US Supreme Court turns down Teva's bid to block Mylan's generic Copaxone

19 Apr 2014

A US Supreme Court judge has rejected a bid by Teva Pharmaceutical Industries Ltd to block generic versions of its Copaxone multiple-sclerosis drug, as the company's appeal was being heard over a patent clash.

The rejection by chief justice John Roberts opens up generic competition for Teva as early as next month.

Mylan Inc, Momenta Pharmaceuticals Inc and Novartis AG's Sandoz would start sales of generic Copaxone in late May, although they would risk payment of damages in case of Teva ultimately winning its patent-infringement case.

Meanwhile a generic version of the drug is being jointly developed by Momenta and Sandoz.

Copaxone accounted for $3.2 billion in annual US sales and accounts for over half of Teva's profit.

With a delay, Teva would get more time to switch patients from the 20-milligram dose that was the subject of the legal fight to a 40-milligram version that, according to the company was covered by other patents.

Teva still had the option of asking for the intervention of another justice, and by custom the application would then go to the full court for consideration.

Roberts said in a one-paragraph opinion that a court-ordered delay was not necessary as Teva could recover damages for infringement if it won the case.

Meanwhile, Mylan Inc announced that Supreme Court chief justice Roberts had turned down Teva's application for an injunction against Mylan's launch of a generic version of Copaxone pending the Supreme Court's decision on Teva's appeal.

RTT News quoted Mylan CEO Heather Bresch as saying the company looked forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the US at market formation. She added, Mylan remained eligible to receive approval from the US Food and Drug Administration on 25 May 2014.

Mylan noted that this was the second instance of the chief justice denying Teva's request for such an injunction.