Hyderabad-based Lee Pharma has approached the Patent Controller on the award of a compulsory licence for manufacturing patented diabetes drug saxagliptin.

Its application for a compulsory licence (CL) – a permission given by the government to an interested party to manufacture a patented product without permission of the patent holder – was ‘prima facie’ rejected by the Patent Office, Mumbai, in August.

Hearing this month

“As the request for the hearing has been made within a month of ‘prima facie’ rejection of the application, the company will now be given the opportunity to present a more detailed case,” a government official told BusinessLine .

The hearing is likely to take place by the end of September.

The application was prima facie rejected by the Patent Controller as it felt that the evidence provided by the company was not enough to convince it that the conditions for grant of CL were satisfied. “During the hearing, the company has to come up with better arguments and prove that the public was actually being deprived of treatment due to the action of the patent holder,” the official said.

Astra Zeneca’s patent

Lee Pharma had applied for a CL this June to manufacture saxagliptin, the patent for which is held by Astra Zeneca, a multinational pharmaceutical company headquartered in London.

The application was filed on the grounds that the drug was not available at an affordable price in the country, public requirement was not being met, and that the patent owner had not taken adequate steps to manufacture the drug in the country (Section 84 of the Patents Act, 1970). Indian patent law allows any interested person to make a CL application for a patented drug where the patent is more than three years old.

Onus on Lee Pharma

Lee Pharma has the difficult task of proving its point as there are already several other diabetes medicines available in the country, the official added.

India has so far granted only one CL, to Hyderabad-based Natco Pharma for Bayer’s kidney cancer drug Nexavar. “In case of Natco, the price of the generic version of the cancer drug was significantly lower than the patented version,” the official said. The second application made by BDR Pharma for Bristol-Myers Squibb’s cancer drug Dasatinib was rejected by the Patent Office. A fresh application was subsequently submitted to the Centre under Section 92 of the Patents Act, which allows such licences to be issued under cases of national emergency. A decision is yet to be taken on the application.