Mashelkar panel's view on wider patentability flayed

The Mashelkar panel's recommendation to consider all modifications and variants of new chemical entities (NCEs) as patentable has invited criticism from sections of Indian pharmaceutical industry and public interest organisations, saying the group had failed to back its case.

Mashelkar could not be contacted for comment.

The Technical Expert Group on Patent Law Issues, in its recommendations submitted on December 29, 2006, had noted that granting patents only to NCEs or new molecular entities (NMEs), thereby excluding modifications and variants of NCEs, would contravene the TRIPS provisions of the World Trade Organisation (WTO). It had also stated that excluding micro-organisms per se from patent protection would be violative of the TRIPS Agreement.

Critics of the panel's views feel the "arguments are based on certain assumptions that are either irrational or highly contestable."

D G Shah, secretary general, Indian Pharmaceutical Alliance (IPA), told Business Standard: "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."

CENTAD, an NGO that deals with international trade policies, was more critical in its response.

"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," K M Gopakumar of CENTAD said.

According to him, the demand for restriction of scope of patentability for pharmaceutical inventions came up for two reasons: First on the grounds of public health, and second due to the adverse effects of misuse of patents on the generic industry.

"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. This forces one to wonder whether public health is not a factor while considering national interest," he added.

Interestingly, Indian patent law, in its current form, is TRIPS compliant and does not limit patents to NCEs or NMEs in a strict sense. Neither does it call for a blanket ban on micro-organisms.

The Mashelkar panel's views were sought after the Left parties, which favoured a stricter patent regime than the current one, wanted to explore the possibility of limiting patentability only to NCEs or NMEs.

With the panel's view in place, there is no chance of the Left demand being re-considered.