Health Administrator Vol : XIX Number 1: 48-50
CHAPTER - 11
INTELLECTUAL PROPERTY RIGHTS (IPRS)
IN PHARMACEUTICAL SECTOR **
R D Hunshyal , S S Biradar *
Abstract : American, & European pharmaceutical
companies are filling “ Evergreen patents , but in
India out of 23,575 pharmaceutical companies only
ten are rich enough original research in international
level number of patent claims could fall in the “Mail
box”. Hence IPR in Pharmaceuticals in India is
major point of concern as liberalization takes place
and the whole world getting an image of “global
village”.
Introduction
Intellectual Property Rights (IPRs) have been
defined as ideas, inventions and creative
expressions on which there is a public willingness
to bestow the status of property (David 1993). IPRs
provide certain exclusive rights to the creators of
IP, in order to enable them to reap commercial
benefits from their creative efforts or reputation. The
purpose of IPR legislation is to protect against
unauthorized imitation, copying or deceptive usage
of identifying marks.1
In Future IPRS with Pharmaceutical Industry 2 currently marketed and in development.
? The pharmaceutical industry has relied to a
considerable degree on contracting and
outsourcing, especially “ upstream “ in R&D
through various licensing arrangements and
down stream through co-marketing
agreements. This is referred to as the cluster
approach.
? Expanded sharing information including
creation / use of collaborative knowledge
network (CNK), can greatly enhance the
company’s performance.
? Flexible and pervasive communications
systems that allow information to flow
*Dept. of Pharmaceutics, KLES College of Pharmacy, Vidyanagar, Hubli, Karnataka,
**Adapted with gratefulness from The Pharma Review , October 2005
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effortlessly within and between contracting
organizations will provide the key to success.
? More web-based approaches will provide the
foundation for these systems.
? The greatest positive impact of IT is likely to
be in R&D Where systems can contribute to
faster approval and market introduction of
products.
? To attain leading position in branded products,
they must emulate their global counterparts
in initiating strategic alliance with smaller
biotech company, which are expected to key
future source of innovation.
? Focusing on physician as key decision-makers
has long been a priority of the pharmaceutical
industry ; physician will continue to be the most
important gatekeeper to the market.
? The patient direct consumer of pharmaceutical
can do this better collection and analysis of
consumer data related to products both
Additional advantage to identify patient
populations for clinical trials, facilitating the
expansion of research efforts related to
personalized medicines and contributing to
overall R&D productivity.
? Lastly , Indian pharmaceutical companies also
face high costs and other obstacles in
implementing any provider/patient information-
based strategies, without a substantial
U.S.presence.
IPR reinforced in terms in TRIPS through WTO
will have a major or paradigm in the way research
/ trade in pharma sector were taking place. In trade
related aspects of IPRs to difficulties experienced
in many places in prosecuting infringements
against process, these amendments were included
in the Patent (World Trade Organization
Amendment) Act 1994 as follows:
? The standard patent term was increased from
16 to 20 years. Pharmaceuticals were already
protected for up to 20 years , in recognition of
the long time lags involved in obtaining
approval from drug safety authorities
? In certain infringement proceedings, it is upon
defendants to prove that their product was
obtained by a process other than the patented
process.
? The conditions for compulsory licensing have
been tightened in line with the requirements
of TRIPS.
? The extension of the standard patent term
from 16 to 20 years was a significant change
in economic terms 3.
Some changes introduced by TRIPS’
As explained earlier, TRIPS is based largely
on earlier international IPR agreements , including
the Paris and Berne Conventions dating back to
the last century and the more recent Rome
Convention and Washington Treaty. In addition to
mandating stricter enforcement procedures, TRIPS
contains a number of additions and elaborations
to the legal and institutional norms and practices
specified in earlier international IPR agreements.
The most significant ones are :
? The minimum patent term is set to 20 years,
the minimum copyright protection term for
sound recordings and performances is 50
years (from the date of recording ) and for
broadcasts 20 years;
? Computer programs and databases must be
protected with copyright;
? Countries must provide for the registration of
service marks;
? The provision of the Paris Convention
regarding the registration of well known marks
have been strengthened;
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? No country can force the use of a foreign trade
mark in combination with a local mark;
? The provision of the Paris Convention
regarding geographical indications have been
strengthened;
? Integrated circuit layout designs must be
protected for at least ten years;
? Artificially developed new varieties of micro-
organisms must be protected through patents;
? No area of technology can be excluded from
patent protection, with the exception of
medical methods and new life forms above
the micro –organism level;
? Countries must protect new plant varieties,
either within their patent systems or with a
separate systems of breeder’s rights ;
? Countries must develop a legal system for
protecting trade secrets from unfair disclosure
in accordance with principles of fair
competition ; and
? The application of compulsory licensing is
subject to severe limitations and must bear
adequate compensation.
The minimum requirements of TRIPS are not
always clearly defined. While TRIPS has clear
provisions on issues such as the minimum time
length of protection, the range of subject matter to
be protected, non-discriminatory treatment of
foreign residents and the enforcement measures
that should be implemented, the agreement does
not codify rules on more technology –specific and
subjective matters, like screening criteria in relation
to novelty and inventiveness for patents or detailed
definition of infringements to copyrights. In these
complicated and ambiguous definitional areas there
may be some scope to change local examination
guidelines to suit national economic interests
without violating the provisions of TRIPS.
Conclusion
Pharmacy is a field which orients as a life
saving sector, performing needs with better focus
and approach in the coming era. Hence at the same
time the protection for IPRs seems to be
considerably week specifically in pharma sector in
India. At this junction we can see both face i.e. pre-
IPR scenario and post-IPR scenario to advance
beyond being primarily an outsourcing arm to global
pharmaceutical industry; Indian companies need
to develop their own “ upstream “ R&D
relationships.
2. Shailendra Kumar “A la Patents, Patents,
Patents….” The Pharma Review., June 2005,
17-19.
3. Revesz, J., Trade-Related Aspects of
Intellectual Property Rights Productivity
Commission Staff Research Paper, AGPS,
Canberra, May 1999, 32-35.

References

1. Subbaram N.R. “what everyone should know

about PATENTS ? Pharma Books syndicate,
Hyderbad., 2003., 1-2.

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