Rejection of Compulsory license application filed by Lee Pharma As you all know recently Indian Patent Office has rejected Lee Pharma’s compulsory licensing application. Before moving forward with the discussion regarding the decision of the Indian Patent Office to reject Lee Pharma’s compulsory licensing application, let me brief you about the case first. Lee Pharma Ltd. had filed a compulsory licensing application on 25th June 2015 for Astrazeneca’s patented drug Saxagliptin, a drug used to cure diabetes.

Lee Pharma pointed out the need to cure diabetes in India and also that diabetes has become an epidemic in the country affecting people of the age group between 25-35 years. Lee further stated that there is no cure for type II diabetes and only can be controlled by DPP-4 inhibitors. As per section 84 of the Indian Patent Act, 1970, a compulsory license can be granted only if the grounds mentioned below are satisfied.

  1. That the reasonable requirement of the public has not been satisfied;
  2. The patented invention is not worked in the territory of India.
Rejection of Compulsory license application filed by Lee Pharma 2

Lee Pharma in its application claimed that all the above-mentioned grounds are being satisfied in order for the grant of a compulsory license.

Lee Pharma claimed that the drug Saxagliptin is imported from Ireland and the US. Further, Lee Pharma stated that the drug is exported to countries like the UK, Slovenia, Mauritius, and the US. According to the compulsory license application filed by Lee Pharma, only a small amount of the drug is able to enter the Indian market and meets the requirement of only 0.23% of the market demand.

Lee Pharma also stated that the drug is not available at cheaper prices to the public. It stated that the drug costs 41-45 rupees per tablet in the market whereas it costs less than a rupee to Astrazeneca on its importation. Patent for Saxagliptin was granted to Bristol-Myers Squibb in 2007, which later assigned its patent to Astra Zeneca.

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On 19th January 2016, the Controller of Patents O.P.Gupta held that due to lack of the evidence provided along with the application and failure to satisfy the Controller regarding any of the grounds mentioned in section 84 of the Indian Patent Act, 1970, the application for the compulsory License is being rejected. This is the third application for a compulsory license that has been filed to date. Only one application for a compulsory license has been accepted till now which is of Natco Pharma to produce a generic version of Nexavar. It would be interesting to see and analyze the cases in which the Indian Patent Office grants the compulsory license and the stand of the Indian patent office on the same.