US Supreme Court denies Teva's petition to delay release of generic Copaxone

By Staff Reporter | Apr 21, 2014 03:33 PM EDT

Teva Pharmaceutical Industries Ltd has failed in court recently wen the US Supreme Court has rejected its bid to ban the access of the generic versions of its lucrative multiple-sclerosis drug. The decision was handed out in the middle of a patent clash appeal also by the pharmaceutical company. Chief Justice John Roberts' decision over the release of the generic versions by Mylan Inc, Momenta Pharmaceuticals Inc and Novartis AG's Sandoz could ultimately hurt Teva to a great degree once the drugs will debut on the market as soon as next month. Bloomberg noted that Copaxone has hauled in $3.2 billion in US sales annually for Teva, and accounts for over a half of its profit.

Sandoz is expected to sell its generic version of Copaxone in late May, while Momenta and Sandoz are working together on the drug's generic version.

Bloomberg said that if Roberts handed a more favorable decision, Teva would have time to switch patients of the drug from the 20-milligram dose to a 40-milligram does it has claimed to be covered by its other patents. Moreover, Teva has the option to ask another justice to intervene with the decision. As by custom, the news agency said that the application will then go to the full court for consideration. In a statement released today, the Petach Tikva, Israel-based company has expressed its intent to defend its intellectual property and will continue to pursue an appeal.

Mylan Chief Executive Officer Heather Bresch said in a statement, "We are pleased with the chief justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. Food and Drug Administration on May 25."

Bloomberg said that the Teva patent at issue will enable the company to shield its prized product from competition until September next year. According to a federal appeals court, the patent was invalid as it did not clearly outlin what Teva had claimed to have invented. On March 31, The Supreme Court had agreed to hear Teva's appeal on the decision. By then, Teva has asked Roberts to issue a halt on the appeals court decision and block generic versions of the drug to enter the market while the case is still ongoing.

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