Novartis Case - IP

Novartis case IP
Novartis Spicy IP
Background: Novartis applied for patent for Glivec in 1997. At
that time IP regime was different. India was coming to terms with
the international standard set by TRIPS Agreement.
(Trade
Regulation Intellectual Property ). It was in the transition phase.
If they dont know what to do, they put the patents in the mail
box, and examine it later, whether to give patent or not.
Earlier there was only process patenting; product patenting was
to come in, to conform to TRIPS agreement. It had removed
product patenting in 1971, and it was to come back. However,
the TRIPS allows every nation to have minor modification in IP
laws that are in the interest of each country. The Supreme Court
derives power from this provision in law.
What is a patent? A type of intellectual property. Glivec comes
under product patent. Product itself is patented.
A patent
prevents copying without a licence. Gives a monetary reward for
innovation, through monopoly; over 20 years. Idea behind
patent is to promote innovation through incentivizing.
Tests of patentability: 1. Novelty 2. Usefulness?
Indian Govt. passed specifically for pharmaceutical industry alone
section 3D.
Put that section.
Highlight of that section : The intent was to prevent people from
overly protecting from incremental innovation and evergreening.
Appellant: NGO (people who wanted patent not to be granted;
Doctors without borders). Others. Their grouse was India is
leading supplier of medicine to poor countries and Glivec happens
to be a life saving medicine for people having leukemia. If Glivec
is granted a patent in India, lot of poor people will not have

access to this life saving medicine, whose price will become out of
reach of poor people. They dont make this argument in 32
nations around the world, where the patent is granted.
The
Indian Patent Appellate Board said that Glivec passes the
patentability test but does not pass section 3D.
3D was passed without a debate by Parliament.
Why is this case a land mark?
In this SC has given the interpretation and definition of what 3D
means. It has given flesh and blood to section 3D and what it
means in India. 3D exists only in India.
Arguments of SC for interpretation of section 3D
1. 3D intended to prevent evergreening of pharmaceutical
patents. Concept of evergreening pertains to incremental
innovation of the original Zimmerman patent , for the molecule
imatinib.
What was sold in the market earlier was a
consumable form of this base imatinib molecule by making it in
salt form, called imatinib mesylate (IM). The present case of
Glivec pertains to a variant of this IM. This variant was called
Beta-Crystalline form of IM. Novartis claimed in its patent
application that this new Beta form had improved physical
characteristics that aided in better bio availability and safety of
storage, i.e. it can be stored better.
2. SC felt that these are only incremental innovations improving
the physical characteristics , there was no proven therapeutic
efficacy.
[Can SC decide on questions of bio availability,
therapeutic efficacy etc.]
Novartis reply:
In reply , Novartis argued that it never prevented the original
IM being made a generic when its patent expired.
Its
application was only for the Beta crystalline form.
1.
2.
3.
4.
2. Novartis was distributing (90%) of the new product free of

cost, as corporate they understood the value of differential
pricing and te imperative that you should not fleece the
customer. This is given per their web site. The judgment also
mentions it.
(like IIM jacking up fees, but giving lot of
scholarships).
3. 32 countries have given their patent for this drug.
General
In US one does not find occurrence of major diseases such as
small pox, due to the free hand given by IP regime to invent
block buster drugs. There are lot of fringe patents which focus
on what are considered as major health problems such as even
male pattern baldness! The no. of fringe patents filed for this
every year goes into hundreds. Also you have a patent regime
2; lot more restrictive, but lot less block buster drugs but more
generic drugs.
Why did biotech not take root in India? After judgement,
Novartis said We will not set up R&D in India.
Losers are India? How? Your problems of Malaria, Dengu, etc.
they can solve it for you, but you prevented them. In the name
of law, are you doing great disservice to citizen, and supporting
vested interest in pharma industry who are making money thro
export, and not doing anything for India.
Is copying OK?

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Novartis case IP

is granted a patent in India, lot of poor people will not have

2. Novartis was distributing (90%) of the new product free of

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