India rejects licence plea for AstraZeneca's antidiabetic drug

The Indian patent office has rejected Hyderabad-based Lee Pharma's application for a compulsory licence on AstraZeneca's anti-diabetic medicine saxagliptin sold under the brand name Onglyza.
"As the applicant has failed to provide evidence along with the application or during hearing or by supplementary submission and failed to satisfy the Controller regarding and of the ground as specified in Sec 84 (1) of the Act...
"I am therefore of the view that a prima facie case has not been made out for making of an order...Therefore, the application for grant of compulsory license by the applicant is hereby rejected," Controller of Patents O P Gupta said in an order.

Under the Indian Patents Act, a compulsory licence (CL) can be issued for a drug if the medicine is deemed unaffordable by the government and grants permission to qualified generic drug makers to manufacture it.
As per the WTO agreement, a CL can be invoked by a national government allowing a company to produce a patented product without the consent of the patent owner in public interest.
Lee filed the application for a CL on grounds that the reasonable requirements of the public were not satisfied, the patented invention is not available to the public at a reasonably affordable price and the patented invention is not worked in India, the 15-page order said.

It said that the applicant has failed to establish that the patented invention is not worked in the country.
The patent for saxagliptin in India was given to Bristol Myers Squibb in 2007 but was later transfered to AstraZeneca.
So far India has granted only one compulsory license against Bayer's Nexavar to Natco Pharma.