Alternatively, the health ministry was told, it would have to establish prevalence of national emergency, extreme urgency or a valid case for public non-commercial use to make a case for invoking Section 92 under which the government can suo motu issue a compulsory licence, sidestepping a patent.
If the ministry of health wants to proceed on the grounds of affordability, then it has to comply with provisions of Section 84, the department of industrial policy and promotion (DIPP) said in a letter to the health ministry. While the health ministry, which has been trying to get a compulsory licence for dasatinib for the last two years, had written to the DIPP on January 17 seeking issuance of compulsory licence under Section 92, it had built its case around (lack of) affordability of the drug. The commerce ministry's remarks are significant as in October last year the Indian Patents Office rejected Mumbai-based BDR Pharmaceuticals' application under Section 84 for a licence to manufacture and market a generic version of dasatinib.
CL is a TRIPS-compliant tool for countries to sidestep patents under defined circumstances. Some argue, citing the Doha declaration on TRIPS, that its use is not strictly limited to emergencies or other urgent situations.
They say that governments can invoke them more flexibly in larger public interest.
The US Chamber of Commerce's Global Intellectual Property Centre in the January edition of its International IP Index retained India at the last slot among 25 countries in terms of protection and enforcement of intellectual property practices and one reason cited for this low ranking was its reported plans to be liberal with issuance of CLs. Domestic industry circles, however, point out that GIPC's is a mistaken notion, stating that India has so far granted only one CL and that was to Hyderabad-based Natco Pharma in the case of German major Bayer's anti-cancer drug Nexavar in 2012.
BMS' drug sold in India under the brand name Sprycel is used to treat a rare form of blood cancer chronic myeloid leukaemia and costs Rs 1.6 lakh for one month's dosage. In comparison, BDR Pharma had proposed to make a generic version of the drug for Rs 8,100 for one month's dosage.
BDR had filed for CL in March 2013 under Section 84 under which a company can file for CL three years after the patent has been granted for a specific drug. However, the patent office rejected BDR's application in October last year on the grounds that the company did not make enough effort to obtain a voluntary licence for the drug from the innovator BMS.
Sources said that the health ministry may also seek interest from companies like Natco Pharma and Hetero Pharma that had earlier sought permission to make generic versions of dasatinib to file for CL under Section 84. Sources added that the health ministry committee on compulsory licences is also in the process of finalising its arguments that a CL is necessary based on the 'public non-commercial use and urgency' clause of Section 92.
Many government institutions including CGHS and Army Hospitals have been procuring dasatinib only in small quantities due to its high price, said industry experts. The health ministry has not responded as yet but if they site urgency reasons, they will have to give cogent reasons with empirical data. Besides, the budget and distribution of the drug will be a problem, said a DIPP official.