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.
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.