Anatomy of NATCO’s compulsory license application

SPICY IP:

We had in two previous posts (here and here)informed our readers about NATCO’s compulsory license (CL) application forBayer’s drug Nexavar.  The actual application for grant of the license isnow available here. This post looks in detail at the specific grounds taken in the CLapplication and does not cover any other material.  Biospectrum Asia edition has carried anexcellent piece onthis CL application and has included comments from officials from Bayer, NATCOand our very own, Shamnad. 

In India, the drug Nexavar is patented (Indianpatent #: 215758; available at our patent office website) by Bayer Inc.,USA. NATCO filed the application under section 84(1).  The patent in India claims priority to PCTapplication number PCT/US00/00648and has a priority date of 01/12/2000.  Interestingly,the PCT site for this application under the ‘National Phase’ tab shows thatKorea has in one family member of this patent refused to grant a patent. At the same time, two other family members also exist and one of whichis published and the other granted. 

The Indian CL application:  NATCO’s CL application starts by stating itscapability, experience and expertise in manufacturing and development ofanti-cancer drugs.  The CL applicationthen describes that the patent 215758 covers an active ingredient ‘Sorafenib’.  Bayer manufactures Sorafenib under the brandNexavar and that Nexavar is used to treat primary kidney and advanced primaryliver cancer.  The Nexavar cost of therapyis stated to be Rs. 280428.00 per month.  The CL application then details factsabout Hepatocellular Carcinoma (stats related to occurrence and survival rate);and facts related to renal cell carcinoma. There are at least 100000 patients in India suffering from differentforms of renal cell and hepatic cell carcinoma and 30000 patients are added tothe patient pool every year.  Over 24000patients die in India every year on account of these diseases.  Various treatment options are then describedincluding the treatment by