The committee was set up following the passing of the controversial The Patents (Amendment) Bill 2005, which led to concerns over whether certain measures would be in violation of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
Specifically the committee was to asses: “whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity [NCE] or to new medical entity involving one or more inventive steps; and whether it would be TRIPS compatible to exclude micro-organisms from patenting."
Some factions within India want patents limited to NCEs, which would prevent companies from protecting “incremental innovations” but the committee has deemed that this is in violation of TRIPS.
The concern surrounding “incremental innovations” is based on allegations that pharma performs “ever-greening”, which is designed to increase a product’s lifecycle with spurious patents.
This is viewed as a threat to the generics industry and the availability of affordable medicines and the committee acknowledges this but insists that “incremental innovations” are fundamental to the pharmaceutical industry.
It states: “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’.”
The Indian patent office has the authority protect against “ever-greening” and the committee believes it must decide what constitutes “a trivial change with no significant additional improvements or inventive steps involving benefits”.
Patenting of microorganisms
The committee also assessed if the prohibiting the patenting of microorganisms is in violation of TRIPS. Patenting of microbiological inventions covers “methods to isolate and obtain new organisms, improve their character, modify them and find their new and improved uses”.
In the report the committee states that Indian patent law allows the patenting of microorganisms and that to prohibit this would be in violation of TRIPS.
The complete document can be found here.