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Vol.
XXVIII No. 40
October 03,
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Final
Amendment To Indias Patent Act
Amit
Sen Gupta
AMONG
all the provisions of the WTO agreement, the one relating to Trade Related
Intellectual Property Rights (TRIPS) has possibly been the most widely debated
in the country. There are very good reasons why this has been so. First, because
provisions in TRIPS relate to the countrys Patent Laws and have a very
serious bearing on major areas of the countrys well being health,
agriculture, research, etc. Second, because India has been particularly
fortunate among all developing countries in having had a very liberal Patents
regime since 1970 that promoted the countrys interests. Third, because in the
initial stages of the Uruguay Round of negotiations under the aegis of the
then General Agreement on Tariffs and Trade (GATT), which finally led to the
formation of the World Trade Organisation (WTO), India had been extremely vocal
in opposing the inclusion of Patent laws in the negotiations. While the Uruguay
Round was initiated in 1986, it was only in 1989 that India did a sudden volte
face and succumbed to pressure from the US and European countries by agreeing to
include TRIPS in the negotiating agenda. Many, today, feel that if India had not
succumbed in that crucial phase of the negotiations, the TRIPS agreement itself
may never have seen the light of day.
EXPERIENCE
SINCE 1995
Since
1995, the experience of countries who have implemented the TRIPS agreement shows
the increasing skewing in the balance between the rights of patent holders and
consumers in favour of the former. The TRIPS agreement marks a fundamental shift
in this balance, as well as a shift in global attitudes where private profits
are put ahead of social benefits. This is further fueled by dependence of
economies in the developed world on industries that require strong intellectual
property protection and require implementation of the TRIPS accord. Of the
fifteen most profitable industries today at the global level, six are from the
pharmaceutical sector and five from the information technology sector all
dependent on strong Patent protection. It was also pointed out that intellectual
property protection allows such industries to create monopolies, not only over
production, but also in the control of knowledge.
The
most dramatic effect is being felt in pharmaceutical sector. The net result
of the TRIPS accord has been high cost of medicines and the consequent denial of
access to medicines to the income poor across the globe. Further, it has also
led to a situation where medicines required to treat diseases that predominantly
occur among the poor are not researched at all.
Instead drugs that are being researched are drugs used for
lifestyle diseases like impotence, baldness, obesity, etc. While the
pharmaceutical industry claims that high prices are explained by the massive
expenditure on R&D, the truth is that drugs they actually research have
little relevance to real medical needs.
Moreover, the kind of profits that big pharmaceutical MNCs generate are
an indication of profiteering and not just legitimate profit making.
AMENDMENTS
TO INDIAS 1970 ACT
As
per the provisions of the TRIPS agreement under the WTO, India is required to
amend its Patent Laws to provide for a TRIPS compliant regime by January 1,
2005. There has been extensive debate within the country about what the contours
of Indias Patent Laws should be. Not surprisingly, the two largest parties in
the country the BJP and the Congress have continuously compromised the
countrys interest and have pushed for Amendments to Indias Patents laws
that actually go beyond what the TRIPS agreement provides for.
It
may be remembered that the 1970 Patent Act, replacing the colonial Patents Act
of 1911, was formulated after an exhaustive process of discussions within the
country both inside and outside Parliament — starting from the Justice
N Rajagopala Ayyangar Committee Report of 1959. The 1970 Act served the country
well and was instrumental in development of the indigenous industry to a
point where the Indian pharmaceutical industry is the leader in the developing
world. It is thus imperative that any fundamental changes in the 1970 Patents
Act need to be carefully examined, so as not to compromise the interests of
Indias pharmaceutical industry and its ability to service the health care
needs of the country.
Since
before the signing of the WTO agreement, and in the ensuing 10 years till date,
globally as well as in the country, diverse contentions have emerged about the
impact of TRIPS compliant Patent Laws on domestic industry especially in
developing countries. There is, however, a wide consensus that domestic laws,
while being TRIPS compliant, need to make full use of flexibilities
available in the TRIPS agreement. This was reiterated in unequivocal terms by
the WTO Doha Declaration on TRIPS Agreement and Public Health (2001), which, inter
alia, commented that countries have the sovereign right to enact laws that
safeguard domestic interests. It recognised the gravity of public health
problems in developing countries and clearly provided that the member countries
had the right to protect public health and to promote access to medicines for
all.
In
pursuance of the necessity to make Indias Patent Laws TRIPS compliant, the
Indian Parliament has enacted two legislations through the Patents (Amendment)
Acts of 1999 and 2002. In order to fulfil the conditions in the TRIPS agreement,
a Third Amendment is now to be tabled in Parliament. The CPI(M) and other Left
parties were of the opinion that the Patents (Amendment) Bill of 2002 did not
make full use of the flexibilities available in the TRIPS agreement, which were
further emphasised in the Doha Declaration. The Left parties have also
consistently argued that, it is also necessary to press for a review of the
TRIPS agreement itself something that is mandated in the original agreement,
but has not been followed up. Such a review, the Left has argued, is necessary
to address the imbalance in favour of developed countries inherent in the TRIPS
agreement.
THE
PENDING THIRD
AMENDMENT
Having
successfully steered the passage of two Amendments the NDA government had
circulated the draft Third Patents (Amendment) Bill in 2003. The Bill could not
be discussed in Parliament, because of the change in government. The draft Bill,
was entirely inadequate in addressing domestic concerns relating both to health
care and development of the indigenous industry. Further, it even sought to
reverse some of the better provisions in the Second (Amendment) Act 2002.
The
government, it is understood, has now referred the same Bill to a Group of
Ministers. As stated earlier, the TRIPS Agreement requires that developing
countries like India to provide for TRIPS compliant measures by January 1, 2005.
Thus it can be assumed that the government will introduce the Bill in the winter
session of Parliament. But any attempt to push through the Bill without any
informed discussion, will not be in the larger interests of the country.
The
January 1, 2005 deadline should not be used as a plea to hasten through a
legislation, for which the country might have to pay a heavy price later. There
is a precedent in India, where the Patents First (Amendment) Bill providing for
Exclusive Marketing Rights (EMR) and a mailbox was passed by Parliament only in
1999 with retrospective effect, though the TRIPS agreement required that the
country provide for the same by January 1, 1995.
It
is imperative that the present UPA government holds discussions on the
modalities that it proposes to use, before the Bill is enacted upon. The Bill
should not be passed after a cursory discussion in Parliament, without adequate
thought being given to its diverse implications. The Bill should, in fact, be
referred to a Joint Select Committee of Parliament, which should solicit views
from different sections, interest groups, and experts. This is necessary today,
as the amended Patents Act would have implications not just for the
pharmaceutical sector but for others sectors such as agriculture, biotechnology,
software, etc. The principal concern should be to ensure that the Amended Law
protects the countrys interest adequately. It is hoped that the UPA
government will keep this in mind and not try to push forward the final
Amendment to Indias Patent laws with support from the BJP and its allies.
