Name of Lead Author: Rujitha Shenoy and Madhuri Anand
Organization: Inter University Centre for IPR Studies
Right to health has become a fundamental right, but access to medicine still remains as unreachable to humankind. In this context Intellectual property, Patents as a factor for non availability/un affordability of the medicine , authors attempt to examine the effectiveness of Section 3(d) of Indian patent Act in preventing patenting of incremental innovations and balancing inventors rights. Whether balance can be attained between inventors rights and access to medicine. Also how far pre-grant opposition helped in maintaining the quality of patent based on the standards. study will be conducted to find out whether Section 3(d) could be adopted as a model for maintaining a balance of inventors rights with providing access to medicine for the humanity
Role of Section 3(d) under Indian Patent Act: Balancing inventors rights and access to medicine
Background of the study
Access to essential medicines - as part of the right to the highest attainable standard of health ("the right to health") is well-founded in international law. The right to health first emerged as a social right in the World Health Organization (WHO) Constitution (1946) and in the Universal Declaration of Human Rights (1948).One of the factor which hinders access to medicine is its high cost due to patent protection. While right to health has emerged as human right the attempt is to examine how Indian patent act balances access to medicine and right of the inventor.
The origin of patent law in India can be traced back to 1853 when we were under the dominion of British rule. The Indian law then was similar to the UK patent Act where product and process patents prevailed without difference on all inventions from different industrial sectors. The 1911 Patent Act made Indian pharmaceutical industries really struggle to thrive in this patent regime. After independence, our policy was to bring up industries, mainly pharmaceutical industries, considering the economic conditions of the country as well as social impact of those industries. Justice Rajagopala Ayyangar committee Report resulted in the revamping of the Indian patent regime. One of the major steps was limiting patent protection of pharmaceutical inventions to processes in the pre-TRIPS era. The Patent Act of 1970, contained an express prohibition dealing with patentability of pharmaceutical products; however, it permitted patents on processes for making pharmaceutical compounds, even though the duration of those patents was shorter than other types of patents. This made India emerge as a globally recognized producer of low-priced generic drugs and leading exporter of medicines.
India’s patent law began to take a different course with its accession to the World Trade Organization and signing of TRIPS Agreement in 1995. Changes were made to the Patent Act to make it TRIPS complaint. The amendment inter alia reintroduced patenting of pharmaceutical products which was excluded by 1970 Act along with product patents. Some of the curative measure adopted by India so as to compact with product patent regime were by tightening the Section 3(d) in 2005 by incorporating the term ‘which does not result in the enhancement of the known efficacy of that substance to lessen the ill effects of product patent for pharmaceuticals’. The objective of this amendment was to prevent incremental innovations, especially in pharmaceuticals, getting property rights. The intention of the Parliament was to prevent the extension of patent life by ever greening, i.e. trying to extend patent protection by obtaining separate patents on multiple attributes of a single product and to ensure that monopoly privileges are not available for new forms without significant evidence of improvement.
In the much debated case of Novartis AG v. Union of India, the Supreme Court of India finally settled the true import of Section 3(d) of Indian Patent Act. The issue before the court was whether the appellant/Novartis is entitled to get the patent for the beta crystalline form of a chemical compound called Imatinib Mesylate which is a therapeutic drug for chronicmyeloid leukemia and certain kinds of tumours and is marketed under the names Glivec. By applying Section 3(d) the court interpreted the term efficacy as“the test of efficacy would depend upon the function, utility or the purpose of the product under consideration in the case of a medicine that claims to cure a disease, the test of efficacy can only be ‘therapeutic efficacy”. The physico-chemical properties cannot even be taken into account for the purpose of the test of Section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy. Even increased bioavailability alone may not necessarily lead to an enhancement of therapeutic efficacy. Thus court held that beta crystalline form of Imatinib Mesylate is not patentable.
The objective of the research is to make a study on how the Patent Office of India dealt with the patent application relating to pharmaceutical products in the light of the Supreme Court decision on Novartis case and the interpretation given to the term “efficacy” of Section 3(d). This will include the total number of patent applications that dealt with Section 3(d); the number of applications rejected based on Section 3(d) and the number of patent granted. Attempt will also be made to trace whether the pre-grant oppositions were filed against these applications and in such cases what is the impact in implementing section 3(d) by the Patent Office.
- To study the effectiveness of Section 3(d) in preventing patenting of incremental innovations and balancing inventors rights with providing access to medicine
- To study the pre-grant oppositions if any, to see how patent offices in India handled such oppositions post Novartis case and the contribution of pre-grant opposition in maintaining the quality of patents based on the standards laid down in Novartis case
- How far has Section 3(d) been effective in preventing the ever greening of patents after the Novartis case?
- Whether Section 3(d) could be adopted as a model for maintaininga balance of inventors rights with providing access to medicine
- Whether the pre-grant opposition helped in maintaining the quality of patent based on the standards laid down in Novartis case?
Collect all the patents issued or rejected relating to pharmaceutical substances based on Section 3(d) after Novartis case by the Indian Patent Office and study them to find out how the Patent Office interpreted and implemented Section 3(d). To collect all the materials relating to pre-grant opposition filed in cases relating to patent applications for pharmaceutical substances after Novartis case from patent offices of India and find out their influence in deciding the application of Section 3(d). The countries having similar provisions to pre grant oppositions or identical provisions will be identified to study effectiveness of pre grant oppositions in preventing ever greening of patents and there by providing access to medicine and quality patents on drugs. ( Expenses incurred for collecting data from patent offices in Delhi Chennai Mumbai. Time period One Year for the completion of the project.
Section 3(d) of Indian Patent Act along with pre grant opposition prevents ever greening of patents and ensures quality of patents on pharmaceutical substances tus ensuring balance of inventors rights and access to medicine.
Bibliography and References
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- FICC’s position on section 3(d) of Indian Patent AcT
 Report on Patent the revisions of the patent laws by Justice N Rajagopala Ayyangar, 1959
 Patent Act, 1970 section5 (a)-(b) and section 53
 Janice M. 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, 514 (2007).
 “Evergreening” is a term used to label practices that have developed in certain jurisdictions wherein a trifling change is made to an existing product, and claimed as a new invention.
 Novartis v UOI, SCC 2013
 SCC 2013
 Ibid p.90
 Id p.93