India – Mashelkar Report Republished

The report of the Technical Expert Group on Patent Law Issues, led by RA Mashelkar, was resubmitted to the Union Ministry for Trade and Commerce in March 2009. It was first submitted in December 2006 and was withdrawn for review owing to some technical inaccuracies in the Report.

Mashelkar and a team of technical members were given the task of verifying the limits of patentability of pharmaceutical substances and the exclusion of microorganisms from patentability in the content of the TRIPs Agreement.

The Mashelkar Committee Report (as it is popularly known) seeks to extend the scope of India’s patentability criteria for new drugs in India to include incremental pharmaceutical inventions.

The revised Report reasserts the same conclusions and recommendations, which are that an attempt to exclude incremental pharmaceutical inventions could violate the mandate under Article 27 of TRIPs to grant patents to all inventions in all fields of technology. It states that restricting pharmaceutical inventions to new chemical entities only would exclude a field of technology, even when they satisfy the basic criteria of patentability. The report favors a patent system which encourages “incremental innovations involving new forms, analogues, etc but which have significantly better safety and efficacy standards.”

At the same time, the Report emphasizes the need for “the patent office to be vigilant about setting high standards of judging such innovations so that efforts on ‘evengreening’ are scrupulously prevented.” It states: Every effort must be made to prevent the practice of evergreening 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 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 t prevent evergreening.

It adds that every possible effort should be made to ensure availability of drugs at affordable prices to the people of the country. In this respect, the Report highlights the need for “detailed guidelines to 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.”

It is notable that India is yet to unambiguously define certain fundamental aspects of patenting in the Patent Law such as patentability and data exclusivity, even though the product patent regime was enforced from January 1 2005, following TRIPs obligations.

On patentability of microorganisms, the Report endorses it earlier view that excluding them from patentability would contravene TRIPs. However, the Report highlights the need for strict guidelines to be formulated for examination of patent applications involving microorganisms, from the point of view of substantial human intervention and utility.

In this respect, the Mashelkar Committee has commented that it is in the interest of the Indian biotechnology industry to “protect and modify new microorganisms isolated from various part of our country, and find their new and improved uses”.