Review Article

Journal of Generic Medicines

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Compulsory licensing of drug products ! The Author(s) 2013

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in developing countries DOI: 10.1177/1741134313503827
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Satish Saroha, Deepak Kaushik and Arun Nanda

Abstract
Compulsory licensing of drug products is a very hot issue in today’s pharmaceutical world. Compulsory
licensing of a drug product allows the government to issue the license of manufacturing the drug to a
third person. The third person has to give some 5–10% royalty to the patent holder (the quantum of royalty
is decided by the government and not by the patentee). The issue emerged after developing nations were given
TRIPS flexibilities to implement the system when lives of large population are at stake. Compulsory licenses
have been given in many countries like Thailand, Brazil, Mozambique, Zimbabwe, Zambia, Rwanda, Malaysia,
Indonesia and recently India. India issued compulsory license over Bayer’s anticancer drug Naxaver
(Sorafenib) to generic company Natco Pharma Ltd. United States has criticized the Indian decision. United
States has also put Thailand on watch list after Thailand has issued compulsory licenses to three antiretro-
viral drugs. Compulsory licensing of drug products is very beneficial for the patients but is considered a big
threat for the pharmaceutical companies. The branded drug makers spend billion dollars to patent a drug
product. It is claimed by the pharmaceutical majors that the royalty of 5–10% given by generic drug makers to
these companies is not enough to recoup their loss. The present article explores the utilization of
‘‘Compulsory Licensing’’ by several countries, exemplified by India and Brazil in particular, and highlights
the patentees’ concerns of losing profits. The authors have attempted to negate the concern of the patentees
over the use of compulsory licensing.

Keywords
Patents, compulsory licensing, generics

Introduction
A compulsory license provides a national government
with the authority to practise an invention covered by a
patent, or authorizes another party to do so, without
permission from the patent holder. The practice of
issuing compulsory licenses is an exception to the gen-
eral rule that patent holders have an exclusive right
over their invention. In this situation authorization is
given to exploit an invention without the patent
holder’s consent. The purpose of a compulsory license
is to increase access to essential goods by providing a
wider use of the invention than the patent holder
intended. As a result, the patent holder is forced to
give up a large part of his property right for the pur-
ported benefit of the public. The practice of compul-
sory licensing is addressed in the World Trade
Organization’s agreement on Trade Related Aspects
of Intellectual Property Rights. The TRIPS
Agreement was negotiated at the 1986–1994
Uruguay Round and is to date the most comprehen-
sive multilateral agreement on intellectual property.1
The goal of the TRIPS Agreement is to standardize
the manner in which intellectual property rights are
protected around the world.2
Although the TRIPS Agreement neither defines
‘compulsory license’ nor specifies when exactly a com-
pulsory license can be granted, Article 31 of the TRIPS
Agreement does authorize any WTO Member to issue
a compulsory license after several ambiguous proced-
ures are met. Taking into consideration the inter-
national and domestic law on this issue, an inevitable
question arises; how will the current practice of com-
pulsory licensing affect the future of the pharmaceut-
ical industry?3 As a major force in the international
Department of Pharmaceutical Sciences, Maharshi Dayanand
University, Rohtak 124001, Haryana, India
Corresponding author:
Satish Saroha, Department of Pharmaceutical Sciences, Maharshi
Dayanand University, Rohtak 124001, Haryana, India.
Email: satish.lovesatish.saroha@gmail.com

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2 Journal of Generic Medicines 0(0)
economy, pharmaceutical companies allocate billions
of dollars each year into research and development in
order to provide the world with life-saving drugs; yet,
any member of the WTO has the authority to essen-
tially override the investment-backed patent a pharma-
ceutical company holds. The issuance of a compulsory
license comes at a high price in the world of pharma-
ceutical products. The patent holder’s investment-
backed expectation of earning a profit from the
patented medicine is disrupted when his exclusive
right over his patented product disappears.
In the recent past, the extent of intellectual property
protection afforded by national governments varied
widely across the globe. As the importance of intellec-
tual property rights became increasingly central to
international trade, economic tension between coun-
tries arose due to the various levels of intellectual prop-
erty protections. The members of the WTO sought to
ease this growing tension by establishing globally recog-
nized minimum levels of protection for intellectual
property rights.3 On 1 January 1995, the WTO achieved
this goal by negotiating the TRIPS Agreement, which
‘‘standardized the protection of intellectual property
rights throughout the world by establishing minimum
levels of protection that each WTO Member country
must provide for the intellectual property of other
WTO members’’. Pharmaceutical products were
among the many inventions required to have a min-
imum level of protection under the TRIPS agreement.
The overall purpose of the agreement was to reduce
obstructions in international trade while promoting
intellectual property protection.3
Nations that have issued compulsory
licenses
High-, middle-, and low-income nations have all
issued health-related compulsory licenses. Examples
of high-income countries which have issued compul-
sory licenses are the United States, Canada, Germany,
Italy, and Israel.
The United States was in a dilemma of whether to
issue a compulsory license on Bayer’s Ciprofloxacin,
an anthrax antibiotic or not, following the 11
September 2001 attacks. The United States wanted
enough antibiotics to treat 10 million people in the
event of a mass anthrax attack. Eventually, the
United States government and Bayer, the German-
based manufacturer, came to an agreement in which
the United States had the ability to treat 12 million
people infected with the anthrax virus.5 Following
the Doha Declaration, large-scale use of compulsory
licenses began. In 2002, after facing high rates of HIV/
AIDS infections, Mozambique, Zambia, and
Zimbabwe authorized compulsory licenses for HIV/
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AIDS medication on the grounds of a national emer-
gency. These nations locally produced antiretrovirals
pursuant to article 31(f) of the TRIPS agreement. In
2004, Malaysia and Indonesia issued compulsory
licenses for HIV/AIDS medications.4 These nations
imported generic HIV/AIDS medications from India,
and became the first middle-income nations to issue a
compulsory license for importation of HIV/AIDS anti-
retrovirals. Both Malaysia and Indonesia justified the
issuance of a compulsory license on the grounds that it
was for public non-commercial use. In 2005, Eritrea
and Ghana also imported HIV/AIDS medications for
public non-commercial use. Starting in 2006,
Thailand, a middle-income country joined the group
of nations issuing compulsory licenses for HIV/AIDS
medications. Thailand imported and domestically
manufactured the drug Efavirenz.4 In 2007, Brazil,
also a middle-income nation, issued a compulsory
license for HIV/AIDS medications. Finally, and most
recently, in 2008, Rwanda issued a compulsory license
on the HIV/AIDS medication Apo-TriAvir. The
nations of Thailand, Brazil, and Rwanda have all
recently issued compulsory licenses, each nation
making groundbreaking international news. Although
compulsory licenses are designed to achieve beneficial
outcomes, it is likely that the practice of issuing com-
pulsory licenses will further be abused which will lead
to global misfortune. In this research, examples of
Compulsory Licensing provisions by India and Brazil
have been explored, as hereunder.5
Compulsory licensing situation in India
Background of Indian patent system
Before 1947, when India gained its independence, pre-
independent patent laws were in effect. India’s first
patent act was instituted in 1856. The patent act
included patents for both process and product and
lasted 14 years, with extensions allowed by the
Governor General. Even after independence, of all
the pharmaceutical industries in India, 80% were
operated by foreign companies owning 80–90% of
the patents, with 90% of the profit being sent overseas.
In order to identify the resulting rise in cost of medi-
cines, two committees were set up in 1970: The Bakshi
Tek Chand Committee and the Ayyangar Committee.
According to the Ayyangar committee, ‘‘The patent
law of an underdeveloped country like India should
be so designed as to enable the country to achieve
rapid industrialization to attain, as quickly as possible,
a fairly advanced level of technology giving inventors
and investors sufficient inducement and protection by
patent grants and at the same time safeguarding its
national economic and social interest’’.6
Saroha et al.
These recommendations resulted in an important
amendment of the Indian Patent Act (IPA) in 1970.
Other safeguards were also included in the act, such as
a shortened life of the patent from 14 to seven years,
the curtailing of product patents on medicine and the
establishment of automatic licensing. With the passing
of the 1970 IPA, it was clear that the policy of the
Indian government was geared towards the protection
of public health and the expansion of the Indian gen-
eric manufacturing industry.6 The Patent Act of 1970
provided only for process patent and no product
patent. The Act had a number of safeguards to prevent
abuse of any kind. These included a much shorter
duration of the rights granted (seven instead of 14
years), the prohibition of product patents on all medi-
cines and a strong compulsory licensing regime.
Among other things, the 1970 IPA prohibited patent
protection on pharmaceuticals/food/agrochemical
products, reduced validity periods of process patents
from 20 years to seven years and introduced ‘‘auto-
matic licensing.’’ As a result of this new patent
regime, India became one of the cheapest drug produ-
cing countries after 1970.6,7 In 1995, India joined the
World Trade Organization (WTO) and automatically
became a signatory to the Agreement on Trade-
Related Aspects of Intellectual Property Rights
(TRIPS). As per the requirements under TRIPS,
India needed to amend its patent law by 1 January
2005. India was required to extend patents to micro-
organisms, introduce TRIPS-compliant compulsory
license (CL) provisions, product patents, extend the
term of protection to 20 years, and remove discrimin-
ation between local production and importation.7
Naxaver case: India’s first compulsory
license
India’s government on 12 March 2012 authorized a
drug manufacturer to make and sell a generic copy
of a patented Bayer cancer drug, claiming that Bayer
charged a price that was unaffordable to most of the
nation. The decision by the Controller General of
Patents, Designs and Trademarks was the first time a
so-called ‘‘compulsory license’’ of a patented drug had
been granted in India.8 Legal specialists and patient
advocates said it could open the door to a flood of
other compulsory licenses in India and possibly in
other developing countries, creating a new supply of
cheap generic drugs. According to the decision, Bayer
must license the drug Nexavar, or Sorafenib, to Natco
Pharma, an Indian company. In exchange, Natco must
pay Bayer a 6% royalty on its net sales and must sell
the drug for 8800 rupees ($176) a month, about 3% of
the 280,000 rupees ($5600) that Bayer charges for it in
India. Natco’s drug will be for use only in India, the
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3
decision said.8,9 Nexavar, which Bayer developed with
Onyx Pharmaceuticals, a California biotechnology
company, is used to treat advanced kidney cancer
and liver cancer and has been shown to extend lives
by a median of about three months. Fewer than 200
Indians used the drug, a tablet, in 2011. Advocates for
cheaper generic medicines cheered the decision, which
they said could provide a model for developing
countries.10
In his decision, the Patent Controller, P. H. Kurian,
said the paltry use of Nexavar in India clearly showed
that the drug was unaffordable. He said a compulsory
license was needed to be granted because Bayer had
not manufactured the drug in India and was treating
only a tiny portion of Indians with liver or kidney
cancer. He said the drug was afforded by only 2% of
the patients with kidney and liver cancer. Bayer argued
that the reasonableness of the price should reflect the
development costs, not only the public’s buying power.
It also said a compulsory license was not necessary
because an inexpensive version of Nexavar was already
being sold in India by another generic company that
has said it does not need to recognize Bayer’s patent.
Bayer has sued that company, Cipla, which is based in
Mumbai, claiming patent infringement in a separate
case that is pending.11 Mr. Kurian rejected that argu-
ment, writing that Bayer was engaged in ‘‘two-
facedness’’ by trying to fight Cipla’s drug while using
it as a defense against Natco. Global sales of the drug in
2011 were 725 million Euros, or about $950 million.12
According to the authors, issue of a compulsory
license in the present case should not be portrayed as
a gross violation of the patentee’s rights, and should
not be viewed as a jolt to the profitability of the paten-
tee (Bayer). The patentee is free to realize its profits in
other (richer) countries, where the ‘‘compulsory
license’’ granted by India does not extend. It is clear
that the Indian government has very judiciously dis-
charged its obligation of providing the life-saving drugs
available to poor patients at a reasonable cost, by uti-
lizing the compulsory licensing in the present case.12
Compulsory licensing situation in Brazil
Background
In 1996, the Ministry of Health pledged to make anti-
retroviral drugs available to all Brazilians who needed
them. The cost of such drugs was manageable when
just a few drugs were available and HIV treatment was
only recommended once patients developed full blown
AIDS, but as more drugs were introduced and doctors
began to prescribe antiretrovirals to asymptomatic
HIV-positive people, the national AIDS budget rose
to more than $300 million a year in 2000 (Ministry
4 Journal of Generic Medicines 0(0)
of Health, 2008). The government responded by limit-
ing the variety of drugs imported for the national pro-
gram. In addition to rationing, the government began
investing in national laboratories to produce generic
drugs locally and began negotiations for reduced
prices and/or the right to produce patented drugs
under licenses from multinational pharmaceutical
companies. Negotiations broke down when the gov-
ernment was unable to secure the discounts it desired
from Abbott Laboratories for its powerful new prote-
ase inhibitor Kaletra in 2005.13 President Lula da Silva
declared a public health emergency and the nation’s
intent to begin producing the drugs under compulsory
licensing. Under the WTO’s TRIPS agreement,
nations set their own standards for defining public
health emergencies and have the right to violate
patents in such cases. They are required to pay a
token amount to the patent holder as a result. While
controversial, Lula da Silva’s decision seems legal and
can be explained by several of the key justifications for
government intervention in private markets cited in
the public finance literature, including equity con-
cerns, a patent-induced market failure that leads to
under provision of drugs, and the existence of positive
externalities of HIV drug treatment that benefit society
beyond just people with HIV.13,14
President Luiz Inacio Lula da Silva of Brazil agreed
on 4 May 2007, to issue a compulsory license on
Efavirenez, an HIV/AIDS drug owned by Merck.
Before the license was issued, Merck offered to lower
the drug price by 30%, but because Brazil justified
their issuance of the license under the ‘‘public non-
commercial use’’ category of the TRIPS Agreement,
Brazil was not required to negotiate with Merck what-
soever. Brazil claimed that importing a generic form of
Efavirenz from India would save the nation’s anti-
AIDS program $30 million dollars annually. Brazil
received the generic import for $0.45 a pill, compared
to Merck’s offer of $1.11 per pill. Merck, disappointed
with Brazil’s actions, has stated that Brazil’s decision is
a major step backward and sets bad policy for two
reasons.15 First of all, Brazil’s actions set bad prece-
dent in the sense that it will encourage overuse of the
compulsory license provision. Brazil is an upper-
middle income country with the 12th largest economy
in the world. Moreover, Brazil has a relatively low rate
of HIV/AIDS infection, and has a well-established
AIDS program which has been successful in control-
ling the national spread of HIV/AIDS. Therefore,
Brazil has more of an opportunity to pay for HIV/
AIDS medications than countries that have less
money and that are hit harder with the epidemic.
The second reason Merck condemns Brazil’s practice
is because future foreign investment will be discour-
aged, which will ultimately result in less drugs being
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introduced into Brazil. This issuance of a compulsory
license has had a negative impact on Brazil’s reputa-
tion as an industrialized country seeking to attract for-
eign investment.16
Efavirenz case
In 1986, Brazil established its National STD and
AIDS Committee (CNAIDS). Only Zidovudine was
available to treat HIV/AIDS in Brazil. The pill form
of antiretroviral Didanosine (25 and 100 mg) was first
available in 1993. Brazil first began using an antiretro-
viral cocktail therapy in 1996.17 Brazil first offered
antiretroviral Zalcitabine (0.75 mg pill) in May. The
injectable form of Zidovudine, Lamivudine (150 mg
pill), Saquinavir (200 mg capsule), and Ritonavir
(100 mg capsule) were also made available in June,
September, December and December, respectively.
On 14 May 1996, Brazil passed National Legislation
for its Intellectual Property Law, which allows for
compulsory licensing. In 1998, Brazil began producing
Zidovudine locally. Brazil also began distributing the
antiretroviral through the National Health System.
Brazil publicly considered issuing compulsory licenses
for Nelfinavir and Efavirenz in 2001.17 The US Trade
Representative filed a complaint in the WTO Dispute
Settlement Body, concerning article 68 of Brazil’s
patent law, which allowed for compulsory licensing
when patent holders do not manufacture their prod-
ucts locally. US Trade Representative Officials labeled
this complaint as the ‘‘Merck’’ case. On 29 March
2001, Merck agreed on price discounts of 59% for
Efavirenz and 65% for Indinavir, as long as Brazil’s
government did not issue compulsory licenses for gen-
eric production. Efavirenz would sell for 84 cents
instead of $2.06 for a 200 mg dose, and Indinavir
would sell for 47 cents instead of $1.33 for a 400 mg
dose. On 5 September 2003, despite its negotiations
with pharmaceutical companies for a 40% discount on
antiretrovirals, Brazil was only offered a maximum
reduction of 6.7%. Brazil issued a public decree allow-
ing for local production or import of generic antiretro-
virals without patent holders’ consent. In particular,
the decree applied to Lopinavir, Efavirenz and
Nelfinavir. On 14 March 2005, Brazil asked pharma-
ceutical companies Merck, Gilead and Abbott
Laboratories, to voluntarily license the generic produc-
tion of their respective antiretrovirals for Brazil’s
National STD/AID Program. Those antiretrovirals
included Merk’s Efavirenz, Gilead’s Tenofovir, and
Abbott’s Lopinavir and Ritonavir.17
After a series of unsuccessful meetings with Merck
Sharp and Dohme, starting in 2006, Brazilian
President Luiz Inácio Lula Da Silva announced
Brazil’s issuance of a compulsory license for Merck’s
Saroha et al.
Efavirenz, on national television on 4 May 2007. After
the grant of compulsory license for the drug Efavirenz,
the price of the drug has been reduced from US$1.59
to US$0.43/tb. The drug has been used by more than
75,000 AIDS patients in Brazil.18
Conclusion
The authors are of the view that issue of compulsory
licensing for drug products is very beneficial for the
public in developing and low developed countries
where people cannot afford branded drugs for diseases
like AIDS and cancer. For example, in the case of
compulsory license in India over liver and kidney
cancer drug, Bayer charges 280,000 rupees ($5600)
for one month while Natco charges only 8800 rupees
($176) for a month. This amount is just 3% of the
amount charged by Bayer’s drug. United States has
opposed the decision. The countries like Brazil and
Thailand have also given compulsory licenses for
AIDS drugs. The common patients in these countries
have definitely been benefitted to get the treatment
after the decision. The use of compulsory licensing
provisions by countries like India and Brazil is con-
sidered a severe threat by the multinational patentee
firms, who claim compulsory licensing provisions have
the following disadvantages:
1. Compulsory licensing does not allow the patentee
company to recover the cost of development of a
new drug (which should also cover the cost of all
unsuccessful drug candidates the patentee company
has worked upon).
2. Compulsory licensing generates fear in the minds of
the future investors, as this causes drastic reduction
in profits.
3. Use of compulsory licensing by one country may
promote the use of similar provisions by several
other countries also.
The authors do not agree with the concerns aired
(as above) by the patentees. Countries like USA have
opposed most vociferously the use of compulsory
licensing, in particular by India and Brazil. Yet, USA
did utilize the compulsory licensing provisions in
‘‘anthrax case’’. Therefore, it must be very clearly left
to the discretion and wisdom of a country (such as
India, Brazil, Thailand, etc.) to decide as to when
and how to use the compulsory licensing provisions.
The concern of the patentee companies, that com-
pulsory licensing provisions drastically reduce their
profits, also seems to devoid of the total truth, as
patentee companies (such as Bayer, in India) do not
disclose as to what is the percentage of their drop in
profits (e.g. in India, Bayer did not disclose as to what
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5
is the percentage of sale of its drug in India, as com-
pared to its sales worldwide, where compulsory licen-
sing was not invoked). Similarly, none of the patentee
companies have proved as to how use of compulsory
license provision by one country has encouraged
another country to follow suit. Each country has a
responsible government, and it must be left to the indi-
vidual country as to how and when the compulsory
licensing provisions must be utilized, in the best inter-
ests of its patients. Thus, the authors appreciate the
use of compulsory licensing by several countries (India
and Brazil in particular) and criticize the patentee
companies, over the fears generated regarding the
use of compulsory licensing.
Acknowledgements
I sincerely thank my thesis supervisor, Mr. Deepak Kaushik,
Assistant Professor in Pharmaceutics, Faculty of
Pharmaceutical Sciences, MD University, Rohtak and
Prof. Arun Nanda, Dean, Faculty of Pharmaceutical
Sciences, MD University, Rohtak for their guidance, help
and motivation. This work could not have attained its pre-
sent form without their active interest, direction and help.
They have been always there with me in providing many
helpful comments. I think this research article would not
have been possible without the confidence, endurance and
support of my family. My family has always been a source of
inspiration and encouragement. My sincere gratitude also
goes to all those who instructed and taught me through the
years. Last but not the least I would like to thank God for
everything.
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