Urmila N Pai
Post and pre TRIPS
• Post TRIPS
• Latest news on drug price reduction
• The patents amendments act 1999 and its
• Mail box provision
The WTO is an international organisation that
deals with the rules of trade between nations. As
of February 2014, 160 countries are Members of
The countries have to undertake 18 agreements
for becoming a member of the WTO.
Of these, 379 were in force. There are 585
notifications of RTA that had been received by
GATT/WTO,among these 379 were in force.
Introduction of pharmaceutical product patents
would have a negative impact on the Indian
pharmaceutical industry by hampering its growth, this
was the initial assumption.
An industry can’t manufacture by reverse
engineering or export drugs whose product patents are
Against or contrary to expectations, the
pharmaceutical industry was developing in post
But there are still conflicts that new patent act might
reduce generic drugs supplies and lower access to medicine in
India is one of the largest pharmaceutical exporters and
a major supplier of affordable and quality generic drugs in the
At the same time, India is also one of the poorest
developing countries lacking a national health insurance
system and suffering from tropical diseases such as malaria
and dengue fever.
• India’s pharma industry accounts for about 1.4
per cent of the global pharma industry in value
terms and 10 per cent in volume terms.
• Among the fastest growing pharma industries
in the world, India’s pharmaceutical sector is
expected to expand at a compound annual
growth rate (CAGR) of 12.1 per cent during
2012–2020 and reach US$ 45 billion.
The TRIPS Agreement not only increased the
R&D expenses of the Indian pharmaceutical
industry but has also changed its R&D structure.
The pharmaceutical industry is a highly R&D-
Under the pro-patent regime of the TRIPS
Agreement, for pharmaceutical companies,
sustainable growth depends on their continuous
R&D for developing new drugs and new
Since 2002, Indian companies have increased
investment in R&D in order to overcome the
competition in the world pharmaceutical market.
Indian pharmaceutical companies are now becoming
more R&D oriented.
While the Indian government lagged behind the
private sector, it recognised the need to radically
improve the policy of the pharmaceutical industry in
view of TRIPS and making changes to the Patent Act
On March 23, 2005, the Indian Parliament passed the Patent
(Amendment) Bill 2005 (Bill No. 32-C of 2005). It was the
third amendment to the Indian Patent Act(1970).
The amended Patent Act conforms to requirements set
forth by the World Trade Organization's (WTO) Agreement
on Trade-Related Aspects of Intellectual Property Rights
Since the new law came into effect on January 1, 2005,
there have been serious concerns regarding the role of
the domestic Indian generic industry in the new product
patents regime, and the continued availability of essential
medicines at affordable prices.
Pharmaceutical companies have to submit test
and clinical data to the national health authorities
to obtain marketing approval for a new drug.
The national health authorities keep the
innovator data confidential against "unfair
commercial use" for a certain time period, thus
barring generic manufacturers from using the
submitted innovator data for the stipulated
Through TRIPS ,IPR protection is made
possible and it encourages innovation leading
to useful products, investments in manufacture
,marketing and consequently impacts trade and
economic growth of nation states.
Intially the founders of wto were not aware of
the restrictive roles that TRIPS could play in
overall development but now 160 members are
well positioned to know about economic and
noneconomic effects of TRIPS, and access to
necessary drugs,which their nation is in need.
• Before TRIPS Indian pharmaceuticals were
floating without any direction and compliance
• Only after the emergence of trips to a new
level, Indian pharmaceuticals woke with the
new challenges of intellectual property regime.
• During many decades, Indian pharmaceutical s
• While few visionary like Dr.Reddy’s has
intiated to face the challenges of product
patent regime in 1990s by setting up the Drug
Development Programme .
• But the real action commenced in post 1995.
• The intellectual property /patent awareness
creation and absorption as well as keenness
have largely helped to find a newborn to set in
motion and not to survive but also to show the
trend of dominance in pharmaceutical industry
that has been showing from few decades.
• A good number of pharmaceutical corporates
to set up research facilities of global standard
and intiated research programmes.
• When the Uruguay Round Conference
commenced in 1986 the global pharmaceutical
giants had a great scope of conquering the
markets that they lost once before years.
• And the signing of TRIPS and WTO gave
great expectations to the global corporate.
• But because of flexibility of TRIPS there
dreams of corporates were thwart.
• During post trips regime there was the
misappropriation of traditional knowledge
• The cases of neem,turmeric and basmati gave
alert to law makers to include extreme safety
measures to prevent the misappropriation.
• The government of India under the auspices of
CSIR through NISCAR and TKDL the
compliation of traditional knowledge and
know how in the field of indigenous wealth.
• The enactment of biodiversity act of 2002 , with benefit
the sharing mechanisms, measuring the patenting is also
the development of post TRIPS.
• The enactment of Plant Variety Protection in 2001.
• The Indian pharmaceutical which commenced export of
bulk drugs and formulations to least developing countries
in late 70’s and 80’s has then emerged as major global
• The post scenario encouraged the technical and legal
professionals to incorporate IP/Patent practices and
upgradation of knowledge and work culture.
• Almost all major global corporates has setup research
facilities in India and have also made mergers and
Prices of widely-used expensive anti-diabetic
and cardiac medicines will reduce by as much
as 35% over the next few weeks, with the drug
pricing regulator, National Pharmaceutical
Pricing Authority (NPPA), deciding to bring
them under price control.
The drugs that will become cheaper include :
LATEST NEWS ON DRUG PRICE
The patents amendments act 1999
and its complications
•As a result of Uruguay round of GATT
which concluded in 1994 and obligued that
to meet all the provisions of TRIPS.
Is was necessary to make changes in the
Indian patents act 1970.
• The minimum steps are:
• Make a mailbox facility to file product patents
related to drugs ,pharmaceutical and agrochemicals.
• Provide an option to obtain exclusive
marketing rights in drugs pharmaceuticals and agro
There was a selection of expert group to suggest
amendments and they recommend a set of
measures to be implemented.
Mail box provision
• Claim a substance is intended to use as a
• Relating to substances prepared or produced
by chemical processes including alloys,optical
glass, semiconductors and intermetalic
o In few years, several foreign drug,
pharmaceutical and agrochemical industries like
Novo Nordisk,Chiron cooperation ,Janssen
pharmaceuticals NV,vertx pharmaceuticals, Eli
lily etc had contributed to increase the number of
patent in India.
o A patent was granted for recombinant lactoferrin
o Pfter approached EMR for the patent of
anticholestrol Lipitor who has already picked up
sales in US market over 1$ billion.
• Within few years there was a dramatic changes in
India in patenting activity compared to other
• The patent amendment bill has been made in right
• The foreign direct investment has been
• Some other foreign countries see the India as
potential market, and a platform for
innovation,research centre and manufacturing