INTELLECTUAL

PROPERTY RIGHTS

PATENTS AND HUMAN

RIGHTS

Presented By:-
AKASH NARAYAN & NAIMISH TRIPATHI

8th SEMESTER
BA.LLB. (Hons.) (Self-Financed)
 ACKNOWLEDGMENT
To start off at the very outset, I would like to express my gratitude towards
Dr. Shabana Shabnam for giving me the opportunity to make this project. I
would like to thank my parents and my seniors without who’s help I wouldn’t
have been able to complete this project.
 INDEX

1. Introduction

2. Right to Health

3. Health and Patents

4. Human Rights and Patents

5. Harmonisation of Interests

6. Conclusion

7. Bibliography
INTRODUCTION

Today inventions of new products or new processes particularly in the field of medicine,
in general, involves the collective effort of many highly skilled professionals and
expenditure of considerable amount of money and time which only big corporations and
institutions can afford. Besides, the manufacture of the article or product on a
commercial scale requires further effort and money.

Accordingly, under modern conditions only big corporations or institutions can afford to
engage in research and development of new products or processes, which truly passes
on to the product price. Health is one of the fundamental basic needs of all human need.
The right to life includes the right to health.

In legal term as well the fundamental human right treaties recognise that the right to
health would encompass a number of elements from prevention to cure to access to
drugs.

India has amended the Patents Act in 1999 and 2002 to comply with the obligations of
Trade- related Aspects of Intellectual Property Rights (TRIPS). The only pending
obligation with regard to TRIPS is the introduction of product patents to medicines and
agro-chemicals. 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 article 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. 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.
The net result of the TRIPS accord has been high cost of medicines and the consequent
denial of access to medicines to the poor across the globe.

This was reiterated in unequivocal terms by the WTO Doha Declaration on TRIPS
Agreement and Public Health (2001), which, inter alia, commented that countries have
the sovereign right to enact laws that safeguard domestic interests. It recognised the
gravity of public health problems in developing countries and clearly provided that the
member countries had the right to protect public health and to promote access to
medicines for all.

1.State of Punjab v. Makinder Singh Chawla, AIR 1997 SC 1225

RIGHT TO HEALTH

A healthy body is that the very foundation of all human activities. the proper to health
has been recognised within the national constitutional and statutory laws also as in law
of nations.

Right to Health within the Indian Scenario:

With 260 million Indian citizens still below the poverty line and without the
fundamental assurance of healthcare, the right to health clearly acquires great
importance in Indian scene. The World Health Organization (WHO) rankings place
India as 112th on the list of 199 member countries with regard to the health care
systems.

With 260 million Indian citizens still below the poverty level and without the
elemental assurance of healthcare, the proper to health clearly acquires great
importance in Indian scene. the planet Health Organization (WHO) rankings place
India as 112th on the list of 199 member countries with reference to the health care
systems.
In India, the government’s concern for health and safety of its people is indicated by
the legislations enacted for health care. Recently Article 21 of the Indian
Constitution has been interpreted to include the proper to health in right to life and
hence this right having now acquired a constitutional status through broad
interpretation , are often judicially enforced. The Directive Principles of State
Policy provide against the exploitation of weaker sections of society, including
children, and mandate the state to boost the amount of nutrition, the quality of living
and improve public health. Protection and improvement of environment and
safeguarding forests and wildlife is additionally an obligation of the state. These are
contained in articles 39, 47 and 48A partially IV of the Constitution.

Access to medicines is a fundamental element of the right to health

Health may be a fundamental right , indispensable for the exercise of the many
other rights especially the proper to development, and necessary for living a life in
dignity. the belief of the proper to health is additionally a fundamental goal of
State’s policies and programmes, no matter their economic, social, cultural,
religious or political background.
From a person's rights perspective, access to medicines is intrinsically linked with
the principles of equality and non-discrimination, transparency, participation, and
accountability. States are obliged to develop national health legislation and policies
and to strengthen their national health systems. For this purpose, key issues
associated with access to medicines must be taken under consideration such as:
sustainable financing, availability and affordability of essential medicines; price
and quality control; dosage and efficacy of medicines; procurement practices and
procedures, supply chains, etc.
October 2010 in Geneva, Switzerland, “for an exchange of views on human rights
considerations concerning the belief of access to medicines together of the elemental
elements in achieving progressively the complete realization of the proper of everyone
to the enjoyment of the very best attainable standard of physical and mental
health”

Government has a constitutional obligation to provide health facilities.

The Hon’ble supreme court has interpreted the proper to health in some ways .
Through public interest litigation also as litigation arising out of claims that
individuals have made on the State, with reference to health services etc. As a result
there's substantial case law in India, which shows the gamut of issues that are
associated with health. the popularity that the proper to health is important for human
existence and is, therefore, an integral a part of the proper to Life, is laid out clearly
in Consumer Education and
Resource Centre Vs Union of India. It also held within the same judgment that
humane working conditions and health services and medical aid are an important a
part of Article 21. Further in, State of :-

HUMAN RIGHTS COUNCIL, Twelfth session , item 3 “Access to medicine within

the context of the proper of everyone to the enjoyment of the very best attainable
standard of physical and mental health” (A/HRC/12/50), chap. I, 12 October 2009“It
is now a settled law that right to health is integral to right to life. Government features
a constitutional obligation to supply health facilities.” the difficulty of adequacy of
medical helath services and affordable medicines was also addressed in Paschim
Baga Khet Mazoor Samiti Vs State of West Bengal it had been held that that Article
21 imposes an obligation on the State to safeguard the proper to life and health comes
with in ambit of life. Apart from recognizing the elemental right to health as an
integral a part of the proper to Life, there's sufficient case law both from the Supreme
and High Courts that lays down the requirement of the State to supply medical health
services.

1. Punjab and Others v. Mohinder Singh

 HEALTH AND PATENTS

Health is one among the elemental basic needs of all citizenry . In legal terms,
fundamental human rights treaties recognise the proper to the 'enjoyment of the very
best attainable standard of physical and mental health’. Health policies encompass
variety of elements, from prevention to cure and access to drugs. While all elements
are important, the question of access to drugs stands call at the context of the TRIPs
Agreement.

Access to drugs generally requires their availability and affordability. there's thus a
robust link between economic poverty and access to drugs. a gaggle of international
organisations recently estimated that but 10 per cent of individuals living with HIV/
AIDS in developing countries have access to antiretroviral therapy.

The human rights treaties haven't devoted significant attention to the impact of
property on the belief of specific rights like right to health. right laws doesn't provide
for any guidance concerning its link with any general field of law. it's rather apt to say
that the connection has been termed and recognized generally terms.

1996 SCC (4) 37

However, it's also true that there are certain adjustments need to be made in laws
concerning property rights including their application so on bring them in consonance
with the spirit of right to health. this is often precisely the scope of the paper which
accepts the existence of IPR regime but at an equivalent time suggest the ways and
means to make sure that the interest of the general public at large especially in terms
of health is taken care of .

2. Parmanand Katara Vs Union of India, 1989 AIR 2039

HUMAN RIGHTS AND PATENTS

The relationship between human rights and property requires elaboration. On the one
hand, property doesn't provide much guidance concerning its links with other fields of
law. On the opposite hand, human rights treaties show that the interests of the patent
holder are recognised but not as fundamental rights which the interests of the
community at large come first.

TRIPs was adopted as a stand-alone agreement which makes no mention of the

impacts it can have, as an example , within the field of health. Nevertheless, WTO
member- states that also are parties to human rights treaties cannot draft legislation to
implement WTO obligations without considering its compatibility with other
international obligations, like human rights commitments.

In fact, the UN Committee on Economic, Social and Cultural Rights has specifically
indicated within the case of the proper to health that states shouldn't comply with
measures that are manifestly incompatible with their previous international legal
obligations. albeit the formulation of the proper to health at the international level is
vague, it gives a minimum of a broad framework within which health policies should
fall. Thus, it imposes on governments to progressively facilitate access to drugs. Since
patents on drugs tend to push prices up, governments have a requirement to make sure
that the introduction of product patents doesn't jeopardise access to drugs.

Indeed, not only should states refrain from taking any steps that limit access to drugs
but also they ought to also actively pursue better access over time. during this sense,
it's doubtful whether the amendment to the Patents Act of 1970 can stand scrutiny
under human rights

treaties. The 1970 Act introduced variety of limitations on the scope of the rights
granted to patent holders with specific public health goals in mind. As widely
acknowledged, the provisions of the 1970 Act might not have solved the matter of
access to drugs, but they contributed to improving access. Dismantling the entire
regime amounts to taking several steps back in terms of access to drugs. This seems
even truer within the context of the HIV/AIDS crisis, where a number of the
prevailing drugs are often available only at prices that are prohibitive for the overall
public.
HARMONIZATION OF INTERESTS

Harmonization is that the absolute best thanks to make sure the interest of two parties.
Need of the hour is to harmonise the interests of both the patent holder and public at
large. The interest of the patent holder is taken care of by granting him the merchandise
patent on his invention. Also, ensuring that the patented drugs are ensured at affordable
rates takes care of the interest of the general public . Thus imbalance wouldn't be created
thereby ensuring conducive environment for the pharmaceutical firms to work without
hassles on one
hand and access to affordable life saving drugs to the common populace on the
opposite .

The project tends to suggest a cushion mechanism in order that the effect of this new
patent regime in terms of high cost isn't passed on to the masses. For this purpose, the
govt has got to play a lively role.

This is more so in cases of Heath Care Welfare States including India. Few of the
suggestions are as follows

I. Compulsory licensing: This refers to use of the patent without authorization of the
Patent Holder .By this, the govt or any third party authorized by the government
can market the merchandise . during this case, the overall belief that the
compulsory licenses are often granted only in cases of national emergencies is
wrong . It also can be granted in cases where the proposed user had made efforts to
get authorization from the proper Holder on reasonable terms and conditions which
such efforts haven't been successful within the reasonable period of your time . In
India the Patent Act 1970 recently was amended to incorporate provisions or
compulsory licensing. Further, the Act provides for compulsory licenses on
notification by the Central government “in cases of national emergencies or in
cases of extreme urgency or in cases of pubic non-commercial use”. this could not
be read within the strict manner even a fear of a public health emergency in future
should be sufficient to evoke this provision.

II. Drug Subsidies: this will be a serious step, which the govt can take so on keep
the costs of medicine within the reach of the pockets of the overall public.
Subsidies are often granted in cases of medicine , within the same manner as
they're granted in LPG, petrol, Kerosene oil, sugar and other essential
commodities. For instance, post 2005 the worth of the actual drug is Rs 10. Then
therein case the govt pays Rs 4. Thus, during this case, public pays only Rs 6. the
thought behind this proposition is to say certain life saving and important health
drugs within the ‘Essential Drug List’, a bit like the Essential Commodities List;
we've for the above stated commodities.
III. Price Control Mechanism: The govt should also introduce a control system for
stringent monitoring of costs of medicine not mentioned within the ‘Essential
Drugs List’. this is often to make sure that the costs of ‘other drugs’ don't increase
which would drill a hole publicly pocket. Nearly 75% of the retail pharma market
is currently outside control and therefore the government should constitute a panel
that might monitor changes in price of unscheduled drug (control free). If the
panel is convinced that rate at which the worth of a specific unscheduled drug has
risen without a legitimate reason or thanks to unfair trade then it can ask the govt
to regulate and convey the worth within the reasonable limits.

IV. Price Ceilings: The National Pharmaceutical Pricing Authority also can perform a
further task of putting a ceiling on the utmost price of a specific product. These
should also include fixing a better ceiling for the generic drugs and a lower one for
branded drugs. This will also put pressure on the massive companies to exit from
generic business. The ceiling on the costs will make sure that the utmost price of a
specific drug is well within the reach of the masses. Few things, which may be
taken under consideration while fixing the ceiling would be the quantity spent in
research and development, the value involved in production of the invention plus
the next marketing of the merchandise . the thought is to balance the interests of
both the inventor and therefore the public. The inventor should get the reasonable
returns on the merchandise also because the public should be ready to avail the
merchandise at an inexpensive rate.

V. Importing Drugs: a rustic can import the generic version of a patented product
and therefore the government has the liberty to work out the grounds upon which
importing of such drug can happen . The imported drug are often from a rustic
during which the drug isn't patented. It also can be just in case of patented drug,
the case during which the exporting country also has got to issue a compulsory
license. India could import on-patent drug from another country if the drug is out
there there at a lower cost . However, this is often not a true option for India,
which may produce, drugs at an inexpensive cost.

VI. Global Health Fund: Another alternative choice available to India would be to
believe funds released by the worldwide health fund. India could use these funds to
fight epidemics HIV/ AIDS, TB, and Malaria. However, this feature has got to be
exercised guardedly mainly due to two factors. Firstly, India has never been a
possible recipient of those funds and secondly, this may raise the difficulty of
accelerating north-south economic dependency which may have serious
implications in terms of national sovereignty.
VII. Manufacture of a drug at a local level: If a specific drug is patented in India,
option should even be available to the govt to locally manufacture drugs if a case
of acute shortage of the supply of the drug arises. this is often to make sure that
the patent protection doesn't take toll of the national health. India also can take
example from the policies of other developing countries like South Africa and
Brazil which have a health policy in situ that creates sure during national health
emergencies drugs are easily available which too at an inexpensive cost.

VIII.Health Insurance: this will be another scheme initiated by the govt so as to

make sure that whatever cost are incurred by the patients during treatments are
subsequently reimbursed, if they need a medical insurance. one among the
ways to harmonise this issue is to aggressively privatise insurance in order that
thanks to competition in insurance sector, the costs of insurance itself is well
within the reach of the masses.

IX. Taxes and duties on medicine: The govt should make sure that the taxes and
duties on medicines aren't exceedingly high so on affect and increase within the
price of the drug normally the taxes and duties on medicines are quite steep and an
amount to about 30% to 40% of their total price. These taxes got to be cut
drastically so on confirm that the drugs are available at affordable rates.
3. Section 92 of Indian Patent Act, 1970

CONCLUSION
The originators of inventions should get just reward/compensation within the
sort of suitable royalty and there should be no grudge in providing for an
equivalent .

Simultaneously, the doors should be opened for obligatory licensing to involve

the domestic enterprises within the production of patented drugs.

India can play an efficient role about the supply of generic drugs at reasonable
prices by the pharmaceutical industry only after the ignored issues are provided
through further suitable amendments to the Patents Act 1970. If the damage to
the amending process of the Patents Act isn't undone, public sufferings will soar
to an unimaginable extent and that we would be heading for a high cost
economy. Poor will suffer and bourgeoisie will suffer.

The problem with the studies under taken on behalf of the industry is that no-one
knows the important cost of the drug research and development, and therefore
the study relies only on industry.

inputs, with no real scrutiny of an equivalent . We must find a typical

mechanism to seek out out the approximate cost of medicine and R & D.
BIBLIOGRAPHY

Books
1. Halsbury’s Laws of India, lexisnexis, butterworth, Delhi, 2004

2. Rodney D. Ryder, Intelleltaul Property and the Internet, Lexisnexis,

Butterworths, New Delhi, 2004

rd
3. Narayanan, P., Intellectual Property Law, 3 edn., Eastern Law House, Delhi,
2004

nd
4. Cornish, W.R., Cases and Materials on Intellectaul property, 2 edn.,
Universal Law Publishing Co. ltd. Delhi, 2004

Websites:
1. http://www.expresspharmaonline.com/20070815/management04.shtml

2. http://www.legalservicesindia.com/articles/pg.htm
3. http://news.indlaw.com/publicdata/articles/article67.pdf