The Hindu Business Line : Intellectual property report favours conditional patenting of micro-organisms

Mumbai, April 23 Without much ado, the Technical Expert Group on Patent Law Issues headed by Dr R.A. Mashelkar has resubmitted its report to the Union Ministry of Commerce.

Dual mandate

And though the report has taken a line similar to the governing law on patentability of new chemical and medical entities, it has departed from the norm in suggesting that keeping micro-organisms, per se, outside the ambit of patent protection would be violative of the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement.

In 2007, the Group’s report had stirred a hornet’s nest, following allegations of plagiarism and it was subsequently withdrawn, with the Chairman Dr Mashelkar seeking Government approval to “re-examine it and resubmit a report, which meets with the requirements of the highest standards”. The Group had been given a dual-mandate in 2005, to see if a pharma patent could be given only to a new chemical or new medical entity with one or more inventive steps; besides evaluating whether it would be TRIPS-compatible to exclude micro-organisms from patenting.

The report will be evaluated by the Union Commerce Ministry, following which it would be decided on whether the recommendations would be taken up with other ministries or the Cabinet, said a source familiar with the development.

Avoiding ambiguity

With the country being in the election-mode, recommendations of the report have not yet elicited major responses from the pharma industry. However, intellectual property (IP) experts say that the report could have dealt with greater clarity on limiting patents only to new chemical and medical entities, keeping out qualifications that give rise to ambiguity.

The amended Indian Patent Law does not allow “evergreening” of patents, where a known drug molecule is tweeked and a fresh period of patent exclusivity is sought. Incremental innovations needed to establish greater efficacy, according to the prevailing law.

Patenting needs

On patenting micro-organisms, pharma industry experts and IP lawyers point out that the Convention on Biological Diversity (CBD) needs to prevail over TRIPS in developing countries like India, a position that the country has been pushing for globally. The CBD pushes for disclosure of the source of the micro-organism and a benefit sharing mechanism with the community that has traditionally been using this knowledge.

In fact, Justice Mr V.R. Krishna Iyer, in his observation says “that micro-organisms, which occur in nature and which at best, could be regarded, as discoveries cannot constitute patentable inventions. There should be no patent protection in respect of such cases.”

But on the ground, bio-prospecting has already started by drug companies. Piramal Healthcare (that has tied-up with Government-run institutions) and Novartis have expressed plans to screen bio-diverse resources in the country to develop medicines from natural sources.

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