In an order dated 19 January 2016 (Order), the Controller General of Patents and Trademarks (CGPTM) rejected the application for Compulsory License (CL), filed by Lee Pharma Limited (Lee Pharma), for the patent covering AstraZeneca’s diabetes management drug Saxagliptin.
The drug, Saxagliptin, is protected and covered by Indian patent no 206543 (Patent) titled “A cyclopropyl-fused pyrrolidine-based compound”, granted on 30 April 2007 to Bristol-Myers Squibb Company (BMS) followed by assignment to AstraZeneca AB. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, used to treat Type II Diabetes Mellitus.
Lee Pharma filed an application for grant of CL under Section 84(1) of The Patents Act, 1970 (the Act). Following which, CGPTM issued a notice to Lee Pharma stating that no prima facie case had been made out on any of the three grounds under Section 84 of the Act:
- Reasonable requirements of the public with respect to patented invention not satisfied;
- Patented invention not available to the public at a reasonably affordable price; and
- Patented invention not been worked in the territory of India.
- In response to the notice, the Applicant requested and was granted a hearing under Rule 97(1) of the Act and the Order is the outcome of such hearing.
CGPTM considered each of the three grounds raised and made the following observations while refusing the application of Lee Pharma under Section 84(1):
Reasonable requirements of the public had not been satisfied: This ground was rejected on the basis that Lee Pharma failed to demonstrate what the reasonable requirement of the public was with respect to Saxagliptin and further failed to demonstrate the comparative requirement of the drug Saxagliptin vis-a-vis other drugs which are also DPP-4 inhibitors.
The patented invention was not available to the public at a reasonably affordable price: This ground was rejected on the basis of comparison of the prices of the various Gliptins available in the Indian market. The CGPTM held that since all the DPP-4 inhibitors were in the same price ranges, it could not be said that the prices of Saxagliptin alone was unaffordable in India as compared to other DPP-4 inhibitors.
The patented invention had not been worked in the territory of India: This ground was rejected on the basis that manufacturing the drug in India is not a precondition to establish working in India and since Lee Pharma had not shown the exact requirement in India, it was difficult to hold whether manufacturing in India was necessary or not.
This is the third CL application to be filed in India so far. The first application for NEXAVAR was granted holding that all three conditions under Section 84 had been satisfied while the second one for DASATINIB was refused on the ground that no proper attempt was made to procure a voluntary license. In this CL application, CGPTM has not only passed an order refusing to grant CL but has now laid down parameters for CL applicants to establish a “reasonable requirement” especially where there are other drugs in the market which treat the same ailment / condition.