A Compulsory licensing in Patented

Inventions: good or evil? Discovering clause of

public interest

Paper for course Human Rights Perspective on Intellectual Property Law - 15 credits(15 ECTS)
Student Anna Balatska
Supervisor - Anna Maria Nawrot
Autumn semester 2010

A Compulsory licensing in Patented Inventions: good or evil?

Discovering clause of public interest
Table of contents
LIST OF ABRAVIATIONS!!!
INTRODUCTION
I. ROOTS FOR COMPULSORY LICENSING: SOCIAL BACKGROUND, HISTORY
AND GENERAL OUTLINE
1.1 When tables are turned. Society: player or arbiter
1.2 The essence of compulsory licensing and public inters clause
1.2.1 Who is who? Compulsory licensing in nutshell
1.2.2 Who is who? Public interest

II. HRBA TO COMPULSORY LICENSING INPATENTS

2.1 Access to Essential Medicines as a Component of the Right to Health
2.2 Public interest v. Right to remuneration

III. COMPULSORY LICENSING AND PUBLIC INTEREST IN THE

INTERNATIONAL LAW
3.1 The Paris Convention for the Protection of Industrial Property of 1883
3.2 TRIPS Agreement
3.3 Declaration on the TRIPS Agreement and Public Health

IV. CONTS TO COMPULSORY LICENSING

4.1 Common critics on CL
4.2 Studying new rules

V.COMPULSORY LICENSING IN PRACTICE: THAILAND

CONCLUSION
BIBLIOGRAPHY
LIST OF ABRAVIATIONS

AIDS - Acquired immune deficiency syndrome

ECHR The European Convention on Human Rights
HIV - Human immunodeficiency virus
ICESCR International Covenant on Economic, Social and Cultural Rights
IGWS - Working Group on Public Health, Innovation and Intellectual Property
IPR - Intellectual property rights
LDC - Least Developed Country
MIPF - The Medical Innovation Prize Fund
TCM - Department of Technical Cooperation for Essential Drugs and Traditional Medicine
TRIPS - trade-related aspects of intellectual property rights
R&D - Research and development
UDHR - The Universal Declaration of Human Rights
UNDP - United Nations Development Programme
WIPO - World Intellectual Property Organization
WHO - World Health Organization
WTO - World Trade Organization

INTRODUCTION
In a lordly bucket of justifications for intellectual property (hereinafter: "IP) protection even an experienced
gourmand may get lost.

However, while peering at this fagot of intellectual property rights (hereinafter: "IPR's") varieties, one will
most probably strike upon overtones that are a bit dropping out from integral outfit. These tiny flowerets of
intellectual property are commonly called limitations and exceptions. These ones are by themselves may
confuse even more. By forming separate corpus in each of IP branches copyright, patents, trademarks
and having peculiar names for each of them- the concept in general and, afterwards, in specific cases
leaves scholars a lot of open questions about its nature and plenty of work both to right holders and stake
holders to harmonize its fruits with our initial IP bucket. Especially, when these branches are giving rise
to its own buds as fair use in copyright, access to medicine in patents.
This paper aims to discover one of these flowerets - concept of compulsory licensing in patent inventions
in relation to access to medicine and its more narrowed bud clause of public interest.
The main point of examination is to not only to give a definition through digging into philosophical soil and
observation of legal instruments, that is surely is going to be done, but also to make an attempt to analyze
practical output of compulsory licensing in health-related cases and to deliberate pro et contra by using
human rights based approach. As soon as essential human rights issues (right to health, development rights
etc.) are under the scope of topic using this method is ideological.
A starting point of the paper is going to touch upon some important non-legal issues, that are, in

authors

point of view, will give a delicate inkling to main idea of the research. Namely, some reflections about
applying questions of current social standards and social ethics in nowadays word, using some of James
Boyle ideas, will be elaborated. This will be done in order to reflect a maternal nature of compulsory
licensing before concentrating on its concrete particularities, namely in relation to patents and, especially,
while tying with public interest clause.
The second part of the paper will reflect normative side and will give overview of main legislation that is
covering chosen topic and illuminates concept of public interest. Apart from classically pro-IP ones as
Paris Convention and TRIPS,

new approach of Doha Declaration is going to be studied. Moreover, main

actors approach, namely WIPO, WHO and WTO will be examined.

To close a frame and to have a functional layer in research Thai case will be examined.

I._ROOTS FOR COMPULSORY LICENSING: SOCIAL

BACKGROUND, HISTORY AND GENERAL OUTLINE

1.1 When tables are turned. Society: player or arbiter

but turn the

"Whosoever thou art that dost another wrong, do

tables: imagine thy neighbour were
now playing thy game, and thou his."
Robert Sanderson XII sermons, 1634

Intellectual property deals with creativity and innovation. Both, despite total technologizing, are still
human-based, social based. It is still all about human beings, alone or as networks, who are original
creators. At least until the world is not occupied by robots or avatars.
Main concern is still with the Society in the core - with a bundle of its own mechanisms and rules that are
not always could be obeyed by politics and law. Moreover, when tables are turned, and history of recent
years showed, that intellectual property it is not only about books, fashion and new sorts of cheese. Lets
remember about aspects that deals with essential human rights issues: patents, that deals with essential
medicine, the transfer of technology to LDCs...And this list becoming more and more supplemented, and
each of the points is of high importance. Moreover, differences in the perception of IP protection by
developing and developed nations also should be taken into account. Hence, social aspects should be the
trigger signal for everyone who deals with IP on all levels: creators, end users, academics, activists and, of
course, governments
Ideas of importance of social background in understanding IP system could be found in works of James
Boyle a contemporary, influential author in pro-public domain circles. He drew an interesting parallel with
the environmentalism. According to his idea, as soon as once in their time pioneers of the movement
succeeded in huge task of changing perceptions and forming new types of coalitions 1, IP activists now need
to implement similar ideas into intellectual space. That means that we also need to make intentions to
construct new models of IPRs by rethinking way of understanding old ones. The inclusion of some social
needs, as knowledge, to normative framework will make it more flexible, social-friendly. Generally
speaking changes in our mind needed for general weal, for intellectual ecology.
In one his interviews2 Boyle, while answering question about nature of IPRs, elaborated on concept of
liability rules that bears upon model of right to payment. In opinion of scholar, within-named could and
even should in some way replace in social consciousness another one - right to exclude. Idea to spread
was in statement that it is important to separate the right to compensation from the right to forbid use. Boyle,
also adverting to his colleagues Jerome Reichman scholar results, stated that these liability rules at same
time are may perform two important functions. Firstly - minimizing part of damages that are produced by
legalized monopoly. Secondly it is still caring about magnitude of compensation of innovators input.
Latter Boyle continued that the case of liability rules is particularly compelling in cases of humanitarian
emergency. 3
That is, by far, deeply concerns issue of compulsory licenses in patents innovations. Doesnt access to
essential medicines seem humanitarian emergent? On the other hand, whence, one should count an
appropriate level of compensation in this case? As it will be described latter, in case of compulsory
licensing that its not the one who will deal with this task a racy couple of State and Market will act on
the stage. And here, lets be honest, notions as state corruption and ongoing tendency of total politicization
of all social processes subconsciously comes to mind.
1

James Boyle, A Politics of Intellectual Property: Environmentalism For the Net? James Boyle web-page - http://jamesboyle.com/
2
Five questions for James Boyle, KEStudies, Vol.1 (2007),
3
Ibid, p. 4

However, there are already numbers of cases in which liability rules worked. We are going to analyze that
both experiences latter on.
1.2 The essence of compulsory licensing and public inters clause

If one, who do not have LLM in intellectual property or even have no connections to law at all, and once
will come across combination compulsory licensing or its synonym non-voluntary contact, an expected
reaction could be like that: it is something scaring!
If having task to explain in general terms to that not-LLM one what compulsory license is the definition is
going to be following: we are dealing with type of limitation in intellectual property rights where the
authors/inventors rights while continuing being protected is abridged by State for some reasons; in our
case the reason IPRs could be limited is explained by expression in favor of public. With last mentioned
such construction of interests arises: public interest justifies the use of patent by those who are not initial
holder, regardless of the authors consent, however with proposing the subject to the payment of
appropriate remuneration.
What if that brave will take a quick look into any handbook of contract law when it is stated that the core of
each contract is a free will? This mentioned principle also may be used while exploring the idea and nature
of compulsory licensing and its public interest clause.
The principle of free will has religious, ethical, and scientific implications 4. For the scope of paper we need
two last ones.
Usually, licenses that are granted by the patent holder are regarded to be voluntary. According to the
definition of the European Patent Office, a patent is a legal title granting its holder the exclusive right to
make use of an invention for a limited area and time by stopping others from, amongst other things, making,
using or selling it without authorization.5
Hence, the beneficiary of achieved voluntary license performs his rights under an authorization from the
owner of the patent. The authorization in a contract is generally called 6 a license contract concluded between
the owner of the patent for invention and the beneficiary of the license.
In contrast, the beneficiary of a non-voluntary, compulsory license has the right to perform acts under an
authorization given by a government authority against the will of the owner of the patent for invention.
1.2.1 Who is who? Compulsory licensing in nutshell
While dealing with those who have heart those combinations not even once or twice, some more deep
questions may be raised. What is actually public interest? Who decides on amount of remuneration? By
what principles balance between interest is supposed to be solved?
For answering these questions, the peculiarities of compulsory licensing of patented inventions should be
illuminated at the first stage.
4

Vihvelin, Kadri, "Arguments for Incompatibilism", The Stanford Encyclopedia of Philosophy (Winter
2003 Edition), Edward N. Zalta (ed.) online version http://plato.stanford.edu/archives/win2003/entries/incompatibilism-arguments/
5
European Patent office official web-page - http://www.european-patent-office.org/gr_index.htm,
15.04.2007 ; definition derived from Case 15/74
6
WIPO Intellectual Property Handbook: Policy, Law and Use.-p.4 - www.wipo.int/aboutip/en/iprm/pdf/ch2.pdf

Compulsory licensing refers to the practice7 of governments to allow parties other than the original
patentees to exploit patented products and processes. In such case, the patentee is forced to grant a license to
a third-party in return for which the patentee generally receives a royalty payment at a rate set by legislative
fiat.
The earliest known attempt to legislate compulsory licensing came in the form of a bill before the US Senate
in 1790.8 The bill contained proposal that compulsory licenses should be granted when patentees had failed
to provide adequate supply of the patented subject, or had charged too high a price. The next important for
us step in history Vienna Congress (1873) - one of the preliminary negotiation rounds that culminated in the
Paris Convention. Although no binding legal instrument was produced by the Congress, it has been resolved
that compulsory licenses should be made available where the public interest required it. 9 The German
Law took this provision in 1877.
As we see, justifications for the grant of compulsory licenses may vary considerably. Commonly10 authors
calling to the following system of granting compulsory licenses, as limitations of a patent as an exclusive
right:
1. In the case of non-working of a patented invention
2. If wide use of a patented invention is necessary for the public interest
3. If an invention of improvement requires the use of the basic invention

There is also another one, for example given by Michael Halewood: 11

1) condition of non-working;
2) other, more broadly defined abuses;
3) the public interest, without consideration of whether or not there has been any
abuse on the part of the patentee.
Author also suggested possibility of elaborating on the existence of a fourth class of
compulsory licenses, which consist of compulsory licenses that are granted to
government (or public bodies) both as a remedy for nonworking, or for some other
policy objective. Unlike the three classes of compulsory which are defined by
reference to the situations they are meant to rectify, this case will be defined by the
identity of the recipient of the license, regardless of the remedial function of the
license. However, the fact those licenses would be awarded exclusively to public
bodies suggests that they are issued with public interest in mind.
1.2.2 Who is who? Public interest

Michael Halewood . Regulating patent holders:local working requirements and compulsory licences at international law, p.246
E.T. Penrose, The Economics of the International Patent System (Baltimore: Johns
Hopkins Press, 1951), p. 76.
9
Ibid.
10
For example - Compulsory License System History and Present Problems, Tadashi Ishii;
Research Guide on TRIPS and Compulsory Licensing: Access to Innovative Pharmaceuticals for Least Developed
Countries by Do Hyung Kim.- February 2007 - http://www.nyulawglobal.org/Globalex/TRIPS_Compulsory_Licensing.htm
11
Michael Halewood . Regulating patent holders:local working requirements and compulsory licences at international law, p. 261
8

Chosen for this paper public interest reason for use by governments compulsory licensing perhaps is the
most contradictory one, as soon as it includes a lot of not solely legal issues, mostly of those are too
political to be clear enough.
Actually, granting a non-voluntary license in order to protect the public interest countries by quantity of cases is
going just after "abuse" of the patent right ones 12. In the early and middle part of 20 th century, many countries had
developed laws whereby they may grant compulsory licenses, despite there being no evidence of abuse by the patentee,
relying upon condition that they consider the public interest to do so. In Germany, for example, compulsory licenses were
granted for such reasons: reducing the cost of vital goods, ensuring an adequate supply to the domestic market, preventing
plant failures, improving the balance of trade.

For example, if talking about public health, one may examine an example of medical equipment: it might be
necessary to import that equipment very quickly in case of a sudden epidemic. Here if the patent holder is not
willing to import or to conclude a license contract for importation on reasonable terms, the Government might
decide to ask another entity to import the apparatus or might decide to import it itself. Once the epidemic has
been brought under control, however, there is no reason to maintain the measure, and the owner of the patent for
invention will recover the full control of the rights attached to the patent.
According to WIPO studies,13 compulsory license granted in the public interest may be one of the types:
1) The one that is granted in favor of private parties - depended patent,
2) The one that is granted in favor of the government itself,
3) The one that is granted in favor of a person acting on behalf of the government.
Two last ones are used by European and certain developing countries and can be grouped into sub-reasons
that includes:14
1) in the fields of military security
2) public health
3) cases to protect the public interest in unhampered technological progress, national economy
What one have to keep in mind, that it is important the State should be sufficient , while acting against the
will of the patent holder, to authorize any entity or person designated by the Government, to perform any of
the acts which are covered by the patent for invention. In each specific case, the Government will decide
which of those acts may be performed. The kind of measure in the public interest also suits situations that
arise in cases of national emergency, the situation that is going to be described in final part of the paper.
The other edges of the concept are going to be covered in following parts of the paper by:

12

Building in relations state-public-inventor into the human rights perspective;

Analyzing exciting definition of clause public interest in legislation;
Studying the case of compulsory licensing in Thailand.

Gianna Julian-Arnold, International compulsory licensing: the rationales and the reality.- The Journal
of Law and Technology
1993, p. 276
13
WIPO Intellectual Property Handbook: Policy, Law and Use - www.wipo.int/aboutip/en/iprm/pdf/ch2.pdf
14
Ibid, p. 38

II.

HRBA TO COMPULSORY LICENSING IN

PATENTS

In order to bring human rights light on notion of compulsory licensing we are going to examine aspects of
public health and inventors right for remuneration.
In the Article 7 of TRIPS15 it is claimed that protection of IPRs should be for the purpose of promoting
innovation "in a manner conducive to social and economic welfare, and to a balance of rights and
obligations. Following Article 8 opens the door to the issue of suspending intellectual property rights for
the purpose of public health and socio-economic need. Furthermore, in Part VI one may find provisions that
allowed flexible transition periods for lesser developed countries to come into compliance.
2.1Access to Essential Medicines as a Component of the Right to Health
It is not surprising, that compulsory licensing is of particular interest to countries seeking to regulate patents
covering medicinal products and food products. Here clause public interest might be directly connected to
fundamental human right to health. Moreover, while keeping in heads (and even better in hearts) that issues
pertaining to access to medicine or public health have attracted the worlds attention to take into
consideration the relation between all IP embodiments and public health. Hence, the one of best examples to
illuminate this connection is compulsory licenses issued in goal for access to essential medicines as soon it
is an global tragedy that 1.7 billion people16, or one out of three on Earth, lack access to essential medicines.
In Human Rights Obligations of Non-State Actors, Andrew Clapham wrote17: Perhaps the most obvious
threat to human rights has come from the inability of people to achieve access to expensive medicine,
particularly in the context of HIV and AIDS.
The right to health, in the interpretation of the Committee on Economic Social and Cultural Rights 18, means
that States Parties have a duty to prevent unreasonably high costs for access to essential medicines.
The Working Group on Access to Essential Medicines of the United Nations Millennium Project approached
the problem from the human rights perspective. It opened its report by stating: The lack of access to lifesaving and health-supporting medicines for an estimated 2 billion poor people stands as a direct
contradiction to the fundamental principle of health as a human right.19
Is compulsory license here a solution for a global task of balancing?
The debate over this question has taken place within the framework of Big Brothers as the World Trade
Organization (WTO) and the World Health Organization (WHO). As a political compromise, the Doha
15

Agreement on Trade-Related Aspects of Intellectual Property Rights official text

at WTO page
http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm
16
The National Board of Tradein Sweden. The WTO Decision on Compulsory Licensing Does it enable
import of medicines for developing countries with grave public health problems?.- Kommerskollegium
2008:2. Pdf version taken from official page - www.kommers.se. p. 15
17
Andrew Clapham, Human Rights Obligation of Non-State Actors (Oxford: Oxford University Press, 2006), p. 175
18

Committee on Economic, Social and Cultural Rights, General Comment No. 17 on the right of Everyone to benefit from the
protection of the moral and material interests resulting from any scientific, literary or artistic production of which he or she is the
author, UN doc. E/C.12/GC/17, 12 January, 2006, para. 35.
19
MDG Gap Task Force, Millennium Development Goal 8: Delivering on the Global Partnership for Achieving the Millennium
Development Goals: MDG Gap Task Force Report 2008 (New York: United Nations, 2008) at 36.

Declaration on the TRIPs Agreement and Public Health and other Decisions have been adopted to tackle
and respond20 to the issue. Accordingly, the amendment of the TRIPs Agreement has been proposed.
In November 2001 the Declaration on the TRIPs Agreement and Public Health was adopted by WTO
Members. It was a political answer to the long debated question whether the exclusive rights of patentees
could be limited beyond the accepted limitations and exceptions provided under laws in field of patents
through compulsory licensing.
Moreover, The General Council of the WTO decided in August 2003 to waive countries lacking
manufacturing capacities from strict compliance with the Article 31(f) of the TRIPs Agreement. The
obligation that was waived was in issuing a compulsory license predominantly for the supply of the
domestic market of the Member authorizing such use and the strict obligation to remunerate the right
holder.21 Question of this remuneration going to be described in next subpart of the paper.
One more important point. An institutional one. In 2003 an independent specialized commission under
umbrella of the WHO was set up The Commission on Intellectual Property Rights, Innovation and Public
Health. 22 Among other settled aims, Commission was to examine the relationship between IP and Public
Health. As a result, in May 2006 Commission produced an huge Report and Working Group on Public
Health, Innovation and Intellectual Property (IGWS) was established to prepare a global strategy and plan of
action on essential health research.
2.2 Public interest v. Right to remuneration
According to article 15, paragraph 1 (c) of the ICESCR everyone has a right to benefit from the protection
of the moral and material interests resulting from any scientific, literary or artistic production of which he or
she is the author. The same protection is also guaranteed in international instruments as article 27(2) of the
UDHR, article 1 of Protocol No. 1 to the ECHR. General Comment No. 17 (2005) 23 states that all
limitations on the rights protected under article 15, paragraph 1 (c), must be determined by law in a manner
compatible with the nature of these rights, must pursue a legitimate aim, and must be strictly necessary for
the promotion of the general welfare in a democratic society, in accordance with article 4 of the Covenant.
Moreover, it is stressed that the imposition of limitations may, under certain circumstances, require
compensatory measures, such as payment of adequate compensation for the use of scientific, literary or
artistic productions in the public interest.
The terms reasonable commercial terms and adequate remuneration are not defined in the TRIPS. Under
paragraph (h) of Article 31 of the TRIPS it is mentioned that: the right holder shall be paid adequate
remuneration. Our aim is to research for the answers for quite logical question what is an adequate
remuneration.
As soon as WTO members are free to determine the appropriate method of implementing the TRIPS, within
their own legal system and practice, this could be extended to the standards they apply for reasonable
royalties, or adequate remuneration.
20

Dr. Tshimanga Kongolo. Unsettled International Intellectual Property Issues.- Kluwer Law International , 2008.- from
introduction(no number of page is provided)
21
Ibid. p 2
22
The Official web-page of the Commission - http://www.who.int/intellectualproperty/en/
23
General Comment No. 17 (2005), 12/01/2006. E/C.12/GC/17. (General Comments)
-http://www.unhchr.ch/tbs/doc.nsf/%28Symbol%29/E.C.12.GC.17.En?OpenDocument

Truly, compensation for the license varies tremendously, from those countries which base the value on what
would have been agreed upon by a willing licensee and a willing licensor to those assessing only a token
value, where the foremost interest in setting royalty is providing the drug to thepopulace at the lowest
possible price. Royalty guidelines proposed by the Japan Patent Office (1998) and United Nations
Development Programme UNDP (2001) set royalties from 0 to 6 percent of the price charged by the generic
competitor.24
United Nations Development Programme25 had its own approach and proposed a Report (2001) in which
generated a system of royalty guidelines, where the base royalty rate is 4 percent of the price of the generic
product. It was suggested that this can be increased or decreased by 2 percent, depending upon such factors
as the degree to which a medicine is particularly innovative, or the role of governments in paying for R&D.
The Medical Innovation Prize Fund (MIPF) approach 26 is quite different it attempts to make all drugs
available to consumers at generic prices. With this approach, remuneration as such is not awarded to
pharmaceutical innovators by a royalty; rather, patent holders will receive a portion of a national budget for
rewarding medical innovation among owners of competing products. The essence of these payments that
they are allocated according to each products contribution to improved health outcomes. The MIPF
approach is claimed to provide the greatest rewards for products that are actually used, and that provide
incremental health care benefits.
Issue of compensation was intensively studied by James Love in paper Remuneration Guidelines for Non-Voluntary
Use of a Patent on Medical Technologies27, produced with the support of the Department of Technical Cooperation
for Essential Drugs and Traditional Medicine (TCM) of the World Health Organization (WHO) and the Bureau for
Development Policy of the United Nations Development Programme (UNDP). Actually paper was initially produced

for expert consultation, jointly organized by UNDP and WHO on 16- 17 September 2004 that concerned
negotiations about building relevant policy guidance for the effective implementation of public health
safeguards and flexibilities in TRIPS Agreement, including the development of guidelines for compensation
in the context of compulsory licensing. In paper author confirmed that there is no single accepted approach:
not only do countries have very different practices from each other - practices also may differ considerably
within countries, depending upon the industry sector or the purpose of the authorization. He gave some
examples: Malaysia set a royalty rate of 4 percent for such licenses, Mozambique percentage is 2 percent
royalty; Zambias - 2.5, Indonesia case - 0.5 percent royalty. In a compulsory licensing and case concerning
patents on an ulcer drug, the UK awarded a 45 percent royalty for a compulsory license for the drug, while
the Philippines chose to issue a 2.5 percent royalty. Japan, in a related case, issued a 3.5 percent royalty on
the same patents.28
What is valuable for our research from Guidelines, that author made a comprehensive study concerning how already
mentioned in the beginning of this part of the paper Article 31 of TRIPs can be treated in relation to remuneration.
24

Michael Halewood. Regulating patent holders: local working requirements and compulsory licenses at
international law, p.260
25
The 2001 UNDP Human Development Report p. 119 http://hdr.undp.org/en/media/completenew1.pdf
26

Medical Innovation Prize Fund official web-page - http://singe.za.net/blog/archives/471-MedicalInnovation-Prize-Fund.html

27

James Love. Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies, WHO/TCM/2005.1 http://www.who.int/medicines/areas/technical_cooperation/WHOTCM2005.1_OMS.pdf
28

Ibid. p. 16

From more than 630 words in 12 paragraphs and Loves analyze 29 well try to amputate the following ones to
illustrate how patent holders right to compensation is responding to public interest demands:

a general requirement that efforts first be made to to obtain authorization from the right holder on
reasonable commercial terms and conditions. Article 31(a)

the requirement for prior negotiation on reasonable commercial terms and conditions in cases of a) Public
non-commercial use, b) National emergency or other circumstances of extreme urgency; - Article 31(b).

a general rule that when governments authorize non-voluntary use of a patent, they must provide patent
owners adequate remuneration, for the circumstances of each case, taking into account the economic
value of the authorization. Article 31(h).

Any decision relating to remuneration must be subject to judicial or other independent review by a distinct
higher authority. - Article 31(j).

In 2003, the WTO agreed on some more additional flexibilities for exports under a limited waiver of
Article 31(f). Paragraph 6 of decision requires the exporting country to provide adequate remuneration to
right owners, consistent with Article 31(h) of the TRIPS, taking into account the economic value to the
importing Member. In these cases, the importing country obligation to remunerate right owners is waived.
In nutshell, the patent holder is supposed to receive remuneration, but the amount is set in the exporting
country, which must consider the economic value of the product in the importing country. 30
As we see, system of remuneration makes a big challenge both for researchers and policy makers. For
example , the TRIPS requires payment of adequate remuneration to right owners, and takes into account
the economic value of the authorization, and in some cases, requires prior negotiation on reasonable
commercial terms and conditions, while the Doha Declaration calls upon Members to implement their
domestic laws in a manner that promotes access to medicine for all. As a result, in practice, governments
do choose very different outcomes, each of which is appropriate under their own legal traditions or to
internal political situation.

III. COMPULSORY LICENSING AND PUBLIC INTEREST IN

INTERNATIONAL LAW

From general perspective, compulsory licensing is definitely not a new system within the international
intellectual property framework. However, while digging into provided articles, some question mark arises.
Mostly of them are of the interpretation nature. The first issue is the absence of direct mentioning the term
compulsory licensing in all documents. Second question how to build in public interest clause into
existing rules.
The present part of the paper is intended to outline the how exactly the aspect of public interest in patent
compulsory licensing is presented in following international conventions and legal documents:

29
30

The Paris Convention for the Protection of Industrial Property of 1883

Ibid. p. 11
Ibid. p. 13

The Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement)
Doha Declaration on the TRIPS Agreement and Public Health

3.1 The Paris Convention for the Protection of Industrial Property of 1883
Initially compulsory licensing was not included in the Paris Convention, 1883. In fact, it was not until the
Revision Conference of the Hague (1925). Pursuant to the amended article 5 of the Hague Revisions,
members were authorized to take necessary legislative measures to prevent the abuses which might result
from the exclusive rights conferred by the patent, for example, failure to work. 31 Thus, one may say that it
only mentioned compulsory licensing as a remedy for abuses. It was silent on compulsory licensing for
other reasons, including public interest reasons.
However, in his studies on Convention, Georg Bodenhausen32 once confirmed that the use of compulsory
licensing to advance the public policy interests are beyond simply ensuring working falls legitimately within
the framework of article 5 of the Paris Convention, 1967:
The provisions in paragraph (2) ... do not deal with measures other than those whose purpose
is to prevent the abuses referred .t o The member States are therefore free to provide
analogous or different measures, for example, compulsory licenses on conditions other
than those indicated in paragraph (4) in other cases where the public interest is deemed to
require such measures .This may be the case when patents concern vital interests of the
country in the fields of military security or public health or in the case of so-calleddependant
patents

Hence, since 1925, through three Revision Conferences (1934, 1958,1967) compulsory licensing has been
finally specifically designated in the Paris Conventions. Even though, it has been mainly done as to the
primary remedy for abuses, it has also been used by a variety of countries, without regulated uniformity, to
promote the public interest even in cases where there has not been abuse. 33 The record of countries
granting such licenses is uneven.

3.2 TRIPS Agreement

The TRIPs Agreement does not use the term compulsory licensing. Instead, it mentions the phrase, Other
Use without Authorization of the Right Holder (Article 31). Attention also should be given on article 30
legitimate interests of third parties and its connection with Article 8 that provides a more
complete picture of what may be intended in article 30 by legitimate interests of third
parties.

Article 8 sets out a number of considerations (principles) that have to be taken into account when a country
adopts intellectual property policy. These considerations are not directly related to the patentee, but rather
focus on the overall domestic national interest as it may be affected by strong patent protections. Article 8
specifies that states may take measures to serve the following public interests:

31
32

Paris Convention, 1925, art. 5(2).

G.H.C. Bodenhausen, Guide to the Application of the Paris Convention for the Protection of Industrial
Property, as Revised at Stockholm in 1967 Geneva: BIRPI, 1968, p. 71
33
Michael Halewood. Regulating patent holders: local working requirements and compulsory licenses at
international law, p.269

1) protection of public health and nutrition; 2) the promotion of public interest sectors of vital importance to
socio-economic and technological development; 3) protection against unreasonably restrained trade; and 4)
protection against practices that adversely affect the international transfer of technology.
Authors argue34 that these four public interest considerations should be included within the meaning of
legitimate interests of third parties set out in article 30, however they must be taken into account when
considering what patent right exceptions can be created within the meaning of article 30.
In his research Regulating patent holders:local working requirements and compulsory licenses at
international law Michael Halewood played interpretation game on that fact that there is no comma
between use and without in the title. If there were such a comma, the implication would be that the
article 31 uses were distinct from article 30 uses because they involved situations without the patentees
authorization. Since there is no such comma, however, the only fair reading of the text requires the
conclusion that article 30 also involves exceptions without the patentees authorization or consent. Of
course, one of the most obvious examples of such an unauthorized exception is compulsory licensing.
However, in 2003 the TRIPS agreement 35 had in some way reinforced intellectual
property rights (IPR) and limited the use of compulsory licensing. WTO General
Council Decision36 of 30 August 2003 introduced a waiver to article 31(f) of the TRIPS
agreement37. To implement this decision, the EU issued Council regulation 816/2006
on 17 May 2006. According to it, the aim of compulsory licensing, which is in essence
nothing else than a licensing contract in which the consent of one party is substituted
by the decision of a public authority38, is to grant access to affordable drugs against
all diseases for poor and developing countries (all least developed and low-income
countries, including those that are not members of the WTO)
3.3 Declaration on the TRIPS Agreement and Public Health
On November 14, 2002, the WTO issued the Doha Declaration on TRIPS and Public Health 39. The Doha
Declaration on the TRIPS Agreement and Public Health, which WTO member countries unanimously
adopted in 2001, established that the TRIPS Agreement should be interpreted and implemented in a
manner supportive of WTO Members right to protect public health and, in particular, to promote access to
medicines for all.
Furthermore, paragraph 5(c) of the Doha Declaration on TRIPS and Public Health adopted a broad
definition of what constitutes a national emergency or other circumstance of extreme urgency. These cases

34

Michael Halewood. Regulating patent holders:local working requirements and compulsory licences at
international law, p.257
35
Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in
Marrakesh,
Morocco on 15 April 1994.
36
The WTO Decision on Compulsory Licensing Does it enable import of medicines for developing
countries with grave public health problems?
37
article 31(f) limits compulsory licensing to ones national territory
38
Jakob Cornides, European Union adopts regulation on compulsory licensing of Pharmaceutical
products
for Export, in: The journal of World Intellectual Property, Vol. 10, no. 1, 2007, p. 71.
39
Ministerial Conference, Fourth Session, Doha, 9 - 14 November 2001, WT/MIN(01)/DEC/2, 20 November 2001

are not limited to situations where time is of the essence, but included more generally public health
crises.40
The Doha Declaration affirmed a sovereign nation's authority to grant compulsory licenses during national
emergencies and to define what constitutes a national emergency 41A country that was suffering a major
epidemic could compel licensure for domestic production of patented medication that they could not
otherwise afford.
The Declaration also brings some interpretation solutions, namely, that the TRIPS requirements in Article
31(b) for prior negotiation with patent owners on reasonable commercial terms is waived if there is a public
health crisis. Paragraph six of the Declaration required the WTO to find a solution to the limitations of
exports of medicines manufactured under a compulsory license. The problem raised in negotiations over
implementation of paragraph 6 was the provision in Article 31(f) that normally limits exports to less than
half of production when goods are produced under a compulsory license. This restriction is waived when
licenses are issued as a remedy to anticompetitive practices.
Still, the Doha Declaration fell short of its objective to "promote access to medicines for all." Even with a
compulsory license, many countries with severe health epidemics did not have the means or capacity to
manufacture drugs. Nonetheless, TRIPS required that the majority of manufacture and sales resulting from
compulsory licensing must be limited within the domestic market.42
Recognizing these shortcomings, the WTO met again in 2003 to continue negotiating on the Doha Agenda at
the Fifth Ministerial Conference in Cancun. 43 There, they passed the Implementation Decision which
extended compulsory licensing provisions by temporarily removing limitations on exports of drugs under a
compulsory license to countries that could not manufacture drugs themselves. This decision was adopted by
the General Council in consideration of the Chairperson's statement, in which he reassured the members that
compulsory licensing is to be used in good faith and stressed the need to prevent diversion of supplied
drugs44

IV.

CONTS TO COMPULSORY LICENSING

4.1 Common critics on CL

The compulsory licensing is controversial instrument. The first argument, that could come into the mind,
that some conflicting social interests at stake. On one side - the global task to stimulate new research, on the
other - improving access to existing inventions.
Compulsory licenses always had its critics that were strongly opposing to the enthusiastic advocates. On its
face, the compulsory licensing provisions contain a number of vague terms that are intended to broaden the
scope, but instead most likely increases the transaction costs of assigning a valid compulsory license. These
40

Dr. Tshimanga Kongolo. Unsettled International Intellectual Property Issues.- Kluwer Law International , 2008.- from
introduction(no number of page is provided)
41
at para. 5.
42
TRIPS, supra note 9, art. 31(f).
43
WTO Ministerial Conferences, Cancun 5th Ministerial, at
http://www.wto.org/english/thewto_e/minist_e/min03_e/min03_e.htm
44
Doha Work Programme, WT/MIN(05)/DEC, (Dec. 18, 2005), at
http://www.wto.org/english/thewto_e/minist_e/min05_e/final_text_e.htm#public_health

ambiguities have been articulated by Vishal Gupta, who suggests some objective approaches in determining
valid circumstances for compulsory licensing45
The first argument against non-voluntary licenses is that they are less effective than voluntary licensing in
encouraging the transfer of technology, and may, indeed, even be counter-productive to that goal. Stated
another way, voluntary licensing clearly offers one means whereby the transfer of technology can be
facilitated, whereas non-voluntary licensing should not be viewed as playing such a role but should be
limited to correcting abuses which may arise in the exercise of patent rights. Here pros arguments in
favor of the transfer of technology is in its atmosphere of cooperation between the transferor and the
transferee. That means between the patent owner and the potential licensee. That cooperation
generally leads to the disclosure of non-patented "know-how" which is necessary to make a commercially
viable product, but which was not necessary to satisfy the disclosure requirement to obtain the patent. In
the case of a non-voluntary license the atmosphere of cooperation, and hence the disclosure of non-patented
know how, is absent. Thus the grant of a non-voluntary license under a patent results in a bare right to
work the patented invention, which is likely to be an insufficient vehicle for the full transfer of technology.
Regarding compulsory licensing in relation to pharmaceuticals, Richard and Selina Taylor mentioned, that
compulsory licensing could reduce the effective period of patent protection by enabling manufacturers of generic
pharmaceuticals to undertake preparations that would otherwise be prohibited during the patent term, in
order to launch their products in wealthier countries at the moment of patent expiry 46

4.2 Testing new rules

Despite the WTO's tremendous efforts to create a diplomatic compulsory licensing system that improve
access to prescription medicine, the latest TRIPS amendment, that was described in previous parts, did not
resolve several existing issues and even created some new concerns.
Firstly, the new rules only touched upon a small part of the interface of IPRs and public health ( as a part of
public interest clause of our research):
a) a good reason to use a compulsory license,
b) no domestic production capacity, and
c) a patent on the medicine in the exporting country47.
We have to understand, that access to medicines is a very complex issue. Thus, trade is only one of the
bricks to build a framework for it a small part of it. That is why it is especially difficult to isolate and assess
the value of 2003-s TRIPS changes. Still, the National Board of Trade, a governmental agency and the
central administrative body in Sweden dealing with foreign trade and trade policy, while analyzing 48 the
new rules and the current situation for access to medicines, has drawn the following conclusions in regards
to the new rules for compulsory licenses adopted by the WTO in August 2003:
45

See Vishal Gupta, A Mathematical Approach To Benefit-Detriment Analysis As a Solution To Compulsory Licensing of
Pharmaceuticals Under the TRIPS Agreement, 13 Cardozo J. Int'l & Comp. L. 631 (2005) PDF version
46
Richard and Selina Taylor, Europe unveils compulsory licensing rules, in: Managing Intellectual Property, Dec2004/Jan2005,
Issue 145.
47
The National Board of Tradein Sweden. The WTO Decision on Compulsory Licensing Does it enable
import of medicines for developing countries with grave public health problems?.- Kommerskollegium
2008:2. Pdf version taken from official page - www.kommers.se. p. 12
48
Ibid.

Firstly, that is true, that by its statutory nature new rules are intended to improve access to patented medicines. So far,
they have not been fully used. This may be simply explained by countries like India having had the capacity to
produce copies of medicines at lower prices. It is likely that the need for new rules will increase as these countries
have recently implemented patent protection for medicines.

These possibilities are limited as soon as the new rules can enable import of medicines to low income
countries. The market value is generally too small. There will probably be few situations when all stated
prerequisites are fulfilled. Moreover, the new rules probably will not improve access to medicines in
developing countries generally. They may be viable for some countries or for some products. Finally,
provisions in regional trade agreements may make use of the new rules more difficult or even impossible.
The same may apply if undefined terms and conditions in the new rules are interpreted in a restrictive way.
Above all mentioned, one have to understand that it always will be a political climate that may influence
use of the new rules49. Here comes the issue, that the importer country wont be able to use the new rules
independently. The importer is by default dependent on the exporting country to allow and grant
compulsory licenses for export.
Furthermore, research-based companies are also often very critical to compulsory licenses 50. The potential
exporting country may therefore conclude that granting a compulsory license for export will send wrong
signals to future investors. As a result, some countries will hesitate or refuse to act as exporters under the
new rules in order not to jeopardize inward investments. The importer cannot control this situation.51
V.COMPULSORY LICENSING IN PRACTICE: THAILAND
This part of paper aims to illustrate how the conflict between IPRs, namely patent rights, and public interest

could arise in practice by applying to highly discussed case of Thai Government compulsory licensing
practice.
Using summery that was done by Intellectual Property Watch52, we can draw a sketch of situation:
On 29th of November 2006, the Thai government made the announcement 53 that it was granting a
compulsory license to the GPOT (Government Pharmaceutical Organization of Thailand) in order to
produce a Mercks patent on Efavirenz - an AIDS drug (sold as Stocrin). Not in long period after, the
compulsory license on Kaletra, another anti retro-viral used to treat HIV/AIDS, was issued. Afterwards, the
third case came. Last one was rather different from the previous licenses, as soon as it concerned Plavix a
blood thinning medicine.
Here an important emphasis should be done - all compulsory licenses have been granted on the ground that
Thailand is suffering a health emergency and the same are necessary for the government to fulfill its
obligations of providing universal access to medicines to its people.54
49

Ibid, - p. 15
Gianna Julian-Arnold, International compulsory licensing: the rationales and the reality.- The Journal
of Law and Technology 1993, p.289
51
The National Board of Tradein Sweden. The WTO Decision on Compulsory Licensing Does it enable
import of medicines for developing countries with grave public health problems?.- Kommerskollegium
2008:2. Pdf version taken from official page - www.kommers.se. - p. 12
50

52

Intellectual Property Watch, 22 December 2006 - Thailand Compulsory License On AIDS Drug Prompts
Policy Debate
http://www.ip-watch.org/weblog/2006/12/22/thailand-compulsory-license-on-aids-drug-promptspolicy-debate/?res=1024_ff&print=0
53
See full text of announcement - http://www.cptech.org/ip/health/c/thailand/thaicl4efavirenz.html
54

Announcement of the Department of Disease Control, Ministry of Public Health, Thailand on the

Reactions to the grant of these compulsory licenses by the Thai government were really different. It is not
surprising, that the pharmaceutical companies concerned offered to reduce the prices of drugs. As to groups
of public interest groups - they seemed to be happy.55
However, from international legal scope, there was therefore, a considerably greater degree of uncertainty as
to the scope of Article 31 of the TRIPs agreement. The mentioned in normative part of the paper, the Article
31 of TRIPS states This requirement may be waived by a Member in the case of a national emergency or
other circumstances of extreme urgency or in cases of public non-commercial use.
Firstly, issue of meeting by Thai Government criteria of emergency. One of the main counterarguments
from the pharmaceutical companies was concerned fact that the Thai government failed to conduct any
negotiations before decision to issue the compulsory licenses.56 However, in response politicians referred to
its own report - Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents
on Three Patented Drugs in Thailand57 where claimed that in period of 2004-2006 the Ministry of Public
health had made several attempts for to negotiate with patent holders and that a Working Group was also
created in order to work on price reduction of patented drugs. Hence, the Government concluded that it
were the patent holders who did not want co-operation. Even more, the Thai government disputed about
need of negotiations under the TRIPs agreement and under the Thai patent law in the present case.
It was noted, that according to national legislation, Thai Patent Law 58 ( 46(2)) an applicant for
compulsory license must show that he has made an effort to obtain a license from the patentee.
However, this is only in case of commercial ventures. 51 of Law allows compulsory licensing with intent
to relieve a severe shortage of food, drugs or other consumption items and, what was stressed by Thai
Government, does not require prior negotiations with the patentee. Making link with TRIPs: a
requirement that the patentee be informed.
What should be taking into consideration, that the requirement of negotiation with the patentee would defeat
the purpose of having emergency provisions. For sure, it may be argued that the AIDS situation in Thailand
had not come about overnight and therefore there was no real emergency as envisaged in TRIPs or the
national laws in Thailand.
However, lets come back to the Doha Declaration59 and its 5(c) point:
Each member has the right to determine what constitutes a national emergency or other circumstances of
extreme urgency, it being understood that public health crisis, including those relating to HIV/AIDS,
Public
use
of
patent
for
Pharmaceutical
Products
http://www.cptech.org/ip/health/c/thailand/thaicl4efavirenz.html
55
Aaron F. Barkoff, Thailand's Compulsory Licensing of Pharmaceuticals Under TRIPS Stirs Controversy http://www.orangebookblog.com/2007/02/thailands_compu.html
56

Intellectual Property Watch, 22 December 2006 - Thailand Compulsory License On AIDS Drug Prompts
Policy Debate
http://www.ip-watch.org/weblog/2006/12/22/thailand-compulsory-license-on-aids-drug-promptspolicy-debate/?res=1024_ff&print=0
57

Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three
Patented Drugs in Thailand By The Ministry of Public Health and The National Health Security Office
Thailand February 2007 - Text of report - http://www.moph.go.th/hot/White%20Paper%20CL-EN.pdf
58
THAILAND Patent Act of 11 March B.E. 2522 (1979) as amended by Act (No. 3) B.E. 2542 (1999) on
March 21, 1999 - http://www.jpo.go.jp/shiryou_e/s_sonota_e/fips_e/pdf/thailand/patents_act.pdf
59

Declaration on the TRIPS agreement and public health, WT/MIN(01)/DEC/2, 20 November 2001

tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstance of
extreme urgency.
That was clear that at least for the HIV/AIDS drugs, no prior negotiations were necessary with the patent
holders. This notwithstanding that issue may well be legitimately raised with regards Plavix. That one did
not treat an epidemic. On the other hand, a drug had been mostly directed to more affluent populations
who have suffered from recent heart attacks or strokes.
Another argument that was given by the Thai government in its White paper sounded as negotiation
attempts prior to grant of compulsory licenses are often a waste of time 60. Following the grant of
compulsory licenses, however, the price decline is rapid. Talking in language of numbers, in Thailand, at the
time the compulsory licenses were announced, the price of the drug Efavirenz was 1,400 Baht/m. After the
grant of licenses, Merck offered to provide the drug at 550 Baht/m (10 Baht less than the price at which the
Government pharmaceutical organization (GPO) could provide it.61
Next issue, that was argued and directly concern our subject of paper is notion of adequate remuneration.
In this case, the Thai government has offered the patent holder a royalty of 0.5% under the compulsory
licenses.
There was not strictly expressed minimum or reasonable royalty both in international (namely, TRIPs) and
national legislation. However, lets remind once more TRIPS Article 31(h)62 provides that the right holder
shall be paid adequate remuneration in the circumstances of each case, taking into account the economic
value of the authorization . As to national Thai perspective, 48 of the Thai patent act states that where a
compulsory license is granted under Section 46, 47 or 47bis, the patentee shall be entitled to remuneration.
Moreover, 46(2) provides kind of interpretative guidance as it states that the remuneration must be
reasonably sufficient under the circumstances.
This case shows how controversially States may use notions of compulsory licensing and treat concept of
public interest in order to serve its own political aims. As we can sum up, in Thai example there were to
major elements for creation of the necessity of making decision to use compulsory licensing. First one is
quite obvious, a perceived need to act due to AIDS epidemic and related to it issues of existence of patents
on special medicine, the implementation of a national treatment access policy and the limited financing
resources available to cover health products and services. The second issue laid down in the social and
political context of that period.

60

Aaron F. Barkoff, Thailand's Compulsory Licensing of Pharmaceuticals Under TRIPS Stirs Controversy http://www.orangebookblog.com/2007/02/thailands_compu.html
61
62

Ibid.
Online version of TRIPs http://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm

CONCLUSION
The concept of compulsory licensing dates back to the 1600s and the use was provided for in the Paris
Convention on Industrial Property 1883. It has been a common and integrated feature of most patent systems
since then, even if it is not often put into practice. By the early 1990s, about one hundred countries patent
laws had some form of CL provision. It concerns mostly developed countries.
The Doha Declaration on TRIPS and Public Health, which was adopted by the WTO in 2001, clarifies that
all member states have the right to grant compulsory licenses to protect public health and improve access to
medicines.
The system of compulsory licensing may constitute a strategic tool for improving the negotiating position of
the general public towards the patent holder in order to improve access to a particular invention. There is,
however, a risk that compulsory licenses could reduce innovation and investment by diminishing the value
of a patent.
Research on general use of compulsory licenses in Canada, the US, Thailand, Malaysia, Zimbabwe and
Brazil shows that while systematic use of compulsory licenses might harm innovation and investments,
sporadic use showed no such effects. An important factor to consider is how important the market in
question is for investment decisions. The compulsory licenses did result in certain downward pressure on
prices, although not always in a significant way. The problem is that, despite lower costs for developing the
medicines, the new producer generally cannot achieve equally effective production as the patent holder.
The conclusion is therefore that compulsory licences may be useful tools in certain cases but are also
associated with risks and limitations. Also, they cannot improve other deficiencies in the health care
systems.

An ethical excuse and public interest are usually concepts which scholars calling upon while describing
notion of exceptions and limitations in intellectual property doctrine. For example, going back to history of
negotiations to formation of the Berne Convention in 1884, we can recall words of Numa Droz , the Swiss

delegate, who stated that it should be remembered that limits to absolute protection are rightly set by the
public interest. Truly, that statement concerned copyright, however it is important for us in order to
understand the general approach to limits as tool of balancing the interest of private party (author, inventor,
holder of trademark).
One of the vague aspects of public interest clause, that it is not so clear enough, whether compulsory
licensing in the light of public interest argument matches ,exciting rules in IP legislation. For example in
case without proof of abuse, would it similarly fall within the meaning of the CL-related Articles 30 and
31 of TRIPS? This unsolved topic now having the practical effect of allowing governments broader
potential field of justifications and conditions under which they could grant compulsory licenses. And this
result is not always positive.

BIBLIOGRAPHY

Legislation
1. Universal Declaration of Human Rights (UDHR), December 10, 1948
2. The International Covenant on Economic, Social and Cultural Rights (ICESCR), December 16, 1966
3. International Covenant on Civil and Political Rights (ICCPR) , December 16, 1966
4. Paris Convention for the Protection of Industrial Property, of March 20, 1883, and as amended on
September 28, 1979
5. The Berne Convention for the Protection of Literary and Artistic Works, 1886
6. Declaration on the TRIPS agreement and public health, WT/MIN(01)/DEC/2, 20 November 2001
7. Agreement on Trade-Related Aspects of Intellectual Property Rights official text at WTO page
8. Committee on Economic, Social and Cultural Rights, General Comment No. 17 on the right of
Everyone to benefit from the protection of the moral and material interests resulting from any
scientific, literary or artistic production of which he or she is the author, UN doc. E/C.12/GC/17, 12
January, 2006
9. Doha Work Programme, WT/MIN(05)/DEC, (Dec. 18, 2005)
10. The 2001 UNDP Human Development Report
11. MDG Gap Task Force, Millennium Development Goal 8: Delivering on the Global Partnership for
Achieving the Millennium Development Goals: MDG Gap Task Force Report 2008 (New York:
United Nations, 2008)
12.
Annex 1C of the Marrakesh Agreement Establishing the World Trade
Organization, signed in Marrakesh, Morocco on 15 April 1994.
13. THAILAND Patent Act of 11 March B.E. 2522 (1979) as amended by Act (No. 3) B.E. 2542 (1999)
on March 21, 1999

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Five questions for James Boyle, KEStudies, Vol.1 (2007)

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Gianna Julian-Arnold, International compulsory licensing: the rationales and the reality.- The
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5.

G.H.C. Bodenhausen, Guide to the Application of the Paris Convention for the Protection of
Industrial Property, as Revised at Stockholm in 1967 Geneva: BIRPI, 1968

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Pharmaceutical products for Export, in: The journal of World Intellectual
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Tshimanga Kongolo. Unsettled International Intellectual Property Issues.- Kluwer Law

International , 2008

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Vishal Gupta, A Mathematical Approach To Benefit-Detriment Analysis As a Solution To

Compulsory Licensing of Pharmaceuticals Under the TRIPS Agreement, 13 Cardozo J. Int'l &
Comp. L. 631 (2005)

Internet related sources

1. Aaron F. Barkoff, Thailand's Compulsory Licensing of Pharmaceuticals Under TRIPS Stirs
Controversy - http://www.orangebookblog.com/2007/02/thailands_compu.html
2. Announcement of the Department of Disease Control, Ministry of Public Health, Thailand on the
Public use of patent for Pharmaceutical Products http://www.cptech.org/ip/health/c/thailand/thaicl4efavirenz.html
3. European Patent office official web-page http://www.european-patent-office.org/gr_index.htm,
15.04.2007 ; definition derived from Case 15/74
4. Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three
Patented Drugs in Thailand By The Ministry of Public Health and The National Health Security Office
Thailand February 2007 - Text of report http://www.moph.go.th/hot/White%20Paper%20CL-EN.pdf
5. James Boyle, A Politics of Intellectual Property: Environmentalism For the Net? James Boyle webpage - http://james-boyle.com/
6. Intellectual Property Watch, 22 December 2006 - Thailand Compulsory License On AIDS Drug Prompts
Policy Debate http://www.ip-watch.org/weblog/2006/12/22/thailand-compulsory-license-on-aidsdrug-prompts-policy-debate/?res=1024_ff&print=0
7. Medical Innovation Prize Fund official web-page - http://singe.za.net/blog/archives/471-MedicalInnovation-Prize-Fund.html

8. The Official web-page of the CIPIH- http://www.who.int/intellectualproperty/en/

9. The National Board of Tradein Sweden. The WTO Decision on Compulsory Licensing Does it enable
import of medicines for developing countries with grave public health problems?.- Kommerskollegium
2008:2. Pdf version taken from official page - www.kommers.se.
10. Vihvelin, Kadri, "Arguments for Incompatibilism", The Stanford Encyclopedia of Philosophy (Winter
2003 Edition), Edward N. Zalta (ed.) online version
http://plato.stanford.edu/archives/win2003/entries/incompatibilism-arguments/
11. WIPO Intellectual Property Handbook: Policy, Law and Use www.wipo.int/aboutip/en/iprm/pdf/ch2.pdf
12. Research Guide on TRIPS and Compulsory Licensing: Access to Innovative Pharmaceuticals for Least
Developed Countries by Do Hyung Kim.- February 2007
http://www.nyulawglobal.org/Globalex/TRIPS_Compulsory_Licensing.htm