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

Background

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).  BMS assigned the ownership rights on the Patent to AstraZeneca AB on 3 April 2014. Saxagliptin is a dipeptidyl peptidase-4 inhibitor, used to treat Type II Diabetes Mellitus by achieving glycemic control without accompanying weight gain.

CL Application

The CL Applicant filed an application for grant of CL under section 84(1) of The Patents Act, 1970 on the following grounds:

  • 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% of the market’s needs and hence there was a shortage of more than 99% of the drug in the market;
  • The patented invention was not available to the public at a reasonably affordable price: The cost incurred for the importation of Saxagliptin was only INR 0.80 - 0.92 per tablet, whereas it was being sold in the market for INR 41-45 per tablet; and
  • 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 had 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.

Khaitan Comment

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.

In view of these precedents, it would be interesting to see the outcome of this third CL Application.