Sontakke / Right to Health and Access to Patented Medicines: Toward Constitutionalisation of IPR

COMMENT

RIGHT TO HEALTH AND ACCESS TO

PATENTED MEDICINES: TOWARD
CONSTITUTIONALISATION OF IPR
Atharva Sontakke*

ABSTRACT

Right to Health has a constitutional foundation in Indian

jurisprudence. Access to essential medicines is an integral part of
that right. By reading Article 21 along with the Directive
Principles, the Supreme Court has established a justiciable right
to health. Patent protections, however, are a hindrance to
affordable access of medicines. A proper balance needs to be
struck between the two seemingly conflicting domains of law, viz.
human rights and IP law. The Article focuses on the recent
landmark judgment of the Delhi High Court in the case of Mohd
Ahmed v. Union of India & Ors. and its impact on Right to Health
in India. It analyzes the Delhi High Court judgment in the context
of the change of approach from a primarily ‘just remuneration’
approach to ‘minimum core’. It also examines the positive
obligations on the state with regard to access to medicines and
what this could mean for Indian patent regime. The article also
discusses various possible legislative and judicial approaches in
dealing with access to medicines. It involves using TRIPS
flexibilities in consonance with the constitutional right to health
among others. And it also presents judicial trend in dealing with
pharmaceutical patent litigations in recent times especially
focussing on compulsory licensing. The Article concludes by
stating that it is necessary to invoke constitutional jurisprudence
to determine the scope of patent rights and to enumerate the role
and obligations of the state in that regard.

KEYWORDS: Right to health, minimum core, public interest.

INTRODUCTION
The Indian Constitution does not explicitly recognize a right to health.
However the Supreme Court has read into Article 21 a right to health in

*
LL.B. Third Year Student, Gujarat National Law University, Gandhinagar, Gujatat.
[atharvas12@gnlu.ac.in], Cell +0091-99303-35190

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multiple judicial pronouncements.1 Access to essential and affordable drugs

and medicines is an integral part of the right to health. But a strict patent
regime is seen as an impediment in realising this right to health especially in
developing countries like India where the access to patented medicines is
restricted primarily due to high prices. A monopolistic patent regime is
often seen to be in a conflict with human rights perspective of access to
medicines. It can impede access to medicines in two ways: by granting
monopolies which often raise medicine prices to unaffordable levels, and by
incentivizing research for developing medicines which will cater to the
needs of developed countries who can afford those and thereby limiting
access to those who cannot afford them.2 Although these two domains seem
conflicting in nature the author argues that a co-existence approach is
feasible, however, with a primacy to the human rights perspective. Human
rights law is often regarded as „soft‟ law in terms of international law
because it is difficult to fully implement it and there may not be consensus
on the substantive content of such rights. Different countries might interpret
a right to health differently according to their socio-economic considerations
and therefore the extent of the requirement to balance patent rights and
human right to health may substantially differ. However in India the right to
health is based in the Constitution of India. Therefore it is only proper to
assess issues relating to right to health including access to medicines in light
of our constitutional jurisprudence and philosophy. Patent monopoly in
essential medicines has a very integral human rights dimension and often
the state justifies such monopoly and refuses to interfere with patent rights.
It is understood that patent laws have in-built mechanisms to deal with
issues of public health and access to drugs like compulsory licensing and
parallel importing. However, the state has not been very proactive in
utilizing these safety valves. Hence the author argues that it is imminent that
all the three branches of the state viz. the executive, the judiciary and the
legislature incorporate a strong constitutional perspective while dealing with
issues of patents relating to essential drugs and medicines. In fact, as it will
be seen in later parts, the recent judicial trend in this regard is encouraging.
I argue that it is necessary to invoke constitutional jurisprudence to
determine the scope of patent rights and to enumerate the role and
obligations of the state in that regard.
Part 2 of the essay introduces the foundations of right to health in
international law as well as in India. Part 3 focuses on the recent landmark
judgment of the Delhi High Court in the case of Mohd Ahmed v. Union of

1
Parmanand Katara v. Union of India , (1989) 4 SCC 248; Paschim Banga Khet Mazdoor
Samity v. State of West Bengal, (1995) 6 SCC 213.
2
Laurence R. Helfer and Graeme W.Austin, Human Rights And Intellectual Property
Mapping The Global Interface 90, Cambridge University Press (2011).

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India & Ors. 3 which I believe is a harbinger of a change in approach

towards right to health in India. Part 4 briefly introduces the three
approaches recognized over the world to resolve the conflict between
intellectual property and human rights viz. „just remuneration‟ approach,
„minimum core‟ approach and „progressive realization‟ approach. It
analyzes the Delhi High Court judgment in the context of the change of
approach from a primarily „just remuneration‟ approach to „minimum core‟.
It also examines the positive obligations on the state with regard to access to
medicines and what this could mean for Indian patent regime. Part 5
discusses various possible legislative and judicial approaches in dealing
with access to medicines. It involves using TRIPS flexibilities in
consonance with the constitutional right to health among others. And it also
presents judicial trend in dealing with pharmaceutical patent litigations in
recent times especially focussing on compulsory licensing. And with part 6 I
conclude.

FOUNDATIONS OF RIGHT TO HEALTH

INTERNATIONAL LAW ON RIGHT TO HEALTH

Under international human rights law, the right to health is primarily and
substantially found in Article 12 of the International Covenant on
Economic, Cultural and Social Rights (ICECSR), which asserts that states
must recognize “the right of everyone to the enjoyment of the highest
attainable standard of physical and mental health.” 4 The right to health
includes “underlying determinants of health, such as access to safe and
potable water and adequate sanitation, an adequate supply of safe food,
nutrition and housing, healthy occupational and environmental conditions,
and access to health-related education and information.” 5 Additionally, it
requires the availability and accessibility of “functioning public health and
health-care facilities, goods and services, as well as programmes.”6Access to
essential medicine is conceptualized as a sub-component of the broader right
to adequate health.7 General Comment No. 14 issued by the United Nations
3
(2014) Indlaw DEL 1272.
4
International Covenant on Economic, Social, and Cultural Rights, art. 12, Dec. 16, 1966,
993 U.N.T.S. 3.
5
United Nations Economic and Social Council [ECOSOC], UN Committee on Economic,
Social and Cultural Rights (CESCR), General Comment No. 14: The Right to the Highest
Attainable Standard of Health (Art. 12 of the Covenant), ^ 4, U.N. Doc. E/C.12/2000/4
(August 11, 2000).
6
Id.,^12(a).
7
See, e.g., U.N. Special Rapporteur on the Right of Everyone to the Highest Attainable
Standard of Physical and Mental Health, Addendum: Mission to the World Trade
Organization, ^ 18, U.N. Doc. E/CM.4/2004/49/Add.1 (March 8, 2004).

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Committee on Economic, Social and Cultural Rights (CESCR) in 2000

substantiates the right to health as including availability and accessibility of
essential medical and health facilities and goods.8 It specifically imposes an
obligation on states to ensure availability of medicines to provide the
minimum essential core content of the right to health.9
CONSTITUTIONAL FOUNDATIONS OF RIGHT TO HEALTH IN INDIA
The Constitution of India does not specifically recognize a right to health.
However, the judiciary has evolved a right to health by reading Art. 21
along with the Directive Principles of State Policy specifically those
incorporated in Articles 38, 39, 41 and 43.10 Thus by reading a right to life
with principles of distributive justice and welfare state the judiciary has
transformed the non-justiciable directive principles into justiciable
fundamental rights widening the scope of Art. 21. The Supreme Court in
Olga Tellis11 has argued that since the Directive Principles are fundamental
in governance of the country they must, therefore, be regarded as equally
fundamental to the understanding and interpretation of the meaning and
content of Fundamental Rights. It has now become a judicial trend to read
Fundamental Rights along with Directive Principles with a view to define
the scope and ambit of the former.12
In Parmanand Katara v. Union of India, 13 the Supreme Court, while
discussing the need for immediacy in medical treatment stated that Art. 21
casts an obligation on the state to preserve life and that it is of paramount
importance. Going one step further in Paschim Banga Khet Mazdoor Samity
v. State of West Bengal,14 the Court has ruled that the Constitution envisages
establishment of a welfare state, and in a welfare state, the primary duty of
the government is to provide adequate medical facilities for the people. 15
The Court, in this case, laid stress on a crucial point, viz. the state cannot
plead lack of financial resources to carry out the directions of the Court
meant to provide adequate medical facilities to the people. The state cannot
avoid its constitutional obligation to provide adequate medical services to
the people on account of financial constraints. Although the Court has not
specifically used the terms „minimum core‟ to define the content of a right
along the lines of CESCR, it has been argued that the decision in Paschim
Banga constructed the right to emergency medical care for accident victims

8
supra note 5, ^ 12; supra note 7, ^ 47.
9
Id.,^ 43.
10
supra note 1.
11
Olga Tellis v. Bombay Municipal Corporation, (1985) 3 SCC 545.
12
M.P. Jain, Indian Constitutional Law 1413, Lexis Nexis (2014).
13
supra note 1.
14
Id.
15
M.P. Jain, Indian Constitutional Law 1164, Lexis Nexis (2014).

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as a core minimum to the right to health.16 The concept also appears to have
been used couched in language such as ― „the essential minimum of the
right‟17.
But, in the cases of State of Punjab v. Ram Lubhaya Bagga 18 and
Confederation of Ex-Servicemen Association v. Union of India, 19 the
Supreme Court has recognized that the provision of medical facilities cannot
be unlimited and that resource constraints must be given due consideration.

MOHD. AHMED V. UNION OF INDIA & ORS. AND THE

‘MINIMUM CORE’
The facts of the case were that Mohd. Ahmed, a minor, was suffering from a
rare genetic disease called Gaucher disease. The Enzyme Replacement
Therapy was exorbitantly priced as only one company sold the required
drug in India and the petitioner could not afford a monthly treatment. The
respondents, i.e. State government argued that the government has launched
welfare schemes for providing financial assistance to patients. However, due
to resource constraints no further assistance could be given to the petitioner.
The Delhi High Court noted that the required drug is an „orphan drug‟.
Since it is used to treat an extremely rare disease not many pharmaceutical
companies manufacture it and hence it is costly. It also noted the fact that
unlike other countries, the government had no policy to address such rare
diseases. The High Court relied completely on CESCR‟s interpretation of
ICESCR to give content to right to health under Art. 21. It ruled that the
state has a positive obligation to take all necessary steps to ensure access
essential medical facilities and goods and services. Although the resource
constraints on the state is a factor, the state cannot delineate itself from the
duty to provide the „minimum core‟ of a right. This minimum core, Court
said, consists of non-derogable obligations which are core to the right to
health and are „minimum decencies of life consistent with human dignity.‟ It
held that access to essential drugs is one such core obligation. Ultimately,
the Court ordered the Delhi government to bear the burden of providing free
treatment to the petitioner as and when necessary.

16
Dr. S. Muralidhar, Economic, Social and Cultural Rights: An Indian Response to the
Justiciability Debate in Economic, Social and Cultural Rights in Practice 23, Interights
(2004).
17
Paschim Banga Khet Mazdoor Samity v. State of West Bengal, AIR 1996 SC 2426,
2429.
18
(1998) 4 SCC 117.
19
(2006) 8 SCC 399.

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BALANCING HUMAN RIGHTS AND IP: MINIMUM CORE

AND REASONABLENESS.
Although Mohd. Ahmed 20 does not specifically discuss patent laws, the
driver of inaccessibility of medicines is the patent regime. Judges and
policymakers over the world have primarily developed three approaches to
reduce the conflict between human rights and IP rights. The just
remuneration approach states that to use the creation of another, one must
adequately compensate the author/inventor first. The minimum core
approach states that all rights have a non derogable core and puts an
obligation on states to ensure maximum utilization of existing resources to
realize these core rights. And according to the progressive realization
approach the states must utilize resources to protect human rights as when
such resources are made available.21
India has primarily used the just remuneration approach to address the
conflict between the two domains, also along with progressive realization
approach which is incorporated in Constitution in the form of Directive
Principles. The system of compulsory licensing is a product of just
remuneration approach where the patented product is made available to
public only after due remuneration has been paid to the patentee. This
approach seems to give primacy to the rights of the patentee over public
interest. A change to minimum core approach would mean that the state
cannot play a mute spectator to market forces and must take positive steps to
ensure access to medicines.
It is difficult to determine the content of a minimum core of a right to
health. It would be worthwhile to examine briefly the South African
experience of the „minimum core‟. In Minister of Health v. Treatment
Action Campaign 22 the South African Constitutional Court rejected the
minimum core approach. In this case, the policy of the government to refuse
to administer a drug on large scale was challenged. The Court held that the
government cannot be made to provide free access to medicines to everyone
as a core obligation, but it has to act according to the availability of
resources. The state has to take reasonable measures to realize those rights.
Thus the Court developed a standard of reasonableness to determine
whether the state has taken enough effective measures to realize socio-
economic rights. In the case at hand, the Court found the policy of the
government unreasonable and thus required the government to remove
restrictions on effective drug administration.

20
supra note 3.
21
Peter K. Yu, Reconceptualizing Intellectual Property Interests in a Human Rights
Framework, 40 U.C. Davis L. Rev. 1039, 1044 (2007).
22
(No 2) (2002) 5 SA 721.

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The author argues that the standard of scrutiny of minimum core rights must
be reasonableness of government actions. In Mohd. Ahmed23 the Delhi High
Court specifically said that since the government had no policy to address
orphan drugs and neither any other steps were taken for ensuring access to
the drug, the state has to provide free treatment. The reasonableness of
government action must be determined by deciding whether the action has
any nexus with the objective sought to be achieved. The Delhi High Court
also rejected the argument that the state had implemented welfare schemes
to provide financial assistance to the needy. The Court seems to suggest that
merely rolling out free welfare schemes giving one-time benefit does not
have any reasonable nexus with the objective to be achieved, which is
improving economic accessibility of the medicines. This might require, as
the Court itself suggests, various policy decisions and also changes in
existing laws. Thus, the onus is on the state to prove that it has done
everything it could by utilizing all existing resources to provide a core
minimum of a right to health which includes ensuring reasonable access to
medicines.
In Kasturi Lal Lakshmi Reddy v. State of Jammu & Kashmir 24 , Justice
Bhagwati explained the relationship between the Directive Principles and
the judiciable fundamental rights:
“The Directive Principles concretise and give shape to the concept of
reasonableness envisaged in [the fundamental rights] . . . . By defining the
national aims and the constitutional goals, they set forth the standards or
norms of reasonableness which must guide and animate governmental
action. Any action taken by the Government with a view to giving effect to
any one or more of the Directive Principles would ordinarily . . . qualify for
being regarded as reasonable, while an action which is inconsistent with or
runs counter to a Directive Principle would incur the reproach of being
unreasonable. . . .”

TOWARDS ENFORCING A ‘MINIMUM CORE’: POSSIBLE

APPROACHES
USING TRIPS FLEXIBILITIES AND DOHA DECLARATION
Article 31 of the TRIPS provides for compulsory licensing primarily in
three situations; „national emergency‟, „extreme urgency‟ and „public non
commercial use‟. These criteria have been incorporated in Indian Patent Act,
1970 by Sec. 92 apart from compulsory license provisions under Sec. 84.
The Doha Declaration of 2001 affirms that TRIPS should not be an

23
supra note 3.
24
(1980) 3 SCR 1338.

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impediment to public health and Paragraph 6 of Doha Declaration grants

freedom to states to determine the grounds for granting a compulsory
license. Also, it gives right to member states to determine the content of
„extreme urgency‟ and „national emergency‟. It also does not define „public
non commercial use‟. This flexibility should be used by developing
countries like India as a tool to improve access to medicines in light of
domestic socio-economic conditions and guided by the philosophy of the
Constitution. For example, a liberal construction of „extreme urgency‟
would require invoking of Sec. 92 even in cases where the medical
condition is rare and restricted to an individual or few individuals, rather
than requiring to interpret it in light of „national emergency; which might
construe a public health crisis on a large scale. It must be reiterated that
human rights are essentially individual rights. Therefore an interpretation
favouring the enforcement of human right of an individual should be
preferred.
Thailand granted compulsory license for drug Plavix under the ground of
„public non-commercial use‟ rather than on the grounds of national
emergency and extreme urgency.25 The law in Thailand allows any ministry
or department of the government, by itself, to issue compulsory license.26
Thus it has implemented the license faster than other countries. Perhaps a
similar change in India law would help in facilitating compulsory licenses.
With a wider interpretation of „extreme urgency‟ and „public non
commercial use‟ the government should grant compulsory licenses which
would avoid unnecessary delay and protracted litigations. Such a threat of
compulsory licensing can also be used as a tool to negotiate prices with
pharmaceutical companies as successfully demonstrated by Brazil where
such a strategy reduced drug prices by margins as huge as 65%.27
Sec. 100 and Sec. 101 of the Patent Act, 1970 provide for Government use
of patented articles without prior permission of the patentee. These
provisions must be invoked to ensure that health related schemes of
government and government agencies like hospitals and health care centres
can provide essential medicines at an affordable cost. However, the
government has not made use of these provisions which has resulted into
frustration of these provisions. Using such administrative mechanisms over
judicial mechanisms for granting compulsory licenses is one effective way

25
Savoie B.,Thailand’s Test: Compulsory Licensing In An Era Of Epidemiologic
Transition, 1 Va. J. Int'l L. 48, 211 (2007).
26
Germano S., Compulsory Licensing Of Pharmaceuticals In Southeast Asia: Paving The
Way For Greater Use Of The TRIPS Flexibility In Low And Middle Income Countries, 1
UMKC L. Rev. 76, 273 (2007).
27
M D Nair, Compromising TRIPS: Brazil’s Approach To Tackle The HIV/AIDS
Imbroglio, 13 J.Intellec. Prop. Rights 456 (2008).

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for developing countries to maximize TRIPS flexibilities. 28 Developing

countries should craft their legislations keeping in view the domestic
requirements.
COMPULSORY LICENSING UNDER COMPETITION ACT, 2002
The Preamble to the Competition Act, 2002 reflects India‟s socialist goals
which provides for „the establishment of a Commission to prevent practices
having adverse effect on competition, to promote and sustain competition in
markets, to protect the interests of consumers.‟ The Competition
Commission of India is authorized to pass any order it may deem fit where
it finds that an enterprise has abused its dominant position by imposing
unfair prices, limiting market access or restricting the development of
goods.29 Although there is no case law suggesting that the CCI may grant
compulsory licenses for such anti-competitive practices, it can do so to
justify the socialist consumer welfare goals of the Competition Act, 2002.
However, principles of competition law have been considered while issuing
compulsory licenses in other jurisdictions, particularly South Africa which
has a strong socio-economic constitutional jurisprudence. In 2003, the
Competition Commission of South Africa found two pharmaceutical
companies guilty of anti-competitive practices by denying a competitor
access to an essential facility and also by excessively pricing the product. A
settlement was eventually reached between the parties to grant a voluntary
license.30

JUDICIAL TRENDS IN PHARMACY LITIGATIONS

India got its first compulsory license in the decision of Natco Pharma Ltd. v.
Bayer Corporation31 in 2012. The Controller General‟s order is an excellent
example of using constitutional aims to interpret patent laws. The Controller
General, while determining what constitutes „reasonably affordable price‟
rejected the patentee‟s argument that costs for research and development

28
James Love, Compulsory Licensing: Models for State Practice in Developing Countries,
Access to Medicine and Compliance with the WTO TRIPS Accord, January 21, 2001,
available at http://www.cptech.org/ip/health/cl/recommendedstatepractice.html (Last visited
Apr. 21, 2014) ; Zita Lazzarini, Making Access to Pharmaceuticals a Reality: Legal
Options Under TRIPS and the Case of Brazil, 6 Yale Hum. Rts. & Dev. L.J. 103-138
(2003).
29
Competition Act, § 27, 2002.
30
James Love, Recent Examples of the Use of Compulsory Licenses on Patents, March 8,
2007, available at http://www.keionline.org/misc-docs/recent_cls.pdf (Last visited May 29,
2014).
31
Natco Pharma Ltd. v. Bayer Corp., (2012) C.I.A. No. 1 of 2011 55 (India),
available at http://www.ipindia.nic.in/ipoNew/compulsory_License_12032012.pdf (Last
visited on May 12, 2014).

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should be considered while determining a reasonable price. It was held that

the cost must be reasonably affordable with regard to the public at large.
The Controller General also questioned the patentee for not implementing
differential pricing system for different classes of public. The author is of
the opinion that the state has an obligation to ensure that pharmaceutical
companies engage in differential pricing mechanisms. The formula for
determining such mechanism must be people-centric and factors like per
capita income, government resources and the severity for need of access to
medicines must be considered as crucial.32
The jurisprudence behind granted patent monopoly is that it will eventually
lead to more innovation by attracting investment in research and
development. But it is relevant to consider what innovation actually is. It is
a technical progress that meets demands of the consumer, thereby increasing
social welfare. 33 However, in case of pharmaceutical patents since the
access is extremely limited due to high prices, the pharmaceutical
companies have little incentive to innovate their products to cater to the
small customer size. For actual innovation to occur the demand of the
consumer must be taken into consideration. In case of patented medicines
the demand of the consumers is not as much for new products but it is for
cheaper products. This does not mean that need for innovation is absent but
is largely insignificant because of the limited access to these medicines. In
such circumstances where the entire purpose of granted patent protection
does not lead to consumer welfare, giving primacy to human rights
considerations is of utmost importance. Otherwise such monopolies will
violate the Directive Principles and concepts of distributive justice
enshrined in the Constitution.
Third Party (Public) Interest and Pharmaceutical Litigations
In L Hoffman La Roche Ltd. & Anr. v. Cipla Ltd.34 a single bench of Delhi
High Court rejected Roche‟s application for an ad-interim injunction to
restrain Cipla from selling generic version of Roche‟s drug. The single
judge in his landmark order gave special consideration to the interest of
third parties who would be deprived of a life saving drug if injunction was
granted. The order specially emphasized the relevance of Art. 21 in
following words, „the Court cannot be unmindful of the right of the general

32
John A. Harrelson, TRIPS, Pharmaceutical Patents, and the HIVIAIDS Crisis: Finding
the
Proper Balance Between Intellectual Property Rights and Compassion, 7 SPG Widener L.
Symp. J. 195, 196 (2001).
33
Viscusi W. Kip, Vernon J. And Harrington J., Economics Of Regulations And Antitrust
583, MIT Press (2001).; Net Le, Intellectual Property Protection For
Non-Innovative Markets: The Case of IMS Health, 1 Erasmus L. & Eco. Rev. 87-98 (2006).
34
I.A. 642/2008 in CS (OS) 89/2008, Order of Delhi High Court dated 19 th March 2008.

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public to access life saving drugs which are available and for which such
access would be denied if the injunction were granted. The degree of harm
in such eventuality is absolute; the chances of improvement of life
expectancy; even chances of recovery in some cases would be snuffed out
altogether, if injunction were granted. Such injuries to third parties are
uncompensatable. Another way of viewing it is that if the injunction in the
case of a life saving drug were to be granted, the Court would in effect be
stifling Article 21 so far as those who would have or could have access to
Erloticip are concerned.‟ The Division bench re affirmed this order and
stated that public access to life saving drugs assumes great significance in
India and the public interest in greater public access to life saving drugs will
have to outweigh the public interest in granting an injunction.35

CONCLUSION
The Delhi High Court by reading a right to access to medicines in Article 21
has given determinable content to the fundamental right to health. Although
the case did not address IP issues directly, the Court made it clear that the
Constitution is relevant. This has paved the way for using constitutional
jurisprudence in cases where IP is more directly linked. Such
constitutionalisation should seek to give primacy to human rights concerns
and carve out a „human rights‟ exception to determine the scope of IP laws.

35
Gopakumar G Nair, Andreya Fernandes and Karthika Nair, Landmark Pharma Patent
Jurisprudence in India, 19 J. Intellec Prop Rights 79 (2014).

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