India rejects compulsory licence bid for AstraZeneca drug

The Indian government has rejected a request by local company Lee Pharma to issue a compulsory licence for AstraZeneca’s diabetes drug Onglyza (saxagliptin).

Rajiv Aggarwal, the controller general of patents, designs and trademarks at the Indian Patent Office (IPO), rejected the application.

Among other things he said that Lee Pharma had not proven that the patented drug was not being worked in India

According to Aggarwal, manufacture in India is not a necessary precondition to establish working of a drug in the country, one of the requirements needed in order to successfully obtain a compulsory licence.

“The applicant has failed to prima facie show that the patented invention is not worked in the territory of India ... I am therefore of the view that [a] case has not been made out for the making of an order under section 84 [Indian Patents Act, 1970],” Aggarwal said in his order.

The patent for manufacturing and selling saxagliptin was granted to Bristol Myers-Squibb (BMS) in 2007 and transferred to UK-based AstraZeneca.

A renewal fee for the patent has been paid up until March 5, 2016.

According to India’s Patents Act, 1970, after three years from the grant of a patent any person may make an application for a compulsory licence. Lee Pharma filed its application at the IPO in June.

An application can be made on three claimed grounds: that the reasonable requirements of the public have not been satisfied, that the patented invention is not available to the public at an affordable price, or that the patented invention is not worked in India.

Aggarwal turned down Lee Pharma’s application on all three counts.

Lee Pharma’s application is the third request for a compulsory licence to be filed in India.

The first, a successful application by Natco Pharma centring on Bayer’s anti-cancer drug Nexavar (sorafenib), was approved in 2012. The second, BDR Pharmaceuticals’s application to market a generic version of BMS’s Sprycel (dasatinib), was rejected by the IPO in 2013.

A spokesperson for AstraZeneca told LSIPR: “AstraZeneca has always maintained affordable access to our medicines in India and elsewhere.

“AstraZeneca has complete confidence in its IP that protects our inventions and does not believe that such IP is a barrier to access to medicines in developing countries.”