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UK court upholds Teva’s patent on Copaxone

Dismisses challenge from Mylan

Teva Copaxone

Teva received good news this week with the decision by a UK court to uphold the company's patent for multiple scleroris (MS) treatment Copaxone.

The Court of Appeal for England and Wales agreed with an earlier decision by the UK's High Court to defend the patent for Copaxone (glatiramer acetate injection) after its validity was challenged by Mylan.

Mylan, through its subsidiary Generics [UK], had applied to revoked Teva's patent for Copaxone, which is approved to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis, in order to market its own generic version.

Following the two court decisions, any generic launch in the UK seems unlikely to happen until May 2015, when the patent for Copaxone expires.

“Thousands of patients in the UK and elsewhere depend on Copaxone for relief in relapsing-remitting multiple sclerosis, and we are pleased that the English Court of Appeal has upheld the validity of the patent until its expiry in 2015,” said Teva's president and CEO Dr Jeremy Levin.

Teva, which primarily focuses on generics itself, will be keen to make the most of Copaxone, which is its leading innovative product, taking in nearly $4bn in 2012.

Times are tough for the drug, however, due to the looming patent expiry in 2015, as well as competition from oral drugs such as Novartis' Gilenya (fingolimod), causing the company to restructure its organisation to cope with declining revenues.

The UK patent decision will offer some brief respite for the company, but the overall picture is less positive, with the US District Court for the Southern District of New York dismissing claims that Mylan was in breach of four of Teva's patents covering Copaxone.

Mylan is also appealing an earlier court decision to uphold nine patents held by Teva on Copaxone, stating that if it were successful, it would be "clear … for launch upon receipt of final regulatory approval”.

31st July 2013

From: Sales, Regulatory



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