CHANAKYA NATIONAL LAW

UNIVERSITY

SUBJECT-HEALTH LAW

PROJECT WORK ON

IPR VS. RIGHT TO HEALTH

SUBMITTED TO- MR. KUMAR GAURAV

SUBMITTED BY
SACHI SAKSHI UPADHYAYA
ROLL NO. 788
10TH SEMESTER

INTRODUCTION
 Abstract

Health is a fundamental human right indispensable for the exercise of other human rights. The
Article 25 of the Universal Declaration of Human Rights, 1948 mentioned health as part of the
right to an adequate standard of living. The International Covenants, Treaties relating to human
rights and the Constitutions of various nations recognize that a number of elements would be
encompassed by the right to health from prevention to cure to access to drugs. However, health
trends indicate that despite progress made in the last 35 years, millions of the people in the
developing countries do not have access to the medicines which are required for treating
diseases. One of the significant reasons for the lack of access of essential medicines required for
needed treatment is the high prices fixed for those drugs. Strong intellectual property protection
keeps prices inflated up to one hundred times the cost of manufacture of drugs. Monopolies are
created by patents and they restrict competition in pharmaceutical market and permit patentee to
set up high prices. It clearly indicates that the linkage between intellectual property rights and
health has been the focus of much debate. Much initiative has been taken by World Intellectual
Property Organization, World Trade Organization(WHO) and World Health Organization(WTO)
through Trade-Related Aspects of Intellectual Property Rights Agreements (TRIPS), Doha
Declaration and then the 30 August 2003 Compulsory License Import Export mechanism for
providing safeguards to remedy the patent abuse, giving primacy to the public health over
private intellectual property and also clarifying the WTO members States rights for using TRIPS
safeguards.
In India Glivec case is remarkable because the judgment has a positive impact on affordability
and accessibility of medicines. Now, it will be more difficult to indulge in ever-greening in India.
This paper attempts to analyze critically at the global and national level two bodies of law,
human right to health and intellectual property rights in order to examine certain core issues
such as how despite the interactions concluded between both the bodies of law at the
international level, the monopoly right conferred via intellectual property legislations
transgresses the right to health particularly right to access to drug through the practice of ever-
greening and threat of trade sanctions or corporate litigation from both pharmaceutical
companies and developed countries. Further this paper aims to study various cases of external
pressures put upon the developing countries from the side of developed nations in order to stop
the entry of competitive generic medicines in the global market in the context of Indian landmark
judgment and then to suggest various measures such as: making coherent, consistent and
balanced legal norms at international level clarifying different concepts and issuing clearly
stringent and mandatory guidelines/regulations in TRIPS providing a place of supremacy to
fundamental right to health over intellectual property right; establishing high patentability
standards at international level; developing Publicly funded research or pharmaceutical
subsidies as well as creating policies to relax patents and increase the affordability of generic
anti-retroviral through coordinated effort of global system. In order t achieve this objective, the
doctrinal research is done by studying various Reports, Declarations, and Conventions of United
Nations Organization and its different specialized agencies like; World Intellectual Property
Organization, World Health Organization and World Trade Organization, free trade treaties
among different nations as well as various other relevant national statutory enactments. The
important works of a number of jurists contributing towards this field has also been the material
of study.

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 AIMS AND OBJECTIVES

This research tries to further the following objectives to realize at the end of the research work:
the use of human rights arguments in domestic court cases that deal with
intellectual property laws,
the articulation of norms in the United Nations (UN) human rights
system,
the use of human rights arguments and frameworks to secure greater
pharmaceutical corporate accountability, and
the use of health-related rights to build multilateral and regional alliances
that can more effectively oppose free trade agreements (FTAs) with
TRIPS-plus provisions (TRIPS being Trade-Related Aspects of Intellectual
Property Rights)

INTRODUCTION

In 2005, India in its patent law included strict patentability criteria for addressing the ever-
greening of patents. Novartis AG, a pharmaceutical company based in Switzerland, filed a case
challenging the order of the Chennai-based Intellectual Property Appellate Board rejecting its
claim for patent for the beta-crystalline of imatinib mesylate, brand name Glivec (Gleevec), on
the ground that patent qualify as a new product which comes by through an invention that has
a feature that involves technical advance over the existing knowledge and that makes the
invention not obvious to a person skilled in the art, which is decided by the Supreme Court of
India on April 1, 2013 as under:
In view of the findings that the patent product, the beta crystalline form of Imatinib
Mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja)
of section 2(1) and section 3(d) respectively, the appeals filed by Novartis AG fail and are
dismissed with cost.
The judgment has evoked extreme reactions. However, Glivec case is remarkable because it has
gone beyond the specific technical and legal issues surrounding patents and has put the matter in
a much larger political and economic perspective. What the judgment said and what it implied
has tremendous significance for the patent regimes in developing countries beyond the secondary
patenting issues. The judgment has a positive impact on affordability and accessibility of
medicines.
The multi-national corporations (MNCs) holding the patents often try to block or delay the entry
of competitive generic medicines into the market by a practice which has come to be known as
ever-greening. Ever-greening refers to indulge in the practice of getting new/secondary patents
on a patented medicine after making minor changes to it. For example, on new uses, forms,
combinations and formulations of known medicines, patents are obtained in a bid for extending

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the period of monopoly of patentee. Now, it will be more difficult to indulge in ever-greening in
India. Considering the strict criterion of efficacy patenting new forms of non patented drugs or
patent-expired drugs will not be easy. The patent office in India is unlikely to grant such patents
unless therapeutic efficacy is demonstrated. And demonstrating new forms are therapeutically
more effective may not be that easy, as the Novartis case suggests. Thus, some medicines which
otherwise would have been patented with high monopoly prices will not be patentable and hence
will be more affordable. On the other hand, a victory for Novartis in the Supreme Court would
have affected the status of India as a major hub for the production of generic versions of cheaper
medicines for life threatening diseases such as HIV/AIDS which is benefiting patients within the
country as well as developing nations across the globe which are importing them from India.

CHAPTERISATION

Introduction

I. Access to Medicines through Human Rights Law in Domestic Courts

Introduction
The Right to Health and IP Protection: The Grammar of a Human Rights Argument
Human Rights Arguments in the Courts: A Lens and a Counterweight
i. The Lens: How Human Rights Law Can Be Used to Reinterpret IP Protection
ii. The Counterweight: How Human Rights Law Can Be Used to Eliminate IP Protection
The Impact of Court Cases: Concrete Change and Norm Mobilization
Insights & Action Steps
II. Access to Medicines through the UN Human Rights System
Previous Developments in the UN Human Rights System
Targeting Stronger and More Specific Human Rights Norms for IP and A2M
Available Mechanisms in the UN Human Rights System
i. Mechanisms for Developing Human Rights Norms
ii. Mechanisms for Applying Human Rights Norms to Particular States
iii. Pursuing the Most Feasible Options
iv. Putting an Issue on the International Agenda: A Case Study on Violence Against
Women
Would UN Human Rights Statements Actually Impact A2M?
Insights & Action Steps
III. Access to Medicines Through Corporate Accountability
Corporate Social Responsibility and the Right to Health
Evolving Human Rights Norms Regarding Corporate Accountability
Application of the Ruggie Framework to Hunts Guidelines
Human Rights Arguments and Practical Solutions
Insights & Action Steps
IV. Access to Medicines Through Multilateral Alliances
Background on FTAs and A2M

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 The Nature of a Possible Alliance
Possible Impact of Multilateral Alliances
The Practical and Normative Role of the Right to Health
Insights & Action Steps
V. Conclusion

CONCLUSION
Public health is inherently a global challenge and thus assumes high priority for international
cooperation. The World Health Organization (WHO) is the directing and coordinating authority
for health, but the interaction between health issues and other policy domains human rights,
development policy, intellectual property (IP) and international trade creates a strong
rationale for cooperation and coordination between the WHO and other international
organizations such as the World Intellectual Property Organization (WIPO) and the World Trade
Organization (WTO).However, the relationship between intellectual property systems and human
rights is so complex that conflicts are always seen to exist between the respect for the
implementation of current intellectual property systems and other human rights, such as the
rights to adequate health care, to education, to share in the benefits of scientific progress, and to
participation in cultural life. A significant proportion of the world's population, especially in
developing countries, have yet to derive much benefit from innovations that are commonplace
elsewhere. The reasons range from weak supply systems to unaffordable prices. The factors that
drive innovation are often biased against conditions that disproportionately affect the
populations of developing countries. In addition to it, lack of capacity along with external
pressures from the side of developed nations has made it difficult for the developing countries to
use and implement TRIPS flexibilities for the promotion of access to medicines.

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