This article makes an attempt to view the interpretation of Section 3(d) by the Intellectual Property Appellate Board (IPAB) in the case of Novartis v. UOI, from a policy perspective. The IPAB rejected the patent application filed by Novartis for Glivec/Gleevec on the grounds that it was a “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance”, and hence, barred by Section 3(d) of the Patents Act, 1970. The decision of the IPAB was appealed almost immediately before the Hon’ble Supreme Court of India in 2009. However, hearings on the matter in the Supreme Court of India were delayed for a number of reasons and as on date, the matter is being argued before the Supreme Court of India.Having said that the article analyzes the decision from a policy perspective, we should clarify that this article does not deal with the public policy objective of Section 3(d); to the extent that Section 3(d) was intended to curb certain illegitimate patent practices which, among others, have been termed as ‘evergreening’ of patents, this issue has been briefly addressed in our previous articles. Rather, we will consider the practical and policy implications of the manner in which Section 3(d) has been interpreted by the IPAB and how it is likely to be applied in future cases as a result. While there are, of course, a number of issues and questions which are to be decided by the Hon’ble Supreme Court of India, the scope of our policy analysis is limited to the question of the evidentiary basis for the rejection of Novartis’s patent application and its possible implications on how the efficacy requirement may be met in future cases. What, for example, is the standard of proof required to fulfill the efficacy requirement? On whom does the burden of proof lie and at what stage must it be discharged? More importantly, how may the burden of proof be discharged? Most significantly, how would this affect the incentives of applicants to innovate and to patent their innovations? None of these questions have been deliberated, even in passing, in the various decisions by the Madras High Court, the IPAB and the Patent Controller, nor has it been considered in the limited literature that has been generated on the issue of Section 3(d). These are important questions that face the Indian intellectual property regime. Indeed, these questions must be faced, and answered, by any jurisdiction which hopes to attempt to curb the illegitimate ‘evergreening’ of patents whilst also encouraging legitimate incremental innovation in all fields of science and technology. This, therefore, is our attempt at providing answers to some of these questions facing jurisdictions hoping to implement a provision similar in effect to Section 3(d). It must be understood, of course, that none of the answers we hope to provide can be definitive; indeed, we would not wish them to be – controversial questions of policy are not, and should never be, susceptible to rigidly definitive answers. Instead, our attempt is as much to provide answers as it is to provoke thought and stimulate further debate and discussion on these contentious issues. Our self-imposed limitation will not limit the scope of our analysis, since we hope to show that such an analysis of the policy aspects and practical implications of implementing and enforcing a provision such as Section 3(d) is an important one. For one thing, such an analysis will serve to inform decision makers within the Indian legal system, especially the judiciary and the executive, as to how best one might approach the task of interpreting and applying Section 3(d). More importantly, if at all a unique provision such as Section 3(d) is to be considered a successful legislative achievement which ought to be implemented elsewhere, the policy aspects as well as the practical implications (including, but not limited to evidentiary requirements) of Section 3(d) can and should be given due consideration and regard. With the arguments before the Supreme Court already underway, it is important to visit the implications of the impugned IPAB decision and the factors that the Hon’ble Supreme Court of India may take into consideration in deciding the matter.
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Jan 1, 2015
Hüseyin Öz + 2
Open Access
