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The government has rejected a compulsory licensing application by BDR Pharmaceuticals to manufacture the generic version of patented anti-cancer drug 'Dasatinib', a decision that is seen as evidence that IP rules prevail in India.
Under the Indian Patents Act, if a medicine is deemed unaffordable, a compulsory licence can be issued to a generic drug maker in public interest.
The Controller General of Patents has rejected the domestic company's application on the ground that the company has not made any "credible attempt" to obtain a voluntary licence for the drug from the US-based Bristol Myers Squibb Company.
"The Controller General of Patents held that BDR had not really made any credible attempt to procure a voluntary licence and therefore could not be said to have satisfied the statutory requirement that the applicant must have negotiated in good faith for six months at least.
"Therefore, BDR did not make out a 'prima facie' case for the grant of a CL (compulsory licence) and the application was dismissed at the threshold itself," the Controller General of Patents said in its 13-page order.
A senior official in the Commerce and Industry Ministry said this order clearly rejects allegations by multi-national pharma companies that India's intellectual property regime is not in conformity with international standards.
"Rule of law prevails in India. This order rejects allegations of MNCs that India issues compulsory licences blindly. They have been proved wrong," the official told PTI.
The Commerce and Industry Ministry deals with FDI and patent-related matters.
"This order has proved that their allegations are completely false," the official added.
After India issued a compulsory licence in March last year to Natco Pharma to manufacture and sell anti-cancer drug Nexavar, several global drug companies alleged that New Delhi's intellectual property (IP) environment is deteriorating and patent rights are unreasonably denied.
Under Section 92 of the Patents Act, a government can ask generic makers to manufacture patented drugs in emergency situations.
When a company applies for a compulsory licence, it first needs to take permission from the patent holder firm and that firm can reject or give permission with some conditions.
This formality is fundamental before issuance of a compulsory licence, National Intellectual Property Organisation Director T C James said.
Dasatinib is used in the treatment of chronic myeloid leukaemia. In India, 60 tablets of 20mg each of Dasatinib is priced at Rs 1.17 lakh. BDR had applied for a compulsory licence for the drug in March and said it would sell the drug for Rs 8,100 a month.
