India: IPO Rejects Compulsory Licensing Application Against The Patented Drug SAXAGLIPTIN By Lee Pharma

Introduction

An application for Compulsory Licensing against 'SAXAGLIPTIN' drug was filed by Lee Pharma, a Hyderabad based Indian pharma company, dated 29.06.2015.'SAXAGLIPTIN' is protected by the patent IN 206543 entitled "A Cyclopropyl-fused pyrrolidinebased compound" granted to Bristol Myers Squibb (BMS) which was subsequently assigned to AstraZeneca by way of deed of assignment. An order issued by IPO on 12th August, 2015, rejecting the application under Rule 97(1) of the Patent Rules, 2003. The Applicant requested a further hearing which was granted on 15/12/2015 along with supplementary submissions on 29/12/2015. Subsequent to this hearing, the IPO passed an order1 dated 19/01/2016 in which the Controller rejected the application for largely the same reasons as stated in its earlier order.

Facts of the case:

SAXAGLIPTIN is a Dipeptidyl Peptidase-4 (DPP-4) inhibitor used in the treatment of Type II Diabetes Mellitus. The drug SAXAGLIPTIN is sold under the brand name 'ONGLYZA' in dosages of 2.5 mg and 5 mg. SAXAGLIPTIN in combination with Metformin is sold under the brand name 'KOMBIGLYZE XR' in dosage 5/500 mg and 5/1000 mg.

Grounds relied by the Applicant for making an application for Compulsory Licensing:

Section 84(1) (a): That the reasonable requirements of the public with respect to the patented invention have not been satisfied

The Applicant submitted that there are nearly 60 million people in India suffering from Type II DM and even if 1 million people were prescribed SAXAGLIPTIN then total number of tablets required for one million patients in one year would be 365,000,000 tablets per year. From Form-27 data submitted by the patentee , the Applicant mentioned the total number of ONGLYZA and KOMBIGLYZE imported for the whole year was

0.23% of the total number required for a year. Hence the Applicant submitted that there is more than 99% of shortage of SAXAGLIPTIN in the Indian market. Upon hearing the arguments of the Applicant, the Learned Controller insisted on authentic report for the data provided on increased diabetic population as well as the number of Type-II DM patients taking prescribed medicines in relation to other steps such as lifestyle change, dietary changes, exercise etc, but the Applicant could not provide authentic data.

Further, the Applicant did not provide any comparative data of SAXAGLIPTIN and other DPP-4 inhibitors such as Linagliptin, Sitagliptin and Vildagliptin which are also available in Indian market so that the reasonable requirements of the public in respect to SAXAGLIPTIN could be arrived. The learned Controller quoted the matter of 'Bayer Corporation Vs Union of India & Ors' which held that in respect of medicines the adequate test has to be 100% i.e to the fullest extent.

Hence the Controller stated that it was unclear from the Applicant's submission whether one million patients need SAXAGLIPTIN despite other alternatives such as Linagliptin, Sitagliptin and Vildagliptin. In the absence of authentic data, there is no way to understand the exact requirements of SAXAGLIPTIN in Indian market to decide or not whether the patentee is meeting with the reasonable requirements of the public in respect to patented invention.

With regards to the above mentioned details, the Controller stated that a prima facie case has not been made out by the Applicant to the effect that the reasonable requirements of the public with respect to the patented invention are not being satisfied and therefore, no case is made out in terms of Clause (a) of section 84 of the Indian Patents Act.

Section 84(1)(b) – That the patented invention is not available to the public at a reasonably affordable price

The Applicant submitted that excessive high price of SAXAGLIPTIN is a barrier for the poor patients in India hence, it is unavailable to a general public at a reasonably affordable price. The Controller again quoted Bayer v. Union of India to hold that the Controller does not have any power of investigations to arrive at a reasonably affordable price, and that such a price must be arrived at on the basis of evidence led by the parties.

The Controller observed that the prices of other DPP-4 inhibitors available in the Indian market despite such large volumes and side effects are also in the same range (Rs.42 to 58) which are at par with the patentee's SAXAGLIPTIN (i.e Rs.41 to 49) based on the daily requirements. Based on the figures submitted by the patentee in Form-27 on 10/02/2014 the Applicant calculated the cost of importing one tablet of ONGLYZA and KOMBIGLYZE in India by the Patentee is only about Rs.0.80 and Rs.0.92 respectively. But the Applicant priced two medicines ONGLYZA and KOMBIGLYZE in the range of Rs.41 to 49 per tablet. Therefore, the Applicant alleged that the patentee remain a monopoly due to high pricing of the drugs despite the small amount of cost involved in manufacturing/importing a single tablet.

However, ironically the Applicant in its application for Compulsory Licensing initially proposed it selling price as Rs.27 to 32 per tablet but eventually revised its price during hearing held on 15/12/2015 in the range of Rs.11 to 16.

It was highlighted by the Controller that the Applicant in its submissions has not furnished the details of reasonable requirements of the public with respect to SAXAGLIPTIN, the comparative requirements of SAXAGLIPTIN and other DPP-4 inhibitors Lindagliptin, Sitagliptin and Vildagliptin or any authentic data or statistics on SAXAGLIPTIN prescription by the doctors over the other DPP-4 inhibitors. Hence in the absence of all the critical data above, the question of SAXAGLIPTIN'S availability and affordability can't be determined. Therefore the Applicant failed to prima facie show that the patented invention is not available to the public at a reasonably affordable price.

Section 84 (1) (c): That the patented invention is not worked in the territory of India

The Controller in this regard reasoned his findings from the judgment of Honorable Bombay High Court in the Bayer case, that to manufacture in India is not a necessary pre condition in all cases to establish patent's working in India. However, the onus is on the patent holder 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. Hence the Controller stated that in the present application since the Applicant has failed to show the exact requirement of SAXAGLIPTIN in terms of the 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.

Conclusion

In the above case, the Applicant has failed to provide evidence along with application or during hearing or supplementary submission. Further, the Applicant had failed to convince the Controller regarding any of the grounds specified under Section 84(1) of the Patents Act, therefore the Controller rejected the application for Compulsory License with a view that a prima facie case has not been made out under Section 84 of the Indian Patents Act.

Footnotes

1 http://www.ipindia.gov.in/iponew/compulsoryLicense_ Application_20January2016.pdf

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