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The Patent Controller has rejected an application from local drug company BDR Pharmaceuticals International Pvt Ltd, seeking a compulsory licence (CL) for its less-expensive version of dasatinib, a cancer drug from multinational Bristol-Myers Squibb Co.
“The applicant (BDR) did not follow the scheme of the law as well as the procedure mandated by the law. I am, therefore, of the considered opinion that the applicant has failed to make out a prima facie case for the making of an order under section 87 of the (Patents) Act,” the Patent Controller said, rejecting the application for the CL , along with all petitions for delay.
A CL allows a third party to make a less expensive version of an innovator company’s drug (dasatinib in this case) on the payment of royalty to the innovator.
The dasatinib order would bring some cheer to multinational drug companies, which have in the recent past seen several judicial orders lean in favour of public health.
Only last year, the country’s first CL was granted to Natco Pharma Ltd on German company Bayer AG’s advanced kidney cancer drug Nexavar.
Natco was allowed to make its less expensive version of Nexavar, on the payment of a revised royalty of 7 per cent.
Dasatinib is a chemotherapy drug used to treat patients with Chronic Myeloid Leukemia.
The order states that BDR had submitted that it would make the drug at Rs 135 per tablet, working out to Rs 8,100 per month for the treatment of a patient with Chronic Myeloid Leukaemia. Bristol-Myers sold the drug at Rs 2,761 per tablet, or about Rs 1,65,680 for 60 tablets per month, per patient.
Voluntary claims
BDR had sought a CL on the drug, as Bristol-Myers was importing the drug, despite it being six years since the multinational was issued a patent on the drug.
The dasatinib order further points out that BDR refrained from entering into any dialogue with the patentee (Bristol-Myers) for getting a voluntary licence and exercised only the CL option without taking the steps outlined in the law.
The Patent Controller also did not entertain submissions by BDR that Bristol-Myers was being “anti-competitive” by filing patent-infringement cases against it on the same drug at the Delhi High Court.
jyothi.datta@thehindu.co.in
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