HUMAN RIGHTS IN THE LIGHT

OF NOVARTIS CASE

Anu.B
Intern at Biz & Legis
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OVERVIEW OF PATENT IN
PHARMACEUTICALS
Patent is an intellectual property tool that safe
guards the invention of an inventor.
The validity of patent is for 20 years from the
date of filing of patent application
Pharmaceutical derivatives are granted patent if
it possess the character novelty.
Pharmaceutical means of or relating to pharmacy
As like other products, for obtaining patent the
molecule structure, function properties etc
have to be specified in detail
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OVERVIEW OF PATENT IN
PHARMACEUTICALS
WHY PATENTS?
1. Prevent others from commercially utilize
that invention
2. Encourage financial risk and long term
research
3. Patents guarantee dissemination of
information

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OVERVIEW OF NOVARTIS CASE

Novartis AG v. UOI decided on 1st April 2013
Facts of the case
Novartis is the worlds leading pharmaceutical
company filed patent application for its new
version of cancer drug.
The drug is called glivec and is very expensive.
Glivec was already in the market, however
they decided to seek a patent on a slightly
altered version potentially giving it longer
period of market exclusivity.
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OVERVIEW OF NOVARTIS CASE

The case hinged on s.3(d) of the Indian Patents
Act which does not allow patents of new
version of known drug molecules if they
make it more effective than before. In the
mean time many Indian companies produced
generic drugs at very cheap rate which was
consumed by 300000 people .
Whereas 16000 people use glivec. Generic
versions can be manufactured when the
product expires the patent.
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OVERVIEW OF NOVARTIS CASE

ISSUES INVOLVED
1. whether glivec is a patentable product?
2. Whether it involves ever greening?
JUDGEMENT
With the majority under the presence of
Aftab Alam .J. and Ranjana Prakash Desai .J.
the court held that the patent application is
rejected on the grounds that :
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OVERVIEW OF NOVARTIS CASE

1.

2.

3.

Mere modification does not give novelty to

the product and the applied product has no
better effect than the already existing drug.
If the application is allowed to grant patent
for glivec it becomes re-patenting and lie
within the purview of ever greening which is
prohibited under the Indian Patent Law.
Since the patent for the already existing
drug has expired manufacturing and selling
of generic versions within the country at
cheap rate.

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MERITS OF JUDGEMENT
A majority of indian population uses generic
version of glivec at cheap rate and enjoy
the easy accessibility of medicine.
The judgment has paved a clear path to
establish and secure human rights by
complying right to health through this
judgment.
It can be proudly concluded that Human rights
win as giant pharma Novartis loses the
case.
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HUMAN RIGHTS
Inalienable fundamental rights to which a person is
inherently entitled simply because he/she is a
human being.
ICCPR 1966
UDHR 1948
ICESCR 1966

Substantive rights- 1. Right to life 2. Freedom from

torture 3. Freedom from slavery 4. Right to fair
trial 5. Freedom of speech 6. Freedom of thought,
conscience and religion 7. Freedom of movement 8.
Rights debates ( Right to keep and bear arms,
future generations, sexual orientation and gender
identity, trade, water, reproductive rights and
information and communication technologies
)
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RIGHT TO HEALTH
Recognized in the UDHR, ICESCR and Convention on
the Rights of Persons with Disabilities.
Art.25 of UDHR- Everyone has the right to a standard
of living and well being of himself and his family.
Preamble of WHO declares it to be a fundamental
right of every human being to enjoy the highest
attainable standards.
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RIGHT TO HEALTH
Defined u/art. 12 of ICESCR
Impliedly involves right to access medicine,
right to treatment and precautionary
measures.
Accessibility increases when the price of
medicine is cheap, nation based production,
availability of alternative at cheap rates etc.
Accessibility decreases when price in high,
imported medicine and rules regarding the
exporting countries etc.
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COMPARISON
Manufactured and
distributed by
Novartis, a foreign
company.
Expensive in nature.
Pack of 30 tablets costs
$ 1,100. Accessibility
is low.
16000 people in India
preferred glivec
GLIVEC

Manufactured and
distributed by approved
local companies such as
NATCO.
Least expensive
Nexavar- generic versionpack of 120 tablets costs
$ 1000. Accessibility is
high.
300000 people prefer
generic version
GENERIC VERSION OF GLIVEC

WHO WILL MEET THE HUMAN RIGHTS

EFFECTIVELY????

GLIVEC OR ITS GENERIC VERSION!!!!!

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HOW THE JUDGEMENT IS

HELPFUL?
The judgment is nothing but the rejection of
patent application of glivec filed by Novartis.
As the application is very related to ever
greening which is barred by Indian Patent
law, no injustice has been done to Novartis
by the judgment.
Since patent period has been expired,
encouragement of manufacturing of generic
version of the same is permissible and do not
amount to violation of law.
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HOW THE JUDGEMENT IS

HELPFUL?
Government shall take quick steps to increase
accessibility of these generic version and the
cheap rate of medicine enhance the mobility
and accessibility.
Cancer is a serious disease that may cause
death. Right to health being a human right is
clearly violated on death of people due to
this reason.

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HOW THE JUDGEMENT IS

HELPFUL?
Judgment makes it easier to extend the
accessibility of the generic drugs through its
extensible manufacturing and distribution.
Governmental steps can be smoothly adopted
and implemented for making the drug to
reach the nook and corner of the country.
It can be noted that the compulsory licensing
of the same drug would not increase its
accessibility .
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HUMAN RIGHTS OR
INDIVIDUAL RIGHTSWHICH SHOULD BE
WEIGHED MORE
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CONCLUSION
The judgment of Novartis case can be regarded
as the most fruitful, viable and traceable
decision that meet the human rights to the
highest ends.
Other Judgments favorable of generic drug
manufacturers
Roche Pegasys case- November 2012
Januvia patent case- 2nd April 2013

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THANK YOU
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