Sunday, April 7, 2013

Is Novartis trying to delay Glivec Generics in the US?

In its latest 20-F 2012 Novartis has announced that they have got new patents issued on Glivec.
Additional patents have been granted on Glivec in more than 40 countries including the US, Japan, France, Germany, UK, Italy and Spain, claiming innovative features of Gleevec/Glivec , including crystal form (expiry 2018), tablet formulation (expiry 2023) and process (expiry 2023). 
Novartis had applied for delisting of the patent 7544799, which has been replaced with a fresh patent  RE43932.

Novartis may litigate generic companies on the ground of infringment of these new patents, in case generics are launched post expiry of the compound patent in 2016 without either proving invalidity or non-infringment on these these new patents.

India based Sun Pharma has filed a Para-IV on Glivec and is supposed to have first to file status. Sun was not litigated by Novartis when they first filed their Para-IV application.  

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