In an unprecedented twist in the legislative process, the Technical Expert Group on Patent Law Issues requested the Government of India to withdraw its Report that was submitted by the Group on December 29, 2006. The Government of India constituted the Expert Group in April 2005 in a follow up of the issues raised in the Parliament during the debate on Patent (Amendment) Bill, 2005. The Government referred two contentious issues to the Group for in-depth analysis and expert opinion and the same formed its terms of reference. The issues were:
- whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to ‘new chemical entity’ or to ‘new medical entity’ involving one or more inventive steps; and
- whether it would be TRIPS compatible to exclude micro-organisms from patenting.
The Technical Expert Group comprised Dr. R. A. Mashelkar, former Director General of the Council of Scientific and Industrial Research as its chairman and renowned scientists and academicians Prof. Goverdhan Mehta, Prof. Asis Dutta, Prof. N. R. Madhav Menon and Prof. Moolchand Sharma as its members.
In order to come out with a comprehensive Report, the Expert Group adopted a consultative approach and invited views, opinions and inputs from a range of stakeholders including industry players and associations, non-government organizations, Intellectual Property think tanks and attorneys. And in fact a large number of submissions were made to the Group. The Group also studied and submitted in its Report, the patenting practices followed in some leading countries in relation to pharmaceutical derivatives and microorganism. Further the Report stated that in making recommendation to the Government, it was guided by the need for access of affordable medicines to Indian people at large, encouraging innovation by Indian pharma industry, its current capabilities in R&D, and balancing of India’s obligations under international agreements with the wider public interest.
It took more than one and half year to the Group to interact with various stakeholders and to conduct a critical examination of technical and legal issues involved in the study and finally in December 2006, the Group formalized its pointed conclusions to the term of reference that:
- it would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only.
- it would not be TRIPS compliant to exclude micro organism per se from patenting.
In addition to the above conclusion, the Group recognized the need and importance of (i) distinguishing "evergreening" from "incremental innovation" and encouraging the later, (ii) making provisions for availability of drugs at affordable prices to the people of India and (iii) preventing grant of frivolous patents leading to "evergreening". Accordingly, the Group recommended, "detailed guidelines should be formulated and rigorously followed by the Indian Patent Office for examining the patent application in pharmaceutical sector so that the remotest possibility of granting frivolous patents is eliminated". Interestingly, the Patents Amendment Act came up with a different definition for section 3 (d), pending the Expert Committee report. But the conclusion and recommendation of the Group had favorable overtones for Novartis as they had challenged the constitutional validity of Section 3(d) of the Patent Act, 1970 (as amended in 2005) before the Madras High Court. Amended Section 3 (d) excludes pharmaceutical derivatives from patenting unless they "differ significantly in properties with regard to efficacy".
Incidentally, Dr. Mashelkar submitted the report on the last day in the office of CSIR after completing a long tenure of thirty years. However, upon submission of the Report to the Government in December 2006, criticism followed from several quarters including from the Left Parties, non-governmental organization, public health groups and Indian generic drug industry. Some national dailies even alleged plagiarism stating that the Report contains verbatim reproduction of passages from a Paper written and submitted by Mr. Shamnad Basheer. Mr. Basheer, is a visiting Associate Professor of Intellectual Property Laws at George Washington University Law School. According to news reports and as quoted at his blogsite www.spicyipindia.blogspot.com Mr. Basheer was commissioned by the Intellectual Property Institute (IPI), UK, to produce a paper titled ‘Limiting the Patentablity of Pharmaceutical Inventions and Micro organisms : A TRIPS Compatibility Review.’ On invitation of inputs by the Group, IPI, UK submitted the extracts from Mr. Basheer’s paper and the same is figured in Anexure III of the Report.
It was alleged that one of the most vital aspect of the conclusions in the report in Para 5.10 was verbatim reproduction of the extracts submitted by Mr. Basheer to IPI, UK. The said paragraph states as follows
"It is important to distinguish 'ever-greening' from what is commonly referred to as 'incremental innovation'. While 'ever-greening' refers to an extension of a patent monopoly, achieved by executing trivial and insignificant changes to an already existing patented product, 'incremental innovations' are sequential developments that build on the original patented product and may be of tremendous value in a country like India. Therefore, such incremental developments ought to be encouraged by the Indian patent regime."
Dr. Mashelkar, the Chairman of the Expert Group clarified the situation by stating "After submission of the report, it has been found that there are certain technical inaccuracies in the report that have inadvertently crept in". He further explained that the error could have crept due to drafting lapses by a sub-group. However, he on behalf of the Group took "full responsibility for this unfortunate development" and requested the Government to withdraw the Report. The request for withdrawal of the Report by the Group was made unanimously.
The Group has requested the Government for three months time to reexamine and resubmit the report. It is still uncertain that whether the entire report will be rewritten or only the alleged plagiarized portions would be rephrased. The left parties and the experts on Patent law are however, demanding that the Union Government should reject any proposal from the Group members to rewrite the "plagiarized" Report and has demanded for the appointment of Joint Parliamentary Committee as the issues involved have serious implications.
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