NovartisVsUnion LAB Team1 Pulkit Apoorva Debayudh

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NOVARTIS

VS
UNION OF INDIA

PRESENTED BY:

APOORVA GOEL

PULKIT KHANDELWAL

DEBAYUDH TALAPATRA
OVERVIEW OF NOVARTIS CASE

• World’s leading pharmaceutical company filed patent application for its


new version of expensive drug, Glivec.
• They decided to seek a patent on a slightly altered version potentially
giving it longer period of market exclusivity.
• The case hinged on Sec 3(d) of Indian Contract Act prohibits patent of
new version of known drug molecule, more effective than before.
• Many Indian companies produced Generic drugs at very cheap rate.
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:
OVERVIEW OF NOVARTIS CASE

1. Mere modification does not give novelty to the product and the applied
product has no better effect than the already existing drug.
2. Re-patenting and Ever greening which is prohibited under the Indian
Patent Law.
3. Patent for the already existing drug has expired, manufacturing and
selling of generic version within the country at cheap rate.
MERITS OF JUDGEMENT

• A majority of Indian population uses generic version of Glivec at cheap


rate and enjoy the easy accessibility of medicine.
• Paved a clear path to establish and secure human rights by complying right
to health.
• Human Rights won against pharma Novartis.
HUMAN RIGHTS

• Inalienable fundamental right to which a person is inherently entitled


simply because he is a human being.
Substantive Rights –
1. Right to life.
2. Freedom from torture
3. Freedom from slavery
4. Right to fair trial
5. Freedom of thought, conscience and religion
6. Freedom of movement
RIGHT TO HEALTH

• Recognized in the UDHR, ICESCR and Convention the Rights of Person


with Disabilities.
• Article 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.
RIGHT TO HEALTH

Defined under Article 21 of ICESCR


• Impliedly involves right to access medicine tight 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.
COMPARISON

• Manufactured and distributed by • Manufactured and distributed by


Novartis, a foreign company. approved local companies like NATCO.

• Expensive in nature • Least expensive.

• Pack of 30 tablets costs $1100. • Nexavar – Generic Version – Pack of


Accessibility is low. 120 tablets cost $1000.

• 16000 people in India preferred • Accessibility is high.


glivec. • 300,000 people prefer generic version.
HOW THE JUDGEMENT IS HELPFUL?

• Government shall take quick step to increase accessibility of these generic


version and the cheap rate of medicine to enhance the mobility and
accessibility.
• Makes it easier to extend the accessibility of the generic drugs through its
extensible manufacturing and distribution.
• The compulsory licensing of the same drug would not increase its
accessibility.
CONCLUSION

The Judgement of Novartis case can be regarded as the most fruitful, viable
and traceable decision that meet the human rights to the highest end.

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