Lee Pharma’s Compulsory License plea rejected

August 17, 2015

We previously reported in our newsletter dated July 06, 2015, Vol VII, Issue. 27 that Lee Pharma Limited has filed an application for the grant of Compulsory License (CL) with Indian Patent Office, Mumbai for manufacturing and selling AstraZeneca’s “SAXAGLIPTIN” in India.

Now as per the news reported by Economic Times on August 18, 2015, the plea of Hyderabad based company Lee Pharma has been rejected by the Controller of Patents for the grant of CL for manufacturing and selling of the product (compound) called “SAXAGLIPTIN” in India which is marketed and sold by AstraZeneca AB. It is a dipeptidyl peptidase-4 (DPP4) inhibitor prescribed for the treatment of Type-II diabetes mellitus.

The application has been rejected on all the three grounds as-

  • Substitutes to the drug are readily available in the market;
  • The claim that requirements of public with respect to the patented invention are not being satisfied, has not been proven; and
  • The Controller of Patents, Mr. Rajiv Aggarwal also said that manufacture in India is not a necessary precondition in all cases to establish working in India.

Further, the Controller of Patents found that Lee Pharma’s proposed selling price is only marginally below than that of AstraZeneca.



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