Indian Patent Office Rejected Compulsory License Application (C.L.A. No.1 of 2015) for “Saxagliptin” Filed by Lee Pharma Ltd.

In an order dated 19^th January 2016, the Controller of Patents rejected the compulsory license application of Hyderabad based drug maker Lee Pharma Ltd. to manufacture generic version of AstraZeneca’s anti-diabetic drug Saxagliptin. The Controller of Patents rejected the application on the grounds that substitutes to the drug Saxagliptin are readily available in the Indian market and the Lee Pharma’s claim that requirements of public with respect to the patented invention are not being satisfied has not been proven.

Lee Pharma filed an application under Section 84 (1) of the Patents Act 1970 on 29^th June 2015, seeking grant of a compulsory license for manufacturing and selling the compound Saxagliptin (an anti-diabetic drug), which is protected by Patent number 206543 titled “A cyclopropyl-fused pyrrolidine-based compound” granted on 30^th April 2007 to Bristal Myers Squibb (BMS). BMS transferred the ownership rights in the Indian patent 206543 to AstraZeneca by virtue of an assignment deed.

While the patent office had heard Lee Pharma’s case in August 2015 and denied a compulsory license, the application was heard afresh after Shri. O P Gupta, the new controller general of patents, assumed office in November 2015. In August 2015, Shri. Rajiv Aggarwal, the then Controller of patents had rejected the compulsory license application. “The applicant has failed to prima facie show that the patented invention is not worked in the territory of India…I am therefore of the view that a prima facie case has not been made out for the making of an order under Section 84,” Aggarwal said in his Aug. 2015 order.

Lee Parma made the compulsory license application on the grounds that the reasonable requirements of the public with respect to the patented invention have not been satisfied, 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 submitted that out of all DPP-4 inhibitors presently available in India, Saxagliptin is the latest and the best option for the treatment of Type-II diabetes while the others have side effects, and there is more than 99% shortage of Saxagliptin in the Indian Market, therefore the reasonable requirements of the public with respect to the patented invention under Section 84 (1)(a) were not satisfied by the Patentee.

However, the Controller observed that Lee Pharma’s submission has not demonstrated the reasonable requirements of the public in respect of Saxagliptin and also the exact quantitative requirement of Saxagliptin in India in terms of number of patients requiring it by way of any authentic data or concrete evidence. The Controller noted that in the absence of any authentic evidence from any statutory authority, it is difficult to conclude whether or not the Patentee is meeting the reasonable requirements of the public in respect of the patented invention.

The Controller further noted that the availability and affordability of Saxagliptin in India could not be determined as Lee Pharma, in their application or in their submissions, has not furnished the details of the reasonable requirements of the public in respect of Saxagliptin, the comparative requirements of Saxagliptin and other DPP-4 inhibitors such as Linagliptin, Sitagliptin and Vildagliptin, or any authentic data/statistics on Saxagliptin prescription by the doctors over other DPP-4 inhibitors.

In addition, under clause (c) of Section 84 (1), Lee Pharma submitted that the Patentee has not taken adequate steps to manufacture Saxagliptin in India and make full use of the invention in India to an adequate extent that is reasonable practicable even after the lapse of a long period of about eight years from the date of grant (30^th April 2007). Lee Pharma also submitted that the working of the patented product in the country was hindered by the importation from abroad.

This ground was rejected on the basis that manufacturing the drug in India is not a precondition to establish working in India. The Controller noted that it was difficult to conclude whether manufacturing in India was necessary or not since Lee Pharma failed to show the exact quantitative requirement of Saxagliptin in India in terms of number of patients requiring it.

In the latest order of 19^th 2016, Gupta said, “As the applicant has failed to provide evidence along with application or during hearing or by supplementary submissions and failed to satisfy the controller regarding any of the grounds as specified in Section 84(1) of the Act, I am therefore of the view that a prima facie case has not been made out for making of an order U/S 84 of the Act. Therefore, the application for grant of compulsory license by the applicant is hereby rejected.”

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: [email protected].