India – prices of patented medicines and compulsory licence test case

UPDATE ON APPLICATION U/S 84 OF THE INDIAN PATENT LAW FOR GENERIC PRODUCTION OF PATENTED CANCER DRUG  –  SORAFENIB TOSYLATE

Background – Changes in price due to the introduction of product patent regime are starting to be experienced in India. This is because the first set of drugs under patent monopoly have entered the Indian market. The price levels of these patented medicines are very high. Peg interferon alphas used in the treatment of Hepatitis C and some cancers are patented in India – both versions alpha 2a and alpha 2b are patented by Roche and Schering- Plough respectively and are excessively high. Click here to see price information on peg interferon.

 Thirdline AIDS medicines patented in India such as raltegravir are expensive even at discounted rates, cost a person living with HIV Rs. 1,20,276 ($2672 USD) per year. Patented cancer drugs are equally expensive. According to data from the Drug Controller General of India’s office, Dasatinib (IN203937) is Rs. 2761 per 50mg tablet. Sunitinib (IN20251) is Rs. 4357 per 25mg capsule.

 As patients and developing countries watch what India will do to reduce prices, including whether it will support CL applications that open up generic competition,  an Indian pharmaceutical company, NATCO has applied for a CL to manufacture a affordable generic version of sorafenib tosylate – the anti-cancer drug for which Bayer has obtained a patent IN215758 in India in 2008, which will expire in 2020. Click here to view CL application dated 28th July 2011.

 US and EU FDA approval for use in the treatment of advanced renal cancer 2005 – 2006. The recommended dosage for advanced renal cancer is 400 mg twice daily. Link to see approval letter .

FDA approval for the treatment of for the treatment of unresectable hepatocellular carcinoma (liver cancer) came in 2007.  See link to approval letter.  

Current availability of sorafenib tosylate – India does not provide expensive cancer treatment under the public health programme. Patients have to pay themselves but Bayer currently markets the drug at a high price of approximately Rs. 2,80,000 per patient per month.

Cipla filed a post grant opposition on the sorafenib tosylate patent and applied for marketing approval with the Indian FDA. Bayer however delayed the market registration of the generic version by filing a case against the Indian FDA to prevent it from registering a generic version of sorafenib tosylate. The Indian courts rejected Bayer’s attempt to link registration of medicines to their patent status (patent linkage), following which, Cipla launched at risk the medicine in the Indian market at Rs. 28,000 per patient per month – 1/10th the cost of the patented version. See news story – Cipla launches Nexavar generic at 1/10th of Bayer’s price.

Bayer has now filed an infringement suit against Cipla  in the High Court of Delhi. The matter is listed as Bayer Corporation ANR vs. Cipla Ltd, CS(OS) 523/2010

In July 2011, NATCO filed a CL application proposing to market the same drug at Rs. 8,800 per patient per month if the patent office grants it a compulsory license. This is 31 times cheaper than Bayer’s sorafenib tosylate or 3% of the price at which Bayer sells the drug in India. 

Even the health systems of developed countries have found the drug too expensive. In the UK, the National Institute for Health and Clinical Excellence (NICE) the body that provides guidance on the use of new drugs by the National Health Service, decided that NHS could not pay for the drug as the price being asked by Bayer was too high. The drug was just too expensive. See BBC News: Liver drug too expensive. 

Perhaps it is time that generic competition was opened up to reduce the price of the medicine. Bayer has to file a response to the CL application by 12th of October 2011 and then the Patent Office will provide a hearing to the CL applicant. Bayer is likely to strongly oppose the grant of the CL in India.