Plagiarism was not the most important charge
against the Mashelkar report; it was its bias towards MNCs that was
most shocking.
The report of the Technical Expert Group on Patent Law Issues is
currently in the eye of a storm. This group was set up by the
government on April 5, 2005, under the direction of Parliament in order
to examine whether India should limit the grant of patents to new
chemical entities (NCEs) and define micro-organisms to exclude
genes/gene-constructs from patent protection. It was also meant to
suggest how this could be done without violating the Agreement on Trade
Related Aspects of Intellectual Property Rights (TRIPS) of the World
Trade Organisation (WTO). Dr. R.A. Mashelkar, who chaired this group
and submitted the report, is a highly embarrassed man because some of
its important conclusions have been criticised for being literally
copied from a paper prepared by Shamnad Basheer, Associate of Oxford
Intellectual Property Research Centre.
This criticism was first made in an article published in The Hindu on
February 12, 2007, by Chan Park of the Lawyers Collective HIV/AIDS Unit
and Achal Prabhala, a researcher on intellectual property rights. They
refer to the issue of plagiarism to show how the report, essentially,
copied its major conclusions from a work that INTERPAT, a Swiss
pharmaceutical lobby group of multinationals, had sponsored.
Mashelkar's stated claim was that the "technical inaccuracy" was very
unfortunate and was basically in terms of the failure to acknowledge
the source of eight to 10 lines that were taken verbatim from Basheer's
paper. If he is to be believed, this error crept in inadvertently at
the hands of a sub-group that the committee had created for drafting
the report. Mashelkar responded to the criticism from all over the
world by withdrawing the report and sought three months' time from the
government to resubmit it.
Multinational connection
The charge of plagiarism is not the only serious allegation against the
Mashelkar Committee. The recommendations of the report are also
influenced by its multinational connection: Ranjit Shahani,
vice-chairman and managing director of Novartis India Limited, chairs
INTERPAT, India, and is also the elected president of the Organisation
of Pharmaceutical Producers of India (OPPI), which advocated the
acceptance of the TRIPS proposals.
The Mashelkar Committee's connection with multinational corporations
(MNCs), including Novartis India, is perhaps evident from the fact that
Novartis could benefit directly from the recommendations of the report.
Currently, this company is fighting a case in the Madras High Court
over the `patentability' of its "new" salt used in the treatment of
cancer. The case is of interest to small and medium Indian companies
and cancer patients who have opposed Novartis' patent application for
Gleevec, an essential medicine for the treatment of leukaemia. If
Novartis is granted the patent for it, the price of the medicine could
increase. The same drug sold by Indian companies is about 10 times
cheaper than Novartis' Gleevec in the Indian market.
Misplaced interest
Experts consider the patent application filed by Novartis to be an
important example of one of the many possible ways of `evergreening' of
patents. This court case effectively challenges the legal validity of
Indian companies' right to produce the drug. Novartis has even
challenged the government on the validity of Section 3(d) of the
Patents (Amendment) Act, 2005. It claims that the provisions of this
law are TRIPS incompatible. Shockingly, the Mashelkar Committee report,
in Para 5.11, endorses this view, tangentially. The issue of the legal
validity of the provisions of the Patents (Amendment) Act, 2005, was
not part of the Committee's terms of reference.
Going by the spirit of the deliberations in Parliament, the Committee's
mandate was to suggest ways by which India would be able to further
strengthen the Patents (Amendment) Act, 2005. The Committee was asked
to suggest strategies to prevent multinational companies from making
use of the `evergreening' possibilities available to them under the
current patents law. The Mashelkar Committee did the opposite: it tried
to pass off the interests of MNCs and select Indian corporations (such
as Ranbaxy and Nicholos Piramal) as the national interest.
The Committee concluded:
1. "[I]t would not be TRIPS compliant to limit granting of patents for
pharmaceutical substance to new chemical entities";
2. "excluding micro-organisms per se from patent protection would be
violative of the TRIPS Agreement";
3. "limiting grant of patents to new chemical entities will not be
conducive to competitive growth and incremental innovations are
sequential developments that build on the original patented product -
and therefore, such incremental innovations ought to be encouraged by
the Indian patent regime";
4. "with an enabling provision for protection of intellectual property
in bio-technological innovations and inventions provided through the
provision of patentability of micro-organisms, the Indian
biotechnological research would be enabled to compete globally, attract
collaborations, FDI, contract R&D etc".
The Committee's conclusions were biased; its analysis was thin and
presented without cogent arguments. The conclusions were not even based
on the clarifications provided in the Doha Declaration on TRIPS
Agreement and Public Health. This declaration clearly affirms that "the
Agreement (TRIPS) can and should be interpreted and implemented in a
manner supportive of WTO members' right to protect public health and,
in particular, to promote access to medicines for all".
The Mashelkar Committee conveniently ignored the recommendations
of the 2002 study entitled "Integrating Intellectual Property Rights
and Development Policy" produced by United Kingdom Commission on
Intellectual Property Rights, an authoritative international group. It
also ignored the conclusions reached by the World Health Organisation
(WHO) Commission on Intellectual Property Rights, Innovation and Public
Health in its 2006 report.
Both these international bodies have unambiguously clarified that
"since there is no definition of invention in the TRIPS Agreement,
developing countries may determine in their own ways, the definition of
an invention, the criteria for judging patentability, the rights
conferred on patent owners and what exceptions to patentability are
permitted".
In fact, the U.K. Commission specifically recommends that developing
countries should aim at "limiting the scope of subject matter that can
be patented". Mashelkar was himself a member of the U.K. Commission.
Furthermore, the Pharmaceutical Research and Development Committee
(PRDC), which produced its report in 2001 and was chaired by Mashelkar,
also recommended that "pharmaceutical patents should be granted only
for new chemical entities or new medical entities".
The Mashelkar Committee's report was full of quotes from laws of
developed nations on the patenting of pharmaceutical inventions and
micro-organisms. It had no analysis of the political economy of these
laws and was hardly concerned about their lessons for the interests of
India. It ignored the views of not only public interest groups but also
of the Indian Pharmaceutical Alliance (IPA) and the Indian Drug
Manufacturers Association (IDMA), the two most important groups of the
Indian drug industry.
The Committee's report indicated that it was in the national interest
to allow incremental innovations since in-house capabilities of the
Indian drug industry were limited. It reached this conclusion on the
basis of the examination of international patents filed by selected
Indian companies. It ignored the fact that patents law was territorial
in nature and had to be in line with both the stage of development of
the industry and the socio-economic conditions of the nation.
Interestingly, Shamnad Basheer himself states: "The key failing of the
Committee is not engaging with the tough policy issues. The conclusions
may be correct, but there is much to be said for the manner in which
they were arrived at."
The issue of the cost of drug research appeared only once, indirectly,
in the report; the Committee was sceptical of the capacity of Indian
companies to raise investments for the development of NCEs. The
Committee noted: "Drug discovery research is still finding its feet in
India. Though many companies are investing, it will at least be a
decade before a critical mass is in place and results start accruing.
Thus, restricting patentability to just NCEs would mean that most of
the pharmaceutical product patents would be owned by MNCs." But it did
not address the obvious question: would MNCs not be successful in
owning the largest number of incremental pharmaceutical product patents
too?
The Committee did not even consider possible alternatives within the
framework of the TRIPS Agreement on the issue of patentability of
incremental innovations. It would be in the interests of both the
public and the Indian industry to design a patents law that would
protect only "new drugs" (NCEs) under the provision of product patents
and use the provision of process patents to protect the remaining
incremental pharmaceutical innovations. In this way, it would still be
possible, in a manner compatible with TRIPS, to use the provisions of
"dependent" non-voluntary or compulsory licences for the introduction
of even those new drugs that are still under product patents. Indian
companies would still be required to use the Patents Act as an
instrument of balanced competition, involving less litigation. If
Section 3(d) of the current Act, which spells out what is not
patentable in the drug industry, is retained in such a law, it will
need to include additional safeguards of clinical superiority. This
strategy would encourage the Indian drug industry to develop as a
complete value chain, allow the national innovation system to become
more oriented to the domestic market and encourage public sector
research-and-development (R&D) organisations to undertake more work
on neglected diseases.
The Mashelkar Committee did not distinguish between discrimination and
differentiation. It cited Article 27.1 of the TRIPS Agreement to argue
that it would be TRIPS incompatible to limit patentability to NCEs and
that India could not exclude certain kind of "pharmaceutical
inventions" from the scope of patentable inventions. The Patents
(Amendment) Act, 2005, excludes patenting of inventions relating to
atomic energy (Section 4) and in the area of national security (Section
39) broadly if the invention is relevant for defence purposes.
As for the problem of attracting foreign direct investment in contract
R&D and the manufacture of bulk drugs, a good contract law that
meets the requirements of confidentiality would suffice. Already, India
has been able to attract a lot of investment in contract R&D and
also foreign direct investment; it can do so in the future, too,
without strengthening the Patents Act in favour of MNCs.
Parliament might consider referring the matter of the Mashelkar
Committee report to the Standing Committee of the Ministry of Commerce,
instead of allowing Mashelkar to resubmit the report. That would put
Parliament in a better position to work out the mechanisms of
strengthening the patents regime and to address the issues raised here.
Dinesh Abrol is co-convener of the National Working Group on Patent Law
and a scientist with the National Institute of Science, Technology and
Development Studies of the Council of Scientific and Industrial
Research.
http://www.frontline.in/stories/20070323001804200.htm
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