By Rajesh Ramakrishnan
26 January, 2007
The Technical Expert Group on Patent Law Issues, headed by the Council of Scientific and Industrial Research (CSIR)’s ex-Director General Dr. R.A. Mashelkar, has opined to the Government of India that restricting patenting of pharmaceuticals to New Chemical Entities (NCE) and prohibiting the patenting of microorganisms per se, would be violative of the TRIPS agreement. The Group claims that its approach to the issue was guided by "...the need for access of affordable medicines to Indian people at large, encouraging innovation by Indian industry, its current capabilities in R&D, and balancing of India's obligations under international agreements with the wider public interest". The main implication of the Mashelkar Group's report is that product patents can be issued even on older off-patent drugs which have been marginally altered by pharmaceutical firms, thereby giving a monopoly over these drugs to the patent holder. While the Mashelkar Group's report expresses itself against 'evergreening' of patents, its recommendations permit exactly that.
Reactions have been swift and damning. D.G. Shah, secretary-general, Indian Pharmaceutical Alliance (IPA): "As the title suggests, the reference to the group was on 'patent law,' but there is hardly any evidence in the report to support its interpretation. Most parts of the report are devoted to narrating the positions of various interest groups, but very little is devoted to what made the Technical Group take the view that to limit patentability to NCEs is not compatible with the TRIPS Agreement." The Centre for Trade and Development (CENTAD), an NGO working on international trade: "The terms of reference clearly mention that the task was to find whether it would be TRIPS compatible to limit the grant of patent for a pharmaceutical substance to a new chemical entity or to a new medical entity involving one or more inventive steps. However, the committee does not answer this question and also cites so-called national interest to make its recommendation. The national interest argument is based on certain assumptions which are either irrational or highly contestable...The so-called national interest perspective considers only the interests of a few big Indian pharmaceutical companies. There is no reference to public health concerns in the report". (Business Standard, January 16, 2007)(Click here to read more)