Indian Patent Office rejected Lee’s Compulsory License Application
Lee Pharma filed an application under Section 84(1) of the Patents Act, 1970 seeking to grant Compulsory License for manufacturing and selling the compound Saxagliptin, an anti-diabetic drug protected by Patent number 206543 granted to Bristol Myers Squibb Compnay (BMS) which by virtue of assignment deed transferred to AstraZeneca AB.
A time period of 3 years from the date of grant of patent which is a mandatory prerequisite for initiating any proceeding under sub-section(1) of section 84 of the Act, has expired and the renewal fee in respect of the patent has been paid till March 5th 2017.
Saxagliptin is used in the treatment of Type-II DM and is sold under the brand name Onglyza in dosages of 2.5 mg and 5 mg. It is also sold in combination with Metformin under brand name Kombiglyze XR.
In repose to the notice dated August 12th 2015, the Lee Pharma’s Counsel requested for hearing under Rule 97(1) and the hearing was held on December 15th 2015.
Person interested and capacity of the applicant:
It is prima facie borne out that Lee Pharma is a person interested and has the capacity to undertake the risk in providing capital and working the invention, if the application is granted. The Lee Pharma has filed a request with the AstraZeneca for grant of a Drug License for manufacturing Saxagliptin.
Lee Pharma has been involved in research and development, production, sales of pharmaceutical products for more than 17 years and its products are sold in India and exported to more than 48 countries worldwide.
Section 84(1)(a): The reasonable requirements of the public with respect to the patented invention have not been satisfied
Lee Pharma has not shown what is the reasonable requirement of the public of Saxagliptin in India and has also not shown comparative requirements of Saxagliptin and other DPP-4 inhibitors, namely Linagliptin, Sitagliptin and Vildagliptin which are available in the Indian market. Further, no authentic data on Saxagliptin prescription by the doctors in India over the other DPP-4 inhibitors was shown. As a result, the exact quantity of Saxagliptin required in the context of number of patients and doctors’ prescription is not established for arriving at a figure, which could be to the fullest extent.
Accordingly, a prima facie case has not been made out by Lee Pharma to the effect that the reasonable requirements of the public with respect to the patented invention are not being satisfied and thus no case is made out in terms of Section 84(1)(a).
Section 84(1)(b): The patented invention is not available to the public at a reasonably affordable price
The other two DPP-4 inhibitors namely Sitagliptin and Vildagliptin which are listed along with Saxagliptin in the Essential Medicines list for the treatment of Type-II DM by Govt of NCT of Delhi are also sold at comparatively similar price.
In the absence of evaluation of exact quantum of Saxagliptin required and the number of patients vis-a-vis the Doctors’ prescriptions as against the other options existing in the market, the question of its availability and affordability can’t be determined. It is not possible to conclude that it is not available to the general public at a reasonably affordable price. It is especially not possible when other options, which fall within the same class and used for the treatment by large number of patients are also available on the relatively same price.
Lee Pharma has failed to show that the patented invention is not available to the public at a reasonably affordable price, and thus no case is made out in terms of Section 84(1)(b).
Section 84(1)(c): The patented invention is not worked in the territory of India
It is not a necessary pre-condition in all cases to establish patent’s working in India. The patent holder is however required to establish the reasons which make it impossible to manufacture the patented drug in India, particularly when the patentee has manufacturing facilities within the country.
In the present application, Lee Pharma has failed to show the exact quantitative requirement of Saxagliptin in terms of number of patients requiring it or whether it is in shortage, it is very difficult to conclude whether manufacturing in India is necessary or not. No authentic data, report, evidence or comparative study has been cited by Lee Pharma which could clearly establish the quantitative requirement of Saxagliptin in India and thus the necessity of its manufacturing in India.
Lee Pharma has failed to establish that the patented invention is not worked in the territory of India and thus no case is made out in terms of Section 84(1)(c).
Conclusion
It is concluded that Lee Pharma has failed to provide evidence along with application or during hearing or by supplementary submission and failed to satisfy the Controller regarding any of the grounds as specified in Section 84(1) of the Act, and hence the Controller of Patents O.P. Gupta rejected the application of Lee Pharma for grant of compulsory licence.
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