Novartis AG v. Union of India and Glivec patenting

Reasons, Results and Repercussions of India’s fight against evergreening

  1. Janice Mueller, “The Tiger Awakens: The Tumultuous Transformation of India’s Patent System and the Rise of Indian Pharmaceutical Innovation”, 68 U. PITT. L. REV. 491,495 []
  2. Id []
  3. Vijay Yalamanchili, “State of India’s TRIPS-compliant Patent Regime”, 26 Biotech. L. Rep., 211 (2007). []
  4. Supra note 1, page 514 []
  5. Contribution of Agriculture to India’s GDP (in 2009-2010) was 14.62% http://www.in.undp.org/content/dam/india/docs/india_factsheet_economic_n_hdi.pdf (last visited 16th June 2014). []
  6. When they come up with the same product innovation, under product patenting only one firm is granted the patent for the product and so it emerges as monopoly, but under process patenting both the firms can get the patent for the product if they have different processes of production. Thus process patenting leads to more competition whereas product patenting lessens product market competition. Indian Statistical Institute, Economic Research Unit, Discussion Paper Series, Tarun Kabiraj, “Product vs. Process Patenting and R&D Incentiveshttp://www.isical.ac.in/~eru/erudp/2005-11.pdf (last visited 25 May 2014). []
  7. Rebecca S. Eisenberg, “Patents, Product Exclusivity, and Information Dissemination: How Law Directs Biopharmaceutical Research and Development”, 72 FORDHAM L. REv. 477, 479 (2003). []
  8. Carlos M. Correa, “Public Health and Patent Legislation in Developing Countries”, 3 TUL. J. TECH. & INTELL. PROP. 1, 3 (2001). []
  9. Official website of Gleevec, United States of America, http://www.gleevec.com/index.jsp?usertrack.filter_applied=true&NovaId=4029462109044365930 (last visited 26th May 2014). []
  10. Novartis AG v. Union of IndiaAIR 2013 SC 1311 []
  11. ‘Pyrimidine derivatives and processes for the preparation thereof’ US 5521184 A []
  12. http://www.medicines.org.uk/emc/medicine/15014/SPC/GLIVEC+Tablets/ last visited 26th May 2014 []
  13. Consumer Medicine Information, Glivec, Imatinib, http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/nvcglitb/$File/nvcglitb.pdf last visited 26th May 2014 []
  14. National Cancer Registry Programme. Two year report of the population based cancer registries 1999-2000. New Delhi: Indian Council of Medical Research; 2005. []
  15. Novartis pleaded before the Supreme Court that even though their drug is heavily priced, they ran several charitable programs under which the drug was provided free of cost to needy persons. However, when the Court asked the Company why they could not close the charitable program and use the same resources to bring down the price of the drug in general (without any adverse impact on their revenue) the Company could not give a satisfactory reply []
  16. Supra note 10 []
  17. World Bank’s poverty headcount ratio at $2 a day (Purchasing Power Parity), at 2005 international prices http://data.worldbank.org/indicator/SI.POV.2DAY last visited 26th May 2014 []
  18. http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm last visited 11th June, 2014 []
  19. Article 65 of TRIPS []
  20. Means a metaphorical “mailbox” where all applications received post 1st January 1995 shall be stored. However, they shall be decided upon only once the country enforces TRIPS. []
  21. Chapter IVA of Patents Act, 1970 (Omitted by the Patents (Amendment) Act, 2005 []
  22. Application No.1602/MAS/1998 []
  23. Ganapati Murdur, “Indian Patients Go to Court Over Cancer Drug”, 329 BRIT. MED. J. 419 (2004). One month’s dose of Gleevec costs $2,600, roughly ten times more than the generic versions. []
  24. Supra note 10 []
  25. The oppositions were made by M/s. Cancer Patients Aid Association, NATCO Pharma Ltd., CIPLA Ltd., Ranbaxy Laboratories Ltd., and Hetro Drugs Ltd. []
  26. Under Section 25(1) of Patents Act, 1970 []
  27. Section 3: “The following are not inventions within the meaning of this Act,- (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;” []
  28. Shamnad Basheer & Prashant Reddy, ““Ducking” TRIPS in India: A Saga Involving Novartis and the Legality of Section 3(d)”, National Law School of India Review, vol. 20(2), 2008 []
  29. Novartis AG v. Union of India (2007) 4 MLJ 1153 []
  30. Equal Opportunities Commission and Anr. v. Secretary of State for Employment, (1994) 1 AII ER. 910 []
  31. Equal Protection (Consolidation) Act, 1978 []
  32. EEC Treaty and Council Directives []
  33. UNCTAD-ICTSD, “Resource Book on TRIPS and Development”, 358 (2005). []
  34. Article 27, TRIPS Agreement, 1869 UNTS 299; 33 ILM 1197 (1994). []
  35. Ibid. []
  36. Article 1, TRIPS Agreement, 1869 UNTS 299; 33 ILM 1197 (1994). []
  37. Intervention petition by S. Basheer, before the Supreme Court in Novartis v. Union of India AIR 2013 SC 1311, http://spicyip.com/2012/11/a-successful-academic-intervention.html (last visited 2nd July, 2014). []
  38. Id []
  39. Hamdard Dawakhana and Anr. v. Union of India and Ors., AIR 1960 SC 554 []
  40. Ameeroonissa Begum v. Mehboob Begum, 1953 SCR 404 (414); Babulal Amthalal Mehta v. Collector of Customs, Calcutta, AIR 1957 SC 877; Gopi Chand v. Delhi Administration, AIR 1959 SC 609; Ashoka Smokeless Coal (P.) Ltd. v. Union of India, (2007) 2 SCC 640, 697 []
  41. In re Delhi Laws Act, AIR 1951 SC 332 []
  42. Girdhari Lal & Sons v. Balbir Nath Mathur, [1986] 1 SCR 383 []
  43. See Lok Sabha Debates (March 22, 2005), available at http://164.100.47.132/LssNew/psearch/result14.aspx?dbsl=1866 (last visited 7th July 2014). []
  44. Statement of Objects and Reasons, Patents Act, 1970 []
  45. Jyoti Pershad v. Union Territory of Delhi, AIR 1961 SC 1602 []
  46. Mafatlal Industries Ltd. v. Union of India, (1997) 5 SCC 536 []
  47. J.K. Industries Ltd. v. Chief Inspector of Factories Boilers, (1996) 6 SCC 665 []
  48. Balbir Singh v. M.C.D., AIR 1985 SC 339 []
  49. Ramkrishna Dalmia v. Tendolkar, Justice S.R., 1959 SCR 279; Jyoti Pershad v. Union territory, Delhi, AIR 1961 SC 1602 (1609);  Neimla Textile Furnishing Mills v. 2nd Punjab Tribunal, AIR 1957 SC 329 []
  50. The Patents (Amendment) Act, 2002 inserted Chapter XIX, which conferred IPAB with the jurisdiction to hear all cases pertaining to patents subject to the provisions of the Patents Act, 1970 []
  51. Zimmermann Patent, Patent Number 5521184, (May 28, 1996). []
  52. Synthon B.V. vs. Smithkline Beecham Plc, [2005] UK HL 59 []
  53. Black’s Law Dictionary, 9th edition, Pg. 901 []
  54. Oxford Advanced Learner’s Dictionary, Oxford University Press,Pg. 818 []
  55. Ibid. []
  56. Out of abundant caution []
  57. Asahi Kogyo KK’s Application, [1991 RPC 485] []
  58. Oxford Advanced Learner’s Dictionary, Oxford University Press,Pg. 489 []
  59. Dorland’s Medical Dictionary, 32nd Edition, Pg. 536 []
  60. Ibid. []
  61. John P Grif & John O’Grady, “The Textbook of Pharmaceutical Medicine”, 4th edition, (2002), Pg. 283 []
  62. Supra note 10 []
  63. An intervenor-cum-amicus in this case []
  64. Cf. Moffitt, Jane, “Appropriateness of Bioavailability and Bioequivalency as Pre-Market Clearance Considerations”, 34 Food Drug Cosm. L.J. 640 (1979) “It is not the intent of a bio-availability study to demonstrate effectiveness, but to determine the rate and extent of absorption. If a drug product is not bioavailable, it cannot be regarded as effective. However a determination that a drug product is bio-available is not in itself a determination of effectiveness.” []
  65. Section 2(l) of the Patents Act, 1970 []
  66. Section 14 of The Patents Act, 1970- “Consideration of the report of examiner by Controller- Where, in respect of an application for a patent, the report of the examiner received by the Controller is adverse to the applicant or requires any amendment of the application, the specification or other documents to ensure compliance with the provisions of this Act or of the rules made there under, the Controller, before proceeding to dispose of the application in accordance with the provisions hereinafter appearing, shall…” []
  67. Section 15 of The Patents Act, 1970- “Power of Controller to refuse or require amended applications, etc., in certain case- Where the Controller is satisfied that the application or any specification or any other document filed in pursuance thereof does not comply with the requirements of this Act or of any rules made there under, the Controller may refuse the application or may require the application, specification or the other documents, as the case may be, to be amended to his satisfaction before he proceeds with the application and refuse the application on failure to do so.” []
  68. Section 2(j) of The Patents Act, 1970- invention” means a new product or process involving an inventive step and capable of industrial application []
  69. Section 64(1)(e) of The Patents Act, 1970- “…that the invention so far as claimed in any claim of the complete specification is not new, having regard to what was publicly known or publicly used in India before the priority date of the claim or to what was published in India or elsewhere in any of the, documents referred to in section 13.” []
  70. Section 25(1)(d) of The Patents Act, 1970- “…that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim.” []
  71. Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, (1979) 2 SCC 511; Polar Industries v. Jay Engineering, (1991) IPLR 150 (Cal); Unique Transmission v. ESBI Transmission, (1990) IPLR 216 (CA). []
  72. Merrell Dow v. Norton, [1994] RPC 1 at 10. []
  73. Genentech Inc’s Patent, [1989] RPC 147. []
  74. Monsato v Coramandal, AIR 1986 SC 712. []
  75. Van der Lely N.V. v. Bamfords, [1963] RPC 61; Bugges Insecticide v. Herbon, [1972] RPC 197 []
  76. The General Tire and Rubber Co. v. The Firestone Type and Rubber Co. Ltd. and Orson’s) Application, [1975] RPC 127 []
  77. Ibid []
  78. Supra note 50 []
  79. Ibid. []
  80. US Board of Patent Appeals, Application No. 09/463, 097, (November 23, 2003). []
  81. Section 2(1)(ja): “Inventive step” means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art. []
  82. P. Narayanan, “Patents Law”, 6th Edition, Pg. 403. []
  83. Olin Mathieson Chemical Corporation v. Biorex Laboratories Ltd., [1970] RPC 157; General Tire & Rubber v. Firestone Tyre & Rubber, [1971] RPC 173. []
  84. Beecham Group Ltd.’s (Amoxycillin) Application, [1980] RPC 261 []
  85. Windsurfing International v. Tabur Marine, [1985] RPC 59. []
  86. Ibid. []
  87. Ibid. []
  88. Societe Technique De Pulverisation Step v. Emson Europe, [1993] RPC 513 (CA). []
  89. Technigraph Printed Circuits Ltd. v. Mills & Rockley (Electronics) Ltd., [1972] RPC 346 []
  90. Safveans Aktic- Bolag v. Ford Motor Co., (1927) 44 RPC 49 []
  91. Curtis & Son Ltd. Heward, (1923) 40 RPC 53 []
  92. Shaw v. Burnet, (1924) 41 RPC 432 []
  93. Beecham Group Ltd.’s (Amoxycillin) Application []
  94. Published by the Office of Controller General of Patents, Designs & Trademarks, available at http://www.ipindia.nic.in/ipr/patent/manual/main%20link.htm (last visited 2nd July, 2014). []
  95. S. Basheer raised these questions in his petition as an intervener. See Supra note 36. []
  96. Supra note 10 []
  97. Alan C. Marco, “The Value of Certainty in Intellectual Property Rights: Stock Market Reactions to Patent Litigation”, Vassar College Economics Working Paper No. 82, November 2005. http://irving.vassar.edu/VCEWP/VCEWP82.pdf (last visited 2nd July, 2014). []
  98. J. O. Lanjouw and J. Lerner, “The Enforcement of Intellectual Property Rights: A Survey of the Empirical Literature”, NBER Working Paper No. 6296, December 1997. []
  99. Linda L. Lee, “Trials and TRIPS-ulations: Indian Patent Law and Novartis AG v. Union of India”, Berkeley Technology Law Journal, vol. 23, Issue 1, February 2014 pp. 310. []
  100. India would be in breach of Article 27.1 if its non-obviousness standards were so rigid such that an invention would require an “inventive leap” rather than an “inventive step”. Rochelle C. Dreyfuss & Andreas F. Lowenfeld, “Two Achievements of the Uruguay Round: Putting TRIPS and Dispute Settlement Together”, 37 VA. J. INT’L L. (1997), pp. 298. []
  101. Janice Mueller, “The Tiger Awakens” Supra note 1 pp. 533 []
  102. In re Hummer, 44 CCPA 814, 241 F2d 742, 112 USPQ 66 (1957). []
  103. Vikram Deo Singh Tomar .v. State of Bihar , AIR 1988 SC 1782 []
  104. Jeremy Bentham, “An Introduction to the Principles of Morals and Legislations”, 1, Dover Publications (2007). []

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