Incremental Innovation – Indian IPR Policy Issue

V.V.Sople1 and Vishal Dakhole2

1Institute for Technology and Management, 25/26, Institutional Area, Sector 4, Kharghar, Navi Mumbai. - 410210, Maharashtra, India
2Nectar Life sciences Ltd, Chandigarh, India
1E-mail: vvsople@itm.edu, 2E-mail: vishaldakhole@gmail.com

Abstract

Great innovation builds on what comes before it. For granting patents to small changes to known drugs, the challenge before the patent granting authority is to distinguish between incremental innovation and evergreening, that is, extending the life of patent for changes that do not involve an inventive step. Section 3(d) of Indian Patent (amended) Act 1970 does not allow patent for derivatives for an incremental innovation provided a new derivative exhibits significant increase in efficacy. This has initiated court wars in India challenging constitutional validity of Section 3(d).

The question is whether such patents are needed in India? The other countries may be granting patents for incremental innovation and their government thinks that "patents" encourages innovation. However, the criterion for granting patent in those countries for incremental innovation is well defined and is based on novelty, non-obviousness and inventive step.

It is fact, patent applicants find it difficult to satisfy the enhanced ‘efficacy test’ at the stage of filing an application. Due to lack of clear and transparent guidelines for defining 'efficacy' in Indian IPR Act, it is likely that for some 'real  good' products research efforts may have to be abandoned considering criteria of efficacy, raising issue on IPR policy to resolve. This paper discusses the issue of granting the patent rights to ‘incremental innovations’ and simultaneously preventing "evergreening" and patenting of worthless inventions, by properly defining and interpreting the term 'inventive step. The objective of the research is to find out whether the incremental innovation issue is resolved through proper policy directives so that innovative spirit amongst the researcher will not get back seat and simultaneously ‘evergreening’ is prevented. 

Keywords: Evergreening, Inventive Step, Drug Efficacy, Novel Drug Delivery System