Intellectual Property Rights and Pharmaceuticals (Following Up the

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Intellectual Property Rights and
Pharmaceuticals (Following Up the Novartis
case )

• Background note prepared for PHM Vic Internet
  Workshop

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Next hearing is on 26th March in Madras High
Court while final ruling is expected after a
month Can legislature specify and comment on
derivative for which patent application was made?
Or should it decide on facilitating Controller of
Drugs to use his discretion either to grant or
reject patent application? Is availability of
generic version a solution?
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What order a Court should pass provided a given
provision of Patent law is found to be
TRIPS-violative? Can an individual/company
challenge a national legislation on the basis
that it is anti- TRIPS, while member countries
have provision to take such issues to a specific
board (dispute resolution) of WTO? 30
enhancement in efficacy, which might be
sufficient for anti-cancer drug, can not be laid
down as criterion for all patent seeking products
uniformly.
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Summary of Recommendations by Report of the
Commission on Intellectual Property Rights,
Innovation and Public Health that can serve as
guiding points to think about what action should
we frame
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Public health research institutes/Universities in
developed world should, -focus on
issues/areas that are of concern to
developing world -tie up with research
institutes /Universities /private sector
organizations in developing country
-adopt policies that make it easier to
transfer its RD outcomes to developing world
(technology transfer)
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Increased funding, political will and policies to
upgrade research infrastructure in developing
countries and to promote research around public
health issues of concern in a way that
innovations fit into socio economic context of
developing world.
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Support from developed country government and
NGOs and other donors in strengthening clinical
trials and regulatory infrastructures and
standards in developing countries Effective
pricing policies to make health care products
available at consistently low and affordable
prices (equitable pricing) in developing
countries Efficient health system research,
improvement in health delivery infrastructure and
Incentives to retain health workers in employment
in developing countries
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Patent offices should have detailed information
on traditional medical knowledge and should
involve traditional knowledge holders in deciding
how to use it for innovative purpose WHO, WIPO
and other international orgs should create a pool
of patents and available information and should
work towards creating sustainable funding to
facilitate research around relatively neglected
issues of developing world.
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Health ministry should play crucial role in
negotiating any bilateral agreements and such
agreements should avoid Trips Plus measures that
can impede access to drugs Developing countries
should make use of public health measures
(flexibilities in TRIPS agreement) in light of
their own circumstances to assure access to
affordable medicines pro competitive measures,
parallel import, provision to facilitate generic
entry on patent expiry (early working exception),
avoidance of data exclusivity etc.
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CGIAR (Consultative group on International
Agricultural Research) includes OECD governments,
World Bank, International Orgs and developing
country governments (with majority of fund coming
from OECD nations) which acts as a central
funding agency to fund research around issues of
concern in developing countries and also act as a
body to facilitate priority setting, monitoring
and evaluating as well as advocacy work. Many
organizations and previous reports have made
suggestion to develop similar body for public
health research.