Indian Patent Office rejects bid for cancer drug compulsory licence

The Indian Patent Office has rejected an application for a compulsory licence that was filed by domestic drug maker BDR Pharmaceuticals.

BDR requested the compulsory licence to make a generic version of US pharmaceutical company Bristol-Myers Squibb’s leukaemia drug Sprycel, which has the active ingredient dasatinib.

The controller general of patents, designs and trademarks Chaitanya Prasad rejected BDR’s application, finding the company had not made enough effort to obtain a voluntary licence from Bristol-Myers Squibb, which has held the patent for the drug since 2006.

BDR filed for the compulsory licence for dasatinib in March this year. It claimed it would offer the drug in India at a “proposed price” of INR 135 (just over $2) per tablet, or INR 8,100 ($132) per month of treatment.

It also said that it would take care to make the patented product available to patients who are “economically weak and also to the patients residing in remote and rural areas”, and that the drug would be offered free of charge to a certain percentage of patients.

Last year, the Indian patent office issued the first compulsory to Indian pharmaceutical company Natco Pharma to make a generic version of Bayer’s kidney cancer drug Nexavar.

The move was welcomed by generic companies, though some authorities have expressed concern that an increase in the number of compulsory licences issued would mean branded pharmaceutical companies may not receive adequate compensation for their patented products.

Natco’s compulsory licence is the only one to have been issued by the Indian patent office so far, though as Tarun Gandhi, a patent attorney at Chadha & Chadha in New Delhi observed, the number of applications for the licences has “definitely” increased since the company’s success.

Dasatinib has received orphan drug status in the US and Europe, which Gandhi said makes it a stronger candidate for being granted a compulsory licence both under section 84 and section 92 of the Indian Patents Act to take care of public health needs.

He added: “Although currently BDR’s application for compulsory license under section 84 of the Act has been rejected, the government may issue a compulsory license under 92 of the Act.

“Herein, the central government itself can issue compulsory license on the grounds of a public health emergency.”

Gandhi said that the controller general had rightly interpreted the law concerning compulsory licences, “which has been very clearly laid down in the Act.”

He said that the controller general must take into account whether credible efforts were made to get a licence from the patentee on reasonable terms, within a reasonable period, which is defined as six months.

“BDR did not make enough efforts within reasonable period,” he said.

“Neither did they respond to the concerns shared by Bristol-Myers Squibb, nor did they make any further attempts. There seemed no intention on BDR’s part to seek a voluntary licence but to merely fulfil the pre-requisite for applying for a compulsory licence,” he said.

Bristol-Myers Squibb told LSIPR: "Bristol-Myers Squibb is aware of the order dated October 29 rejecting the section 84 compulsory license application by BDR Pharmaceuticals for Sprycel in India. We believe that IP protection is important for the sustainability of the innovative biopharmaceutical industry in India and for patients who benefit from innovative medicines like Sprycel."