Mashelkar Committee

On 29 December 2006, after 21 months, the Mashelkar Committee submitted its report, concluding that it would not be TRIPS -compliant to restrict patent protection to only NCEs and micro-organisms.

Introduction

In March 2005, when the 2005 amendments to the Patent Act,1970 were being debated in Parliament, Minister for Commerce Sri Kamal Nath, responded to the concerns expressed by other members, referred two issues (Parliamentary debates - 22.3.2005) to an expert group headed by Dr. R. A. Mashelkar.

Kamal Nath felt that section 3(d) of the Patent Act provided sufficient protections against evergreening. However, on the concerns expressed by other members, the following questions were referred to the Technical Expert Group on Patent Law Issues (the "Mashelkar Committee"): "(a) whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity (NCEs); and (b) whether it would be TRIPs compatible to exclude micro-organisms from patenting."

The expert committee called upon various interested parties to present their views. LCHAU through AMTC made submissions on the issue relating to NCEs, asserting that it would be fully TRIPS-compliant to limit the grant of patents to NCEs,[Attachment below] and that such a limitation would be the only effective way to ensure against evergreening[Attachment below]. AMTC also made an oral presentation of the submissions before the committee.

On 29 December 2006, after 21 months, the Mashelkar Committee submitted its report[Attachment below], concluding that it would not be TRIPS -compliant to restrict patent protection to only NCEs and micro-organisms.

However, shortly after the report was released, members of LCHAU found that many of the key conclusions of the Mashelkar Committee's report were lifted essentially verbatim from a submission[Attachment below] funded by Interpat, a coalition of major multination pharmaceutical companies, of which Novartis is a member. These findings were presented in editorials published in the Times of India and the Hindu. Various supporting materials substantiating these allegations can be found here.

Based on these findings, LCHAU wrote a letter to the Ministry of Commerce demanding that the government reject the report, launch a full investigation, and re-constitute the Committee to reexamine these issues.

The Government of India has yet to comment on the report.