The rebuff is a victory for the generic-drug makers challenging the Teva patents. Those include Momenta Pharmaceuticals Inc., which is developing a generic version with Novartis AG’s Sandoz, and Mylan Inc., which has said it expects to be on the market in May.
Teva, based in Petach Tikva, Israel, said in court papers that it would suffer “irreparable injury” if the lower court ruling remained in effect. Even if the court were to take up the company’s appeal, review wouldn’t take place until the nine-month term that starts in October 2014, Teva said.
“Because the key Teva patent that the Federal Circuit invalidated will expire in September 2015, proceedings on the merits in this court could easily consume most of the remaining life of the patent,” the company argued.
The generic-drug companies said the case would have been eligible for the court’s current calendar had Teva moved more quickly after the July 26 appeals court decision.
Competition “would greatly benefit multiple-sclerosis patients, who pay about $40,000 per year for Copaxone,” the companies argued.
Multiple sclerosis causes the immune system to attack the insulating tissue around nerve fibers. It stops nerve cells from sending signals, sapping patients’ energy, blurring their vision and slowly depriving them of mobility, balance and coordination. Copaxone is an injection designed to work with the body’s immune system to cut relapses of the disease.
The case is Teva v. Sandoz, 13A458.