Much water had flown down the bridge thereafter, which we shall not deliberate upon here. Ultimately in March 2009 the TEG submitted its revised report.
In terms of overall content, the revised report is similar to the previous one, which was withdrawn earlier.
Conclusions of the revised TEG report:
The conclusions of the report against the terms of references given to the TEG are as follows:
1. “It would not be TRIPS compliant 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’. However, every effort must be made to provide drugs at affordable prices to the people of India. Further, every effort should be made to prevent the grant of frivolous patents and ‘ever-greening’. Detailed Guidelines should be formulated and rigorously used by the Indian Patent Office for examining the patent applications in the pharmaceutical sector so that the remotest possibility of granting frivolous patents is eliminated.”
2. “Excluding micro-organisms per se from patent protection would be violative of TRIPS Agreement.”
Does section 3(d) warrant an amendment now?
It is indeed interesting to note that under Para 5.11 the TEG says, “the committee 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 into these issues.”
However, in Para 5.32 the report observes the following:
“Innovative incremental improvements based on existing knowledge and existing products is a ‘norm’ rather than an ‘exception’ in the process of innovation. Entirely new chemical structures with new mechanisms of action are a rarity. Therefore, ‘incremental innovations’ involving new forms, analogs, etc. but which have significantly better safety and efficacy standards, need to be encouraged.”
With this observation, TEG has also clarified the scope of section 3(d), indirectly though.
The report further recommends, “detailed Guidelines should be formulated and rigorously used by the Indian Patent Office for examining the patent applications in the pharmaceutical sector so that the remotest possibility of granting frivolous patents is eliminated.”
What next?
It will be interesting to watch what the Department of Industrial Policy and Promotion (DIPP) does with this revised report. As we have seen that the report categorically states:
“It would not be TRIPS compliant 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”
And
“Innovative incremental improvements based on existing knowledge and existing products is a ‘norm’ rather than an ‘exception’ in the process of innovation. Entirely new chemical structures with new mechanisms of action are a rarity. Therefore, ‘incremental innovations’ involving new forms, analogs, etc. but which have significantly better safety and efficacy standards, need to be encouraged.”
Therefore, taking these two recommendations together my questions are as follows:
1. Will the DIPP conclude that Section 3(d) of the Patent Acts 2005 is not TRIPS compliant?
2. If so, will the DIPP recommend an amendment of this section sooner to encourage ‘incremental innovation’ within the country?
3. If not, will the DIPP clarify now the need, purpose and the importance of this report?
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.