Start afresh

The report of the R A Mashelkar-headed technical experts group (TEG) has been embroiled in bitter controversy ever since it was presented to the government over a month ago. But the charges of plagiarism that have led now to the withdrawal of the report by the panel's chairman raise questions that go beyond these dissensions. As it happens, the portions of the report that were allegedly copied from a paper published by a UK-based, industry-friendly think tank, strengthen the argument of the report's critics that the TEG recommendations favour multi-national drug companies, at the cost of home-grown companies. It would be best if the committee is now asked to forget the whole issue, because anything that it now says will face a credibility gap, and to appoint a new committee that will go into the issue, de novo.

The Mashelkar committee report had held that the Indian patent law, as amended in 2005 after protracted deliberations, was incompatible with the trade-related intellectual property rights (TRIPs) agreement of the World Trade Organisation (WTO). As such, it suggested that the law should be amended so as to extend patenting to the new forms and uses of older entities, including those of products whose patents had expired. This caused concern in a large section of the domestic industry which feared that such a provision would create room for ever-greening of patents by international firms""who would claim new or incremental uses for old molecules and products. This would bring more drugs under (virtually indefinite) patent protection, and lead to higher prices.

The other major conclusion of the Mashelkar panel""that the exclusion of micro-organisms per se from patent protection would be violative of TRIPs provisions""had evoked equally strong reactions. Microbes are of immense commercial importance for the entire bio-science industry, as they are donors of valuable genes, antibiotics, enzymes, proteins and other ingredients. The apprehension here has been that the patenting of microbes, which are the creation of nature, would limit access to them for the development of new drugs and other commercial products. TRIPs does provide for the patenting of microbes and the bio-technology processes applied to them, but most other global conventions on intellectual property leave the microbe-patenting regime fairly vague. This is true for the global Convention on Biological Diversity (CBD) and the Budapest Treaty on International Recognition of Micro-Organisms, administered by the Geneva-based World Intellectual Property Organisation (WIPO). What blurs the picture even further is the stand taken by several United Nations-sponsored bodies, that germplasm like microbes should be freely exchangeable for the generation of products and processes, the objective being the welfare of humankind rather than the commercial interests of a few. But these organisations are silent on the microbial collections that have already been patented by companies in different countries under their domestic laws.

In view of all this, it is clear that there is need for a fresh look at the whole issue of patentability. A good opportunity for doing so has been provided by Prof. Mashelkar withdrawing his committee's report. However, his offer to produce a freshly cast document will only lead to extending the life of the controversy over the panel's views and how it arrived by them. It would be wiser to apply closure to this chapter and start a fresh examination of the complex issues involved.