Ravi Sharma and Sara Hiddleston

Cites technical inaccuracy and plagiarism as reasons

BANGALORE/CHENNAI: The Dr. R.A. Mashelkar-headed expert committee on Patent Law has written to the Government of India asking that its 56-page report submitted last December is withdrawn on the grounds of "technical inaccuracy and plagiarism."

In a letter dated February 19 and addressed to Ajay Dua, Secretary of the Department of Industrial Policy and Promotion, Ministry of Commerce and Industry, the committee has requested three months to re-examine and resubmit the report.

The `Technical Expert Group on Patent Law Issues' was chaired by Dr. Mashelkar and comprised four other renowned experts (Professors Goverdhan Mehta, Asis Datta, N R. Madhava Menon, and Moolchand Sharma). It was set up in April 2005 to look into two contentious issues that were referred to it by the Government of India following a debate in Parliament after the Patents (Amendment) Bill, 2005 was introduced.

The issues were whether it would be compatible with the World Trade Organisation's Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to: a) "limit the grant of patents for pharmaceutical substances to new chemical entities or new medical entities involving one or more inventive steps only," and b) "exclude micro organisms from patenting." The committee took over a year and a half to reach its conclusions.

Dr. Mashelkar confirmed to The Hindu over the telephone that the group had "unanimously" sought the report's withdrawal. He said that certain lines used in their report's conclusion had been taken "verbatim" from a November 2005 paper (Limiting the Patentability of Pharmaceutical Inventions and Micro-organisms: A TRIPs Compatibility Review) that was authored by Shamnad Basheer, a doctoral student and an Associate at the Oxford Intellectual Property Research Centre, University of Oxford.

A footnote in Mr. Basheer's paper indicates that his work was commissioned by "the Intellectual Property Institute, a United Kingdom-based independent charitable organisation which carries out research on intellectual property matters." It was "financially supported by Interpat, a Swiss association of major European, Japanese and U.S. research-based pharmaceutical companies committed to the improvement of intellectual property laws around the world."

According to Dr. Mashelkar, it was only after the committee had submitted its report that it came to their notice through newspaper articles that some plagiarism had occurred: "We have identified eight to ten lines that have been extracted verbatim from Basheer's paper. As a scientist I see this as not a good practice. In keeping with the highest and best ethical practices we want to withdraw the report."

Dr. Mashelkar termed it "very unfortunate" and expressed the opinion that the "technical inaccuracy" could have happened when the report was being "drafted by a sub group."

Asked whether the committee would now like to rewrite the report or just change the "eight to ten lines" that have been plagiarised, Dr. Mashelkar said that "that depended on the members of the committee."

Even while admitting that it had been ethically wrong to plagiarise, Dr. Mashelkar said that Mr. Basheer in an e-mail had indicated that he was "not aggrieved" by the Mashelkar report "using his conclusions." He also stressed that it was "mischievous" to insinuate that multinational pharmaceutical companies had funded the committee's study. "We are not aligned to any industry."

The recommendations of the technical expert group were significant for multinational pharmaceutical companies, the Indian generic industry, and patient groups.

Novartis AG stated in a press release dated February 15: "A report from the Mashelkar committee, commissioned by Indian Government and comprised of Indian experts, supports many of the concerns about Indian patent law expressed by Novartis, mentioning that the laws are not complying with international agreements like TRIPS."

Public health groups and patient associations were concerned that the recommendations would encourage renewals of patents and block entry of cheap generic drugs into the market. A paper by Professor Brook Baker, Northeastern University School of Law Programme on Human Rights and the Global Economy, said that the "Mashelkar report misstates India's right to define the scope of patentability and threatens access to medicines."