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Astra zeneca vs lee pharma

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Astra zeneca vs lee pharma

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Astra zeneca vs lee pharma

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.

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