This document discusses an application by Lee Pharma to the Indian patent office for a compulsory license on AstraZeneca's patented anti-diabetic drug saxagliptin. The controller rejected the application on the grounds that Lee Pharma did not adequately demonstrate that the patented invention was not meeting the reasonable requirements of the public, was not available at a reasonably affordable price, or was not being worked in India's territory.

1. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
ASTRA
ZENECA
Vs
LEE PHARMA
KIRANMAYI N
PATENT
DEPARTMENT
COMPULSORY
LICENSING

2. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
COMPULSORY LICENSING
• Any time after the expiry of 3 years from date of grant of a patent,
any person interested may make an application to controller for
grant of Compulsory
Reasons for filing Compulsory license Section 84:
• The reasonable requirements of public with respect to the
patented invention have not been satisfied; and
• The patented invention is not available to the public at a
reasonably affordable price; and
• The patented invention is not worked in the territory of India.

3. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
(Anti cancer Drug)
Natco Pharma Co.
Against
Bayer
(Anti cancer Drug)
BDR Pharma
Against
BMS

4. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
VsVs
Assignee: Astrazeneca API: Saxagliptin
Applicant: Lee Pharma Category: Anti Diabetic –Type II
 Request for License – May 2014 [Unavailable to Public at an affordable Price]
 AstraZeneca seeked certain clarifications
 One year lapsed - some communication failure
 Lee Pharma then decided to approach the Controller of Patents.
Brand name: Onglyza , Kombiglyze XR(API + Metaformin)
Patent No: 206546
Title “A Cyclopropyl-fused pyrrolidine-based compound”
Granted date : 30th
April 2007 to BMS (Bristol Myers Squibb).

5. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• Feb , 2014 - BMS assigned to AB
• June, 2015 - Lee Pharma seeking CL
Based on the evidences submitted to the Controller by the applicant.
Lee Pharma had made efforts to obtain a license from the patentee on
mutually agreeable terms and a reasonable period as envisaged under
Section 84(6) of the Act had elapsed without the efforts being
successful.

6. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
Section 84 (1)(a)
The applicant submitted data and statistics to show that the
reasonable requirements of the public had not been satisfied by
the patented invention. However, due to the availability of
substitutes to the drug under question, the Controller found that
a case could not be made out by the applicant to the effect that
the reasonable requirements of the public were not being
satisfied.

7. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
Section 84 (1)(b)
Controller observed that the Lee Pharma’s proposal to sell
the drug in the range of Rs 27 to 31.50 per tablet was
paradoxical to its claim that AstraZeneca’s drug was not
available to the public at a reasonably affordable price,
because the selling price range proposed by Lee Pharma
was several times the alleged cost of import and thus the
applicants own argument went against itself, and hence no
case was made out in terms of clause (b) of sub-section (1)
of section 84 of the Patents act.

8. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
Section 84 (1)(c)
Controller pointed out that it had been clearly borne out from the
judgment of the Hon. Bombay High Court in the Bayer case and the
IPAB in the same case that, “manufactured in India is not a necessary
precondition in all cases to establish working in India and that the patent
holder however is required to establish the reasons which make it
impossible / prohibitive to manufacture the patented drug in India,
particularly when the patentee has manufacturing facilities within the
country”. In this light, the Controller observed that the Applicant had not
submitted any data relating to the manufacturing facilities of the
Respondent within India and thus failed to make a case that the invention
was not being worked in the territory of India.

9. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
CONCLUSION
Lee Pharma could not make prima facie case.
Grant of Compulsory License was rejected.

10. CHENNAI
C2-A, Industrial Estate,
Guindy,
Chennai - 600 032.
Tel: +91 - 44 – 42104341/ 7341
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 65462400
COIMBATORE
#1533, Trichy Road,
Coimbatore – 641018.
Tel: +91 - 422 - 6552921
HYDERABAD
Flat No. A-701,
Brindavan Apartments,
Niloufer Hospital Road,
Redhills, Hyderabad - 500034.
Tel: +91 - 40 - 60506009
COCHIN
Suite 49, 8th Floor, Centre A,
Alapatt Heritage Building,
MG Road, Cochin – 682035
Tel: +91 - 484 - 6506216
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
CONCLUSION
Lee Pharma could not make prima facie case.
Grant of Compulsory License was rejected.