Intellectual Property Rights Vis-A Vis Right To Health: A Critique

Intellectual Property Rights Vis-a Vis Right to Health: A Critique
Anuradha Chadha
Department of Law
Guru Nanak Dev University Regional Campus
Ladhewali, Jalandhar
Punjab, India
Email:dranuradhachadha@gmail.com
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. However, such measures failed to resolve the terrific issue ensuring
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production and export of generic medicines to developing countries that were incapable to
produce them and also certain concepts remained un-clarified demanding clear guidelines to be
issued in this respect at the international level for removing various types of controversies which
still arise between developed and developing member States. Moreover, the intellectual property
rules in TRIPS have been observed to be considerably less stringent than the rules developing
countries are increasingly adopting in free-trade agreements known as "TRIPS-plus" agreements
with the United States and other Western Governments which put greater restrictions on the use
of TRIPS flexibilities like, compulsory licensing and parallel imports making it much more
difficult for generic drugs to enter the market upon patent expiration and then extend patent
periods beyond twenty years. Consequently, the developing countries that attempt to bring the
price of the medicines down have to come under pressure from the industrialized countries and
multi-national pharmaceutical industry for implementing patent legislation that goes beyond the
obligations of TRIPS. However, 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
Electronic copy available at: http://ssrn.com/abstract=2529105

affordability of generic anti-retroviral through coordinated effort of global system. In order to

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.
Key Words: Generic drugs, Human Rights, Intellectual Property Right, Patent Protection, Right
to health.
Introduction
“Idea of a better world is one in which medical discoveries

would be free from patent and there will be no profiteering
from life and death”.
----------Mrs. Indira Gandhi[1]
The human rights dimension has provided an important legal and policy vantage point of
concern for public health and pharmaceutical issues [2]. Health is one of the fundamental basic
requirements of the human beings.[3] The enjoyment of the highest attainable standard of health
is one of the fundamental rights of every human being without the distinction of race, religion
and political belief, economic or social condition[4]. However health trends indicate that despite
progress made in the last 35 years, massive inequalities remain in access to health services and
medicines around the world.[5] Each year, over 13 million people are killed by infectious
diseases, more than 90% of whom are in the developing world.[6] In Asia, Africa and South
America-regions which comprise almost four-fifths of the population at the world level, the
foremost causes of the ill health and death are—cancer, HIV/AIDS, respiratory infections,
malaria and tuberculosis[7]. Nearest eight thousand people die of AIDS each day in the
developing nations.[8] “Diseases of poverty” (i.e., communicable, maternal, perinatal and
nutritional diseases) still account for 50 percent of the burden of disease in developing countries,
nearly ten times higher than in developed countries.[9] It is partly because of the reason that
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millions of the people in the developing countries do not have access to the medicines which are
required for treating disease or assuaging suffering. Report from World Health Organization
(WHO) and Health Action International on the results of surveys undertaken in 36 nations
reported that only one third of essential medicines needed were available in the public sector and
remaining two thirds of such medicines were available in the private sector[10]. 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.[11] Exorbitant drug prices are frequently the result of
strong intellectual property protection[12]. The creation, use and the exploitation of mental or
creative labour are regulated by the intellectual property law and it also consists of copyright,
trademark, geographical indications, industrial designs, layout designs of integrated circuits,
patents and their designs, undisclosed information and trade secrets. On inventors, legal rights
and more significantly over the product inventions or process, negative rights are conferred by
patents. Therefore, the persons not authorized by patentee can be prevented by him from making,
using, offering for sale, selling or importing the patented invention.[13] While absolute
monopolies are created by product patents, so patents lead to relative monopolies.[14] These
monopolies when created by patents restrict competition and pave way for patentee to set up
high prices. Thus, patent protection keeps prices inflated up to one hundred times the cost of
manufacture of drugs also as a patent product. So, it is evidently clear that there is very close
relationship between intellectual property rights (IPR) as human rights on the one hand and right
to health as another human right on the other hand. Intellectual property law has a very strong
influence upon the right to health as the pharmaceutical products are protected by it.[15]
However, the linkage between intellectual property rights and health has been the focus of much
debate. No other legal subjects have been attracting so extensive social and academic concerns as
the confliction between intellectual property rights and the right to health for the last few
decades.[16] However, in the last few years, between intellectual property law on the one side
and human right to health on the other side, international standard setting activities have started
mapping formerly unexplored crossroads.[17]
Objective of the Study
4
This paper attempts to analyze at the global and national level two bodies of law, human right to
health and intellectual property rights which were once strangers and developed for decades in
virtual isolation from each other but due to international standards setting have now become ever
more intimate bedfellows. Further this paper aims to examine the core issue of infringement of
right to health by the intellectual property rights despite the interactions concluded between both
the bodies of law at the international level. The next objective of this paper is to study various
cases of external pressures put upon the developing countries from the side of developed nations
in order to uphold their monopolistic intellectual property rights in pharmaceutical industry and
then to suggest various measures providing a place of supremacy to fundamental right to health
over intellectual property right in order to establish high patentability standards at international
level.
Methodology
In this paper, the doctrinal research is depended upon in the form of study of 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. Moreover, this paper
also studies various relevant national statutory enactments and the important works of a number
of jurists who contributed a lot towards this field.
Evolutionary Trends of Intellectual Property Rights and Right to Health
At an international level, the World Intellectual Property Organization (WIPO)

superintends a number of treaties for the promotion of IPRs. The different subject areas of
intellectual property originate in different places and at different times. Very probably all these
laws can be traced back to the system of royal privilege-giving which seems to have operated in
most of medieval Europe.[18] The history of patents and patent laws is generally considered to
have started in Italy with a Venetian Statute which was issued by the Republic of Venice on
19.03.1474.[19] In England the Statute of Monopolies of 1623 swept away all monopolies except
those made by the “true and first inventor” of a “method of manufacture.”[20] Revolutionary
5
France recognized the rights of inventors in 1791 and, outside of Europe; the U.S.A. enacted a
patent law in 1790.[21] These patent laws were nothing like today’s complex systems.[22] They
were mercifully short, simply recognizing the rights of the inventor.[23] After these beginnings,
patent law spread throughout Europe in the first half of the nineteenth century.[24] Statutory
forms of trade mark law only make their appearance late in the second half of the nineteenth
century, even though trademarks had been in use for much longer.[25] The English courts
developed protection for trademarks through the action of passing off.[26] For a variety of
reasons, this proved unsatisfactory and statutory systems of trade mark registration began to
make their appearance in Europe: England 1862 and 1875, France 1857, Germany 1874 and the
U.S.A. 1870 and 1876.[27] Copyright follows a similar kind of pattern, modern copyright law
beginning in England with the Statute of Anne of 1709.[28] Dealing with free-riding and positive
externalities led States into the next phase of intellectual property protection: the international
period. In copyright, a French decree of 1852 granting copyright protection to foreign works and
foreign authors without the requirement of reciprocity did much to keep bilateral treaty-making
in copyright alive.[29] Those States that were worried about the free-riding problem began to
negotiate bilateral treaties with other States. The Americans were not the only culprits.[30] The
UK passed in 1838 and 1844 Acts that protected works first published outside of the UK. These
Acts grounded a strategy of reciprocity. The 1844 Act saw a considerable number of bilateral
agreements concluded between the UK and other European States.[31] International copyright
policy in the U.S.A. took a different turn to that of the UK. The U.S.A. Copyright Act of 1790
only granted copyright protection to citizens and residents of the U.S.A. In fact, it was not until
after the Second World War that the U.S.A. began to exercise real leadership in international
copyright.[32] The German Patent Act (Reichspatentgesetz.) of 1877 was in line with several
laws of the time in not allowing the patenting of inventions that were considered to be against
public order or morality.[33] Patenting of inventions regarding luxuries, medicines, articles of
food, or chemical products was prohibited.[34] By 1883, there were 69 international agreements
in place, most of them dealing with trade-marks.[35] Two of the major driving forces have been
the Paris Convention of 1883 and the Berne Convention of 1886.[36] The Paris and Berne
Conventions ushered in the multilateral era of international cooperation in intellectual
6
property.[37] The twentieth century saw the proliferation of international intellectual property
regimes.[38] During the international period the harmonization of intellectual property was a
painstakingly slow affair. After the Second World War more and more developing countries
joined the Paris and Berne Conventions. The Paris and Berne Conventions saw the creation of
international bureaus (secretariats) which were merged in 1893 to form the United International
Bureaux for the Protection of Intellectual Property (known by the French acronym of
BIRPI).[39] The Convention establishing the World Intellectual Property Organization (WIPO)
came into force and BIRPI was thus transformed to become WIPO in 1970. WIPO joined the
United Nations (UN) family of organizations, becoming a specialized agency of the UN in 1974.
Although the growth of economic globalization started at the end of the nineteenth century duly
facilitated by the internationalization of intellectual property institutions but it was accelerated in
the twentieth century by the adoption of the TRIPS Agreement developed and negotiated in the
context of the General Agreement on Tariffs and Trade (GATT) Uruguay Round (1986–1994).
In copyright, led by India, developing countries succeeded in obtaining the adoption of the
Stockholm Protocol of 1967. The aim of the Protocol was to give developing countries greater
access to copyright materials. The Paris Convention also became the subject of Diplomatic
Conferences of Revision in 1980, 1981, 1982 and 1984 with developing countries pushing for
more liberal provisions on compulsory licensing.[40] On 15 April 1994, the Uruguay Round
concluded in Marrakech with the signing of the Final Act Embodying ‘The Results of the
Uruguay Round of Multilateral Trade Negotiations’. It contained a number of agreements
including the Agreement Establishing the WTO and the TRIPS Agreement. The TRIPS
Agreement was made binding on all members of the WTO. The TRIPS Agreement marks the
beginnings of the global property epoch. It establishes minimum global standards for all major
intellectual property rights and sets rules for their enforcement[41]. On December 20, 1996,
under the auspices of WIPO, the WIPO Performances and Phonograms Treaty and the WIPO
Copyright Treaty were concluded.
The right to health is a fundamental part of our human rights and of our understanding of
a life in dignity. There is a foundational logic for health concerns to be addressed through the
7
language of human rights. The right to the enjoyment of the highest attainable standard of
physical and mental health[42], to give it its full name, is not new. Even if professional ethics in
the medical profession have retained an individual-centric focus on curative treatment, the
evolution of international human rights norms pertaining to health has created a normative
framework for Governmental action.[43] Internationally, the right to health was first articulated
in the 1946 Constitution of the WHO, whose preamble defines health as “a state of complete
physical, mental and social well-being and not merely the absence of disease or infirmity”. The
preamble further states that “the enjoyment of the highest attainable standard of health is one of
the fundamental rights of every human being without distinction of race, religion, political belief,
economic or social condition.”[44] The 1948 Universal Declaration of Human Rights also
mentioned health as part of the right to an adequate standard of living[45]. Since then, the right
to health has been enshrined in international[46] and regional[47] human rights treaties as well as
national Constitutions all over the world. The right to health was again recognized as a human
right in the 1966 International Covenant on Economic, Social and Cultural Rights. Specific
reference can be made to the provisions in the Convention on the Elimination of all forms of
Discrimination Against Women, the Convention on the Rights of the Child and the International
Convention on the Elimination of all forms of Racial Discrimination [48].The right to health is
relevant to all States: every State has ratified at least one international human rights treaty
recognizing the right to health. Moreover, States have committed themselves to protecting this
right through international declarations, domestic legislation and policies, and at international
conferences.[49]
The Committee on Economic, Social and Cultural Rights recognized that the
understanding of what constitutes ‘health’ had changed considerably since the drafting of the
International Covenant on Economic, Social and Cultural Rights (ICESCR) in 1966. General
Comment 14 adopted a broader definition of health which includes social determinants such as
access to safe water and food, adequate nutrition and housing, healthy environmental conditions,
access to health-related education and information.[50] It also acknowledged global changes
such as rapid population growth, the emergence of infectious diseases such as HIV/AIDS and the
8
fact that chronic diseases have become more widespread.[51] Article 15 of this Covenant
guarantees all the individuals the right to the benefits of scientific progress, which could include
access to break-through medications[52]. Comment 14 also concentrates on economic
accessibility (affordability), asserting that “equity demands that poorer households should not be
disproportionately burdened with health expenses as compared to richer households”[53]. In this
respect, General Comment 14 enumerated a set of universal minimum core obligations on State
Parties. Most of these resonated with the health-related Millennium Development Goals
(MGD’s) articulated under the aegis of the United Nations.[54]
Public health and medical technologies are an important focus of the international
system, including in the system wide work of the United Nations – most notably in the (MDGs).
The MDGs are a set of eight international development goals to be achieved by 2015. All of
them relate in some way to improving physical, mental and social wellbeing. The WHO World
Health Report 2010 focused on strategies for, and progress in, providing universal health
coverage through member states’ health financing systems as a means of promoting and
protecting health, but without prohibitive costs. In the area of medical technologies in particular,
not only the price but also the ultimate availability, quality and appropriateness of resources are
reflective of a long chain of policy decisions, market forces and other factors. Therefore, access
to medical technology needs to be considered from the standpoint of a comprehensive
framework of determinants that ultimately relate back to product innovation, Intellectual
Property (IP) protection, trade and distribution. MDG 8 calls for enhanced global partnership for
development issues. Target 8.E therefore focuses specifically on global collaboration for access
to essential medicines, of which universal access is guaranteed as a right, stating: “In
cooperation with pharmaceutical companies, provide access to affordable essential drugs in
developing countries”.
As the world becomes ever more integrated, it becomes less and less feasible for different
policy areas to be handled independently. Therefore, it was human rights community by whom
for the first time; the intellectual property law was taken notice of. As it was asserted by Yamin,
“From a human rights perspective, the rights to life and dignity supersede the private sector’s
right to profit, especially when that profit offers only dubious budding ever to benefit the
9
people most in need.”[55] Before Millennium Development Goals demanding partnership of

laws at global level for providing access of essential medicines to developing nations, no
references to human rights appear in the major intellectual property treaties like, Paris and Berne
Conventions, or even in the recently adopted TRIPS Agreement.[56] In 2000, the United Nations
human rights system turned to TRIPS, just when for the developing nations, the transitional
periods or treaty was expiring[57]. The Resolution 2000/7 on intellectual property rights and
Human Rights adopted by Sub-Commission on Promotion and Protection of Human Rights
stresses that “actual or potential conflicts exist between the implementation of the TRIPS
Agreement and the realization of economic, social and cultural rights”[58]. In the health sector,
intellectual property rights can provide an important stimulus for the development of new drugs
and medicines. However, the statement “The allocation of rights over intellectual property has
significant economic, social and cultural consequences that can affect the enjoyment of human
rights” by the United Nations Committee on Economic, Social and Cultural Rights in 2001 is
also clearly indicative of the fact that intellectual property rights and the right to health were
heading for a conflict. These conflicts are driven by the manner in which creative works, cultural
heritage, and scientific knowledge were turned into property which, creative works, cultural
heritage, and significant human rights implications,[59] particularly the right to health. To
address these conflicts, an ambitious new agenda was set out by the Sub-Commission for
reviewing intellectual property issues within the United Nations,[60] an agenda animated by the
principle that human rights must be given “primacy ….. over economic policies and
agreements.” The Doha Declaration is an excellent example of how a human rights issue can be
raised in the trade context and can obtain the support of key developing countries.[61] The
interpretation of TRIPS was called by the Doha Declaration that would permit the member States
suffering crises of public health for balancing patent protection with access to pharmaceutical
products.[62] In 2001, the problem of intellectual property right of technologies that affect
public health was addressed by the WTO in the Doha Declaration on the TRIPS Agreement and
Public Health. In the declaration, compulsory licensing of technology of intellectual property that
is critical to the health of the public was granted in a time of national emergency. However, what
constitutes an “emergency” rests in the hand of individual Government [63]. The TRIPS
10
agreement, although providing hints at the problem of manufacturing the necessary drugs under
compulsory licensing in developing countries that lacked the sufficient resources, failed to
consummate a proper solution. Many developing countries that lacked the resources to
synthesize drugs at a cheaper cost must depend on the original manufacturers who hold the
patents. The TRIPS agreement further prevented developing countries from helping one another.
Under it, a country had the right to copy these drugs, but did not have the right to export them
[64]. Developed countries that had the resources to synthesize, these countries often had laws
that allowed the drugs to be patented and were thus the ones who held the patents for these
drugs. However, in order to curtail or lessen the effect of the restriction on compulsory license
rights in TRIPS to domestic markets for the benefit of poorer member countries having no
manufacturing capacity, an “expeditious solution” was sought by the Doha Declaration.
Use of the 30 August 2003 Compulsory License Import Export mechanism
In August 2003, after two years of tough negotiations, WTO Members agreed to waive
the TRIPS limit on the export of drugs under compulsory license. To ensure that the mechanism
was only used “in good faith to protect public health,” a number of countries agreed to forego or
limit their right to use the solution. For instance, several countries decided to limit their use as
importers to situations of “national emergency or other circumstances of extreme urgency.”
Asian WTO Members having done so include Hong Kong, China, Korea, Macao, Singapore and
Chinese Taipei.
The 30 August Decision set out a detailed import/export compulsory licensing

mechanism that goes beyond the TRIPS main compulsory licensing criteria. In order for a
country to qualify as an importer it either has to be a Least Developed Country (LDC) or
demonstrate that it has insufficient or no pharmaceutical manufacturing capacity. Exporting
countries, on the other hand, are not subject to qualifying criteria. For the mechanism to work,
two compulsory licenses are needed: one in the importing country and one in the exporting
country. Finally, there are a number of other criteria that need to be fulfilled for the license to be
valid, such as notification to the TRIPS Council, and the establishment of measures to avoid
cheap drugs produced for low income countries being sold in rich country markets.
11
The 30 August 2003 WTO General Council Decision regarding the problem of countries
with insufficient or no manufacturing capacity in the pharmaceutical sector can be an important
part of the efforts to maximize the impact of the LDCs 2016 transition. This decision permits
antiretroviral export by a country that is TRIPS compliant, by waiving their obligation (under
Article 31(f) of the TRIPS Agreement) that the majority of products produced under a
compulsory license is used only for a domestic market, and also waiving their obligation (under
Article 31(h)) that payment of adequate compensation to the patent holder is required when a
compulsory license is issued. This decision can be used to facilitate the continued production by
key middle-income countries (MIC), such as India, of generic antiretroviral (and other
medicines) for supply to LDCs. Provided that LDCs make the legislative changes discussed
above, middle and upper income countries in the WTO can help LDCs maximize the
opportunities under the 2016 transition by putting in place the legal mechanisms that will allow
them to use the 30th August decision. So far, only Canada[65] countries in the European
Community[66] and India[67] have put in place the system to allow the functioning of the 30
August 2003 decision. However, the concepts like ‘national emergency or other circumstances of
extreme urgency’ still require clarifications and clear guidelines to be issued at the international
level in order to remove any type of controversies which arises between developed and
developing member States. No doubt, all these measures at the international front have broken
new grounds in guaranteeing member nations’ access to medical products but it did not solve all
the problems associated with the intellectual property protection and public health.
Concept of Intellectual Property Rights and Right to Health in India
The Constitution of India has incorporated provisions guaranteeing everyone's right to the
highest attainable standard of physical and mental health. Article 21 of the Constitution
guarantees protection of life and personal liberty to every citizen. The Supreme Court has held
that the right to live with human dignity, enshrined in Article 21, is derived from the Directive
Principles of State Policy and therefore includes protection of health.[68] Further, it has also
been held that the right to health is integral to the right to life and the Government has a
Constitutional obligation to provide health facilities[69] under Part IV of the Constitution which
12
deals with Directive Principles of State Policy which has several provisions that touch on the
subject of health and one can refer to the text of Articles 39(e), 39(f), 42 and 47.[70] It would
also be essential to delve briefly into the legislative history of the law of patents in India. At the
time of Independence, India’s patent regime was governed by the Patents and Designs Act, 1911,
which had provisions both for product and process patents. It was, however; generally felt that
the patent law had done little good to the people of the country. The way the Act was designed
benefited foreigners far more than Indians and it curbed the innovativeness and inventiveness of
Indians. Therefore, shortly after independence, in 1949, a committee was constituted under the
chairmanship of Justice (Dr.) Bakshi Tek Chand, a retired judge of the Lahore High Court, for
undertaking a comprehensive review of the functioning and working of the Patents and Designs
Act, 1911.[71] On August 4, 1949, the interim report was submitted by the Committee
recommending that the Patent Act should contain a clear indication that food and medicine and
surgical and curative devices were to be made available to the public at the cheapest price
commensurate with giving reasonable compensation to the patentee.[72] Based upon the
recommendations given by the Committee, the 1911 Act was amended in the year, 1950 (by Act
XXXII of 1950) relating to the working of inventions, including compulsory licensing and
revocation of patents. In 1952, a further amendment was made (by Act LXX of 1952) for
providing for compulsory license in respect of food and medicine, insecticide, germicide or
fungicide, and a process for producing substance or any invention relating to the surgical or
curative devices. In 1957, under the chairmanship of Justice N. Rajagopala Ayyangar another
committee came to be appointed in order to take fresh look at the law of patent and to completely
revamp and recast it to best sub-serve the (contemporary) needs of the country.
It was observed by Justice Ayyangar that the provisions of the Patent Law have to be
designed, with special reference to the economic conditions of the country, the state of its
scientific and technological advancement, its future needs and other relevant factors, and so as to
minimize, if not to eliminate, the abuses to which system of patent monopoly is capable of being
put. Bearing in view the matters set above, he recommended retaining the patent system, but with
a number of improvements. One of the improvements suggested was to define, with precision,
those inventions which should be patentable and equally clearly identify certain inventions, the
13
grant of patents to which would retard research or industrial progress, or be detrimental to the
national health or well-being and to make those inventions non-patentable. He suggested that not
allowing grant of patents in respect of articles of food and medicines was necessary in order
that important articles of daily use such as medicine or food, which are vital to the health of
the community, should be made available to everyone at reasonable prices and that no monopoly
should be granted in respect of such articles. It was considered that the refusal of product
patents would enlarge the area of competition and thus result in the production of these articles in
sufficient quantity and at the lowest possible cost to the public. Justice Ayyangar submitted a
Comprehensive Report on Patent Law Revision in September 1959 and the new law of patent,
namely, the Patents Act, 1970, came to be enacted mainly based on the recommendations of
the report, and came into force on April 20, 1972, replacing the Patents and Designs Act,
1911. The Act thus clearly recognized and maintained the distinction between invention and
patentability.
Impact of the Patent and Designs Act, 1911, and the Patents Act, 1970 on Pharmaceutical
Industry and the Availability of Drugs in India
The fall and the rise of the Indian pharmaceutical industry is explained as the result of
certain factors, not the least important of which was the change in the patent law in the country,
which made medicines and drugs and chemical substances non-patentable. [73] By the time the
Second World War started (1939), several indigenous firms were engaged in manufacturing
drugs, and indigenous producers met 13 percent of the medicinal requirements of the country.
They still had a long way to go to attain self- sufficiency but in terms of the range of operations
they were already manufacturing all types of drugs. By the early 1950s, because of the spread of
manufacturing activities, the indigenous sector dominated the pharmaceutical industry in India. It
accounted for about 62 percent of the market in 1952. However, the rise and growth of
multinational corporations (MNCs) worldwide in the post-Second World War period, as well as
the therapeutic revolution changed these dynamics. The MNCs started research for developing
new drugs in the 1940s and during the 1950s and even after that at a slower rate, new drugs
discovered by the MNCs began to be available for medical use. The indigenous sector was not
14
equipped for research for developing new drugs, that is, for developing a new chemical entity.
With the introduction of new drug at a rapid rate by the MNCs, the role of patents became
important. Because of the patent regime under the 1911 Act and the unsupportive industrial
policy, the indigenous sector lost its status in the 1950s and the 1960s. In contrast to 62 percent
of the market in the early 1950s, the market share of the indigenous sector declined to 32 percent
by 1970. In contrast, the market share of the MNCs increased from 38 percent in 1952 to 68
percent in 1970.
However, the situation changed in the 1970s. Several official initiatives taken in the
1970s, of which the most important one was the enactment of the Patent Act, 1970, which
changed the environment in favor of the indigenous sector.[74] Under the Patent Act, 1970, the
patent reforms contributed directly to the transformation of the pharmaceutical industry. Under
this Act, articles of food, medicines and drugs and the chemical substances could be patented
only for a new method or process of manufacture, not for the products as such (section 5 of the
1970 Act). Further, unlike in the previous patent regime, for each particular drug only one
method or process--the best known to the applicant—could be patented (section 5 and 10 of the
1970 Act). Also, even in case of a process patent for an article of food, medicine or drug, the
term of the patent was brought down from fourteen years to five years from the date of sealing of
the patent, or seven years from the date of the patent whichever was earlier.[75]
The Growth of the Indian Pharmaceutical Industry by New Patent Regime
The growth of the Indian pharmaceutical industry driven by the new patent regime passed
through three phases:
1. Till the early 1970s;

2. The late 1970s and the 1980s; and
3. Since the 1990s.
Till the early 1970s the industry was dominated by MNCs who commanded 68% of the
market share. India was dependent on imports for many essential bulk drugs. This import
15
dependence constricted consumption in a country deficient in foreign exchange, and inhibited the
growth of the industry. Drug prices in India were high.[76]
In the late 1970s and 1980s, Indian companies started large-scale production of bulk drugs.
The development of the bulk drugs sector is actually the most important achievement of the
pharmaceutical industry in India. This led to the transformation of the industry.
The most rapid growth of the Indian pharmaceutical industry took place from the 1990s
onwards. Both production and exports grew remarkably fast. The production of both bulk drugs
and formulations started increasing sharply and steadily.[77] From Rs. 6,400 million in 1989-90,
bulk drugs production increased to Rs. 77,790 million in 2003-04; and from Rs. 34,000 million
in 1989-90, formulation productions increased to Rs. 276,920 million in 2003-04. The growth
was most remarkable from 2000-2005, when production increased much more than it had in the
last two decades. Indian companies further consolidated their domination in the domestic market.
Their market share increased from 60 percent in 1991 to 68 percent in 1998 and 77 percent in
2003.[78]
The growth was also very fast in the export markets. India became a net exporter by the year
1988-89, and since then there has only been an increase in the Indian exports. As a result, net
exports as a percentage of exports have increased from 4.4 percent in 1988-89 to about 50
percent in the early1990s and more than 75 percent in the early 2000s. More than three-fourths
of bulk drug production and almost one-fourth of the formulations production were exported.
The USA, which has the toughest regulatory requirements, has emerged as India’s largest export
partner in pharmaceuticals.[79]
Because of the rapid growth and structural transformation in the last three decades or so,
India occupied an important position in the international pharmaceutical industry. India had
received worldwide recognition as a low cost producer of high quality bulk drugs and
formulations. It produced about 350 bulk drugs ranging from simple pain killers to sophisticated
antibiotics and complex cardiac products. Most of the bulk drugs were produced from basic
stages, involving complex multi-stage synthesis, fermentation and extractions. For more than 25
bulk drugs, India accounted for more than 50 percent of the international trade. India was a major
force to reckon with in the western markets for such drugs as ibuprofen, sulphamethoxasole. And
16
this could be made possible due to the implementation of the 30 August 2003 Decision in
India.[80]
Implementation of the 30 August 2003 Decision in India
The approach by India (under Section 92A of the Indian Patent Act) could provide a
model for a legal framework. The impact of this legislation in India is that Least Developed
Countries (LDCs) only have to notify the Controller of Patents in India that they do not grant or
enforce patents on pharmaceuticals and that they require supplies from India.
The WTO Doha Declaration on TRIPS Agreement and Public Health (2001), in which,
inter alia, observed that countries have the sovereign right to enact laws that safeguard domestic
interests. It recognized the gravity of public health problems in developing countries and clearly
provided that the member countries have the right to protect public health and to promote access
to medicines for all. The declaration focuses mainly on questions related to the implementation
of patents, such as compulsory licensing. Compulsory licensing has been used as a tool to
regulate the exclusive rights conferred by patents. Further, especially for developing countries a
wide consensus that domestic laws, while being TRIPS compliant, need to make full use of
“flexibilities” available in the TRIPS agreement. Indian Patent Act, 1970 strategically exploited
TRIPS flexibilities to the hilt. It introduced higher standards for pharmaceutical
patentability,[81] a very potent opposition mechanism where any member of the public could
effectively oppose a patent grant and some of the widest compulsory licensing norms that the
world had ever known.[82] Section 92A of the Indian Patents Act of 1970 (as amended by the
Patents (Amendment) Act, 2005) provided for Compulsory license for export of patented
pharmaceutical products in certain exceptional circumstances.[83] From 1st January 2005, drug
product patent protection has been reintroduced in India for complying with the requirement
under the Trade-related Aspects of Intellectual Rights (TRIPS) of the General Agreement on
Tariffs and Trade/World Trade Organization.[84]
17
Findings and Discussion
Intellectual property rules in TRIPS are considerably less stringent than the rules developing
countries are increasingly adopting in free-trade agreements with the United States and other
Western Governments. These "TRIPS-plus" agreements place greater restrictions on the use of
TRIPS flexibilities. For example, many free-trade agreements make it much more difficult for
generic drugs to enter the market upon patent expiration and extend patent periods beyond
twenty years.[85] Moreover, they limit compulsory licensing and prohibit parallel imports. The
product patent prohibits others from making, using, offering for sale, selling or importing the
patented product. As a result, the product patent gives a monopoly to the patent owner for the
production of patented articles during the term of the patent (20 years). Therefore, product patent
protection for medicines and agro-chemicals creates monopoly and eliminates competition in the
pharmaceutical market. The United States has concluded bilateral and regional trade agreements
containing TRIPS-plus standards with over sixty countries, many of which are developing
countries with extremely high disease burdens, including HIV/AIDS.[86] Drug companies often
abuse the patent monopoly and fix exorbitant prices for the patented medicines. The introduction
of product patent thus reduces accessibility and affordability of drugs and the consequent denial
of access to medicines to the poor across the globe. The pharmaceutical industries claim the high
prices explained by the massive expenditure on research and development (R&D), however the
truth is that drugs they actually research have little relevance to real medical needs. Thus, the
kinds of profits that big pharmaceutical Multi-national Companies (MNCs) generate are an
indication of profiteering and not just legitimate profit making. Finally, it can be concluded that
the monopoly right conferred via Intellectual Property legislations transgresses the Right to
health especially right to access the drug at the global level and even as enshrined under Article
21 of Constitution of India.
So, the developing countries are still under pressure from the industrialized countries and
pharmaceutical industry for implementing patent legislation that goes beyond the obligations of
TRIPS. These countries while attempting to implement and use TRIPS flexibilities as
compulsory licensing and parallel importing in order to address public health concerns have
18
often faced the threat of trade sanctions or corporate litigation (which often came as a single
combined assault) from both pharmaceutical companies and developed countries. Despite the
confirmation of the legality of compulsory licensing and parallel imports in the WTO's Doha
Declaration on Public Health, corporate and Governmental challenges continue. This has been
the case for Thailand, Mexico, Chile, Brazil, Indonesia, Bolivia, Colombia, Ecuador, Peru,
Venezuela, South Korea, and South Africa.
In 1996, a new National Drugs Policy was adopted by South Africa with the objective of
“ensuring an adequate and reliable supply of safe, cost-effective drugs of acceptable quality to all
citizens of South Africa”.[87] The South African Government following the principles of the
Policy amended its existing Medicines Act for improvement of access to medicines.[88] In
response, South Africa was placed on the United States Special 301 Watch List[89] and
challenging the amendments, a suit was filed by 39 pharmaceutical companies contending that
patent protections would be destroyed by them by giving the Health Minister overly broad
powers for producing or importing cheaper versions of drugs still under patent.[90] Global public
outrage ultimately went ahead to a change in the position of United States[91] and then in 2001,
to the withdrawal of the law suit by the pharmaceutical companies.
In 2002, for example, the U.S. Government pressured South Korea to refuse a
compulsory license for Gleevec, a leukemia drug that costs around $27,000 per year per person.
In 2006, Pfizer sued a Philippine company and Government officials in their private
capacity to prevent parallel importing of a generic version of Norvasc, a hypertension drug.[92]
Pressure was also faced by Thailand following its attempts for lowering the prices of
medicines through compulsory licensing. Compulsory licenses were issued by Thailand for HIV
and heart disease medicines for meeting its obligations to provide universal access to
medicines.[93] Thailand was also placed in 2007 on the Special 302 Priority Watch List.[94] The
European Commission also did not welcome the measures taken by Thailand.[95] Seven pending
applications for the registration of new medicines in Thailand were withdrawn by one of the
affected companies, thus withholding them effectively from the Thai market.[96]
19
Again in 2008, Thailand Government issued compulsory licenses for three anti-cancer
medicines noting the burden of cancer and the requirement for the Government health program
for providing access to cancer medicines.[97] For the use of this TRIPS flexibility, a worldwide
campaign for supporting the Thai compulsory licenses led to several statements of support;[98]
however growing pressure was continued to be faced by Thailand in response to its use of
compulsory licensing.[99]
Similarly, India faced pressure for attempting to use the same safeguards. However, the
order awarding a compulsory license to Nactco, a Hyderabad based Pharmaceuticals Company
for manufacture of the anti-cancer drug Nexavar by Controller General of Patent concluded that
in physical sense Bayer[100] was not working the patent and not meeting the condition that the
Public’s “reasonable requirements” with respect to the patented invention were being
satisfied.[101]
So, in 2005, India in its patent law included strict patentability criteria for addressing the
ever- greening of patents.[102] Novartis AG, a pharmaceutical company based in Switzerland,
filed a case[103] 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
20
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 [104]. For example, on new
uses, forms, combinations and formulations of known medicines, patents are obtained in a bid
for extending 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.
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
21
health care, to education, to share in the benefits of scientific progress, and to participation in
cultural life.[105] 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.
The Commission on Intellectual Property Rights, Innovation and Public Health report
states that "the economic problem is the lack of effective demand for health products needed by
developing countries."[106] This statement effectively illustrates the fatal flaw in the current
global patent system, where medical needs, unmatched by money, simply are not seen to
constitute demands. It demonstrates why using purely economic criteria to allocate medicines
globally are inappropriate, and why the present system is so blind to the needs of the global poor.
In the name of innovation, mindless patenting goes in countries such as the United
States—a model which many developing countries willingly or not so willingly follow—much
against the interests of the consumers. The ever-greening of patents by pharmaceutical
companies from a right to health perspective is of particular concern. However, linking patenting
to therapeutic benefit is a simple but powerful idea. The Supreme Court decision of India is
consistent with TRIPS and has been arrived at not arbitrarily but by following transparent and
internationally accepted legal processes. Thus, other countries which have stricter patent regimes
might be induced to introduce similar provisions in their patent laws to make drugs more
affordable. Thus, the judgment has significant and deeper international implication in the sense
that it is not at all justified to deny patents when incremental innovation is trivial, as in the case
of the beta crystalline patent application. The judgment has linked the entire question of
patenting with net benefits to society and has highlighted the relevance of specific conditions of
a country for deciding the appropriate patent regime. In addition to that, even the Supreme Court
of India has not commented on the fairness or otherwise of TRIPS. But what it has said and
22
implied provide a justification for a review of TRIPS just for the health care and health care
products to be treated differently from other products at the time of its implementation.
Moreover, this judgment seems to call attention towards the need of developing additional
international mechanism for addressing health requirement in the developing countries due to an
increasingly globalized economy.
Human rights provide a critical corrective by transforming human needs into legal
entitlements and by placing a nonmaterial value on them that demands action from social
institutions and agents. Certainly, the force of human rights in this respect also arises from the
fact that law irrespective of the extent to which it is complied with by States is intimately linked
to power. To this extent law can be seen as an important terrain of struggle for a more humane
trade system. Human rights therefore not only hold the potential to alter the behavioral incentives
currently driving the system but, as law intimately linked to social design, may provide a
mechanism capable of reforming the system itself. In an era where health risks assume a
transnational character, it is important for all the nations to ensure effective engagement at an
international level.
A human rights-based approach focuses particularly on the needs of the most

disadvantaged and marginalized individuals and communities. Because a right to health as a
human right is a universal entitlement, its implementation is evaluated particularly by the degree
to which it benefits those who hitherto have been the most disadvantaged and marginalized and
brings them up to the mainstream level of protection…..Thus, in adopting intellectual property
regimes, States and other actors must give particular attention at the national and international
levels to the adequate protection of the human right to health of the disadvantaged and
marginalized individuals and groups, such as indigenous peoples by providing them access to the
drugs and medicines at affordable prices. In order to achieve this objective, the following
solutions can be recommended:
1) the need of the hour is to make coherent, consistent and balanced legal norms at
international level clarifying different concepts and issuing in clear terms stringent and
23
mandatory guidelines/regulations in TRIPS to be followed by both developing and

developed nations regarding allowing greater opportunity for airing a human rights
perspective on intellectual property issues in order to facilitate the integration of an
increasingly impenetrable thicket of legal rules governing the same broad subject matter
that boost up both individual rights and global economic welfare. It is essential to
distinguish the inability from the unwillingness of a State Party to act in accordance with
its right to health obligations.
2) High patentability standards should be established at international level and national level
(particularly by developing countries and LDCs) for exclusions from patentability, such
as new forms and new or second uses, and combinations, with the aim of addressing
ever-greening, ensuring the grant of patents only to genuine inventions in the
pharmaceutical field so as to facilitate the generic entry of medicines into the market.
3) Innovative approaches to medical research and development (R&D) and its funding need
to be developed particularly for the neglected diseases with the emphasis upon public-
private initiatives for developing required medical technologies. Publicly funded research
or pharmaceutical subsidies might not only help ensure that pharmaceutical corporations
prioritize affordable diseases-related innovations but also provide a better balance
between humanitarian urgency and patent protection.
4) A coordinated effort of global system consisting of international lawyers, world leaders
and public health experts for creating policies to relax patents and increase the
affordability of generic anti-retroviral would be one step in this direction providing
patients with the right to live longer, more dignified and productive lives.
In such a scenario, the importance of the international human rights discourse particularly
right to health cannot be understated. The ‘right to health’ has to be formulated and
acknowledged as a positive right at a global level—one which all of us have an interest in
protecting and advancing. Because health is a fundamental human right indispensable for the
exercise of other human rights which concentrate on integral components of the right to health
24
like; right to food, housing, work, education, life, non-discrimination, access to information,
equality and no doubt intellectual property rights.
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[14]. Ibid. Product patents can create absolute monopolies as they can limit use of product. Process patents only
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[15]. Helfer, Laurence R., Human Rights and Intellectual Property: Conflict or Coexistence?. Minnesota Journal
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[17]. Supra note 13.
25
[18]. John Braithwaite and Peter Drahos (2000). Global Business Regulation. Cambridge: Cambridge University
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[20]. Hans Henrik Lidgard & Jeffery Atik (editors)(2008). The Intersection 0f IPR and Competition Law:
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[21]. Ibid.
[22]. Ibid.
[23]. Ibid.
[24]. F. Machlup and E. Penrose (1950), “The Patent Controversy in the Nineteenth Century”, X No. 1 (May
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[25]. Frank. I. Schechter, “The Rational Basis Of Trademark Protection”, 40 (1927) Harvard Law Review, pp.
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[26]. Staniforth Ricketson and Chris Creswell (1984). The Law of Intellectual Property. Sydney:Law Book Co.
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[27]. Stephen P Ladas(1975) Patents, Trademarks, and Related Rights: National and International Protection,
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[29]. H. G. Henn, “The Quest For International Copyright Protection”, 39 (1953) Cornell Law Quarterly, pp.43,
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[30]. Brad Sherman, “Remembering and Forgetting: The Birth of Modern Copyright Law”, 10 (1995)
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[31]. Ibid. pp. 1, 10.
[32]. Barbara A. Ringer(1968). The Role Of The United States In International Copyright - Past, Present, And
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[33]. UNCTAD-ICTSD, Intellectual Property rights and Development: A Policy Discussion Paper, Project on
IPRs and Sustainable Development (2002) at 34.
[34]. Ibid.
[35]. Stephen P. Ladas (1975), Patent, trademark and Related Rights: National and International Protection.
Cambridge: Havard University Press. Vol. 1. Pp. 43, 54-55.
[36]. UNCTAD-ICTSD, Intellectual Property rights and Development: A Policy Discussion Paper, Project on
IPRs and Sustainable Development (2002) at 35.
Press, UK. pp. 60
[38]. Examples of areas that became the subject of international agreements include trade marks (Madrid
Agreement (Marks), 1891 and Madrid Agreement (Indication of Source), 1891), designs (Hague
Agreement, 1925), performance (Rome Convention, 1961), plant varieties (International Convention for the
Protection of New Varieties of Plants, Acts of 1961 and 1991), patents (Patent Cooperation Treaty, 1970),
semiconductor chips (Treaty on Intellectual Property in Respect of Integrated Circuits, 1989). The Paris
and Berne Conventions also underwent numerous revisions.
[39]. Arpad Bogsch(1992). Brief History of the First 25 Years of the World Intellectual Property Organization
Geneva:World Intellectual Property Organization. pp. 7-8.
[40]. Sell, Susan,(1998), Power and Ideas: North-South Politics of Intellectual Property and Antitrust, Suny
Series in Global Politics, State University of New York Press, Albany, 1998
[41]. C Decree(2008). The Implementation Game: The TRIPS Agreement and the Global Politics of Intellectual
Property Reform in Developing Countries, (Oxford University Press, 2008).
[42]. Article 12.1 of the International Covenant on Economic, Social and Cultural Rights.
[43]. Lawerence O. Gostin(2001), “Public Health, Ethics and human rights: A tribute to the late Jonathan
Mann’, 29 Journal of Law, Medicine and Ethics 121-129, Summer 2001.
26
[44]. The Right to Health, Fact Sheet No. 31, United Nations High Commissioner for Human Rights, Geneva,
Switzerland.
[45]. Article 25 of Universal Declaration of Human Rights1948, .
[46]. Examples of UN human rights treaties:International Covenant on Economic, Social and Cultural Rights
(ICESCR), 1966; Convention on the Elimination of All Forms of Discrimination Against Women
(CEDAW), 1979; Convention on the Rights of the Child (CRC), 1989.
[47]. Examples of regional human rights treaties: European Social Charter, 1961; African Charter on Human
and Peoples’ Rights, 1981; Additional Protocol to the American Convention on Human Rights in the Area
of Economic, Social and Cultural Rights (the Protocol of San Salvador), 1988.
[48]. See Articles 11(1)(f), 11(2), 12 and 14(2)(b) in the Convention on the Elimination of all forms of
Discrimination against Women (CEDAW); Articles 3(3), 23(3), 23(4) and 24 in Convention on the Rights
of the Child (CRC); Article 5(e)(iv) in International Convention on the Elimination of all forms of Racial
Discrimination (ICERD).
[49]. Refer: Articles 11 and 13 of the European Social Charter; Article 35 of the Charter of fundamental rights
of the European Union; Article XI of the American Declaration on the rights and duties of man; Article 16
of the African Charter on Human and People’s rights; and Article 14 of the African Charter on the Rights
and welfare of the Child.
[50]. Committee on Economic, Social and Cultural Rights General Comment 14—The Right to the Highest
Attainable Standard of Health, E/C. 12/2000/4 at para. 11.
[51]. Id., para 10.
[52]. International Covenant on Economic, Social and Cultural Rights, at Article 15, G. A. Res. 2200, U.N.
GAOR, 21st Sess., Supp. No. 16, at 49, U.N. Doc A/63/6316 (1966), 993 U.N.T.S. 3,6 I.L.M. 360, available
at http:// www.unhchr. Ch/html/menu3/b/a_cescr.htm
[53]. General Comment No. 14: The Right to the Highest Attainable Standard of Health, U.N. Committee on
Economic, Social and Cultural Rights, 20th Session, U.N. Doc. E/C. 12/2000/4, 1(2000), available at
http://www.washington.edu/courses/kuszler/H540_Sp05/Documents/general _comment_14.pdf (hereinafter
at 12(b).
[54]. See: United Nations, The Millennium Development Goals Report 2006.
[55]. Intellectual property protection that restricts, rather than increases, access to life-saving medication belies
the ultimate justification for patents as an end toward engendering net social good.
[56]. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh
Agreement Establishing the World Trade Organization, Annex IC, LEGAL INSTRUMENTS –RESULTS
OF THE URUGUAY ROUND. Vol. 31, 33 I.L.M. 1197 (1994) [hereinafter TRIPS Agreement]; Paris
Convention for the Protection of Industrial Property, Mar. 20, 1883, last revised at Stockholm, July 14,
1967, 21 U.S.T. 1583, 828 U.N.T.S. 305 [herein after Paris Convention]; Berne Convention for the
Protection of Literary and Artistic Works, Sept. 9, 1886, last revised at Paris, July 24, 1971, 1161 U.N.T.S.
31 [hereinafter Berne Convention].
[57]. For a review of the changes TRIPS wrought, see J.H.Reichman, The TRIPS Agreement Comes of Age:
Conflict or Cooperation with the Developing Countries? 32 CASE W. RES. J. INT’LL. 442 (2000).
[58]. Intellectual Property Rights and Human Rights, Res. 2000/7, U.N. Sub-Comm’n, on the Promotion and
Protection of Human Rights, 52nd Sess., pmbl. 11, U. N. Doc. E/CN.4/ Sub. 2/RES/2000/7 [hereinafter
Resolution 2000/7] (stating that “actual or potential conflicts exist between the implementation of the
TRIPS Agreement and the realization of economic, social and cultural rights”).
[59]. For a health discussion on this point see Implementation of the International Covenant on Economic,
Social and Cultural Rights. Discussion paper, submitted by Audrey R. Chapman, American Association for
the Advancement of Science (AAAS), Washington, USA, to the United Nations Committee on Economic,
Social and Cultural Rights, E/C. 12/2000/12,3 October 2000.
[60]. The Sub-Commission requested four different sets of actors- national Governments, intergovernmental
organizations, U.N. human rights bodies and NGOs—to address the intersection of human rights and
intellectual property. It asked national lawmakers to integrate “human rights obligations and principles”
into their activities, with a particular focus on the social function of intellectual property. Similar
exhortations were directed to intergovernmental organizations, whom the Sub-Commission in effect urged
27
to act as watch dogs of TRIPS by “deepening their analysis of the impacts” of the treaty and its human
rights implications. The Sub-Commissioner’s most detailed requests were aimed at other U.N. human
rights bodies, whom it asked to clarify the relationship between intellectual property and human rights.
(requesting action by the High Commissioner, the CESCR, and the Special Rapporteurs on Globalization).
Finally, to ensure visibility for its new agenda, the Sub-Commission encouraged civil society groups to
lobby Governments for economic policies that fully integrated human rights obligations and “to monitor
and publicize the effects of economic policies that fail to take such obligations into account”.
[61]. The Right to Health, Fact Sheet No. 31, United Nations High Commissioner for Human Rights, Geneva,
Switzerland.
[62]. Mile Moore (2004), Doha and beyond : the future of the multilateral trading system .Cambridge:
Cambridge University Press.
[63]. Declaration on the TRIPS Agreement and Public Health, Nov. 14, 2001, 4th Session, Doha Ministerial
Conference, WT/MIN (01)Dec/2 (Nov. 20, 2001) .
[64]. Susan K. Sell(2003), “Trade issues and HIV/AIDS,EMORY INT’L L. Rev. at 935- 936 (Summer, 2003).
[65]. Canada implemented the 30 August 2003 decision through amendments to its Patent Act in 2005.
[66]. Regulation (EC) No 816/2006 of the European Parliament and the Council of 17 May 2006 on
Compulsory Licensing of Patents relating to the Manufacture of Pharmaceutical Products for Export to
Countries with Public Health Problems, Official Journal of the European Union L 157/1-L157/7.
[67]. The Patent (Amendment) Act of 2005.( No. 15 OF 2005) notified in the Gazette of India dated 5 April
2005 come into force with effect from 1 January 2005.
[68]. Bandhua Mukti Morcha v. Union of India, AIR 1984 SC 802.
[69]. State of Punjab v. Mohinder Singh Chawla, AIR 1997 SC 1225.
[70]. The text of the Directive Principles dealing with health, is as follows:
Article 39(e): “that the health and strength of workers, men and women, and the tender age of children are
not abused and that citizens are not forced by economic necessity to enter avocations unsuited to their age
or strength.”
Article 39(f): “that children are given opportunities and facilities to develop in a healthy manner and in
conditions of freedom and dignity and that childhood and youth are protected against exploitation and
against moral and material abandonment.”
Article 42: “The State shall make provision for securing just and humane conditions of work and for
maternity relief.”
Article 47: “The State shall regard the raising of the level of nutrition and the standard of living of its
people and the improvement of public health as among its primary duties and, in particular, the State shall
endeavor to bring about prohibition of the consumption except for medicinal purpose of intoxicating drinks
and of drugs which are injurious to health.”
[71]. Government of India (1950). The Patents Report of Enquiry Committee (1948-50). Delhi: Government of
India, PP. 1
[72]. Ibid, at pp. 65-66
[73]. Sudip Chaudhry (ed.), The WTO and India’s Pharmceutical Industry: Patent Protection, TRIPS and
Developing Countries, Oxford University Press, 2005.
[74]. Ibid.
[75]. Ibid.
[76]. Ibid.
[77]. Ibid.
[78]. Ibid
[79]. Ibid.
[80]. Ibid.
[81]. Section 3 (d) of the Patents (Amendment) Act, 2005 “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.
28
Explanation.—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;"..
[82]. V. Venkatesan (2012). The current patent system is deeply flawed. Frontline (21 April-4 May 2012) Vol.
29 Issue 8. Pp. 26-31.
[83]. '92A. (1) Compulsory licence shall be available for manufacture and export of patented pharmaceutical
products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for
the concerned product to address public health problems, provided compulsory licence has been granted by
such country or such country has, by notification or otherwise, allowed importation of the patented
pharmaceutical products from India.
(2) The Controller shall, on receipt of an application in the prescribed manner, grant a compulsory licence
solely for manufacture and export of the concerned pharmaceutical product to such country under such
terms and conditions as may be specified and published by him.
(3) The provisions of sub-sections (1) and (2) shall be without prejudice to the extent to which
pharmaceutical products produced under a compulsory licence can be exported under any other provision
of this Act.
Explanation.—For the purposes of this section, "pharmaceutical products" means any patented product, or
product manufactured through a patented process, of the pharmaceutical sector needed to address public
health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits
required for their use.'
[84]. Sudip Chaudhuri, “Multinationals and Monopolies: Pharmaceutical Industry in India after TRIPS”
Economic and Political Weekly (March 24, 2012), Sameeksha Trust Publication, Vol XLVII No. 12. Pp.
46-54.
[85]. L. Forman, "Trading Health for Profit: Bilateral and Regional Free Trade Agreements Affecting Domestic
Property Rules on Intellectual Property Rules on Pharmaceuticals," in Jillian Clare Cohen, Patricia
Illingworth, Udo Schuklenk, eds., The Power of Pills: Social, Ethical, and Legal Issues in Drug
Development, Marketing, and Pricing (London: Pluto Press, 2006), p.190.
[86]. Ibid
[87]. National Drug Policy for South Africa, 1996, p.3. Available at
http://apps.who.int/medicinedocs/documents/s17744en/s17744en.pdf
[88]. Medicines and Related Substances Control Amendment Act No. 90 of 1997. Available at
www.gov.za/documents/download.php?f=70836
[89]. Office of the United States Trade Representative (USTR), Special 301 Report 1999. This list is maintained
under the United States Trade Act, 1974, in respect of each country. It is a precursor to trade sanctions that
the United States may impose on any country unilaterally. ava liable at
http://www.keionline.org/ustr/1999special301
[90]. Department of Essential Drugs and Medicines Policy, WHO(2001). Essential Drugs in Brief: A bulletin on
major WHO Country and Regional work in the field of Essential Drugs and Medicines Policy, issue No.
04, April 2001. Available at http://www.who.int/medicines/publications/brief/en/edb04.pdf
[91]. Executive Order 13155(10 May 2000). Access to HIV/AIDS Pharmaceuticals and Medical Technologies.
Available at http://www.gpo.gov/fdsys/pkg/FR-2000-05-12/pdf/00-12177.pdf
[92]. J. R. Sanjuan,(2006) "Pfizer is Suing Philippine's Government Officials in their Personal Capacity in Order
to Stop Parallel Trade," IP-Health Mailing List, March 31, 2006. Available at
http://secondview.blogspot.in/2006/03/pfizer-is-suing-philippines.html
[93]. Compulsory Licences were issued for clopidogrel for heart disease, and lopinavir/ritonavir and Efavirenz
for HIV.
[94]. Office of the United States Trade Representative (USTR), Special 301 Report, 2007. Available at
http://www.ustr.gov/sites/default/files/asset_upload_file230_11122.pdf
[95]. F.M.Abbott and J.H.Reichman(2007). The Doha Round’s health legacy: strategies for the production and
diffusion of patented medicines under the amended TRIPS provisions”, Journal of International Economic
Law, vol. 10, No. 4, (2007), p. 921. Available at
29
http://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=2490&context=faculty_scholarship. “In a letter

dated 10 July 2007 to the Minister of Commerce of Thailand, the EU Trade Commissioner claimed that,
“neither the TRIPS Agreement nor the Doha Declaration appear to justify a systematic policy of applying
compulsory licenses wherever medicines exceed certain prices.” doi:10.1093/jiel/jgm040
[96]. World health Organisation(2008). WHO Access to Medicines, Briefing Note – Country Experiences in
Implementing TRIPS Safeguards,. Available at http://198.170.119.137/doc/WHO_TRIPsafeguards.pdf
[97]. A fourth drug, imatinib, for treating leukaemia and other cancers was also to have been subjected to a
compulsory license, but the license was not implemented after it was given for free to a Thai public health
program.
[98]. Asia Pacific Network of People Living with HIV/AIDS (APN+)(2008). Our Health, Our Rights: The roles
and experiences of PLHIV networks in securing access to generic ARV medicines in Asia. Bangkok:
APN+. pp.73.
[99]. The Pharmaceutical Research and Manufacturers of America (Ph RMA)(2008) Submission to United
States Trade Representative (USTR) for the Special 301Annual Report,2008, excerpt on Thailand.
[100]. Bayer is a Multinational Medical Giant which invented and was selling the anti-cancer drug Nexavar.
[101]. C.P. Chandrasekhar(2012), A big step forward. Frontline (21 April-4 May 2012) Vol. 29 Issue 8. Pp. 10-
12.
[102]. Section 3(d) of The Patents (Amendment) Act 2005.
[103]. Novratis AG V. Union of India & others Civil Appeal Nos. 2706-2716 of 2013 (Arising out of SLP (C )
Nos. 20539-20549 of 2009); Natco Pharma Ltd. V. Union of India & others, Civil Appeal Nos. 2728 of
2013 (Arising out of SLP (C) Nos. 32706 of 2009) and M/s Cancer Patient Aid Association V. Union of
India & others Civil Appeal Nos. 2717-27 of 2013 (Arising out of SLP (C) Nos. 12984-12994 of 2013)
SLP (C) ………../2011 CC Nos. 6667-6677.
[104]. United Nations Economic and Social Council,Commission on Human Rights, Sub-Commission on the
Promotion and Protection of Human Rights Fifty-second session, Report of High Commissioner,
E/CN.4/Sub. 2/2001/13 dated 27 June 2001. Available at http://daccess-dds-
ny.un.org/doc/UNDOC/GEN/G01/143/45/PDF/G0114345.pdf?OpenElement
[105]. “Human Rights and Intellectual Property: An Overview” available at http://www.wipo.int/tk/en/hrm (last
visited on 5 july, 2012.
[106]. Who (2006) Public health, innovation and intellectual property rights: report of the Commission on
Intellectual Property Rights, Innovation and Public Health. Geneva: WHO. p.19.
The author of this article is presently working as Assistant Professor, Department of Laws, Guru Nanak
Dev University Regional Campus, Ladhewali, Jalandhar, Punjab, India. She has done her Doctorate from Guru
Nanak Dev University, Amritsar, Punjab, India. Mobile: +91 869 903 5499.
30

Intellectual Property Rights Vis-A Vis Right To Health: A Critique

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affordability of generic anti-retroviral through coordinated effort of global system. In order to

“Idea of a better world is one in which medical discoveries

Objective of the Study

Evolutionary Trends of Intellectual Property Rights and Right to Health

At an international level, the World Intellectual Property Organization (WIPO)

people most in need.”[55] Before Millennium Development Goals demanding partnership of

The 30 August Decision set out a detailed import/export compulsory licensing

Concept of Intellectual Property Rights and Right to Health in India

The Growth of the Indian Pharmaceutical Industry by New Patent Regime

1. Till the early 1970s;

Implementation of the 30 August 2003 Decision in India

Findings and Discussion

A human rights-based approach focuses particularly on the needs of the most

mandatory guidelines/regulations in TRIPS to be followed by both developing and

http://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=2490&context=faculty_scholarship. “In a letter

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