Report on pharma patents retains key conclusions

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A revised version of the Mashelkar Committee report, which concerns patents for pharmaceutical substances and micro-organisms, was recently presented to the government. The Technical Expert Group (TEG) on Patent Law Issues, more commonly known as the Mashelkar Committee, was constituted under the chairmanship of Dr RA Mashelkar in April 2005. The TEG was set up to analyse two issues which were heavily debated in parliament before the enactment of the Patents (Amendment) Act, 2005.

The two issues were: (i) whether excluding micro-organisms from patent protection would violate article 27.3 of the Agreement on Trade Related Aspects of Intellectual Property Rights (the TRIPS agreement); and (ii) whether restricting the grant of product patents for pharmaceutical substances to new chemical entities (NCEs) or new medical entities (NMEs) involving one or more inventive steps would be TRIPS-compatible.

The TEG originally submitted its report to the government on 29 December 2006, but subsequently withdrew it following allegations of plagiarism. The TEG then resubmitted the revised report in March, and it has reportedly been accepted by the government.

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The legislative and regulatory update is compiled by Nishith Desai Associates, a Mumbai-based law firm. The authors can be contacted at nishith@nishithdesai.com. Readers should not act on the basis of this information without seeking professional legal advice.