CHANAKYA NATIONAL LAW UNIVERSITY

PATNA - 800001

A 2nd ROUGH DRAFT ON

“Novartis Verdict And Right To Medicine”

Submitted To: Mr. Kumar Gaurav,

Subject :- Health Law.

Submitted By: MADHUKAR ANAND

Roll No. : 747

AIMS AND OBJECTIVES:

THE AIM OF THE PROJECT IS TO PRESENT A DETAILED STUDY OF “NOVARTIS VERDICT AND

RIGHT TO MEDICINE ” THROUGH THE BOOKS , SUGGESTIONS AND DIFFERENT WRITINGS AND

ARTICLES .

SCOPE AND LIMITATIONS:

THOUGH THIS IS AN IMMENSE PROJECT AND PAGES CAN BE WRITTEN OVER THE TOPIC BUT

BECAUSE OF CERTAIN RESTRICTIONS AND LIMITATIONS I WAS NOT ABLE TO DEAL WITH THE
TOPIC IN GREAT DETAIL.

SOURCES OF DATA:

THE FOLLOWING SECONDARY SOURCES OF DATA HAVE BEEN USED IN THE PROJECT-

1. ARTICLES

2. BOOKS

3. WEBSITES

METHOD OF WRITING:

THE METHOD OF WRITING FOLLOWED IN THE COURSE OF THIS RESEARCH PAPER IS

PRIMARILY ANALYTICAL .

MODE OF CITATION :

THE RESEARCHER HAS FOLLOWED A UNIFORM MODE OF CITATION THROUGHOUT THE

COURSE OF THIS RESEARCH PAPER .

1. INTRODUCTION
2. BACKGROUND
 HISTORY OF PATENT LAWS & PHARMA INDUSTRY IN INDIA
 INITIAL PATENT PROSECUTION AND LITIGATION
 TRIPS AND WTO COMMITMENTS OF INDIA AND THIER EFFECT ON DOMESTIC

PATENT LAW

3. CASE STUDY NOVARTIS V. UNION OF INDIA & OTHERS

5. RIGHT TO HEALTH AND RIGHT TO MEDICINE.

INTRODUCTION

Novartis v. Union of India & Others is a landmark decision by a two-judge bench of

The patent application at the center 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.

The patent application claimed the final form of Gleevec (the beta crystalline form of
imatinib mesylate). In 1993, during the time India did not allow patents on products, Novartis
had patented imatinib, with salts vaguely specified, in many countries but could not patent it
in India. The key differences between the two patent applications, were that the 1998 patent
application specified the counterion (Gleevec is a specific salt - imatinib mesylate) while the
1993 patent application did not claim any specific salts nor did it mention mesylate, and the
1998 patent application specified the solid form of Gleevec - the way the individual
molecules are packed together into a solid when the drug itself is manufactured (this is
separate from processes by which the drug itself is formulated into pills or capsules) - while
the 1993 patent application did not. The solid form of imatinib mesylate in Gleevec is beta
crystalline.

As provided under the TRIPS agreement, Novartis applied for Exclusive Marketing Rights
(EMR) for Gleevec from the Indian Patent Office and the EMR were granted in November
2003. Novartis made use of the EMR to obtain orders against some generic manufacturers
who had already launched Gleevec in India. Novartis set the price of Gleevec at USD 2666
per patient per month; generic companies were selling their versions at USD 177 to 266 per
patient per month. Novartis also initiated a program to assist patients who could not afford its
version of the drug, concurrent with its product launch.

When examination of Novartis' patent application began in 2005, it came under immediate
attack from oppositions initiated by generic companies that were already selling Gleevec in
India and by advocacy groups. The application was rejected by the patent office and by an
appeal board. The key basis for the rejection was the part of Indian patent law that was
created by amendment in 2005, describing the patentability of new uses for known drugs and
modifications of known drugs. That section, Paragraph 3d, specified that such inventions are
patentable only if "they differ significantly in properties with regard to efficacy." At one
point, Novartis went to court to try to invalidate Paragraph 3d; it argued that the provision
was unconstitutionally vague and that it violated TRIPS. Novartis lost that case and did not
appeal. Novartis did appeal the rejection by the patent office to India's Supreme Court, which
took the case.

The Supreme Court case hinged on the interpretation of Paragraph 3d. The Supreme Court
decided that the substance that Novartis sought to patent was indeed a modification of a
known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent
application and in scientific articles), that Novartis did not present evidence of a difference in
therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that
therefore the patent application was properly rejected by the patent office and lower courts.
Although the court ruled narrowly, and took care to note that the subject application was filed
during a time of transition in Indian patent law, the decision generated widespread global
news coverage and reignited debates on balancing public good with monopolistic pricing and
innovation with affordability. Had Novartis won and gotten its patent issued, it could not
have prevented generics companies in India from continuing to sell generic Gleevec, but it
could have obligated them to pay a reasonable royalty under a grandfather clause included in
India's patent law.

Background:

As part of the Commonwealth, India inherited its intellectual property laws from Great
Britain. However, after gaining independence in 1947, there was a growing consensus that to
boost manufacturing restrictive product patents must be temporarily removed. In 1970,
amendments to the Indian Patents Act abolished product patents but retained process
patents with a reduced span of protection.

During the absence of any product patent regime, the Indian pharmaceutical industry grew at
a remarkable pace, ultimately becoming a net exporter, the world's third-largest by volume,
and fourteenth-largest by value.

However, in the 1990s, during the Uruguay Round negotiations of the World Trade
Organisation (WTO), India pledged to bring its patent legislation in tune with
the TRIPS mandate in a phased manner. Consequently, in 1999 India allowed for transitional
filing of product patent applications, with retrospective effect from 1995. Full product and
process patent protection was re-introduced beginning in 2005 when all transitional
regulations ended.

CASE STUDY

Novartis

The legal team of Novartis was led by ex-Solicitor General of India Gopal Subramaniam and
senior advocate T. R. Andhyarujina. Novartis had attempted to patent imatinib mesylate in
beta crystalline form (rather than imatinib or imatinib mesylate), thus they sought to prevent
extant literature on imatinib or imatininb mesylate from being considered as prior art. The
thrust of the arguments by Novartis' legal team was two-fold: firstly, that the Zimmerman
patents and the journal articles published by Zimmerman et al. do not constitute prior art for
the beta crystalline form as it is only one polymorph of imatinib mesylate, thereby providing
the required novelty and inventive step; and secondly, that imatinib mesylate in beta
crystalline form has enhanced efficacy over imatinib or imatinib mesylate to pass the test of
section 3(d).

Respondents

There were seven named respondents who were represented before the court along with two
Intervenor/Amicus. The respondents were led by Additional Solicitor General of India Paras
Kuhad.

Various arguments were brought before the court but primarily focussed on proving imatinib
mesylate in beta crystalline form is neither novel nor is it non-obvious due to publications
about imatinib mesylate in Cancer Research and Nature in 1996, disclosures in Zimmerman
patents, disclosures to FDA and finally that efficacy as referred to in section 3(d) should be
interpreted as therapeutic efficacy and not merely a physical efficacy.

The respondents quoted extensively from Doha Declaration, excerpts from parliamentary
debates, petitions from NGOs, WHO, etc. to highlight the public policy dimension of
arguments in regards to easy affordability and availability of life saving drugs.

Critical Analysis

The judgement garnered widespread support from international organisations and advocacy
groups like Médecins Sans Frontières, WHO, etc. who welcomed the decision against
evergreening of pharmaceutical patents.

Most news item contrasted the huge price difference between patented Gleevec of Novartis
and the generic versions of Cipla and other generic companies. Some commentators have
stated that this strict patent requirement would actually enhance innovation as the
pharmaceutical companies would have to invest more in R&D to come up with new cures
rather than repackage known compounds. Others have suggested that exclusions under
section 3(d) present the hard cases that lie at the margins of the patent system due to the
eternally unsettled nature of the definition of the term 'invention'. Several patent law experts
have also pointed out that stringent conditions for patentability are followed in many
jurisdictions around the world, and there is no reason India should not follow the same
standards, given the extent of poverty and lack of availability of affordable medicines in the
country.

CONCLUSION: