Lee Pharma files for compulsory license on AstraZeneca diabetes drug

9 July 2015

India’s Lee Pharma has filed a compulsory license (CL) application for the patent covering Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) diabetes management drug saxagliptin, marketed under the trade name Onglyza, according to local media reports.

According to a posting on Lexology by Indian law firm Khaitan & Co, Lee Pharma 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 eight 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.

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