Health min pushes for cancer drug licence, DIPP pushes back

Apr 03 2014, 04:49 IST
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SummaryThe US’ tirade against India for the latter’s “poor record” in protecting intellectual property (IP) seems to have made the commerce and industry ministry

The US’ tirade against India for the latter’s “poor record” in protecting intellectual property (IP) seems to have made the commerce and industry ministry more cautious despite its public posturing to the contrary, report Kirtika Suneja & Jayati Ghose in New Delhi. While the health ministry sought compulsory license (CL) for Bristol-Myers Squibb’s (BMS) anti-cancer drug dasatinib, Anand Sharma’s ministry has told it to let a domestic firm ask for a CL if the issue was one of “affordability”. The commerce and industry ministry has sought details and empirical data from the health ministry to support any claims of non-affordability (which calls for issue of CL under Section 84 of the Patents Act at the instance of a local firm).

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

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