Generic-drug makers including Momenta Pharmaceuticals Inc. urged the U.S. Supreme Court to let them introduce generic versions of Teva Pharmaceutical Industries Ltd.’s Copaxone multiple-sclerosis drug next month.
In a court filing today, Momenta, Novartis AG’s Sandoz and Mylan Inc. said they would suffer “immense harm” if barred from selling generic Copaxone in the U.S. after some of the drug’s patents expire May 24.
Teva is asking Chief Justice John Roberts to block generic Copaxone while the high court considers a case involving a different patent claim that may shield Copaxone from competition until September 2015.
Momenta, Sandoz and Mylan haven’t explicitly said whether they will press ahead with plans to sell generic Copaxone while the Supreme Court fight plays out. They suggested in today’s filing that they would do so, though they didn’t say so directly.
The companies said a Supreme Court order blocking generic versions would in effect “decide this litigation for Teva” by giving it time to switch patients from a 20-milligram dose to a 40-milligram version covered by other patents before any generic competition begins.
Copaxone brings in $3.2 billion in annual U.S. sales and accounts for more than half of Teva’s profit. Should the generic-drug companies start selling their versions in May, they would be at risk of having to pay Teva for its lost profit in the event that company ultimately wins the case.
Momenta has developed a generic version of Copaxone with Sandoz, and Mylan is planning its own version.
A federal appeals court last year threw out the disputed Teva patent, saying it didn’t clearly outline what the company claimed was invented.
In November, Roberts refused to put the appeals court ruling on hold while the justices decided whether to take up Teva’s appeal. The Supreme Court later agreed to hear the case, putting it on a timeline to be resolved early next year.
Roberts handles emergency matters from the appeals court that handled the Copaxone case. Roberts can either act on the Teva request himself or refer it to the full nine-member court.
The case is Teva v. Sandoz, 13-854.