KrISHnA & SAUrAStrI
regimes of countries such as South Korea, manufacturers of the West see it as a delay tactic. before the patent protection expires, envisaged
China, Indonesia and even, the US. However, when thousands of applications were under Section 107A(a) of the Patent Act, 1970.
received under the mail-box provision, the pre-
To date, India has not ratified the WIPO
grant opposition system was rightly introduced
Thus, this is a key consideration for India’s IP
Internet treaties. A consequence of ratification
so as to facilitate the public scrutiny of the mail-
regime, which needs to be carefully assessed,
is likely to be that India will be obliged to
box patent applications.
as per the contemporary requirements. At the
make significant amendments to the Indian moment, India is making substantial efforts to
Copyright Act, 1956 and introduce “effective Similarly, India is compliant with the minimum bring its IP regime up to global standards. Some
measures to regulate the devises and services requirements of data protection, as mandated laws are proposed that would improve India’s IP
intended for technology-defeating purposes”. under TRIPS, and has, under its Drugs Act, regime.
Such provisions would prohibit the use of adopted the requirement and guidelines on
circumvention devices to have easy access to the clinical trials for import and manufacture of a
For instance, The India Innovation Act, which
legally acquired copyrighted material. At this new drug (Schedule Y). What has been demanded
will be similar to the America COMPETES Act?,
juncture, the digital technologies in this context from India, at present, is to incorporate in its
would focus on three primary areas of importance,
in India are still in the development stage law, the provisions of data exclusivity. Specialists
increasing research investment, strengthening
themselves and such stringent provisions in the are of the view that the same facilitates the ever-
education opportunities in science, technology,
copyright system would result in hampering the greening of pharmaceutical patents and is a
engineering and mathematics from elementary
development of such technologies. TRIPS-plus provision. Even the Indian judiciary
through graduate school and developing an
is vigilant enough not to pronounce any verdict
innovation infrastructure. Further, the Public
It is worth mentioning that WIPO Internet
that may lead any Western substantive concept
Funded Research and Development (Protection,
treaties have come into focus because Western
of the IP system to penetrate into the Indian
Utilisation and Regulation of Intellectual
rights holders want to protect copyrighted digital
legal system.
Property) Bill 2007 is likely to be enacted,
technologies that have already significantly been enabling government institutions to work in
developed. Recently, the Supreme Court analysed the a manner that promotes research and allows
linkage of pharmaceutical patents with the drug them to secure patent protection in the original
On a different note, the Indian government has
regulation, normally referred to as the ‘patent work created by the institution.
left the door open for it to adopt optical disc
linkage’ concept embedded in the US Hatch-
legislation (ODL). An ODL, which is aimed
Waxman Act, 1984 (an Act to amend the US
at regulating the manufacturing processes of
Food, Drug and Cosmetic Act). It considered it
optical discs, is likely to lead to the regulation of

to be a TRIPS-plus provision, not supported by
distribution channels of copyrighted material or
Indian legislative policy. The ‘patent linkage’ is a
data embedded in the discs, which may in turn
system wherein, the Drug Regulatory Authority
lead to unfavourable consequences.
is required to check the patent status of the drug
Aditi Verma is an advocate and associate at
For instance, there might be overlapping
for which regulatory approval is sought. This
Krishna & Saurastri Associates. She can be
regulation of the distribution channels with the
is a practice in the US, however, that has been
contacted at: aditi@krishnaandsaurastri.com
copyright law provisions, which are designed to
criticised by the rest of the world.
prevent the unlawful distribution of copyrighted
In Bayer Corporation v. UOI (decided on
works. Trade is likely to be slowed down in such
August 18, 2009), Bayer alleged that the concept
situations, and this is against the spirit of TRIPS,
of ‘patent linkage’ also finds a place in the
which calls for the avoidance of the creation of
Indian system and it is a mandate for the Indian
barriers to legitimate trade.
Drug Authority to check the patent status of a
However, the Indian Information and
drug, before granting a regulatory approval.
Broadcasting Ministry has been taking initiatives
However, the Apex Court refused Bayer’s
to bring into force an ODL to check piracy in
contention. It was also of the opinion that Bayer
the film and music industry, which would surely
was attempting to ‘tweak’ public policy through
be well suited in the present scenario.
court-mandated regimes.
According to the Apex Court: “Such linkage
patent regime
potentially undermines the Bolar-like provision
The provision that prevents the ever-greening of that encourages quick access to the post-patent Aditi Verma
patents (Section 3(d) of the Patents Act, 1970) markets for generic medicines and this is a chief Aditi Verma is an advocate and associate
states that “a new form of a known substance public policy consideration.”
attorney in the trademarks department at
is not patentable”, and the same has been
Krishna & Saurastri Associates. Her practice
perceived as a major hindrance by the MNCs.
The Indian IP policy of maintaining equilibrium
areas include trademarks and copyrights.
However, the provision strictly checks the
is likely to get tempered in the presence of
She holds a Masters Degree in Law with a
period of a patent that is fraudulently extended
provisions of data exclusivity or drug linkage
specialisation in intellectual property rights
with a minor tweaking in the original invention,
in its IP regime. This is because it undermines
from the National Law University, Jodhpur
thereby causing injustice to the consumers by
the provision for manufacture of generic drugs
(India) and a certificate for completing the
making them pay for such patented products.
to use the patented inventions for development
general course on intellectual property
Furthermore, the pre-grant opposition system
and submission of information required under
from the WIPO Worldwide Academy.
of patent law is criticised, as the branded drug
law without the patent owners permission and
www.worldipreview.com World Intellectual property review September/October 2009 51
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