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The application was rejected on the basis that BDR Pharma failed to make out a case for the grant of a compulsory licence.
The application was rejected on the basis that BDR Pharma failed to make out a case for the grant of a compulsory licence.

BDR Pharma’s compulsory licensing application for blood cancer drug rejected

BDR filed an application to get a compulsory licence to make and sell patented blood cancer drug dasatinib

Mumbai: India’s patent office on Wednesday rejected an application filed by local drug maker BDR Pharmaceuticals International Pvt. Ltd to issue a compulsory licence to make and sell patented blood cancer drug dasatinib.

Chaitanya Prasad, the controller general of patents, designs and trademarks, rejected the application saying that the applicant failed to make out a case for the grant of a compulsory licence.

Justifying the need for a compulsory licence such as affordability, shortage of supply or a medical emergency in the local market and also completion of other formalities such as seeking a voluntary licence from the patentee are the threshold requirements to be satisfied before engaging the patent office for hearing a compulsory licence application.

Dasatinib, sold under the brand name Sprycel, was patented by the inventor, US drugmaker Bristol-Myers Squibb Co. (BMS), in 2006 in India, and retails at 1.65 lakh for a month’s treatment, according to BDR Pharma.

BDR sought the compulsory license for this drug after the ministry of health proposed that a compulsory licence should be issued on cancer drugs including dasatinib, trastuzumab and ixabepilone early this year.

An expert committee on compulsory licensing had also recommended that the department of industrial policy and promotion issue a compulsory licence for the manufacture of dasatinib to two companies.

A compulsory licence would allow local firms to produce a generic version of the patented medicine and sell it at a cheaper price.

“Under Indian patent law, a compulsory licence applicant must first attempt to procure a voluntary license from the patentee. If this attempt does not succeed within six months of the initial request, the applicant is free to file a compulsory licence application," Shamnad Basheer, a professor in intellectual property law at National University of Juridical Sciences, Kolkata, wrote in a blog post on Wednesday.

The controller’s order rejecting the application, published on the patent office’s website, stated that BDR initially sent a request for a voluntary license to BMS, which responded with a series of questions that included queries such as whether BDR had the necessary wherewithal to produce quality active pharma ingredeints.

BDR did not answer any of these queries, but filed a compulsory licence application after a year of its initial request letter, the order stated.

The regulator held that BDR had not really made any credible attempt to procure a compulsory licence and could not be said to have satisfied the statutory requirement that the applicant must have negotiated in good faith for six months at least.

“BDR now has two routes open to it. One is to mount a legal challenge to this order. The second (and I think the more pragmatic option) is to renegotiate the license with BMS, comply with the six month time period and come back with a fresh application," said Basheer.

Both BDR and Bristol-Myer could not be immediately reached for comments.

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