Hyderabad-based drug maker Lee Pharma's application for compulsory license on AstraZeneca's anti-diabetes drug saxagliptin has been rejected as it failed to satisfy the Patent Controller as per the Patent Act.
The Indian Patent Office rejected the application of the company against AstraZeneca's anti-diabetes drug saxagliptin branded as Onglyza. The first filing for the compulsory license was made by Lee in June 2015.
Lee filed the application 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.
As part of its 15-page decision, the patent authority said Lee has not shown how the reasonable requirement of the public for saxagliptin and other similar drugs like linagliptin, sitagliptin and vildagliptin were not met. Besides, the authority termed as assumptions Lee Pharma's grounds that the product was not made available in sufficient quantities and at an affordable rate.
"As the applicant has failed to provide evidence along with application or during hearing or by supplementary submissions and failed to satisfy the Controller regarding any of the grounds as specified in Section 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 U/S 84 of the Act. There, the application for grant of compulsory license by the applicant is hereby rejected," the patent office order of January 19 signed by OP Gupta, Controller of Patents said. The case was heard in Mumbai in December.
As per company sources, Lee Pharma's plans appeal against the decision to the Intellectual Property Appellate Board. Lee had offered a price of Rs. 11 per tablet, which was roughly 300 per cent lower than the prevailing price of the branded drugs. To date, India has granted one compulsory license against Bayer's Nexavar to Natco Pharma.