Have complete confidence in our IP: AstraZeneca

MNC reviewing options on Lee Pharma’s CL for saxagliptin

In a statement reacting to Lee Pharma’s application for a compulsory license (CL) for saxagliptin, AstraZeneca has said that it was aware of the CL application filed with the Indian Patent Office and are reviewing their options.

The statement goes on to say that the company enables affordable access to their medicines in India and elsewhere and has “complete confidence in its intellectual property that protects our inventions and does not believe that such intellectual property is a barrier to access to medicines in developing countries.”

Lee Pharma’s CL application is being closely watched as were the decisions on India’s previous two CLs. The first went in favour of the CL applicant (Natco Pharma) when 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 for Bayer’s Nexavar.

On the other hand, the second CL, BDR Pharma’s CL for BMS’ dasatinib was rejected as BDR had not made a sufficient attempt to procure a voluntary license from the patentee, therefore not fulfilling this condition under section 84(1) of The Patents Act, 1970.

Commenting on the developments, a spokesperson from law firm Khaitan &Co said, “In view of these precedents, it would be interesting to see the outcome of this third CL application.”

AstraZenecaBDR Pharmacompulsory licensesaxagliptin