Novartis AG v.

Union of
India & Others
CIVIL APPEAL No.2706-2716 of 2013

Presentation by : RAJINI BOLLERA KUSHALAPPA

III LLB
 INTRODUCTION

 LANDMARK JUDGEMENTS OF THE SUPREME COURT

Relief for millions of people around the world-to have access
to medicines at a low cost-preventing the pharmaceutical
industries from “evergreening” their patents.
The availability of life-saving drugs at an affordable price to
people in India
Defined the scope of Section 3(d) of the Indian Patents
(Amendment) Act, 2005.
SECTION 3(d) of The Patents Act
An invention has to satisfy the conditions of Novelty, Inventive
step, and Industrial Applicability in order to be patentable in
India, just like any other jurisdiction.
However, along with the said pre-requisites, the Indian Patent
Law provides an additional bar to the patentability of inventions
by defining non-patentable subject matter under Section 3 of
the Indian Patents Act.
 Therefore, in India, the inventions should not only be novel,
inventive, and industrially applicable but also should not
attract any of the provisions of non-patentability laid down in
Section 3 of the Patents Act in order to be patentable.
› Section 3(d) is unique to the Indian jurisdiction and is contemplated
as additional scrutiny for patent applications. The intention of
keeping the said section is to prevent the ever-greening of the
chemical compounds and to provide a fair chance to all the players
to monopolize the market for a specific duration.
› Section 3(d) of the Patents Act bars, “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.
For the purposes of this clause, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations, and other derivatives of
known substance shall be considered to be the same substance,
unless they differ significantly in properties with regard to efficacy,”
from patentability.
As noted, the said section is divided in to four categories i.e., “mere
discovery of a new form of a known substance,” “mere discovery of
any new property for a known substance, “mere discovery of new
use of a known substance,” and “mere use of a known process,
machine, or apparatus.” Any invention lying in the ambit of any of
the above categories is considered non-patentable.
 BRIEF FACTS OF THE CASE
In 1997, Novartis, a Swiss based pharmaceutical giant filed an
application to grant patent to an anticancer drug Glivec which is used
to treat Chronic Myeloid Leukemia (CML) * and Gastrointestinal
Stromal Tumours (GIST)** on the basis that it invented the beta
crystalline salt form (imatinib mesylate) of the free base, imatinib..  It
is a critical drug which is patented in about 35 countries of the world.
*CML --- A slowly progressing and uncommon type of blood-cell cancer
that begins in the bone marrow. Chronic myeloid leukaemia typically
affects older adults. It's caused by a chromosome mutation that occurs
spontaneously. Doctors aren't sure what causes the mutation.
** A gastrointestinal stromal tumor (GIST) is a type of cancer that
begins in the digestive system. GIST s happen most often in the
stomach and small intestine. A GIST is a growth of cells that's thought to
form from a special type of nerve cells. These special nerve cells are in
the walls of the digestive organs
However during those days, India did not grant patent to
pharmaceutical products and agrochemical products.  
It was in the year 2005 in India; the drug products became the subject
of patent in compliance with the TRIPS agreement.
India thereon revised its patent law and started granting patents on
pharmaceutical drugs.
 The patent application at the centre of the case was filed by Novartis in
India in 1998, after India had agreed to enter the 
World Trade Organization and to abide by worldwide intellectual
property standards under the TRIPS agreement.
As part of this agreement, India made changes to its patent law; the
biggest of which was that prior to these changes, patents on products
were not allowed, while afterwards they were, albeit with restrictions.
These changes came into effect in 2005, so Novartis' patent application
waited in a "mailbox" with others until then, under procedures that
India instituted to manage the transition. India also passed certain
amendments to its patent law in 2005, just before the laws came into
effect, which played a key role in the rejection of the patent application.
Subsequently in 2006, the Madras Patent Office refused the
patent application of Novartis for its drug Glivec stating that the
said drug did not exhibit any major changes in therapeutic
effectiveness over its pre-existing form, which was already
patented outside India.
The said decision was based on Section 3(d) of the Indian Patents
(Amendment) Act, 2005 which provides  a known substance can
only be patented if its new forms exhibit “enhanced efficacy”.
The Patent Office did not find any enhanced efficacy in the drug
Glivec and, therefore, considered it incapable of patentable under
Section 3(d) of 2005 Act.
In May 2006, Novartis filed two writ petitions under Article 226 of the Indian
Constitution before the High Court of Madras – one appealing against the order
of Madras Patent Office rejecting its patent request
The other contesting that Section 3(d) of the Indian Patents Act is not in
compliance with TRIPS* and is vague, arbitrary and violative of Article 14 of the
Constitution.
The Madras High Court refused the Writ Petitions of Novartis holding that it did
not have jurisdiction to determine whether a domestic law is in contrary to
international treaty, so it  cannot decide whether Section 3(d) is in compliance
with TRIPS.  
As far as Section 3(d) is considered, the objective of the Amending Act was to
prevent evergreening and to make easy  the access to life-saving drugs to the
citizens. Therefore, it cannot be considered to be vague and arbitrary.
*The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
is an international legal agreement between all the member nations of the 
World Trade Organization (WTO). It establishes minimum standards for the
regulation by national governments of different forms of intellectual property (IP)
as applied to nationals of other WTO member nations.
The new phase of litigation started in Intellectual Property
Appellate Board, which is an appellate body of  patent
controller. IPAB considered the beta-crystalline form of
imatinib mesylate as new and an inventive step but refused
to grant a patent to the drug of Novartis since it was hit by
Section 3(d) of the Act.
Novartis challenged the said order by filing Special Leave
Petition before the Supreme Court.
The free base form of anti-cancer agent imatinib. Imatinib
mesylate is a salt formed by a 1:1 reaction of imatinib and 
methanesulfonic acid.
 ISSUES FOR CONSIDERATION
QUESTION OF LAW :
› Whether the invention is in consistent with Section 3(d) of the
patent act?
QUESTION OF FACT :
› Whether the said invention qualifies for the test of novelty
and inventive for the alleged product?
ISSUE 1 : Court observed that the product was one of the new forms of
the substance and not the whole substance. It has always existed in the
original amorphous form. The product thus has to qualify the test laid
down in Section 3(d) of the Patent Act.
› The Section clearly specifies that a new form of the substance in not
patentable under Indian law unless it enhances its “known efficacy”.
› Novartis contended that the physico-chemical properties of the
polymorph form of the imatinib molecule, i.e. better flow properties,
better thermodynamic stability and lower hygroscopicity, resulted in
improved efficacy and hence is patentable under Indian law.
› The Apex Court rejected this contention stating that in the case of
medicines, efficacy means “therapeutic efficacy” and these
properties while they may be beneficial to some patients do not meet
this standard. The Supreme Court also held that patent applicants
must prove the increase in therapeutic efficacy based on research
data in vivo in animals.
ISSUE 2 :
› The Supreme Court held that the true intention to enact
section 3(d) was to prevent the concept of ever greening and
thus if the invention does not fulfil the test of Section 3(d), it
cannot be granted a patent.
› The court further specified that this case should not be
interpreted to mean that Section 3(d) bars all incremental
inventions. It is with regard to the field of medicine especially
in cases of life-saving drugs, a great acre and caution needs to
be taken so as to protect the right to life of the masses.
 CONCLUSION

The SC judgement comes as a huge relief for those people who can’t afford the
lifesaving drugs manufactured by these big pharma giants.
These companies who have already made billions of dollars prevent people from
purchasing the drugs at low price thus endangering the very life of the poor people
by acquiring patents over their drugs. The importance of patent cannot be denied
to prevent a new invention provided such invention is available to all the individuals
at a reasonable rate.
On the contrary, companies like Novartis are putting the life of these poor people at
stake by obtaining a monopoly over its drugs. However, the Supreme Court in its
judgement made clear that India is a developing country and the availability of
medicines at a cheap price is necessary for the lives of 1 billion people.
The Supreme Court is thus justified in its decision thereby prohibiting the liberal
approach in granting patents and granting patents only to genuine inventions as
against frivolous inventions.
SUPPLEMENTARY READINGS
“All You Need to Know about IP Rights in Covaxin - iPleaders”
(iPleaders, May 8, 2021) <https://blog.ipleaders.in/need-know-ip-
rights-covaxin/> accessed November 29, 2022
“Novartis v. Union of India & Others - Wikipedia” (Novartis v. Union of
India & Others - Wikipedia, June 8, 2010)
<https://en.wikipedia.org/wiki/Novartis_v._Union_of_India_
%26_Others#Arguments_before_the_Supreme_Court> accessed
November 29, 2022
Rawat B, “Patenting Landscape in India 2009” (Patenting Landscape
in India 2009 by Balwant Rawat :: SSRN, November 9, 2009)
<https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1502421>
accessed November 29, 2022