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ARTICLE · 23 JANUARY 2016

Lee Pharma's Compulsory License Application For Saxagliptin Rejected By Indian Patent Office

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In an order dated 19 January 2016 (Order), the Controller General of Patents and Trademarks rejected the application for Compulsory License for the patent covering AstraZeneca's diabetes management drug Saxagliptin.

IndiaIntellectual Property
Adheesh Nargolkar
Adheesh Nargolkar
Nishad Nadkarni
Nishad Nadkarni
Nisha Austine
Nisha Austine
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In an order dated 19 January 2016 (Order), the Controller General of Patents and Trademarks (CGPTM) rejected the application for Compulsory License (CL), filed by Lee Pharma Limited (Lee Pharma), for the patent covering AstraZeneca's diabetes management drug Saxagliptin.

Background

The drug, Saxagliptin, is protected and covered by Indian patent no 206543 (Patent) titled "A cyclopropyl-fused pyrrolidine-based compound", granted on 30 April 2007 to Bristol-Myers Squibb Company (BMS) followed by assignment to AstraZeneca AB. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, used to treat Type II Diabetes Mellitus.

Lee Pharma filed an application for grant of CL under Section 84(1) of The Patents Act, 1970 (the Act). Following which, CGPTM issued a notice to Lee Pharma stating that no prima facie case had been made out on any of the three grounds under Section 84 of the Act:

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