1. Whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps.
2. Whether it would be TRIPS compatible to exclude micro-organisms from patenting.
Today I shall restrict my comments only on the point 1 of the terms of reference. Keeping this mind, let me try to analyze what various stakeholders had expected from the report. Against those expectations, what the report has actually articulated. And how have all these comments/ recommendations been able to keep almost all the stakeholders, with widely varying expectations, reasonably happy.
Why is the revised report a ‘please all’ report?
The key stakeholders who were interested in the revised report are as follows:
A. Research-based pharmaceutical companies who expressed concerns on the patentability of ‘incremental innovation’.
B. The Government of India (GoI) who may not be keen to revisit section 3(d) of the Indian Patents Act 2005, at least for now.
C. All voices supporting price regulations for patented products, in some form, the Department of Pharmaceuticals (DoP) being one of them.
D. Domestic generic pharmaceutical companies who want safeguards within Indian Patents Act 2005 against ‘ever greening’ of patents to ensure that there is no delay in launching generics after patent expiry.
Well crafted and well reasoned revised report from the TEG has been able to please all these stakeholders, to a great extent, which I shall analyze hereunder:
A. Expectations of the Research-based pharmaceutical companies from the report:
The research-based pharmaceutical companies seem to have expected that the report will recommend in specific terms that Section 3(d) of the Patents Act 2005 is not TRIPS compliant, as it restricts patentability of ‘incremental innovation’.
What the report actually says:
- “The Technical Expert Group (TEG) concludes that it would not be TRIPS compliant (Article 27 of TRIPS) to limit granting of patents for pharmaceutical substance to New Chemical Entities only, since it prima facie amounts to a statutory exclusion of a field of technology”.
- “The process of innovation is continuous and progressive leading to an ever extending chain of knowledge. Innovative incremental improvements based on existing knowledge and existing products is a ‘norm’ rather than an ‘exception’ in the process of innovation.”
“The TEG carefully examined the flexibilities allowed under the TRIPS Agreement to the member states (especially Articles 7 & 8 ) and also as a consequence of the Doha Declaration. The detailed analysis and reassessing provided in the report has led TEG to conclude that it is debatable as to whether national interest or the flexibility allowed under the agreement to member states would be accommodated by such ‘statutory exclusion’ of an entire class of (incremental)inventions.”
Very cleverly dodging the section 3(d) issue, the report supported the argument of the research-based pharmaceutical companies that ‘incremental innovation’ in pharmaceuticals cannot summarily be kept out of the criteria of patentability.
B. Government of India (GoI):
The GoI wanted to keep section 3(d) unchanged, till some sort of stakeholders’ consensus is arrived at in favor of its amendment, if at all.
What the report actually says:
“The TEG was not mandated to examine the TRIPS compatibility of Section 3(d ) of the Indian Patents Act or any other existing provision in the same Act. Therefore, the committee has not engaged itself with these issues.”
The TEG with this comment keeps the GoI satisfied, as the lawmakers are of the view that section 3(d) is not against incremental innovation. They believe, section 3(d) helps to avoid ‘frivolous’ innovation and ‘evergreening’ of patents by ensuring that all patentable ‘incremental innovations’ have ‘properties leading to incremental efficacy’. The revised TEG report, some people argue, vindicates this important point.
C. All voices supporting some form of price regulations of patented products, which include the DoP.
Both the DoP and other stakeholders want to keep the price of patented products under GoI control.
What the report actually says:
“Every effort must be made to provide drugs at affordable prices to the people of India”.
Thus the report satisfies the proponent of ‘affordable prices’ for patented products
D. Domestic generic pharmaceutical industry:
A large majority of the domestic generic pharmaceutical companies is of the opinion that most ‘incremental innovations’, are usually attempts to ‘evergreen’ patents for sustained commercially monopoly over the products for a much longer period of time than what it should have been otherwise. Hence patentability for ‘incremental innovation’ is to be restricted by law.
What the report says:
“TEG recommends that every effort must be made to prevent the practice of ‘ever greening’ often used by some of the pharma companies to unreasonably extend the life of the patent by making claims based sometimes on ‘trivial’ changes to the original patented product. The Indian patent office has the full authority under law and practice to determine what is patentable and what would constitute only a trivial change with no significant additional improvements or inventive steps involving benefits. Such authority should be used to prevent ‘evergreening’, rather than to introduce an arguable concept in the light of the foregoing discussion (paras 5.6 – 5.8 and paras 5.12 – 5.29) above of ‘statutory exclusion’ of incremental innovations from the scope of patentability.”
Many will believe, with the above recommendations in their revised report, the TEG also meets the expectations of the domestic generic pharmaceutical industry, on this contentious issue.
The revised report of ‘The Mashelkar committee’ has definitely addressed its terms of references, pretty well. However, being ‘advisory’ in nature, the report was expected to be more specific, unambiguous and directional. Unfortunately, the comments/recommendations are neither specific without any ambiguity nor directional in nature; unless, between the lines the ‘please all’ report suggests its agreement with all stakeholders in unison, with perfect balance and elan, without making even a slightest attempt to ‘rock the boat’ in any manner, whatsoever.
By Tapan Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.