In the high profile patent tussle on multiple sclerosis drug Copaxone, for which Natco has a first to file status, the US Supreme Court has favored Teva. It's a ruling that will delay entry of generics in the market.
US supreme court has suggested that Appeals court did not use the right approach in analyzing whether Teva's September 2015 patent is valid or not.
In 2013 The US Appeals court had ruled that Teva's patent was invalid and had cut off 16 months of patent protection, opening mkt for generic entry.
Teva had, however, contested that order. And now SC has vacated Appeals Court decision and sent the case back to Federal court for further review.
The current ruling extends legal tussle and delays approval and entry of generics till September.
Copaxone clocks in USD 4.3 bn in annual sales for Teva. Sandoz-Momenta and Natco-Mylan have six months exclusivity on Copaxone generic. Natco has a supply deal with Mylan for the drug and this is a sizeable opportunity for Natco.
The delay also allows Teva to shift patients to a new & stronger version of Copaxone, so analysts say even when generics enter, post September 2015, it will be a tough market.
The ruling also impacts, Dr Reddy's that also filed for generic version of Copaxone and awaits to launch post 180 days.
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