NOVARTIS AG

INTELLECTUAL PROPERTY RIGHTS

Presented By :
Vidit Garg 221164
Himalaya Tarani 221173
Jai Chowdhary 221176
Akshay Maken 221177
Presented To:
Prof. Neeti Shikha
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.



INTRODUCTION
Novartis International AG is a Swiss multinational
pharmaceutical company based in Basel, Switzerland.
In 1993, Novartis AG filed an initial patent application in
the United States covering the drug imatinib which got
a patent in US.
A patent could not be secured for a pharmaceutical
company at that time in INDIA.
In 1997,Novartis applied for a patent for a new form of
imatinib, the beta crystalline form. Which was again
granted patent for the United States.(Zimmerman Patent)
INTRODUCTION (CONT.)
In 1998, Novartis applied in India for patent on Gleevec (the
beta crystalline form of imatinib mesylate). It was kept in the
mail box for 7 years before getting processed.
In2003, the Patent Office granted Novartis Exclusive
Marketing Rights (EMR) in India, which allowed Novartis to
enjoy generic Gleevec manufacturers and raise the price
of Gleevec almost ten-fold.
In 2005, the application was processed once the law
allowed product patent in pharmaceutical.
In January 2006, the Madras Patent Office refused to grant
Novartis a patent for imatinib mesylate.


ISSUES REGARDING THE CASE
Is Imatinib Mesylate, the salt version of the free base form
of Imatinib, an invention that is patentable under Indian
law?
Is the beta crystalline version of Imatinib Mesylate an
invention patentable under Indian law?
Section 3(d) is unconstitutional as it violates the provision
of the TRIPS agreement.
The Indian patent act doesn't define the term 'efficacy'
and provides unguided power on the Controller. Hence it
is arbitrary, illogical and vague.

RULE
Sections 2(1)(j), 2(1)(ja) and 3(d) of Indian Patent Act,
1970 (as amended in 2005)
Section 2 (1) In this Act, unless the context otherwise
requires-
(j) "invention" means a new product or process involving
an inventive step and capable of industrial application;
(ja) "inventive step" means a feature of an invention that
involves technical advance as compared to the existing
knowledge or having economic significance or both and
that makes the invention not obvious to a person skilled in
the art






RULE (CONT.)
3(d) - the mere discovery of a new form of a known
substance which does not result in the enhancement of
the known efficacy of that substance or the mere
discovery of any new property or new use for a known
substance or of the mere use of a known process,
machine or apparatus unless such known process results
in a new product or employs at least one new reactant.
MERE DISCOVERY OF A NEW FORM OF KNOWN
SUBSTANCE
MERE DISCOVERY OF ANY NEW USE OF KNOWN
SUBSTANCE


ANALYSIS
Novartis had filed for a patent application in 1998. However,
the application for the patent filing was processed only in the
year 2005 after India allowed for product patents.
The authority in charge of granting patents, The Assistant
Controller of Patents and Designs rejected the application of
Novartis on the ground that if failed to satisfy the requirement
of novelty and non-obviousness as per the Indian Patents Act,
1970.
Novartis filed for appeal before the Madras High Court in
2006. But the case was transferred to Appellate Tribunal Board
under Sec117G.

ANALYSIS
The board held that Novartis met the requirements of
novelty and non-obviousness as per the Patents Act.
The enhanced efficacy was asserted by Novartis with
respect to the better flow properties and thermodynamic
stability, but the most important being bioavailability( 30%
increase).
However it was discovered that they did not compare it with
the salt that they marketed but with the free form of
imanitib.
The board argued that Novartis failed to fulfill the
requirements as per Section 3(d) of the Indian Patents Act,
1970 and the efficacy could only be therapeutic efficacy
Novartis decided to go for a proceeding before the Madras High Court with the
contention that Section 3(d) is not compliant with TRIPS and therefore violative of Article
14 of the Constitution of India.
The Madras High Court held that it did not have jurisdiction to decide a case concerning
the compliance of a domestic Indian law with an international treaty
Novartis relied on a case from the United Kingdom, Equal Opportunities Commission &
Another v. Secretary of State for Employment.
The Madras High Court distinguished the facts of the Novartis dispute with those under
Equal Opportunities Commission, because the European Community Law had been
domesticated as the domestic law of England through the European Communities Act,
whereas the Indian government had not domesticated TRIPS.
Since Article 64 of TRIPS expressly provides that disputes should be taken to the Dispute
Settlement Body of the WTO, the Madras High Court held that Novartis should seek to
enforce TRIPS though that mechanism and not an Indian court




ANALYSIS(CONT.)
The Court interpreted Section 3(d) in accordance with the text of
the statute and context of the legislation, to mean that it was
meant to deal with pharmaceutical products and chemical
substances only.
Major objective of this section was to prevent "Evergreening" and
thus discourage monopoly of certain players in the market.
Therefore a higher threshold of qualifying standards was set up for
pharmaceutical products
The test of efficacy can only be 'therapeutic efficacy.
Novartis claimed that the beta crystalline form had 30% more
bioavailability as compared to the older versions, but later it was
discovered that they did not compare it with imanitib mesylate
(the salt that was previously marketed) but with the free form of
imanitib.


THE DECISION TAKERS
JUSTICE
AFTAB ALAM
JUSTICE RANJHNA
PRAKASH DESAI
CONCLUSION
While no doubt the effect of the judgment was to ensure
the availability of affordable life saving drugs to people in
India and elsewhere, the crux of the judgment lies in the
fact that Novartis AG was denied a patent not on
account of the pricing of its drugs or its profit motive but
on the basis of invention.
The Court also suggested that efficacy can be defined
as the ability of a drug to produce a desired therapeutic
results but it did not provide any guidance on how
enhancements might be quantified.
CONCLUSION( CONT.)
The decision of the court was to prevent the
practice of abuse of patents through Evergreening ,
thus preventing anti -competitive practices in the
market.
The Court has also laid down a very strict and high
standard for the qualification of a product as an
"invention", thereby upholding the principle of social
welfare.
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.

THANK
YOU