Compulsory Licensing and Interest of the Inventor

"Most patented cancer drugs cost $5,000-6,000 a month. How many patients in India, where there is no public insurance facility, can afford these prices?"

According to section 84 of the Indian Patents Act, 1970, a Compulsory License (CL) can be issued if the patented drug is unavailable, unaffordable or not supplied properly. With Compulsory License domestic companies can manufacture and market generic versions, paying a royalty to the patent holder company

Last year, Hyderabad-based Natco Pharma had won the first ever CL to manufacture its generic version of Bayer's patent-protected anti-cancer drug, Nexavar. With the licence, Natco sold the drug at Rs 8,880 for a pack of 120 tablets, a month's therapy, as against Rs 2.8 lakh, the cost at which Bayer sells Nexavar.

Recently, Government's decision to issue compulsory licences (CLs) for three more patented cancer drugs has joggled the multinational pharmaceutical companies. CLs are being issued for Trastuzumab (or Herceptin, used for treating breast cancer), Ixabepilone (used for chemotherapy in breast cancer treatment) and Dasatinib (or Sprycel, for leukaemia). These cost an average of $3,000-4,500 (Rs 1.64-2.45 lakh) for a month's treatment. Natco is pricing Dasatinib at Rs 9,000 for a month, as compared to BMS’ Rs 1 lakh for a month's treatment. 

Issuing CLs is a matter of concern. CLs cannot solve India’s larger problems regarding access to medicines and healthcare. A pharmaceutical company invests millions of dollars in the development of a new drug. In the absence of these investments and the resulting research and development, there would be no generic medicines for the world’s patients. The research-based pharmaceutical industry fully supports the objective of improving access to innovative medicines but the responsibility to promote development of new drugs lies with all countries, not solely those in the developed world. 

There are access programs by MNCs for medicines which, very often, bring down the prices significantly." Novartis's cancer drug, Glivec, was given free for 16,000 patients in India, claimed to be about 95 per cent of the patients, through The Glivec International Patient Assistance Program (GIPAP). In March, Roche had given a manufacturing and marketing license for Herceptin to Pune-based Emcure Pharma. Herceptin is priced between $3,000 and $4,500 for a month's treatment.

Though issuing CLs is a welcome move but considering the investments of the pharma company and years of research in developing a novel drug makes us think how far the the CLs protect the interest of the inventor??