Lee Pharma’s Compulsory License Application Rejected


A Compulsory License (CL) application was filed by Lee Pharma with respect to AstraZeneca’s  patent covering the anti-diabetes drug Saxagliptin. The Controller General of Patents issued a notice stating the Applicant’s failure to establish a prima facie case. The Controller General after hearing the Applicant on establishment of a prima facie case has rejected the CL application for failure to establish the grounds for obtaining a CL u/s 84 of the Patents Act.

The following findings emerge from the rejection:

  • On the issue of reasonable requirements of the public being met, the Controller held that currently there are four key gliptins available in the market to treat type 2 diabetes, namely, Linagliptin, Sitagliptin, Saxagliptin and Vidalagliptin. In absence of data/ statistics, there is no way to understand the requirement of saxagliptin in the market or to decide whether its reasonable requirement is being met. The Applicant has therefore failed on this ground.
  • Regarding availability to the public at a reasonably affordable price, the Controller held that the Applicant failed to establish the number of people being denied access due to pricing of the patented drug. The Controller further observed that other drugs in the same category are being sold at similar prices and if the price of said drugs is affordable, it is difficult to fathom how the price of AstraZeneca’s saxagliptin is unaffordable. Further, since the information regarding number/ type of patients in the market is not available, availability and affordability cannot be predicted. The Applicant has therefore not been able to establish that the drug is not available to the public at a reasonably affordable price.
  • On the issue of working of the patented invention in the territory of India the Controller held that manufacturing in India is not a pre-requisite to establish the working of the Patent in India. The need for manufacture in India has to be determined on a case-to-case basis. Since the Applicant has failed to show the exact requirement of saxagliptin or whether it is in short supply, it is very difficult to conclude whether manufacturing in India is necessary or not. Further, the patented drug, inspite of importation, is being made available in the same price range as other DPP-4 inhibitors. Therefore, pricing also does not justify the need to manufacture in India. The Controller further held that the Applicant led no evidence to establish any shortage of supply due to importation alone. The Applicant has therefore failed to establish that the patented invention has not been worked in the territory of India.

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