The Hyderabad-based pharmaceutical company, Lee Pharma Limited, has filed a compulsory license (CL) application for the patent covering AstraZeneca’s diabetes management drug Saxagliptin. Lee Pharma is engaged in the manufacture and supply of pharmaceutical products, pharmaceutical formulations, intermediates and active pharmaceutical ingredients.

The drug, Saxagliptin, is protected and covered by Indian patent no 206543 (Patent) titled “A cyclopropyl-fused pyrrolidine-based compound”, granted on April 30, 2007 to Bristol-Myers Squibb Company (BMS). BMS assigned the ownership rights on the patent to AstraZeneca AB on April 3, 2014. Saxagliptin is a dipeptidyl peptidase-4 inhibitor, used to treat type II diabetes mellitus by achieving glycemic control without accompanying weight gain.

The applicant has filed the CL application under section 84(1) of The Patents Act, 1970.

In the CL application, Lee Pharma has argued that reasonable requirements of the public had not been satisfied: The CL applicant had stated that the quantity of Saxagliptin in the market fulfilled only 0.23 per cent of the market’s needs and hence there was a shortage of more than 99 per cent of the drug in the market.

It said that the patented invention was not available to the public at a reasonably affordable price as the cost incurred for the importation of Saxagliptin was only Rs.0.80 - 0.92 per tablet, whereas it was being sold in the market for Rs.41-45 per tablet. The company further said that the patented invention had not been worked in the territory of India. Even after about 8 years from grant of the patent, no efforts had been taken to manufacture Saxagliptin in India and the working of the patent was being hindered by importation of the patented product from abroad.

The CL applicant has further stated that they had made a request to AstraZeneca for a voluntary license for the patent, in reply to which, clarifications had been sought by AstraZeneca regarding the CL applicant’s manufacturing capabilities. After providing the clarifications, despite repeated reminders, AstraZeneca did not reply regarding issuance/refusal of the license.

This is the third CL application to be filed in India so far. The first CL application was filed by Natco Pharma Limited in respect of patent no 215758, held by German drug major Bayer Corporation for the cancer drug Nexavar and it was found that all three conditions under section 84(1) of The Patents Act, 1970 had been satisfied, leading to grant of the CL.

The second CL application had been filed by BDR Pharmaceuticals International Private Limited in respect of patent no 203937 for anti-cancer drug Dasatinib, patented by BMS. The CL application was rejected in this case since BDR had failed to make out a prima facie case for grant of a CL i.e., BDR had not made a sufficient attempt to procure a voluntary license from the patentee.