Friday, September 09, 2011
We had in two previous posts (here and here) informed our readers about NATCO's compulsory license (CL) application for Bayer's drug Nexavar. The actual application for grant of the license is now available here. This post looks in detail at the specific grounds taken in the CL application and does not cover any other material. Biospectrum Asia edition has carried an excellent piece on this CL application and has included comments from officials from Bayer, NATCO and our very own, Shamnad.
In India, the drug Nexavar is patented (Indian patent #: 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 PCT application number PCT/US00/00648 and has a priority date of 01/13/1999. Interestingly, the PCT site for this application under the ‘National Phase’ tab shows that Korea 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 which is published and the other granted.
The Indian CL application: NATCO’s CL application starts by stating its capability, experience and expertise in manufacturing and development of anti-cancer drugs. The CL application then describes that the patent 215758 covers an active ingredient ‘Sorafenib’. Bayer manufactures Sorafenib under the brand Nexavar and that Nexavar is used to treat primary kidney and advanced primary liver cancer. The Nexavar cost of therapy is stated to be Rs. 280428.00 per month. The CL application then details facts about 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 different forms of renal cell and hepatic cell carcinoma and 30000 patients are added to the patient pool every year. Over 24000 patients die in India every year on account of these diseases. Various treatment options are then described including the treatment by Sorafenib. Physicians prescribe Sorafenib @800mg per day which translates to 4 tablets per day (400mg tabletsX2) at a cost of Rs. 280428.00 per month and that the patient has to pay the entire amount from his pocket.
NATCO then argues that Sorafenib had a limited availability in India as it was entirely imported and it was only available in major cities (Delhi, Mumbai, Kolkata, Chennai) at pharmacies attached to large hospitals. The distributors of Sorafenib were in Delhi, UP, Punjab, Gujarat, West Bengal, Bihar, Kerala and Tamil Nadu to the exclusion of all other states and territories. The applicant specifically stated that Sorafenib reaches less than 1% of the patients and that 99% of the patients who are unable to afford the drug are left to die (because of the non-availability). NATCO has also stated in the application that the drug is considered to be expensive even by US ($4300/month) and UK (GBP2900) standards.
The application then stated that the requirements of section 84 had been met: More than 3 years have elapsed since the grant of the patent (03/03/2008) and yet Bayer had not taken adequate steps to manufacture the invention in India; and that a prima facie case of reasonable requirements of the public not being met is made because of unavailability (access and price).
The application concludes by stating that NATCO has existing capability to manufacture Sorafenib; NATCO has approval from Drug Controller General of India for manufacturing and marketing Sorafenib; efforts to secure a voluntary license had failed; and NATCO also had a patent on the process of manufacturing Sorafenib. NATCO’s stated capability is 2Million tablets a day whereas there was a requirement of 480K/month and that NATCO could supply the tablet @Rs.74/tablet working out to Rs.8800.00/month and that NATCO was willing to provide the tablet free of cost to patients who could not even afford the proposed price (74/tablet). NATCO has also specifically stated that in case a CL is granted, it would not export Sorafenib to other countries and that the CL would be limited to India.
Conclusion: In my opinion, this is a textbook case for grant of a CL. But that said it also reasons that Bayer may itself reduce the prices of Nexavar rendering the issue of nonavailability moot. It may even grant a license to another generic manufacturer in India to produce Sorafenib thereby addressing the concerns in NATCO's CL application.