On June 25, 2015, Lee Pharma Limited has filed an application for the grant of Compulsory License (CL) with Indian Patent Office, Mumbai for manufacturing and selling of the product (compound) called “SAXAGLIPTIN” in India. The product is marketed and sold in India by AstraZeneca AB. It is a dipeptidyl peptidase-4 (DPP4) inhibitor prescribed for the treatment of Type-II diabetes mellitus.
Lee Pharma Limited is a Hyderabad based company, incorporated in the year 1997 and is involved in research and development, production, distribution, sales, marketing and export of pharmaceutical products, pharmaceutical formulations, intermediates and APIs.
Saxagliptin is protected by Indian Patent No. 206543 titled “A CYCLOPROPYL-FUSED PYRROLIDINE-BASED COMPOUND” which was granted on April 30, 2007 to M/S Bristol-Mayers Squibb Company. It was then transferred/assigned to AstraZeneca AB.
Currently, Saxagliptin is being sold in tablet dosage form as a single active agent under the brand name “ONGLYZA” (strengths 2.5 mg and 5 mg) and also in combination with Metformin under the brand name “KOMBIGLYZE XR” (strengths 5/500 mg and 5/1000 mg). Their current price in India are as shown in below table-
|S.no||Brand||Cost Per Strip||Cost Per Tablet||Monthly Cost|
|Rs. 43.211||Rs. 1296.42|
|Rs. 41.5||Rs. 12.45|
(5/500 and 5/1000 mg)
|Rs. 49||Rs. 1470|
In its CL application, Lee Pharma stated that it has made sincere efforts to obtain a license and received no response in regard to the same from the patentee. Now Lee Pharma has filed a CL application against AstraZeneca on the following grounds of Section 84 of the Indian Patents Act, namely:-
- that the reasonable requirements of the public with respect to the patented invention have not been satisfied;
- that the patented invention is not available to the public at a reasonably affordable price; and
- that the patented invention is not worked in the territory of India.
Lee Pharma alleged that:
- Even after eight years of grant of patent, Saxagliptin is not been manufactured by the Bristol-Mayers Squibb or AstraZeneca within the territory of India;
- Saxagliptin and Saxagliptin + Metformin combination is imported in India at a cost as low as less than one Rupee per tablet;
- However, the same tablet is sold to Indian patients at a price as high as Rs. 41-45 per tablet;
- Quantity of the imported tablets is too less to meet the requirements of Indian Patients suffering from Type-II Diabetes Mellitus;
- Whereas, the import of the tablets in India itself is too less to meet the Indian requirements, a majority of the imported medicine is again being exported back to foreign countries making this medicine virtually unavailable to Indian patients.
Further, Lee Pharma proposed the following cost for the said product if CL is granted:
Cost per strip
(14 tablets)Cost per tablet
|1.||Saxagliptin||2.5 mg||Rs. 378||Rs. 27|
|2.||Saxagliptin||5 mg||Rs. 406||Rs. 29|
|3.||Saxagliptin + Metformin XR||5/500 mg||Rs. 210||Rs. 30|
|4.||Saxagliptin + Metformin XR||5/1000 mg||Rs. 220.50||Rs. 31.50|