UN World Intellectual Proper Ty Organization: Background Guide

World Model United Nations 2011
UN Wor l d I nte l l e c t ual Proper t y O rganizatio n

Bac kgro u n d G u i d e
World Intellectual
Property Organization
Table of Contents
Letter from the Secretary General..............................................................1
Letter from the Under-Secretary General...................................................2
Letter from the Chair...................................................................................3
Introduction................................................................................................6
History of the Committee...........................................................................6
Topic A: Gene Patenting
History of the Problem............................................................................................7
Current Situation...................................................................................................18
Past UN Actions........................................................................................................18
QARMA...................................................................................................21
Key Actors and Positions.......................................................................................22
Topic B: Protection of Indigenous, Ancient, and Traditional Knowledge
History of the Problem...........................................................................................24
Case Studies ...........................................................................................................30
Past Un Actions......................................................................................................34
QARMA.................................................................................................36
Key Actors and Positions.......................................................................................36
Position Papers..........................................................................................37
Closing Remarks.................................................................................................38
Appendix.................................................................................................42
Bibliography................................................................................................45
Cover image courtesy of Singapore Tourism Board.

Letter from the
Secretary-General
March 14 - March 18 2011
Dear Delegates,
Reihan Nadarajah
Secretary-General It is my utmost pleasure to welcome you to World Model United Nations 2011!
My name is Reihan Nadarajah, and I will serve as your Secretary-General for
Remen Okuruwa WorldMUN’s 20th conference. The conference staff of WorldMUN has been
Director-General hard at work, ensuring that you receive the best substantive experience before,
during and even after conference has ended. Within this document, you will find
Ioana Calcev the study guide for your committee. Each Chair has worked to display his or her
Under-Secretary-General for General interest and passion for the topics found within this guide. They have researched
extensively to provide you with the best possible overview of each committee’s
Assemblies
topic area.
Samir Patel
This study guide should serve as a launching pad for all your research; research
Under-Secretary-General for Economic
that will be pivotal in ensuring you have as rewarding an experience as possible
and Social Councils and Regional
in committee. The WorldMUN Spirit asks each delegate to step into the shoes
Bodies of those from entirely different cultures to yours, to gain a better understanding
across borders, and this starts with your research. As you prepare for conference,
Kathleen Tang look closely at this guide, and use the additional resources suggested by your
Under-Secretary-General for Chair to learn more about the topic, and your represented position on it. Please
Specialized Agencies also use the additional resources on our website: WorldMUN 101 (a guide
to everything MUN), and the Rules of Procedure – both of which have been
Kenneth Li revamped this year. Also feel free to e-mail your Chair, or your Under-Secretary-
Under-Secretary-General for Strategy General at any point during the preparation process if you have questions or
would like assistance. Later in the winter, we will also place updates on recent
Charlene Wong developments on the topics on the website, written by your Assistant Chairs.
Under-Secretary-General for
Administration Good luck with your preparation, and I hope you enjoy reading this Study
Guide! I look forward to meeting you in Singapore in March!
AParajita Tripathi
Under-Secretary-General for Business Sincerely,
Reihan Nadarajah
Secretary-General
World Model United Nations 2011
secretarygeneral@worldmun.org
Letter from the
Under-Secretary-General
Reihan Nadarajah Dear Delegates of the General Assembly,

Secretary-General
It is with great pleasure that I welcome you to the General Assembly of WorldMUN
Remen Okuruwa 2011! My name is Ioana Calcev and I am very excited to be Under-Secretary-General
Director-General for this conference. Model United Nations has been an important part of my life since
high school and throughout college, and I am genuinely thrilled to meet students
Ioana Calcev from all over the world who strive to make the world a little better each day.
Under-Secretary-General for General
The General Assembly is the organ where every nation has an equal voice in
Assemblies
addressing international problems and promoting new initiatives. This year, the
General Assembly is home to some of WorldMUN’s most challenging committees.
Samir Patel
Ranging from traditional United Nations bodies such as the Disarmament and
International Security Committee and the Special Political and Decolonization
and Social Councils and Regional Committee to the World Intellectual Property Organization. The issues discussed in
Bodies committee promise to be both a great learning experience as delegates participate in
intense debate, negotiation, and diplomacy.
Kathleen Tang
Under-Secretary-General for Please take the time to read the background guide thoroughly and familiarize yourself
Specialized Agencies with the topics at hand. Your Chair and Assistant Chairs have been working very
hard to put together amazing committees that will help you have the best possible
Kenneth Li experience in Singapore. The following guide is the result of many hours of research
Under-Secretary-General for Strategy and hard work. However, the background guide is by no means all encompassing.
Rather, it is meant to serve as a launching pad for further research and investigation.
Charlene Wong If you have any questions about the material at hand please do not hesitate to contact
Under-Secretary-General for your Chair or myself.
Administration
Enjoy reading this study guide and be sure to make the most of it. I look forward to
AParajita Tripathi meeting all of you in Singapore!
Under-Secretary-General for Business Sincerely,
Ioana Calcev
USG General Assembly
Harvard WorldMUN 2011
ga@worldmun.org
Letter from the Chair
Dear Delegates,
Reihan Nadarajah
It is my pleasure to welcome you to WorldMUN 2011 and to the World Intellectual
Secretary-General
Property Organization! My name is Varun Bansal, and I am absolutely thrilled to be your
chairoo this year. I am especially excited about our committee, which is unique for a
Remen Okuruwa MUN conference, but crucial to global trade, innovation, and international relations.
Director-General
I am a sophomore at Harvard, concentrating in Applied Mathematics and Economics.
Ioana Calcev I grew up around Washington, D.C., and first participated in Model UN in high school,
Under-Secretary-General for General serving as a delegate and chair for many conferences. Beyond academics and WorldMUN,
Assemblies I am involved with the Harvard International Review, a magazine on international affairs,
and EnviroEd, a volunteer group that teaches underprivileged students in Boston about
Samir Patel environmental issues.
and Social Councils and Regional This year, WIPO will be debating gene patenting and the protection of traditional
Bodies knowledge. Though research into gene patenting has been ongoing for many years now,
there is still no global agreement that sets forth the rules, limits, and procedures of gene
Kathleen Tang patenting. Similarly, though various international agencies have, for decades, repeatedly
Under-Secretary-General for stated their commitment to protecting traditional knowledge, there is still no single global
Specialized Agencies system for protecting traditional knowledge and determining how it fits into the current
system (if at all). Thus, for each topic, the goal is to create a comprehensive framework
Kenneth Li that, for the first time, unifies and clearly sets out global standards on gene patenting and
Under-Secretary-General for Strategy traditional knowledge.
Charlene Wong Debate will be shaped not only by your country’s position, but also by your personal
opinions. While our topics are certainly difficult, I am confident that you are more than
Under-Secretary-General for
capable of handling them, and will come prepared to discuss these issues. Until we meet,
Administration
please feel free to email me with any questions or just to introduce yourself. I look forward
to meeting each of you in Singapore at WorldMUN 2011!
AParajita Tripathi
Under-Secretary-General for Business
Sincerely,
Varun Bansal
Chair, World Intellectual Property Organization WorldMUN 2011
WIPO Chair
Varun Bansal WIPO@WorldMUN.org
WIPO@WorldMun.org
World Intellectual economic development while safeguarding the public
interest.” 3
the operations of the other two organs.10 After the
governing bodies come the standing and permanent
tailored through genetic engineering. Animal species
are being changed, fused, and spliced by human
Of the two founding agreements of WIPO, the committees, groups of experts convened for specific researchers. Genetic engineering, with all its stunning
Property Paris Convention is more relevant to the topics our
committee will discuss. In a very real way, modern
purposes by the governing bodies. These standing
and permanent committees can then further create
technological advances, is nothing short of a revolution
that is changing the nature of our interaction with
Organization international cooperation in intellectual property

and patents was pioneered with the adoption of the
working groups, convened to examine specific
questions in great detail. Behind all this organization is
living organisms. This revolution pervades every facet
of life for every human on the planet. Food agriculture,
Paris Convention, which crafted a broad set of rules the International Bureau, or WIPO Secretariat, which novel medicines, and even humans are now potential
Introduction regarding industrial property. The most significant takes care of budgeting, implementation, and other candidates for genetic engineering.
A s I mentioned in my letter, the topics our outcome of the Paris Convention was the provision administrative functions.11 With this whirlwind of advancement, however,

committee will deal with are gene patenting and that each contracting member state had to “grant the Today, everything WIPO does is in the spirit has come a time of incredible uncertainty. Humanity
the protection of traditional knowledge. The goals same protection [of intellectual property] to nationals of its five core tasks: developing international has embarked on a journey with no clear end and no
for this committee are deceptively simple: to create of the other contracting States as it grants to its own IP laws and standards, delivering global IP protection clear paths. Genetic engineering has the potential to
a unifying, global framework for each topic. These nationals.”4 The Convention was revised and amended services, encouraging the use of IP for economic open incredibly beneficial advances for humanity,
goals directly follow WIPO’s strategic goals for the numerous times since then, most recently in 1979, has development, promoting a better understanding of solving issues ranging from disease to world hunger.
millennium, including the “balanced evolution of the 173 member states party to it, and is administered by IP, and providing a forum for debate. WIPO also But it also opens the possibility of irreversible damage
international normative framework for IP [intellectual WIPO.5 “administers 24 international treaties (16 on industrial to the Earth and to its people, damage so large and so
property], coordination and development of global IP There are two other major, milestone treaties property; 7 on copyright; as well as the convention unanticipated that we would be helpless, as we watch
infrastructure, international cooperation on building that have had a significant bearing upon WIPO and establishing WIPO).”12 Unlike other UN committees, our creations ravage the Earth and the systems on
respect for IP,” and “addressing IP in relation to global our debates this session, as both have laid the modern which may depend on external factors for their power which we depend.
policy issues.”1 Solving the issues of gene patenting and system for a synchronized global patenting system. or success, WIPO’s powers derive from the agreement Our notions of how ethics, law, and economics
traditional knowledge would be a huge step forward The first is the Patent Cooperation Treaty (PCT), of member nations. If enough member nations agree apply to these situations are not yet as advanced as the
for WIPO and for IP in general across the world. concluded in 1970, which makes it possible to obtain to, ratify, and participate in a system, its successful science is. It is still unclear when and if it is morally
patent protection in many nations by filling out just a implementation is assured. permissible to modify an organism, and to what
History of the Committee few forms—the first major step towards international extent. Nor are we sure of when it is ethical to patent
T he World Intellectual Property Organization

(WIPO) has a long history, by UN standards. The
precursor to WIPO was founded in 1883, when the
harmonization of patenting procedures.6 The second is
the Patent Law Treaty (PLT), concluded in 2000, which
Gene Patenting a genetically modified organism, if at all. Even in the
more dispassionate realm of economics, we are still
went a step beyond PCT and formally harmonized S tat e m e n t of the Problem engaged in a fierce debate on whether gene patents will
I
two international bureaus administering the Paris and simplified various patenting procedures in many ntellectual property protection is a widely hamper or assist research.
Convention for the Protection of Industrial Property nations, to increase the ease of obtaining patent implemented reality around the world. Whether As a result, there is also no unified, global
(“the Paris Convention”) and the Berne Convention protection.7 it takes the form of a patent or a copyright, the ideas policy or agreement on genetic engineering and gene
for the Protection of Literary and Artistic Works WIPO itself is organized into various bodies. and principles behind intellectual property protection patents, posing a major problem to international
merged to form the United International Bureaux for On the highest level, WIPO is composed of three are generally well understood; when someone creates cooperation and trade. There are currently a large
the Protection of Intellectual Property (“BIRPI”). In organs (the three “governing bodies”), the WIPO something, be it a new light bulb or a new book, they number of agreements, many of which briefly mention
1967, due to the Convention Establishing the World General Assembly, the WIPO Conference, and the receive protection under the government. This very and briefly touch upon the issue of genetic engineering
Intellectual Property Organization, BIRPI became WIPO Coordination Committee. These three organs clear system begins to break down, however, when and gene patenting. These agreements range from
WIPO, and in 1974, WIPO became a specialized are of equal size—each is composed of one delegation genetic engineering enters the question. the powerful Agreement on Trade-Related Aspects
agency of the United Nations. Today, as WIPO itself per member state—and are the highest decision- At its most basic, genetic engineering is a type of Intellectual Property Rights (TRIPS) to many
puts it, WIPO is “a dynamic entity with 184 member making bodies of WIPO. The WIPO General Assembly of biotechnology that involves the modification of an smaller agreements, such as International Treaty on
States, a staff that now numbers some 938, from largely deals with logistical issues, such as budgeting, organism’s genes to change what the genes do. Already, Plant Genetic Resources for Food and Agriculture.
95 countries around the world, and with a mission finances, and status and approval of member states.8 genetically modified products are readily available in Of greatest significance, however, is TRIPS, which is
and a mandate that are constantly growing.”2 Today, The WIPO Conference, among other duties, discusses global markets. Entire industries, such as corn and administered by the World Trade Organization (WTO)
WIPO summarizes its core mission as “dedicated to and adopts recommendations for matters dealing with soy production, have been reshaped by genetically and effectively rules the global patenting regime. There
developing a balanced and accessible international IP and adopts amendments to the WIPO Convention modified crops. New medicines are being developed are also many points of discord between national or
intellectual property (IP) system, which rewards itself.9 Finally, the WIPO Coordination Committee that are grown and created in living laboratories, regional patent laws, most notably between United
creativity, stimulates innovation and contributes to creates the agenda and drafts recommendations for States patent law and the law set under the European
Harvard WorldMUN 2011 World Intellectual Property Organization 6 Harvard WorldMUN 2011 World Intellectual Property Organization 7
Patent Convention in Europe. genetic information, is made of simple building blocks, genome—the string of genes that make up each products contain medicines and nutrients, and salmon
Even the existing gene patenting systems in encodes for all the features of a living organism, and is individual human’s genetic structure. A gene is a have been modified to grow faster. Food crops—most
individual nations, all of which are largely based on passed from generation to generation.] ‘Recombinant’ stretch of A-T and C-G pairs that, by their complex notably, soybean, corn, and canola crops—have been
older systems of patenting, are coming under heavy means combining genes from different sources in a arrangement, lay out the instructions for a cell to modified to grow faster, be resistant to herbicides,
criticism from scientific researchers, ethicists, and different manner than occurs naturally. Genes are the produce a particular protein. Proteins are the basic pesticides, and various diseases, and produce
lawyers. Among other criticisms, the current system units formed by combinations of the nucleotides G agents, formed from amino acids, that determine the medicines. Non-food plants, such as cotton, have also
of gene patents has been characterized as unsuited (guanine), A (adenine), T (thymine), and C (cytosine), chemical reactions in the cell.”14 For the purposes of been modified with commercial success.18
for the fast-paced biotechnology industry, restrictive which lie in two equally long and twisting strings (the this study guide, a gene will be defined as the complete Although genetic engineering has been largely
to scientific innovation, harmful to patients and famous ‘double helix’) that are attached to each other DNA sequence that encodes the instruction to build a limited to non-human genetic engineering, human
consumers, and as an obstacle to scientific progress.13 throughout their length. G, A, T, and C nucleotides protein.15 genetic engineering is a reality already in motion. Gene
Despite our doubts and uncertainties, however, combine in pairs, across the space between the two Some may say that genetic engineering is a therapy, the deliberate insertion of foreign genes into
advances in genetic engineering are racing on at an strings. About three billion pairs form the human natural extension of ancient agricultural practices, a host (human) to cure disease, is still in its infancy,
ever-accelerating pace. It is no longer such as burning brush to encourage the growth of though the field is rapidly developing and holds great
feasible to simply ignore the field, hoping specific flora, domestication of animals, and most promise. There are two forms of gene therapy: germ
that a discovery or breakthrough in the important, the selective breeding of plants and line gene therapy and somatic gene therapy. Germ line
future will provide the crucial insight animals to extinguish undesirable traits and promote gene therapy is the modification of gametes (sperm
needed to formulate guidelines. For a desirable characteristics. Most scientists, however, and eggs) to alter the next generation of humans. Such
field with such huge potential—both for draw a contrast between these practices and genetic gene therapy holds promise to “edit out” inheritable
good and bad—to be so unregulated is engineering, as these older practices indirectly altered diseases or predispositions forever. Somatic gene
alarming and untenable. Thus, WIPO the genes of living beings, while genetic engineering therapy is the modification of the somatic cells (all cells
is tasked with the duty of formulating directly alters the genes.16 in the body besides of gametes and undifferentiated
a comprehensive, international Genetic engineering, as understood today, stem cells) in order to cure the subject human of
agreement covering all aspects of gene began in the early 1970s, when scientists in the United a disease without affecting, either positively or
patenting. In other words, WIPO will States managed to have bacteria take up foreign negatively, the next generation of offspring. Current
have to debate the moral controversies, DNA segments and add it to their genomes. In 1976, research has been limited to somatic gene therapy due
overhaul the archaic patenting system the first true application of genetic engineering was to ethical qualms within the scientific community, but
regulating genetic engineering, created; insulin, a human protein, was produced as advances continue, germ line gene therapy may be
and address the legal technicalities inside a genetically altered bacterium. For the next the logical next step in research. As the reasoning goes,
that surround patenting genes. The twenty years, the technology was further perfected once this generation has been cured, why not eliminate
establishment of these guidelines will until 1994, when the first large-scale genetically the disease from the next generation as well?19
certainly be challenging, but appropriate, engineered animal product entered the market: bovine
modernized international guidance somatotropin (BST), a growth hormone that, when Sources of Controversy Regarding Genetic Engineering
T
tailored to the radically different field of given to cows, induces them to produce more milk. In hough the controversies surrounding genetic
genetic engineering is crucially needed 1996, genetically modified Roundup Ready soybean engineering are many, the vast majority are rooted
in today’s world. crops were introduced to the market, introducing in two fundamental uncertainties. First, the largest
genetically modified organisms (GMOs) into source of controversy stems from the great doubt
History and Discussion of agriculture. A GMO is “a plant, microbe, or animal surrounding the future implications of this field. No
the Problem whose genetic material has been intentionally altered one is entirely sure what the effects of genetically
Introduction to and History of Genetic through genetic engineering”.17 engineered products will be on human health, the
Engineering Since these landmark beginnings, genetic
A
environment and global ecosystems, and the economy.
s stated earlier, genetic engineering engineering has found its way into a wide variety of The second largest source of controversy pertains to
is “the manipulation of genes using applications. Genetically modified (GM) animals are the ethics of genetic engineering. The frontiers being
recombinant DNA techniques to modify Simplified structure of DNA showing nucleotide combinations and routinely used in research, such as GM mice. A variety
double-helix structure. explored by genetic engineering are so novel that our
what the gene does, either by itself or in of domesticated animals have also been engineered
http://www.stkate.edu/physics/Astrobiology/DNA Structure.jpg ideas of ethics have yet to catch up with the field. It
combination with other genes. [DNA, for various purposes. For instance, milk and egg is not yet clear when it is permissible to genetically
short for deoxyribonucleic acid, carries producing animals have been altered to make their
form of the precautionary principle could be a critical products before safety tests were completed.23 On the
safeguard against horrifying mistakes and accidents. ethical side, many people harbor concerns stemming
There is so much uncertainty, that many feel that from the idea of the intrinsic value of life; is it ethical
mistakes are bound to happen. For instance, if a to modify the genes of, say, a dog? Is that a violation of
human heart is grown in a pig and is then transplanted the integrity of the dog?24
into a human, is the human now susceptible to pig Human genetic engineering, of course, carries
diseases? (And what happens if the disease evolves with it a vast set of ethical concerns. To what extent
in the human into a dangerous human disease?) can humans be altered? When can we declare a
What if, in the process of adding a gene to a cell, an disease as cured? It is one thing to use gene therapy
unintended consequence arises? What if a previously on someone to cure Alzheimer’s disease, but can a
unknown, devastating disease is created in a lab, scientist use gene therapy on a person’s reproductive
either intentionally or unintentionally? And what cells to prevent Alzheimer’s in future generations?
happens if this disease makes its way into the general Can a doctor genetically engineer a fetus in a womb
population—either by accident, due to terrorists, to enhance certain traits? If a fetus is exhibiting signs
biological warfare, or some other means? Already, we that it will develop Down syndrome, can a doctor
are seeing indications of this possibility; Australian engineer its DNA to prevent it? When gene therapy
scientists recently caused alarm when they announced moves out of the “treatment” and into the realm of
they had created a disease that was lethal to mice. “enhancement,” the situation becomes even less clear.
More frighteningly, a group of British scientists, while What if this is taken a step further; if genetic tests
working on a vaccine, accidentally spliced together reveal that a baby may be of below-average intelligence,
genes from hepatitis C and dengue fever, sparking fears can a doctor change the DNA of the fetus to make it
that a super-hybrid would be formed.22 smarter?25
Furthermore, there are vast concerns regarding The line between treatment and enhancement
the products of genetic engineering, GMOs, as well. is not as clear as it might seem, though. Consider the
Practically speaking, people are unsure of issues such following scenario, as proposed by Nils Holtug. “Jane
as the health effects of GMOs (e.g. allergies to new is infected with HIV. Her immune system is starting to
food substances or creation of new toxins due to give in and she is about to develop AIDS. Fortunately,
genetic changes), biological contamination (also called there is a new kind of gene therapy available—call
Cattle and other livestock are often genetically engineered to conform to human tastes and desires for meat and “biopollution,” or the mixing of genetically engineered it therapy A—that will boost her immune system,
animal products, the ethics of which are disputed. Above, a standard cattle feedlot in the U.S. plants with native plants, resulting in new, unnatural and bring it back to normal, such that she will in fact
http://specialtyfabricsreview.com/repository/1/638/full_0808_sw7_1.jpg strains, such as “superweeds”—weeds contaminated never develop AIDS. By performing the therapy, we
modify an organism, to what extent, and for what a philosophy known as the “precautionary principle,” by pesticide-tolerant genetically engineered crops), are providing her with a treatment. Now consider
purposes. This guide will attempt to briefly discuss a which states that dramatically new advances not antibiotic resistance (as a result of the research Helen. She has not yet been infected with HIV, but
few, but certainly not all, of the issues currently being be allowed to take place in research until their techniques used to create GMOs), and gene transfers she is a hemophiliac and, since blood reserves at the
debated. potential safety has been conclusively demonstrated. (bacteria naturally swap genes with each other, giving hospital have not been screened for HIV, we know it is
The earliest significant concerns were voiced Unfortunately, the application of such a principle rise to the possibility that genetically modified genes only a matter of time before she is infected, unless she
by Paul Berg, who received the Nobel Prize in would greatly hinder advances in critical science and passing through the human digestive system may affect receives a new kind of gene therapy—call it therapy
Chemistry 1980, “for his fundamental studies of the technology. For instance, the vast majority of insulin the bacteria naturally living there, causing harm to the B—that will make her immune. […] By performing
biochemistry of nucleic acids, with particular regard for diabetics is now produced in recombinant bacteria. human host). In addition, many people argue that we the therapy, we are enhancing her (or her immune
to recombinant-DNA”.20 As one of the pioneers of Had the precautionary principle been applied at the do not yet know the long-term effects of GMOs on system), since we are giving her a desirable property,
the genetic engineering revolution, Berg was among time of the creation of this process, would this new human health, and argue that the negative secondary where her present condition does not constitute
a group of scientists who called for a moratorium process of synthesizing insulin ever have been created? effects of GMOs on other species of animals (e.g. an adverse departure from species-typical normal
on recombinant DNA research until the risks How many diabetics around the world would have cows) have already been demonstrated. And as an functioning”.26 Should this be allowed? There is no
and potentials could be more fully evaluated. His seen their lives cut short as a result?21 indicator of the future of regulation, in June 2010, the clear answer to this question, yet, it figures into the
statements were among the first seeds that grew into On the other hand, the application of some United States Supreme Court ruled that biotechnology calculus of the ethics of genetic engineering.
companies could sell their genetically modified
Introduction to and Evolution of Gene Patenting breakthroughs. The title of an April 2010 article is the incredible controversy and
T o understand the current systems of gene

patenting that exist across the world, it is
important to briefly examine the history of intellectual
discussing the grim future of gene patenting aptly
summarizes the situation: “Think Gene Patents Are
Controversial Now? Just Wait.”31
uncertainty surrounding it.
Courts and patent offices have
continually tried to cut through the
property (IP) and the patent systems in place to protect The early history of gene patenting largely haze and develop clear-cut guidelines
IP, as modern gene patenting systems are based upon played out in the United States, a country strongly for patents, but to date, none have
these older models. A patent is “an exclusive, but concerned with protection of intellectual property. In been successful. The 1995 In Re Deuel
temporary right granted to an inventor or to their the past, granting patents was fairly straightforward. case in the United States made it
successors. It prevents others from exploiting the If an invention was created by a human, it was harder to reject a patent as obvious.37
invention unless they have the patent owner’s consent. patentable. Otherwise, it was not. Patent applications In 1997, courts in the United States
Exploiting an invention includes making, using, for new breeds of animals and plants, for instance, attempted to simplify the matter by
selling, or importing it. Patents provide protection were repeatedly rejected on the grounds that these declaring that if a patent could provide
only for a limited time (normally 20 years). The patent breeds were natural, not man-made, and belonged a nucleotide sequence of the gene (i.e.
owner also can let others use it. For example, he or to nature. It was not until 1970 that, in the United the G, A, T, C sequence) then it could
she can grant a license for an appropriate fee.”27 It is States—the leading proponent of intellectual property be patented.38 After intense criticism,
important to note that a patent does not necessarily rights—granted new breeds patent protection.32 the guidelines were updated such
allow the license-holder to create, use, or sell the The turning point came in 1980, once again that although a product of nature
invention him/herself; it simply bars anyone else from in the United States, in the Supreme Court case may not be patentable, a “product of
making, using, or selling it.28 The new invention being Diamond v. Chakrabarty (1980). Anand Chakrabarty, nature may be patentable if significant
patented must be “useful, novel, and non-obvious”.29 a microbiologist, had created hybridized bacteria, new artificial changes are made. By Gene patents are highly fragmented and split among a variety of patent
Generally, gene patents are understood to be types of bacteria formed as a result of the combination purifying, isolating, or otherwise holders, often causing delays and obstacles to research.
patents on whole genes. However, a variety of other of various other bacteria. Under the old patent system, altering a naturally occurring Source: Science Magazine: “Intellectual Property Landscape of the
inventions are also classified under gene patents. his patent was rejected. But this was overturned in product, an inventor may obtain a Human Genome”
These include not only the specific DNA sequence the Chakrabarty decision, which ruled that “anything patent on the product in its altered University decision ruled that the unlicensed use of
that encodes a protein, but also DNA sequences under the Sun made by man” could be patented, and form.” In Britain, it was decided that “a naturally
39 intellectual property was illegal even in university
that regulate other genes. They can also cover the thus, a life form could be patented. When Chakrabarty occurring human gene or protein in people cannot be research, effectively striking down the “research
links between specific DNA code and the ultimate was given the patent for his bacteria, the floodgates patented, but human genetic material removed from exemption.” As a result, research at universities around
outcome of the code. Gene patents may also cover opened for gene patenting.33,34 Just six months later, the an individual and then refined or reproduced in the the world became hampered, as universities now had
RNA sequences. RNA (short for ribonucleic acid) is first patent on recombinant DNA was granted.35 laboratory can be patented.” Though these guidelines to deal with patents and royalties they were previously
40
a molecule very similar to DNA; when a cell wants Since then, gene patenting has gone in constitute the essence of the current methods of exempt from. Although the decision sparked a fierce
to read DNA for instructions, it creates a copy of the different directions in different parts of the world. evaluating patents, these systems have been criticized, backlash by the scientific and academic community, it
by a range of individuals—scientists, ethicists, lawyers, was never overturned.
41
DNA to work off of, similar to how someone writing In the United States, “courts treat genetic material as
a report may make a copy of their original file and a ‘composition of matter’ and typically use the rules and the general public—for a variety of reasons. The most recent evolution in this issue may also
use the duplicate copy as their “working draft.” This that have developed for the patentability of smaller, Among the criticisms are that the “simplifications” be one of the most significant. In March 2010, a court
“working copy” of the DNA is made of RNA. Beyond less complicated chemical compounds… The EPO have created guidelines unfit for the industry, that the in the United States “shocked the biotech community
the molecular level, gene patents can also cover newly [European Patent Office] wrestles with, among other new guidelines are actually more confusing than the by invalidating patents covering mutations in the
invented cells, treatments, diagnostics, transgenic issues, what ‘morality’ forbids and whether technical old, and that it is now too easy for a discovery to be BRCA1 and BRCA2 genes that are used to assess the
animals, and novel diseases. intervention renders a process no longer ‘essentially patented, even if it does not merit protection. risk of breast and ovarian cancer. Myriad Genetics, a
Most legal scholars agree that the patent biological’”36 and thus unpatentable. Laws regarding One of the more significant rulings took place company based in Salt Lake City, Utah, holds exclusive
system, when applied to established sectors, the manipulation of human genes become even more in the United States in 2002. In the past, although licenses on these patents and has aggressively defended
encourages innovation and investment. When applied complex; for example, the United States has one set unauthorized use of intellectual property was illegal, them. In 2009, a group of patients, researchers
to genetics and biotechnology, however, controversy of laws, the European Union has another, and France the “research exemption” always held. This exemption and clinicians sued Myriad, asserting, among
erupts, and has been flaring since the inception of gene and Germany each have even more specific laws. allowed scholars and academics at universities to other complaints, that the patents hamper medical
patenting three decades ago. The situation will only German law goes even further and places restrictions liberally use intellectual property in the pursuit research.”42 The results of this case (hereafter referred
become more controversial as time goes on, due to on the manipulation of primate genes as well. A of scholarly research, and generally applied to all to as the “2010 Myriad case”) are far-reaching, as the
more sophisticated and advanced genetic engineering common thread unifying all patent laws, though, university research. However, the 2002 Madey v. Duke court ruled that genes and human genetic sequences
could not be patented because they are naturally dubious legal validity.”43 not covered by patents that already exist. However, it is compound.’”49 The economic arguments traditionally
occurring things, not inventions. Though experts agree The problems surrounding gene patenting not possible to invent an alternative to a gene because used in favor of patenting are being called into
that this specific case is likely to be overturned when begin from the very definitions of “gene” and “gene there is no alternative substance. This suggests to me question, however. A study published in April 2010 in
it is appealed to higher courts, the case is incredibly patent” themselves. Although this study guide defined that it is something fundamental in nature and that it Genetics in Medicine found that, “Exclusive licenses to
revealing. It is indicative of the growing discontent a gene as the DNA sequence needed to create a shouldn’t be patented.”45 gene patents … do more to block competition in the
among academics, scholars, researchers, scientists, protein, there is no set definition of a gene, even in the As a result, gene patents are a tangle as well. A gene testing market than to spur the development of
consumers, and medical patients of the current gene- scientific world. Conventional wisdom held that genes paper published in June 2010 found that over 20% of new technologies for gauging disease risk.”50
patenting regime. If the next few years do not bring were like “discrete beads” sitting on the long wire of the the human genome is explicitly patented as intellectual Many researchers also criticize the traditional
meaningful changes to the gene patenting system, it is DNA. But the reality, it turns out, is far more complex. property, of which 63% are patented to private firms. patenting model, upon which the current system
possible that the entire industry may grind to a halt, Some DNA sequences, when combined in certain ways More confusingly, “BMP7, an osteogenic factor, and of gene patenting is based, as incapable of handling
entangled in a web of patents. with other sequences, encode a vast array of proteins. CDKN2A, a tumor suppressor gene, … were each the incredible speeds of innovation taking place. An
Some genes overlap. Some genes lie within genes.44 The claimed in 20 patents.”46 And in a worrying sign for editorial published in Nature Biotechnology in May
Issues Regarding Gene Patenting complexity is staggering. These problems themselves researchers wanting to work with certain genes, some 2010 explains, “Broader concerns about gene patents,
D espite the potential of genetic engineering, the stem from a more fundamental fact: gene patents are gene patents were so fragmented that they were near exclusive licensing and aggressive IP infringement
current system of gene patenting is drawing dealing with living organisms. Whereas past patents impossible to work with; PSEN2, a sequence relating strategies are finding an echo within research. It
more criticism than ever. As summarized in an article dealt with immutable, unchanging objects—light to neurological disorders and arthritis, was split into often seems unfair that the patent system rewards
in Nature Biotechnology in May 2010, “In the last bulbs, microprocessors, engines—gene patents deal nine patents licensed to eight different assignees, and only the last inventive step—the small breakthrough
few decades, the application of the patent system to with organic, changing organisms. As David Ledbetter, BRCA1, a breast cancer gene, was split into 14 patents that enables a concept to be realized. The research
the field of biotech has faced an increasing amount director of the division of medical genetics at Emory licensed to 12 different assignees. As a result, research enterprise, which continually renews itself, especially
of criticism from scientific researchers, ethicists and University School of Medicine, said, “Legally, I also in these areas may be greatly inhibited, as “such in rapidly moving areas like genetics, is increasingly
lawyers alike. According to these critiques, the broad think there are flaws with patenting genes, which are fragmentation raises the possibility that innovators at odds with the commercial conservatism of
utilization of the patent system in this scientific field substances that occur in nature. One purpose of the may incur considerable costs securing access to genes patent monopolies based on gene findings that are
leads to counterproductive results, is unethical, and of patent system is to stimulate people to invent in areas via structuring complex licensing agreements.”47 obsolescent compared with current art. Despite both
Another study examined one of the most important cultural and economic incentives for innovation,
gene patents, the Myriad BRCA patent, that claimed the difficulty in dislodging incumbent approaches is
15-letter stretches of DNA in the patent. The study reinforced by a patent system that insists that any use,
found that “15-letter stretches of DNA claimed in however small, of a protected method is infringement.
the Myriad patent are common throughout the Is it so outrageous to expect that a properly
human genome and could be found in 80 percent functioning IP system could provide an unobstructed
of the gene sequences placed in a publicly accessible path to the market both for the initial innovators and
database—GenBank—the year before Myriad sought for subsequent improvers?”51
patent protection.” GenBank is database of the human Some also criticize the gene patenting
genome created by the Human Genome Project system for distorting incentives away from the most
that is available for free to anyone with access to the beneficial research. They argue that patents create a
Internet.48 The current system of gene patenting has concentration of wealth for the patent holders, and
grown so complex and so dense that scientists often thus, researchers and universities are compelled to
complain of having to hack their way through a “patent do research in areas that will make them money, as
thicket” in order to do even the smallest bit of research. opposed to areas that will have the most benefit for
Traditionally, industrial leaders have defended people and science. Studies examining the situation
gene patents on the basis of the need to protect have been inconclusive and contradictory, and there
innovation. A report by the United States Congress is no clear conclusion. Seeing as patents can be
notes that, “…patents are particularly important in this enormously lucrative, “are publicly funded researchers
Map showing legality of genetically modified crops across the world. Banned means either a full ban or a ban on sector [biotechnology] because of the relative ease of going to ignore ethical, moral, and social concerns
everything but scientific research. replicating the finished product. Costs associated with in a desire to make money for themselves or their
http://upload.wikimedia.org/wikipedia/commons/0/07/Gm_accept_map.png imitating a product ‘...are extremely low relative to the employers?”52
innovator’s costs for discovering and developing a new Further issues arise when considering how
to enforce patents and determining when patents monoculture; in other words, farmers could grow no
have been violated. A case highlighting the problems other crops but Bt cotton. When the Bt cotton crops
is Monsanto Canada Inc. v. Schmeiser, which was began to fail due to various reasons—the emergence
debated in front of the Canadian Supreme Court of new pests, for instance—farmers were thrown into
in 2004. Monsanto sued Percy Schmeiser, a farmer, debt so severe that 25,000 farmers have taken their
for “infringing its parent to a genetically engineered lives since 1997.54,55 Whether patent-holders should
form of canola by deliberately growing the crop in his be given this kind of power, backed by the current
fields without having paid a license fee for doing so. international system, is certainly a matter of debate
…Schmeiser claimed that the genetically engineered that needs to be considered.
crop had ended up in his field by accident—by the Some critics, particularly those with heavy
wind blowing pollen, by seeds blowing off trucks, anti-globalization sentiments, take this argument
and by other paths… The Federal Court of Canada even further, and say that gene patents have the
judge found that it did not matter whether Schmeiser potential to perpetuate the current world order. They
had deliberately planted the genetically engineered argue that gene patents, inevitably held by companies
canola and did not bother to determine whether based in wealthy countries such as the United States
Schmeiser was telling the truth about how his fields and Western European nations, have the potential
became seeded by the legally-protected crop. The judge to control developing and underdeveloped nation
Map showing countries party to the WTO and to TRIPS. Dark green signifies a founder member of the
determined that Schmeiser was guilty of infringing on development with the use of said patents. Access to
WTO, and light green a subsequent member.
Monsanto’s patent because he knew that the crop he critical medicines, for instance, or access to much-
http://upload.wikimedia.org/wikipedia/commons/thumb/b/be/WTO_members.svg/1000px-WTO_members.svg.png
grew was mostly of the type covered by the Monsanto needed crops, could be controlled by corporations. granted to a single laboratory. For 2 years, the exclusive part of the patent application must show that the
patent.”53 The controversial case drew criticism around Critics point to the Indian farmer suicide epidemic, licensed laboratory went into bankruptcy and no other invention being applied for is moral.60 But we have
the world. and note that farmers were forced to buy Bt cotton due laboratory could test for this gene. During this hiatus, no guidelines by which to judge this. An interesting
Additionally, gene patenting has drawn to trade policies forced onto the Indian agricultural Abigail, a 10-year-old child with long QT syndrome, example of the fragmentation of the patent system
criticism for the powers it gives the patent-holder, market by the World Trade Organization, a body often died. … [There were also] persistent problems with a came to fruition in 1992, with the invention of the
particularly concerning genetically engineered crops accused of perpetuating a Western hegemony.56,57 test performed by this exclusive laboratory, including “Harvard mouse,” or the “onco-mouse.” As detailed by
and gene therapy. The rash of farmer suicides reported On the medical side, gene patents have long delays in getting results, indeterminant findings, Stephen R. Munzer, “Scientists at Harvard University
in India over the past few years has thrown the issue been criticized for restricting competition and thus high costs, and just the basic lack of improvement engineered transgenic mice that are highly likely to
into the international spotlight, highlighting the effects reducing the quality of healthcare available to patients, …. We can make a better test, but under the existing develop malignant tumors early in life. The mice are
that are possible. In these cases, farmers were forced increasing the cost of healthcare, and stifling medical system, we cannot.”58 On the flip side, however, it could useful in research on cancer. Harvard obtained a US
to purchase genetically engineered cotton, known advances in the field. When a single company holds be argued that the initial research done in the field patent in 1988, and sought European patents on both
as Bt cotton, from the multinational corporation the patent to a gene, they also, effectively, control may not have been conducted without the incentive of the process of genetic manipulation and the transgenic
Monsanto in order to compete with other farmers in any procedures using that gene, and can thus charge patents to protect the resulting breakthroughs. mice themselves. The EPO Examining Division refused
the global market. Bt cotton was genetically engineered high rates for these procedures. As described by Marc The recent 2010 Myriad case ruling invalidating a patent on the animals in 1989 [on moral grounds],
to be resistant to pests and have higher yields, and Grodman, CEO of Bio-Reference Laboratories, “The the Myriad BRCA1 and BRCA2 gene patents, though but the Technical Board of Appeal remitted the case in
was covered by patents held by Monsanto. Earlier, first example [of the problem with gene patents] likely to be overturned, has been widely hailed within 1990. …the Examining Division issued a patent on the
indigenous cotton seeds were sold on the market concerns one of our society’s most dangerous killers, the scientific community for the benefits it may bring. onco-mice in 1992, but stressed that the patent gave
for roughly US$0.15 per kilogram, and reproduced breast cancer, and the related breast cancer genes Nobel Prize-winning economist Joseph Stiglitz called Harvard only the right to exclude others rather than a
themselves. In other words, the seeds only needed to BRCA1 and BRCA2. The patent holder has granted the ruling “a major victory to science and medical ‘positive right to use the invention.’”61 Legal wrangling
be bought once. The indigenous cotton crops could an exclusive license to one company to do the innovation.”59 The overwhelming support the ruling over the patenting of the onco-mouse continued until
also be grown with other crops, to ensure farmers had diagnostic testing for these genes. Not surprisingly, has had in the scientific and academic community is a 2006 in Europe, and until 2002 in Canada.
a varied crop yield. Monsanto’s Bt cotton, however, over the course of time, quality issues arose. … for prescient indicator of the direction gene patents ought Although the patent was granted for this
cost roughly US$369.50 per kilogram. Bt cotton has a about 10 years the tests of breast cancer genes was to head in, and is an acute indication of the shambles significant alteration of a mouse, many ethicists
“terminator sequence” engineered into it, meaning that not as comprehensive as it might have been … . The the current system lies in. argue where we draw the line. Would it be permissible
unlike indigenous cotton, the Bt cotton grown does second example involves long QT genes that can On the more ethical side of the argument, to grant a patent for a new, cancer-prone dog? How
not produce seeds, forcing farmers to purchase new cause sudden death from heart arrhythmias. These under both American and European guidelines, about a chimpanzee? As Philip Grubb, Professor at
seeds every year. And Bt cotton is engineered to be a genes were patented and an exclusive license was
the Franklin Pierce Law Center, stated in 1999, “Given that promise will require a view of gene patenting that comprehensive and expansive set of rules governing broad and imprecise exceptions to the rule that
that the genome of a human is 98 per cent identical is considerably more sophisticated than the one-size- global IP.65 everything must be patentable.
with that of a chimpanzee, how many genes does it fits-all standard that now prevails. Genetic testing TRIPS derives part of its power from the Although TRIPS clearly sets the need for a
take to really make a difference?”62 The ethics of gene is undergoing a revolution. Classic tests relying on intimate link that it has with the World Trade strong patenting system, it is, in the words of the
patenting are intrinsically related to the ethics of mutations in one or two genes, such as the BRCA1 and Organization (WTO); countries cannot join the WTO World Health Organization (WHO), “deliberately
genetic engineering itself, as explained in an earlier BRCA2 tests, [the same tests stripped of their patents without ratifying TRIPS, and countries that violate ambiguous, which gives countries some freedom to
section of this guide. in the April 2010 court decision], are giving way to the TRIPS agreement can be punished by the WTO’s interpret this in their national legislation as they deem
complex analyses involving many genetic signatures. Dispute Settlement Body. As a result, all 153 WTO fit.”70 The wording is so vague that it specifies very
Tests for a genetic heart condition called long QT, for members are also party to the TRIPS agreement. The little. The exceptions that it grants to patentability are
Current s i t u at i o n a n d p r e s e n t
example, now assay a dozen genes. Moreover, these link that TRIPS established between trade and IP vague; WHO notes that “countries could consider to
r e l e va n c e complex analyses will themselves give way to whole- was a major triumph for developed nations, notably specify in their national legislation that the following
A s discontent with the current gene patenting

system increases, there is more pressure than ever
to reform the system. The recent 2010 Myriad case is
genome sequencing. Strict enforcement of single-gene
patents in this landscape could ensnare genetic tests
in a patent thicket — a tangled web of patents that
the United States, who had been pushing for the
hyphenation of trade and IP for years. The culmination
of these efforts was the creation of the 1995 Agreement
shall not be patentable: plants and animals, in whole
or any part thereof, including DNA, cells, seeds,
varieties and species; [and] the human body and all
just a taste of what is to come, and will likely open the would have to be negotiated before a given test could Between the World Intellectual Property Organization its elements, in whole or in part.”71 As a result, the
door for a flood of court cases, objections, and reforms be performed. Such a situation threatens to hinder and the World Trade Organization.66 enormous discrepancies created are not conducive to
to the system. As a result, like the genetic engineering
industry itself, the field of gene patenting is likely to
rapidly evolve over the next few years.
innovation.”63
Genetic engineering has the potential to
alleviate world hunger, provide highly-effective
The most relevant portion of TRIPS is
Part II, Section 5. Article 27 of this section
states, that, “…patents shall be available for any
international-level research.
An additional problem with TRIPS is that, as it
is over a decade old, it does not appropriately deal with
This evolution has the potential to be a personalized medicine at low costs, cure diseases inventions, whether products or processes, in all the advanced genetic engineering and biotechnology
welcome relief from the current situation. At the that we could only think of curing now, and provide fields of technology, provided that they are new, that we face today, creating a need for a more updated
moment, genetic engineering is a powerful industrial solutions for environmental remediation. But it also involve an inventive step and are capable of industrial agreement.72 In addition, TRIPS itself has become
and scientific research area, but it is being burdened has the potential to introduce unforeseen tragedies into application. …[P]atents shall be available and patent an enormously polarizing agreement, and has been
with a patent system designed for non-living human health, unleash novel diseases upon humanity, rights enjoyable without discrimination as to the place plagued by many of the accusations levied against
inventions from the previous millennium that was and wreak environmental destruction. For over a of invention, the field of technology and whether the WTO. Many developing nations have accused
slightly modified to fit biotechnology. The job of decade, scientists have been calling for an international products are imported or locally produced.”67 This developed nations of forcing harmful IP laws upon
patents should be to protect and spur forward an gene patenting system with harmonized regulations.64 strongly-worded section single-handedly demands that them by bundling them all together in one agreement
industry, not be the obstacle to development. It can Without a properly functioning, international patent countries patent any new inventions. The agreement and forcing countries to adopt the agreement in order
provide a moral check, but it should not hamper system in place, global genetic engineering research goes on to broadly state, however, that “[m]embers to join the WTO. Economist and Nobel laureate Joseph
progress. cannot function. The sooner a well-functioning system may exclude from patentability inventions, the Stiglitz warns that, “Intellectual property is important,
Despite the controversies and moral questions is put in place to allow international cooperation and prevention within their territory of the commercial but the appropriate intellectual-property regime for
surrounding genetic engineering itself, it is important competition and to guide genetic engineering, the exploitation of which is necessary to protect ordre a developing country is different from that for an
to remember that there is vast potential for human better off humanity will be. public or morality, including to protect human, animal advanced industrial country. The TRIP[S] scheme
betterment in the field. There are many systems in or plant life or health or to avoid serious prejudice failed to recognize this. In fact, intellectual property
place to ensure that genetic engineering—or any P a s t UN A c t i o n s to the environment.”68 The agreement then specifies should never have been included in a trade agreement
cutting-edge field—goes in a direction that benefits
humanity. One of these systems is supposed to be
the patenting system, which is intended to monitor
H istory of the Committee discussed various
treaties that were pivotal in the creation of
WIPO and directly influence this topic. Despite
that certain other items can be “exclude[d] from
patentability,” notably, “diagnostic, therapeutic and
surgical methods for the treatment of humans or
in the first place… an international organization
[WIPO] already exists to protect intellectual
property.”73 Stiglitz also issued a harsh condemnation
the ethics of research being done. An ideal patenting the groundbreaking work of the Paris Convention, animals” and “plants and animals other than micro- of TRIPS, saying that, “I [Stiglitz] served on the
system should accelerate advancements by offering however, the single most important agreement relating organisms, and essentially biological processes for Clinton administration’s Council of Economic
incentives and protection. But the current gene to this subject is the Agreement on Trade Related the production of plants or animals other than non- Advisors at the time [that TRIPS was created], and it
patenting system does not do this. As summarized in Aspects of Intellectual Property Rights, also known as biological and microbiological processes.”69 The full was clear that there was more interest in pleasing the
an editorial in Nature in April 2010, “As the biotech the TRIPS agreement. Negotiated at the 1994 Uruguay text of Part II, Section 5 of the TRIPS agreement is pharmaceutical and entertainment industries than in
industry inches closer to the long-anticipated era of Round of the General Agreement on Tariffs and Trade available in the appendix to this study guide. This ensuring an intellectual-property regime that was good
personalized medicine, genetic tests promise to exert (GATT), TRIPS was the first international intellectual portion, however, indicates that although TRIPS for science, let alone for developing countries.”74
increasing influence in the clinic. But fully realizing property (IP) agreement, and remains the most demands a strong patenting system, it also allows Despite these criticisms, TRIPS has lasted for
over a decade, serving as virtually the only source of
international guidance on gene patenting. Though it
has worked well enough in the past despite not being
Such a principle, instead of rewarding companies
that managed to surround the early gene mutant
discoveries (which now look rather trivial) with an
with patent aggregators
Point 9: Consider including provisions that address
unmet needs, such as those of neglected patient
T he goal of this committee is to create a
comprehensive, unifying, international treaty
on genetic patenting. When creating this agreement,
revised or replaced thus far, international agitation for impenetrable wall of IP, would incentivize those who populations or geographic areas, giving particular the following points should be considered and/or
a new gene patenting system is on the rise. This makes continue to develop tests of high medical value with attention to improved therapeutics, diagnostics and incorporated into the final agreement:
it more likely that additional agreements regarding commensurate financial remuneration.”75 agricultural technologies for the developing world
gene patenting must be negotiated by WIPO to either Other scientists call for an “open These nine recommendations would occur 1. Will this new treaty supplement or entirely replace
supplement or entirely replace TRIPS. biotechnology” movement, “inspired by the open in an ideal world, as described by the academic the few guidelines in the TRIPS agreement?
source movement in the field of information community. They are included as guidelines to 2. If any new bodies, organizations, or agencies are
Proposed s o luti ons technology (IT), as well as by the already existing open consider when creating additional solutions, and are created, who will administer them? WIPO, or the
W ith the whirlwind of activity surrounding

gene patenting, it is imperative that solutions
be implemented. Two popular solutions among
science ideal within the academic community.” Similar
to open source projects within computing, where a
large pool of researchers can rapidly contribute to an
not solutions in and of themselves. However, the more
of these recommendations that can be included and
incorporated into the solution, the better the final
WTO (under TRIPS)? Seeing as the WTO seized
power from WIPO over IP rights in the 1990s
via the TRIPS agreement, how will WIPO work
the scientific community are patent pooling and invention without being hampered by IP restrictions, outcome will be. At the very least, these nine points with the WTO, if at all, to administer a properly
clearinghouse mechanisms. an open biotechnology project would be open for should guide the work being done in committee. thought-out and implemented gene patenting
A patent pool is formed when many contribution by a large pool of scientists.76 While open system?
companies, academic institutions, and other inventors source IT projects have flourished because of copyright Qu e s t i o n s a Re s o lu ti o n 3. How will issues of morality be dealt with? What
give their patents to a central organization, a patent laws though, open biotechnology is not possible due is considered “moral” and “immoral”? Are there
pool. When other inventors want to use the patent,
Must Answer
to the nature of patent laws. This is an extremely limits to what can be engineered,
they go to the patent pool and pay a fee. Part of this promising idea, however, and the open source software based on these concepts of morality?
fee goes back to the original inventors who filed the movement has shown it to be possible. This idea 4. What exactly can be patented?
patent, and a small portion goes to maintaining the could be taken further, and perhaps its ideals and Will patenting of animal “inventions”
patent pool. In this way, the “patent thicket” is cleared, implementation can be written into an agreement that and plants be allowed? Will patenting
work is streamlined, researchers no longer need to comes out of this committee. of the human body and its parts
deal with multiple companies, and novel treatments, In 2006, a group of American university- be allowed? How do you deal with
agricultural practices, and other genetically engineered affiliated researchers who were concerned about the human ownership of genes (i.e. a
products critical to human development are no current patenting system gathered to create nine company owning a certain gene
longer monopolized. Many companies can pay the fee points to aspire towards when creating a new licensing sequence from your cells)?
for the patent for, say, pesticide-resistant soybeans, system. These nine points, as summarized by Jon 5. Where do we draw the line
keeping prices low. In addition, most research today Soderstrom of the Office of Cooperative Research at between naturally-found genes
needs multiple patents to work, as it builds upon Yale University, are:77 and biological products (and thus
many previous discoveries. An entire project can be Point 1: Universities should reserve the right to unpatentable) versus man-made
destroyed if one company rejects an application for the practice licensed inventions and to allow other non- and “invented” products (and thus
use of its patent. A patent pool would allow researchers profit and governmental organizations to do so patentable)?
to build upon previous achievements unhampered. Point 2: Exclusive licenses should be structured in a 6. Which genes can be licensed?
Despite the potential of a patent pool, there manner that encourages technology development and Do we draw distinctions between
has not yet been a successful one. As explained in an use broad and specific genes?
editorial in Nature, “Patent pooling and clearinghouse Point 3: Strive to minimize the licensing of “future 7. How do we deal with the
mechanisms are probably not going to emerge in improvements” two aspects of a patent—the right
biotech of their own accord. … It will therefore Point 4: Universities should anticipate and help to to exclude others from using an
probably take some form of government or legal manage technology transfer related conflicts of interest invention and the right to use
coercion to get things moving for gene tests. As we Point 5: Ensure broad access to research tools invention—in international gene
move from single-gene tests to multiple-gene signature Point 6: Enforcement action should be carefully Ingredients used in traditional Chinese medicine for sale patenting law?
testing and whole genome sequencing, it might also be considered in a market in China. 8. How powerful and exclusive are
http://www.absolutechinatours.com/UploadFiles/ImageBase/Chinese%20Herbal%20
possible to assign rights according to the importance Point 7: Be mindful of export regulations the patents? How do we deal with the
Medicine%201.jpg
of any specific gene sequence in the utility of the test. Point 8: Be mindful of the implications of working interface of patent law and academic
research (i.e. how do we deal with the traditional can operate. Companies involved in biotechnology by their desire for easy access to patent rights. more are the values, ideals, and interests represented
“research exemption”)? How do we keep the free and in the pharmaceutical industry would be most Universities may also push for a royalties program to in your nation’s patenting procedures, not the specific
and open flow of information so cherished by interesting, though genetic engineering has a broad ensure that they make profits from the research done details. By going into negotiations with an open mind
academics without destroying incentives? impact. For instance, manufacturers may be interested, in their laboratories. and the knowledge that the new agreement will be
9. Will an international agreement set up coordinated since genetically modified bacteria can make plastic, Bloc Positions a radical change from the status quo for all nations,
efforts, such as patent pools and clearinghouses?
10. Will inventions made at an early stage of research
and development, upon which entire fields may
farmers would be interested in how their seeds may be
affected, and energy companies may be interested since
bacteria may be able to split water into hydrogen and
T his is an unusual topic, in that you may not break
into the traditional “developing versus developed”
country blocs as in most other committees. It is
hopefully a high-quality, comprehensive international
agreement can be crafted.
rely, be treated differently from those made later in oxygen for energy. possible that the blocs that you will form will be driven
the process? Curiously enough, the WTO itself may take by personal biases, prevailing attitudes in each nation, Suggestions for Further Research
11. What are the repercussions for violating the
agreement? What constitutes a violation?
an interest in our proceedings. When TRIPS was
passed, the WTO imposed itself into the world of
and other non-political factors.
A potential divide may arise based on I would like to briefly re-emphasize that there is
no need to do further research into the science of
genetic engineering. If you are interested in more
intellectual property, leveraging its power in global governmental regulation within each country. If
you are representing a country that favors strong specifics, I certainly do not want to discourage you
trade to try and police global intellectual policy as
Key Ac tors and Positions well. When it did this, it stepped into the jurisdiction government regulation, such as one from the from pursuing the science. However, all the science
NGOs, Universities, and Corporations European Union, you may favor a patenting system that you need to know has been included in this study
of WIPO. If WIPO were to pass a new, more powerful,
N on-governmental organizations (NGOs)

representing various groups of people will have
a vested interest in the issue. NGOs representing
comprehensive intellectual property agreement dealing
with genetic engineering, the WTO would likely be
that emphasizes morality, public safety, and consumer
protection. If you are representing a country that
is more in favor of free markets, such as the United
guide; additional research will prove to be of little
use in committee. Further research should instead be
focused on the legal, moral, and philosophical aspects
concerned about whether the power they transferred
scientists and academics may push for increased ease States, you may be in favor of a less involved patenting of the issue.
to themselves via TRIPS might flow back to WIPO.
of access to patents to facilitate research, the creation system that dictates less and leaves moral issues to the Everyone should be familiar with the Part
Universities, as major hubs of international
of international patent pools and other cooperative market. II, Section 5 of TRIPS, as it directly lays out the
research, will also have a strong say, as they wish
mechanisms, safeguards against egregious patenting Another divide may emerge based on the framework for the current global patenting system.
to protect their ability to do research in the field of
practices by corporations, and increased safeguards activities of multinational corporations. Countries The full text can be found in the appendix. Scientific
biotechnology. They may push for a strong inclusion
over research based patents. NGOs representing that are home to various multinationals may pursue publications, such as Nature, also publish many useful
of the “research exemption.” They will advocate on
environmentalists may argue for a morals-based policies favorable to these corporations, such as articles and editorials on the issue that provide specific
various fronts, pushing for increased ease of access to
patenting process, emphasizing that new innovations strong patenting rights for license holders and easy details that may prove useful. These articles can be
patents and a clearer set of guidelines for patenting
are not good just because they are new. They will likely patenting procedures to make obtaining patents easy. If found in the features section of the magazine, and are
novel innovations. They may also push for easier
emphasize the many harms of genetic engineering, and you represent a country that may be the victim of written in plain English and are easily understandable
patenting laws, to make it easier for universities to
argue for a patenting system that allows contemplation multinational activities—be it through unfair sales of by a non-scientific audience. Many governments have
retain credit for research; this is likely to be tempered
over each new process in order to deem whether the seeds, increased medicine prices, etc.—you may be in held proceedings in front of their legislative bodies or
benefits outweigh the risks. NGOs representing animal favor of a patenting system that emphasizes consumer in committees to explore reforms in patent law. These
rights activists might argue for the full ban of genetic rights, and tries to limit the power patent license proceedings often bring in experts from the field that
engineering involving sentient creatures, arguing that holders have over their products. This very well could give lengthy, very useful testimony on the subject.
altering the genetic makeup of an animal violates its result in the usual divide of developed nations versus Many of these proceedings make their transcripts
“biological integrity,” and that creating genetically developing nations. available for free online, and are excellent resources as
modified animals to test genetic engineering on is akin In many cases, you will have to balance various well.
to a gruesome, more sophisticated form of animal interests when representing your country: your It may also be useful to follow the news
testing. NGOs representing farmers and those involved country’s commitment to regulation versus the free regarding the latest developments in this field. For
in agriculture may push for looser patent laws with a market, importance placed on consumer protection instance, there will likely be many updates on the
clearer set of guidelines and procedures, in order to versus advancing corporate interests, etc. The best court cases ongoing in the United States regarding
Tribes in the American Southwest make approxi-
reduce the hold biotechnology corporations have on way to get a feel for where your country stands is to the 2010 Myriad case, which will in turn open up a
mately US$800 million per year selling traditional
global farming practices. look into national laws. Keep in mind, however, that flood of new court cases. A growing coalition against
goods. Above, pots for sale in the
Various companies may also take a keen just because your country currently uses a certain the current patenting system is also forming, which
American Southwest.
interest in our proceedings, as the new agreement http://www.zanzibartrading.com/images_0-f/talaveracatrinac- patenting process, it does not mean it will argue strictly may also create newsworthy items. There may also be
would affect the bounds by which these corporations laypotplant71023_small.jpg for this process on an international level. What matters editorials and opinion pieces by well-known scholars—
geneticists, lawyers, and economists—that could be it originated from. It must protect TK by bringing explained by Nuno Pires de Carvalho, head of the TK by protecting TK against exploitation, additional
useful. These scholars often bring a new, eye-opening it into the intellectual property system, but it must program at WIPO, who notes that, “TK comprises resources may flow back into the communities where
perspective to the table and are worth examining. not impose the system upon these traditional and two main (and to some extent, distinct) categories: TK originates, further stimulating the creation of
Following reputable international news sources will indigenous communities. It must reform the current on the one hand, TK consists of knowledge itself, that TK.82 “Traditional” simply refers to the sharing and
keep you informed of the evolution of the field. system, but the resulting product must be adopted by is, ideas developed by traditional communities and learning methods by which TK is created. As clear
enough nations to be useful. The task is difficult, but by indigenous peoples, in a traditional and informal way, examples that TK is still evolving and advancing, one
sharing the knowledge and experience of each nation, as a response to the needs imposed by their physical needs to look no further than the traditional medical
Protection of and through measured and deliberate conversation and cultural environments and that serve as a means systems of many South and East Asian societies,
indigenous, ancient, and compromise, a solution can surely be found. of cultural identification. This … contrasts with
‘expressions of TK,’ also named ‘expressions of folklore’
all of which are based upon ancient texts. Yet, each
country continues to publish advancements and
and traditional History and Discussion of the or ‘expressions of traditional culture’, such as verbal
expressions (tales, poetry, riddles), musical expression
refinements of their traditional medical systems, for
example, through the Chinese Academy of Traditional
knowledge Problem
Defining Traditional Knowledge
(songs and instrumental music), … , tangible
expressions” etc. 80
Medicine, or the Indian Central Council for Research
in Ayurveda and Siddha.83 It is also important to
S tat e m e n t Problem
T
of the
Thankfully, the difficult issue of the definition dispel the misconception that TK is “primitive.” TK
F
he difficulty and failure of integrating traditional
or almost a decade, international bodies have
knowledge (TK) into global thought and is not a major obstacle for discussions. WIPO has encompasses a broad range of fields, and includes areas
been struggling with the issue of the protection of
protection manifests itself from the starting point of spent much of the past decade struggling with the from refined surgical techniques to complex perfume-
traditional knowledge (TK). Instances of biopiracy,
the discussion: the definition of TK. To date, no one definition of TK, and concluded that although it is making processes. Too often, people associate TK with
situations when TK is commercially exploited
has created a non-controversial, working definition critical to have a grasp of what TK entails, there is scientifically corrupt techniques, and fail to see the
without the consent of the community it originated
of TK. Though the reasons are complex, there are little need for a precise and universal definition of TK massive contributions that TK continues to make to
in, provoked public outrage throughout the 1990s
a few overarching reasons for the difficulty. Much in order to develop a legal system for its protection. modern science.
and early 2000s. And even today, TK is slowly being
TK, such as indigenous knowledge, is very different Many patent laws that are currently in place are also In economic terms, as knowledge already
pilfered from traditional and indigenous communities
from the Eurocentric point of view that dominates based on undefined concepts; for instance, most patent present in nations, TK has the potential to pull
around the world and being used for commercial
global forums. For instance, TK is often intricately laws do not define ‘inventions’. Instead, these laws underdeveloped nations up, by jumpstarting their
purposes. It is clear to most people and nations that
intertwined with ideas of the natural elements, making set out the characteristics necessary for something to economies. Nuno de Carvalho, head of WIPO’s TK
such cases are wrong, and ought to be addressed. But
it difficult to isolate and define. In addition, TK is be an invention. In the same way, a definition of TK division, explains, “…some indigenous peoples and
the mechanism by which this can be done is yet to be
extraordinarily diverse, and has few unifying features. can contain the integral characteristics needed for traditional communities live in the direst poverty,
negotiated.
TK ranges from ancient surgical techniques to farming something to “qualify” as TK, such as a definite link and yet they are potentially rich in intangible
At stake is a vast collection of knowledge. TK
practices. Also, TK is often so much a part of the to a traditional community. This would be a more assets; however, assets (intangible or not) can
represents the sum of thousands of years of organic
community it comes from that it is often impossible to practical strategy that trying to create a lengthy and only be capitalized and become tools of economic
evolution of human thought and accomplishments.
extract what one may call the “traditional knowledge” universal definition of what TK actually is, something development upon their formalization and recording.
Most of the food we eat, medicines we use, and
and define it.78 that has proven to be a fruitless endeavor.81 While [Indigenous peoples and traditional communities]
cosmetics we apply today were developed from plants
Given these limitations, some scholars have reassuring, this conclusion is also incredibly revealing. … could formalize their intangible assets, … , which
and techniques first found from TK. In fact, many
made attempts at defining TK. For instance, Thomas Although WIPO has not yet created any sort of would permit their transformation into capital.”84
modern advances in the pharmaceuticals industry and
Cottier, of the University of Bern, defines TK as “the framework for bringing TK into the global intellectual As a tangible example, TK can be converted into an
the material sciences are based on information gleaned
ways and means by which individuals or communities property (IP) system, WIPO has, in the past, leaned attraction for tourism, providing a major boost for
from TK. and But the communities this TK originated
identify and improve genetic resources over time, towards the creation of a system that creates a set of least developed countries. For instance, it is estimated
from have received virtually no compensation,
including processes related to their extraction from criteria to qualify something as TK, rather than create that the TK of various Native American tribes in the
compared to the massive profits reaped by those who a definition to encompass all TK.
nature and their preparation for human usage. Also Southwest United States produced approximately
used the TK. The Importance of TK
implicated by the term are methods and techniques for US$800 million in annual sales, primarily through the
T
The challenge this committee faces is to create he impacts of TK are enormous. To fully
preserving the communities’ accumulated information sale of traditional pottery and earthenware.85
a system that protects TK from exploitation, but does understand the need to protect TK, it is important
about genetic resources for future generations.”79 This The economic impact of TK is also immense.
not stifle it and prevent future development of TK. to clear a misconception: TK is not necessarily old, and
inclusive definition categorizes not just the knowledge The field where TK has probably made the greatest
This system will have to weigh many considerations: therefore, not necessarily automatically in the public
itself, but the methods by which the knowledge is impact is medicine. Traditional and indigenous
it must allow TK to do good for as many people as domain. TK continues to be created by traditional
practiced and disseminated as well. This is further communities have discovered and recorded knowledge
possible, but not at the expense of the community and indigenous communities, building on itself. Thus, of a vast range of medicinal plants and herbs, as
well as combinations and This emphasis on protection of novelty while ignoring that since TK is a communal good, it has no right to
preparations of these plants to the sources has become more pronounced with the be protected as IP, and thus should not be protected.
boost health. TK also possesses progress of biotechnological innovations making use A third group argues that TK, while different, can be
a wealth of information on of genetic resources and giving rise to complaints by accommodated into the current IP system with slight
agricultural and forest products developing countries about ‘biopiracy.’”95 Another modifications to the current IP protection regime.
that now generate massive issue driving biopiracy is that TK is extremely open. While the various sides argue over the issue, TK is left
flows of revenue worldwide. If someone visits a community and realizes a certain unattended to, and becomes a de facto public good,
Additionally, TK is used as plant has medicinal benefits in their TK system, (s) resulting in its exploitation.100
“leads” for the development he can take the plant back home and patent it without Closer examination, however, reveals that
of new medicines, and is used the next “inventive” step that is usually needed. And traditional communities themselves do not see TK
in various industries, such as since TK is not in the current IP regime, biopiracy as a public good. Many indigenous and traditional
pharmaceuticals, cosmetics, has consistently worked in the past (though that has communities already have systems in place to regulate
agriculture, and biotechnology.86 quickly changed in recent years, in large part due and share TK. Jean Homere, of the U.S. Patent and
In fact, de Carvalho writes to major pushes by various countries and NGOs). Trade Office, shares that, “For instance, local shamans
that, “The relevance of The holder of the patents now reaps the benefits view shamanic knowledge as a commodity that can
TK as a useful source of without the consent of the original community, and be lent, sold, exchanged, and stolen. Similarly, locals
information for researchers in has no obligation to share the economic value of the from Melanesia trade their secret knowledge for food
the pharmaceutical field who knowledge.96 and/or money.”101 Due to the fact that much TK is so
seek to identify new chemical On a fundamental level, TK poses a new easy to replicate, traditional cultures have in the past
and biological elements, as challenge for the existing IP regime. It is important created indigenous systems to deter knowledge theft.
well as new approaches to The periwinkle, a plant from Madagascar with anti-leukemia applications that to remember that the “tradition” in “traditional Social barriers (e.g. ceremonies), rituals, secrecy (e.g.
disease treatments, is generally fell victim to biopiracy. knowledge” does not connote “old,” but, in the words shrouding experimentally-proven herbal remedies
undisputed.” For instance, in
87 http://www.biolib.cz/IMG/GAL/54089.jpg of the Bern convention, “‘the manner of producing with “magical” preparations) have all served as
1990, the “estimated market the people of their capability to lead a higher quality such knowledge, and not to the date on which the methods to prevent others from easily duplicating TK.
value of plant-based medicines sold in OECD life.92 Moreover, TK plays an integral part in the social knowledge was produced.’ Thus, TK is knowledge that In much of the world, the legal system has been created
countries … was [US$]61 billion,” an extremely and spiritual well-being of global traditional and has been developed based on the traditions of a certain to serve this very function, giving hope of the potential
conservative estimate in light of the fact that “of indigenous communities, which could be jeopardized community or nation.”97 At the moment, international to merge the two systems.102
the 119 plant-based compounds used in medicine by exploitation of TK.93 agreements on IP are based entirely on individual Given this protective nature of TK, it is
worldwide, 74 percent had the same or related uses as TK and Intellectual Property rights. Thus, to provide international legal protection important not to take the communal versus individual
the medicinal plants from which they were derived.”
T he issue of TK and IP fully emerged onto the for TK is a significant departure from this individual- rights aspect of the issue too far. Although it is
88
It has been further estimated that rice strains derived international scene in 1999, when issues of TK rights system to a system that recognizes and protects certainly true that many indigenous and traditional
from TK in India alone account for US$400 million were formally integrated into the official WIPO communal rights. A communal patent on TK would societies are more community-based than those
worldwide.89 agenda, and further in 2001, with the creation of the benefit no single person, but an entire community, currently in the global IP system, concepts of
Recent scholarship has also linked the Intergovernmental Committee on Intellectual Property since it takes a community to keep the TK relevant, ownership exist in most of these societies, as
protection of TK to human rights. These arguments and Genetic Resources, Traditional Knowledge, and intact, and accurate.98 The departure from a highly evidenced by careful study of anthropological
stem from the Universal Declaration on Human Traditional Cultural Expressions (previously called individualistic to a community-based approach is literature. Furthermore, many of these societies have
Rights and the International Covenant Economic “folklore”) of WIPO. Progress on the issue has been unprecedented. But it is possible that the international actual systems of IP in place, though these systems
Cultural and Social Rights, which “recognize the slow and disjointed since then; in other words, almost legal framework will shift towards a new system. vary widely from each other and from the Western
rights of everyone to protection of the moral and a decade has passed without significant movement in Finding a way to harmonize and keep these systems IP regime currently in place. The biggest difference
material interests resulting from any scientific, bringing TK to the world of IP.94 cooperating may prove to be a challenge.99 between these traditional IP protection systems and
literary, or artistic production of which he [or she] According to Weerawit Weeraworawit, Minister The communal rights versus individual rights Western ones is that these societies consider each
is the author, and to share in scientific advancement of Commercial Affairs of Thailand, “Patents [and the debate has created major factions, each radically member of the community as “having individual
and its benefits.”90 Considering that over 80% of the current IP system] afford protection to something different from the other. One group of advocates rights and collective responsibilities that are linked
world’s population depends on traditional medicine new without giving regard to the sources of research says that since communal rights are so different from inextricably.”103 Individuals in these societies “think in
for health needs,91 and that much of the world’s diet is and development giving rise to such new invention. individual rights, an entirely new system must be terms of the freedom … to be what they were created
based on TK, depriving a culture of its TK also robs created for IP protection of TK. Another group says to be, rather than being free from certain kinds of
dilemmas. As traditional ways of life are over the current system. For instance, there are a of TK. If patents were filed in offices in other countries
being eroded worldwide, “external legal group of plants in Mexico that scientists had always attempting to patent TK, a country could present
recognition of TK ‘will make the learning regarded as belonging to the same species. But the information in the database as evidence that the
and development of such knowledge a traditional communities in the area realized that each knowledge was already known. Although this solution
more attractive prospect for the younger plant actually possessed “very different biochemical has worked for some countries, some traditional
members of such communities, thus properties that are indicated by indigenous categorical healers have begun to object to the use of databases
perpetuating its existence.’”108 In addition, systems and local knowledge.”111 Had this TK been on the grounds that the databases document only the
it is a known fact that most TK is passed forced into the current IP protection system, it is very technical expertise and not the complex social customs
on and preserved via oral transmission, likely that the current system would have prevailed surrounding the techniques.114
from generation to generation. There are, over the traditional. The Western categorization of Another major issue has to do with the
of course, major exceptions. For instance, these plants as a single species would have overridden protection of TK itself. How do we protect TK
much knowledge from African, Latin the TK that realized the differences, and this TK would without stifling its further creation? By its very
American, and Asian civilizations were have been lost.112 Fears of such a scenario replicating nature, TK builds upon itself. The IP protection
written thousands of years ago and thus, itself across the world have driven some activists to system currently in place effectively locks out others
persist today. In general, however, TK urgently warn that the status quo may be better than a from using knowledge that is patented. If this were
is orally transmitted, and therefore not misguided and improperly created IP system for TK. applied to TK, then TK would fail to evolve. As WIPO
written or recorded in any permanent But a larger plurality of NGOs and activists warn that, itself recognized, “Challenges of multiculturalism
Turmeric has been used for its medical and culinary applications way. Part of TK itself depends on the “The claim that ‘we’ should just leave ‘them’ alone is … require cultural policies that maintain a balance
for millennia in India, but was patented in the context and community in which it simply a recipe for the continuing loss of languages, between the protection and preservation of cultural
United States in the 1990s. exists, and on the language it is told in. livelihoods, and the resources that the world’s poor rely expressions—traditional or otherwise—and the free
http://www.allbestindiarecipe.com/blog/wp-content/uploads/2009/04/turmeric.jpg Unfortunately, “around 90% of the more on.... It is also a recipe for undermining the continued exchange of cultural experiences. Mediating between
state encroachments,”104 but are aware that along with than 6000 currently spoken languages” survival of modern medicine and agriculture, which the preservation of cultural heritage and cultural
this comes “a sense of unique personal responsibilities are projected to go extinct in the next 10 years.109 are crucially dependent on the genetic resources distinctiveness on the one hand, and nurturing and
to kin, clan and nation.”105 A well-crafted IP system Addressing the reasons behind this is beyond our produced with the knowledge held by the world’s nourishing of ‘living’ culture as a source of creativity
will take into consideration the current systems of scope. However, a thoughtfully created IP system will poor.”113 and development on the other, is another challenge.”115
IP protection present in traditional communities, also serve as a way for TK to be archived and retained An additional dilemma arises when questions
and rather than trying to replace these systems, will for perpetuity, despite the loss of the original languages Dilemmas Regarding TK and the Need for Reform of enforcement are considered. It is important to
T
expand, strengthen, and build upon them. they were transmitted in. he complex interplay between TK and IP remember that TK encompasses a range of knowledge,
As a result of such a broad and flexible Other scholars are concerned that TK will be protection, as outlined in the previous section, including agricultural knowledge. The examples cited
mindset, the resulting IP protection systems are also forced to be integrated into the current IP system, brought about many dilemmas regarding TK that in previous sections of cosmetics, herbs, and even the
very diverse. Some traditional communities find it and that TK will be molded and warped to fit into the were discussed. Among these were the fundamental pharmaceutical industry pale in comparison to the
presumptuous to attribute certain knowledge to any current system, resulting in a loss of TK. This worry differences between community-based versus most stunning example of the influence of TK. Ikechi
human. Instead, they attribute the knowledge to stems from the fact that the current system in place individual-based property rights, the fact that Mgbeoji, Assistant Professor of Law at the Osgoode
pre-human creators and spirits. But another study is highly compartmentalized; science and religion do traditional communities have extraordinarily diverse Hall Law School, writes, “…of the twenty major food
conducted by the Honeybee Network found that many not mix, humans and the environment they live in and disparate customs surrounding IP protection and crops, none originated in North America or Australia
of the 10,000 innovations they had documented were are highly disconnected. Most traditional societies, mindsets about ownership and IP, and that forced and only two—rye and oats—originated in the Euro-
“attributed to and claimed by individuals.”106 And in however, live in a connected world, and the TK coming integration into a poorly-created IP protection system Siberian area. Virtually ‘all of the developed countries’
an entirely different realm, a recent study showed that out of these communities is extremely holistic. Western could backfire and destroy TK. foodstuff originated in the tropical countries [where
IP protection is not feasible for many crops because observers often believe that TK has both a scientific As briefly mentioned earlier, the Western way the majority of the world’s traditional communities
their origins cannot be properly traced to a particular and a religious component, and are compelled to of thought has a tendency to look at TK and separate are located].’”116 Jack Kloppenburg, Professor of
source. The same study noted, however, that TK strip the TK of the spiritual elements and leave only it into “rational” and “irrational” parts, valuing only Community and Environmental Sociology at the
created in the past 50 years could, in general, be traced the “science.” But such practices are misguided and what is deemed rational and scientific. Although this University of Wisconsin, goes even further to say that,
and attributed.107 destructive, for leaving just the “practical” core will may at first seem like an easy obstacle to overcome, “Of crops of economic importance, only sunflowers,
IP also has the potential to serve a crucial destroy much of the value of TK that is embedded in it has broad implications. A common solution to blueberries, cranberries, pecans, and the Jerusalem
function unrelated to economic and property the religious context in which it was developed.110 In biopiracy and theft of TK has been to create databases artichoke originated in what is now the United
fact, the traditional approach has yielded advantages States and Canada. … Northern Europe’s original
genetic poverty is only slightly less striking; oats, rye,
currants, and raspberries constitute the complement
of major crops indigenous to that region. Australia
T he continent of Africa is the birthplace of
humanity, where modern humans first evolved
and formed communities. As a result, “the terms
International observers, NGOs, activists, and
researchers were far from satisfied, however.
Some criticized the deal for not providing
has contributed nothing at all to the global ladder.”117 ‘indigenous’ or ‘native’ peoples are for the most the San with enough compensation. Others
Almost all the major crops of the world originated in part inapplicable in Africa.”119 Issues relating to the criticized the deal for monetizing a life form, an
traditional communities currently mired in debt. How protection of TK are still major issues in Africa, idea alien to the San way of life. Others criticize
are we to compensate them for their past knowledge, if however. Various African nations and tribes have fallen the agreement for the burden placed on the San
at all? How do we integrate knowledge so fundamental victim to biopiracy and other illegitimate uses of their peoples. To operate within this new framework,
to humanity, so deep, and so profound, into a global TK, such as the patenting of periwinkle (a traditional the San had to rapidly educate themselves on the
system? When the current inequities between the medicine from Madagascar used in anti-leukemia global IP regime and had to learn how to defend
“global South” and the “global North” are also brought applications).120 their rights in this unknown field. But some say
into the picture, it becomes clear why negotiations are To combat these, in 2002, the WHO convened a this was actually a blessing; whereas the San
so difficult. Progress on TK and IP become entangled special meeting in Africa on TK. The outcome was a were once one of the most studied and exploited
in a web of other considerations. new system of classification, by which all medicines communities, WIMSA used its newfound
The last major dilemma that will be would be classified into three categories: traditional knowledge to create an entire system to protect
mentioned in this guide is a difficulty that plagues any medicine, traditional medicine with commercial San TK. The SASC created media and research
system of IP protection: the need for international applications, and products from research and policies and began to carefully monitor and
cooperation, and more importantly, the need for academic institutions. Though this is a good first step, control access the media and researchers had to
high levels of cooperation between developed, comprehensive and unifying actions to protect TK the San community, to prevent the exploitation
developing, and underdeveloped nations. Countries across the continent have, unfortunately, been unable seen in the past. The SASC also took up the
acting independently cannot achieve the goals this to be agreed upon and implemented. 121 protection of San heritage, ensuring that San
committee is trying to achieve—namely, economic, Within the larger African framework, South art, history, and rich cultural traditions were not
environmental, and social equality and fairness. Africa has made additional progress in TK protection. A member of a San tribe from South Africa. plundered. A vivid example of their progress
http://www.cosmosmagazine.com/files/imagecache/news/files/
Protection of TK will only work if a critical mass In 2004, the Indigenous Knowledge Systems (IKS) was demonstrated when the San insisted on
news/20070926_san.jpg
of both developed and developing countries sign Policy was passed. This policy is described in the participating in the planning of a museum of
onto an agreement and are bound by it. Only such a detailed information on Hoodia gordonii (henceforth
legislation as “an enabling framework to stimulate rock art, whereas previous plans neglected to contact
widely accepted and followed agreement can protect referred to as Hoodia), a plant they utilized for its
and strengthen the contribution of indigenous or consult the San community at all, despite the
traditional and indigenous communities from the appetite suppressing qualities. In the 1990s, these
knowledge to social and economic development in contents of the museum. 126
exploitation of their TK.118 accounts were rediscovered, Hoodia patented, and
South Africa.”122 The IKS created various bodies within Whether you view these outcomes as positive
licensed to Phytopharm, a company based in the
the government to protect and develop TK, increased or negative, it is clear that the San have progressed
UK, for millions of dollars, all without the consent
Case Studies funding for research and development of TK, created
of the San. In 2001, an international NGO found out
a long way since the 1990s, and are now capable
T here have been various attempts in communities a system to record TK and their holders and to players in the current global IP regime, something
about and alerted the San of the patent. The San had
around the world to try and secure their TK from attempt to secure IP rights, and various structures for that would not have been possible without the massive
previously created the Working group of Indigenous
being exploited and biopirated by others. Almost all holders of TK to convene and discuss the issues.123 support given to the San people by NGOs in its earliest
Minorities in Southern Africa (WIMSA), which
of these actions have been defensive measures, put This legislation was the first major milestone in TK stages. Though the global IP protection system did
although previously reluctant to get involved, was
into place after a portion of the country’s or peoples’ protection in South Africa. Since then, attempts at not change, the San were able to protect their TK by
mobilized to action when the head of Phytopharm
TK was exploited; very few, if any, of the measures furthering TK have largely been unsuccessful; the learning the system. Whether the result destroyed
claimed that the San were “extinct.” In 2003, all
were proactive. As a result, the measures implemented most recent bill, designed to amend the current South some of their fundamental values, such as the non-
involved parties announced the completion of a deal
should be seen as stepping stones and events to learn African IP system to better accommodate TK, failed in commercialization of life forms, is still a matter of
through which the San would receive eight percent of
from in working towards a more unified, strengthened, May 2010.124 debate. 127
all “milestone payments” and six percent of all future
international system for TK IP protection, not as The most interesting—and controversial (and
royalties. The payments would go to a trust established
stand-alone solutions in and of themselves. thus instructive)—case to come out of South Africa Case Study 2: India
for this purpose, the South African San Council
A
involves the San peoples. The San have been identified, s a country with various types of traditional
(SASC), which was run by elected members from the
Case Study 1: South Africa using genetic studies, to be the “first humans;” they knowledge (indigenous, agricultural, medical,
various San communities. All involved parties were
carry the oldest genes known to humankind. In the etc.), India has developed a variety of techniques that
satisfied with the agreement and lay the issue to rest. 125
1930s, the San provided a Dutch anthropologist
may prove illustrative to other countries. In addition, Company, a Brazilian cosmetics company,
as one of the few countries with a continuous history extremely active, documenting the knowledge, making interviewed various women selling herbs
dating to an ancient civilization, most Indian people manuals on TK for distribution to tribal peoples, and at the traditional Ver-o-Peso market, an
are themselves holders of and creators of TK. India is educating indigenous and traditional populations on area known for its history and culture, for
also home to various tribes, which are groups of people their IP rights. Influenced by NGOs, certain states the production of a documentary. Natura
who have had little to no interaction with the rest of have established Community Biodiversity Registers then created a line of fragrance products
the world for millennia, resulting in highly distinctive to document environmental TK at a local level. Other created with these herbs and began
cultures. These tribes possess additional indigenous states have also created systems to create networks of selling them. When the women heard of
knowledge that calls for protection. village councils to promote organization and action. 129 this, they felt as if their rights had been
Much TK has been integrated into the The most significant accomplishment, from violated; they had given permission to
mainstream. Traditional Indian Systems of Medicine WIPO’s perspective, was passed in 2000 with the be filmed for a documentary, not for the
(ISM) are part of the formal medical system, are assistance of WIPO: the Indian Biological Diversity creation of commercial products to be sold
overseen by various government agencies, and are Bill, the first legislation of its kind. The bill set up an based on their knowledge of the herbs.
taught in universities. Indigenous peoples, who authority whose approval is now needed before firms In subsequent legal wrangling, Natura
are primarily forest dwelling, create and maintain can apply for IP protection for any invention based on claimed that it thought that the herbs
“sacred groves” in forest areas that they deem to any biological source or TK that originated in India. were widely known TK and thus public
have significance. These areas have been found to The authority has the power to impose benefits sharing knowledge, while the women claimed
have extraordinarily high levels of biodiversity, and in the form of royalties, technology transfer, payments, it was protected TK. In the end, the
have been turned into national parks and biosphere or other methods. This type of legislation was later government ruled in the women’s favor,
introduced in other nations—notably, Brazil, which The Natura Company created a line of products, above, derived from
reserves. Much of Indian agriculture is also based and they were awarded royalty fees and
will be examined in greater detail in the next case breu branco, a traditional Brazilian herb.
upon TK, which has often proven more successful http://naturaconsultorasandra.files.wordpress.com/2008/09/prod_breubranco.jpg
compensation.135
than “conventional” techniques. As a result, traditional study.130 Partially in response to the Natura
Perhaps India’s most famous contribution medicines.133 Yet, as stated earlier, some NGOs and
agricultural techniques have been given priority over activists warn that databases must be used with caution case, the government began to pursue the novel idea
other considerations with the adoption of farmers’ to international TK protection has been the defense
of its TK through the intensive use of databases and and with prudence, to ensure that TK is recorded in its of disseminated traditional knowledge (DTK), TK
rights in India’s legislation. These farmers’ rights entirety, and not simplified and placed into databases. that is widely known across the nation, and not just
include “the right of farmers to save the harvested knowledge libraries. When turmeric (anti-cancer in certain communities. Legislation currently being
seed of protected varieties, and also to sell it….” This and anti-Alzheimer properties), neem (anti-fungal drafted and debated says that DTK would be usable
properties and a pesticide), and basmati rice (an Case Study 3: Brazil
W
seemingly ordinary right has given farmers power ith a large portion of the Amazon rainforest by all Brazilians (but not by those outside Brazil),
over multinational biotechnology firms that would aromatic rice of India) were patented in the United
States and Europe, the international outrage that and many indigenous peoples located within its including for commercial purposes. The idea of DTK,
otherwise entirely control the farming process. In borders, Brazil has a wealth of TK. As a result, Brazil in effect, transfers the rights of certain widely known
addition, a national gene fund has been created for followed resulted in the invalidation of the patents.
As a result, in 2001, India announced the Traditional has developed an approach to TK that is fairly different TK from communities (if applicable) to the national
farmers to share their knowledge, especially traditional from those seen in other nations. Under the law, government. Although the motivation behind the idea
strains of crops, such as rice. Agricultural products of Knowledge Digital Library (TKDL), a database of is admirable—namely, to promote open access to TK
Indian TK that (as of June 2010) contains a staggering access to TK (whether it is for research or commercial
TK, such as Darjeeling tea, basmati rice, and alphonso purposes) must be approved by the government and allow TK to build upon itself unhindered—the
mangos have been trademarked, and products must 34 million pages of information on TK, compiled by idea of DTK raises concerns. For instance, it is possible
government scientists. By partnering with patenting and requires prior informed consent forms with the
pass inspection to be certified as products allowed to traditional or indigenous community in question and that a certain piece of TK may be widely disseminated
carry these names.128 offices across the world, the system has been successful in society, but at the same time be directly and
so far in preventing additional acts of biopiracy, a benefit sharing form detailing the shared benefits
There are, however, many aspects of TK that will arise. Both providers and users must sign all recently connected to a certain community.136 How
that have not been brought into the system. Many but many note that the system is simply a defensive disseminated must the knowledge be to become
response to biopiracy, and not a system to actively forms. Due to the legal uncertainties, however, few
indigenous and traditional societies in India have applications are filed, and as a result, from 2002 to DTK, and what happens to the original community’s
extensive knowledge of sustainable hunting, farming, protect TK before exploitation.131,132 rights? It is also conceivable that a company desiring
Whether the strategies being pursued by India 2008, only two applications for commercial purposes
fishing, veterinary techniques for domesticated were approved.134 to use a piece of TK might purposely disseminate the
animals, and maintaining crop diversity. Unlike other suit your nation’s problems or your nation’s view of knowledge, then use it for its own means to avoid legal
the issue will vary. For instance, after the creation Despite the proactive approach taken by
TK, such as traditional medicine, this TK has yet to be the Brazilian government to protect TK, there have issues and royalties. 137
brought into the system. To fill the void, NGOs (such of the TKDL, China, Korea, and various African A potential solution to part of the problem
nations created similar databases of their traditional been some notable controversies. In 2003, Natura
as Samata and Mulnivasi Mukti Manch) have been is to create different types of TK and DTK. John
Kleba, Professor of Political Science and Sociology Appendix. The CBD also reasserted each individual Expressions in 2001 was a milestone in the area. Since warrant recognition as distinct genera, under the aegis
at the Aeronautics Technology Institute in Brazil, country’s sovereignty over their TK and natural then, WIPO has helped countries create databases of a general set of core principles.”152
has proposed a four-category system: “community- resources, and formally introduced the ideas of “access to assist with the creation of laws friendly to TK Finally, there are two different ideological
based TK,” “trade and urban TK,” “DTK of national and benefit-sharing” and “prior informed consent” into and to combat biopiracy. WIPO has also “devoted positions on the protection of TK: positive protection
custodianship,” and “TK in the worldwide public international lawmaking. However, these ideas never considerable effort to seeking a consensual definition and defensive protection. Positive protection is the
domain.” 138 Community-based TK and trade and became the fully formed systems that were intended.144 of TK. As a result, regional model laws based on the “creation or recognition of positive rights [author’s
urban TK would be restricted, and would be under Unfortunately, there are significant disparities WIPO initiatives are full of definitions but rather note: positive rights are rights that permit or oblige
the control of the communities in which they between the CBD and TRIPS relating to the protection devoid of operational language.” 149 At long last, action by one party against another] over how TK,
originated. The other two types would be under looser of TK, which poses a conundrum to nations party to perhaps it is time for WIPO to create legislation that or protected aspects of it, are to be used, it at all, by
control, under national or no protection. However, both agreements, as both are binding. For instance, the actually creates a system that can be used. others.” 153 Defensive protection consists of “the steps
although the system is compelling, it still leaves open CBD states that communities have to be recognized taken to ensure that third parties do not obtain IP
the question of where the lines are drawn between for their contribution to certain inventions, while rights over TK subject matter, or that once obtained
different types of TK. 139 TRIPS says that corporations and individuals alone Pr o p o s e d So lu ti o n s such rights are revoked or rendered unenforceable.”154
P a s t UN A c t i o n s
can be assigned IP protection, and has limited scope
in granting collective rights. Additionally, the CBD V arious intergovernmental bodies have sketched
rudimentary approaches to the issue of the
The vast majority of laws enacted so far for TK
protection have been defensive protection, but some
T
says that any use of TK (via biological material) protection of TK. WIPO advocates a “bottom-up say that positive rights are the best, and most effective,
he two dominating international instruments on
requires informed consent of the communities who approach,” 150 recommending that countries evaluate way of protecting TK.
the issue are the Agreement on Trade Related
are “custodians of the biodiversity,”145 while TRIPS how national systems of IP protection can be used In discussing the many issues surrounding
Aspects of Intellectual Property Rights (TRIPS)
says that the patent holder need not disclose the to protect TK, expand their systems, and then bring the protection of TK, various solutions have already
and the Convention on Biological Diversity (CBD).
source. Furthermore, the CBD says that these two their acquired knowledge to the international level. been surfaced. The most basic solution concerned the
General background information on TRIPS is
parties (patent holder and community) must share The WTO recommends the opposite, proposing definition of TK. WIPO has, in the past, suggested that
provided in Section IV (Gene Patenting), Part C (Past
the benefits, but TRIPS says that the patent holder that nations should first decide on an international pursuing a complete, universal definition of TK is a
UN Actions) of this study guide. Section 27.1 of TRIPS
would be the sole beneficiary. The list of contradictions approach, then implement the systems nationally. In wasteful task. Instead, a list of characteristics should
calls for patenting of all inventions, but Section 27.3(b)
continues, but these major points are illustrative of the the middle lies the approach espoused by the United be created that qualifies something as TK. Once this
of TRIPS explicitly states that, “…Members shall
dilemma. 146 Nations Conference on Trade and Development has been addressed and it is clear what exactly will
provide for the protection of plant varieties either by
It is has been speculated, and later proven to (UNCTAD), which recommends that minimum fall under this new system, other solutions can be
patents or by an effective sui generis system or by any
be possible, that countries can create IP protection standards be set worldwide for a sui generis (literally, examined.
combination thereof.”140 The full text of this portion
systems within their nations that fulfill the major “of its own kind”) system, after which the system could The solution most implemented worldwide is
of TRIPS is available in the Appendix. Unfortunately,
terms of TRIPS (the most powerful of the relevant be implemented at the national level. 151 the use of databases, led by India’s TKDL. A solution
the sui generis system that TRIPS allows has created
agreements) and protect TK. The key is that the At the most fundamental level, there are also that comes out of this committee must find a way
many problems, as it is extremely vague and open
language in TRIPS is incredibly broad. For instance, three different viewpoints on what the framework of to ensure that TK is properly stored in databases,
to interpretation, causing much legal trouble. This is
TRIPS says that “a patentable invention should meet the actual solution should be. The first side believes however, and is not just stripped down to its “practical”
exacerbated by the fact that TRIPS does not explicitly
three basic requirements: industrial application that the current IP system has the capability and tools parts. An ideal solution would also find a way to
refer to TK.141,142
(patent eligibility), novelty, and the inventive step to accommodate TK, and can be slightly modified to preserve TK for posterity, even if misfortunes such as
In fact, the CBD, adopted in 1993, is the only
(non-obviousness).”147 These terms are never defined, work fine. The second side believes that the current fading away, integrating with the larger population, or
major international treaty that explicitly calls for the
though, so countries are free to define them on their system is designed such that no matter what is done, losing their language struck the original communities.
protection of TK and indigenous communities. Section
own terms, so as to include TK and protect them. Such TK cannot be accommodated. The second side Finally, the best system would build upon the diverse
8(j) of the text states that member parties will, “…
a system would allow nations to remain members of advocates what is called a sui generis system for TK. systems of IP protection currently in place in different
respect, preserve and maintain knowledge, innovations
the WTO, protect TK, and potentially commercialize But there is a third group of people who say that traditional and indigenous communities around the
and practices of indigenous and local communities …
TK (if permitted by the communities) to financially the incredible diversity of beliefs and ideas, and the world. The mechanism by which this is done will vary,
and promote their wider application with the approval
enrich the traditional communities themselves. 148 fact that TK is fundamentally local, requires that an but whatever comes out of this committee should
and involvement of the holders of such knowledge,
WIPO itself has, of course, attempted to IP protection that come into place be based upon enhance the cultures of traditional and indigenous
innovations and practices and encourage the equitable
make progress on the matter. As described earlier a suorum genorum, an “heterogeneous network peoples, not replace them.
sharing of the benefits arising from the utilization of
the creation of the Intergovernmental Committee of mutual recognition that does not confine TK to
such knowledge, innovations and practices.”143 The
on Intellectual Property and Genetic Resources, one distinct genus, but recognizes that divergent
full text of Section 8 of the CBD is provided in the
knowledge traditions, integrated with customary law,
Questions a Re s o lu ti o n Mu s t
Traditional Knowledge, and Traditional Cultural
Answer not overlook any aspects that may spell failure, it is nations. valuable sources of information. By seeing what has
T he overarching goal of these committee sessions critical for traditional and indigenous communities to Nonetheless, the most general split will be gone wrong and how countries and people have dealt
will be to create a document that creates an provide an enormous amount of information to the between developed and developing nations. Developed with these mistakes, you can ensure that the same
international framework to deal with the protection process. It will also be crucial for all WIPO members nations, as the ones who pushed through TRIPS and mistakes are not repeated in the new system created in
of TK. Thus, the main question is: What treaty can be to heed the information provided. The policies enacted the current IP regime, will be interested in trying committee.
created that effectively protects TK and is acceptable will directly impact traditional and indigenous to work within the current system and maintain as
to most nations? Within this question there are other communities, and thus, these communities know the much of the status quo as possible. They may also
Position Papers
P
points to take into consideration. landscape being worked in best. be interested in keeping TK protection agreements
osition papers serve the critical function of
Corporations will have an interest in loose and favorable to corporations based in their
• How, if at all, do legal systems allow for the crystallizing and condensing your research. They
negotiations as well. Corporations—especially countries. Developing nations are more likely to push
commercialization of TK without adversely both provide a way for you to fully flesh out your ideas
pharmaceutical and cosmetics firms—will have a keen for significant reform, and will push for strong TK
affecting the communities possessing the TK? and positions, and a mechanism by which the dais may
Consider, for example, the case of the San peoples interest in the outcome of these committee sessions. protection. They will desire agreements favorable to
examine your position, preparation, and coherency.
of South Africa. Is the overall outcome positive or “Bioprospecting” (a euphemism for biopiracy) is a the nations where the TK originated, and will likely
Position papers are especially important when
negative? major source of leads for many modern medicines, push for terms that are advantageous to the holders of
• How does one enforce the protection of TK, should examining emerging and controversial issues such as
perfumes, and cosmetics. These companies are TK.
a party or government violate the treaty? gene patenting and traditional knowledge.
interested in keeping access as open as possible. These blocs are likely to be fluid, however.
• Should the new system created penalize nations There are three major topics I would like you
or regions for past injustices against traditional Some universities and research institutions may find Emerging economies and newly industrialized nations
to address in your position papers. First is how your
and indigenous communities? This includes both themselves desiring a similar outcome to increase will have to find a balance between maintaining the
country currently deals with gene patenting and
biopiracy and larger issues like agricultural crops. the ease of research, while others may place a higher system in which they are advancing so rapidly and
• How do we balance individual versus community- traditional knowledge. This includes the systems it has
emphasis on preservation and conservation of the protecting the TK that they possess. How various
based IP rights? in place (if any) and its history with the topics, what
communities being studied. nations deal with these competing interests may well
• How does a system both protect TK, but allow it to its patent office has to say, what officials may have said
continue to evolve, since TK is created through a National patenting offices, and even the be one of the critical factors in deciding the final
regarding the matter, what courts have ruled on the
dynamic, “living” process? WTO, will also have an interest in negotiations. It outcome of this committee.
subject, laws or guidelines that may have been passed,
• How are issues like DTK integrated into the is important that national patenting offices have a
agreement and addressed? hearings and statements in your nation’s legislative
say in the issue and collaborate on the final result, Suggestions for Further Research
• How will this new agreement interact with existing body, etc. Most countries do not have an official
A
as they will, most likely, be the ones to administer s far as international legislation goes, it would be
ones, especially TRIPS (which has powerful statement or position on the matter, but examining the
economic sanctions behind it to penalize violators)? the procedures and systems laid in place (unless helpful to be familiar with Section 5 of TRIPS and nation’s activities can prove very useful.
countries decide to create entirely new systems for Article 8 of the CBD. Browsing through the website Second—and this is very atypical for a
TK, divorced from even the existing patenting offices).
Key Ac tors and Positions The WTO, as the body that administers TRIPS, will
of the Intergovernmental Committee on Intellectual committee—I would like to see a very brief synopsis of
Key Actors: NGOs and Communities Property and Genetic Resources, Traditional your personal views of each subject. More often than
also be interested in seeing how the document coming
N on-governmental organizations (NGOs) play
a major role in the protection of TK. These
NGOs can range from groups representing certain
out of this committee affects their current powerful
position in the IP rights landscape. As mentioned in
Knowledge and Folklore may also prove to be of use.
(The URL can be found in this footnote).157
Perhaps the most useful thing to do would be
not, your country will not have a clear position on the
topic (though there are certainly notable exceptions,
for there are indeed some nations who have very
the previous topic, the WTO, through the power of its to continue to examine case studies of what countries
communities, general activist groups working to well-defined positions on the topics). Thus, personal
economic sanctions, has a tight control over IP rights, and specific indigenous and traditional communities
protect TK worldwide, environmental groups, trade biases and values will sway the flexible position of your
and is the target of frequent criticism for overstepping have done, and what the outcomes have been. These
groups, etc.155 A full list of groups accredited by WIPO nation, and it would be useful and revealing to be able
its bounds.156 case studies are extremely instructive; they show how
and allowed to participate in proceedings of the to see where you think your personal biases lie. If you
Intergovernmental Committee on Intellectual Property systems and idea will actually turn out in the real honestly do not think you have a personal stance on
Bloc Positions world. The actual results of these systems are usually
and Genetic Resources, Traditional Knowledge and the matter, that is acceptable, though if neither you nor
Blocs will vary widely on this issue. Most countries very different from what is expected, as there are so
Folklore can be found at http://www.wipo.int/export/ your country has a position on the topic it may make
agree that something has to be done to protect TK. many factors in place. Past actions taken by various
sites/www/tk/en/igc/ngo/accreditedlist.pdf. debate rather difficult.
Even in nations where biopiracy has occurred, the nations and peoples is useful to get a sense of what
Beyond NGOs, traditional and indigenous Third, and most importantly, I would like to
government has stepped in to cooperate with other has been done, and studying the impacts of these laws
people currently may not have a say in the process, but see some creative solutions to the problems we face.
nations and overturn the patents. Many developed provides an excellent way to gauge the effectiveness.
their input is crucial to ensuring the system created Please go beyond what is written in this study guide, as
nations are home to populations of indigenous and Examining failed systems can be one of the most
actually works. To create an effective system that does this is only supposed to be a starting point. Be sure to
traditional communities, as are many developing
keep in mind the points brought up in the “Questions 1 “What is WIPO?,” World Intellectual Property Modified Organisms,” in Battleground science and (Washington, D.C.: AEI Press, 2005) 4-5.
a Resolution Must Answer” section, as these have Organization, <http://www.wipo.int/about-wipo/en/what_ technology, ed. Sal P. Restivo and Peter H. Denton 38 Robin Feldman, The role of science in law. (Oxford,
been stumbling points for negotiations in the past. The is_wipo.html >. (Westport, CT: Greenwood Press, 2008) 182-195. NY: Oxford University Press, 2009) 27-35.
2 “Treaties and Contracting Parties: General 18 Delborne and Kinchy 39 Schacht
solutions need not be written out in great detail, but Information,” World Intellectual Property Organization,
they should be thought out well. If your solutions are <http://www.wipo.int/treaties/en/general/>.
19 Delborne and Kinchy 40 White 165-173
incorporated into debate and into the final resolution, 3 “What is WIPO?,” World Intellectual Property 20 “The Nobel Prize in Chemistry 1980”. Nobelprize. 41 Hahn
it would certainly reflect very well upon your Organization, <http://www.wipo.int/about-wipo/en/what_ org. 17 Jun 2010 <http://nobelprize.org/nobel_prizes/ 42 “Testing time for gene patents,” Nature 15 Apr.
is_wipo.html >. chemistry/laureates/1980/> 2010: 957.
delegation.
4 “Summary of the Paris Convention for the 21 Delborne and Kinchy 43 Joly
On the technical side, two position papers Protection of Industrial Property (1883),” World Intellectual
will be submitted, one for each topic. The position 22 Delborne and Kinchy 44 Darkin
Property Organization, <http://www.wipo.int/treaties/en/
papers will follow the common WorldMUN format ip/paris/summary_paris.html >.
23 “Monsanto GM seed ban is overturned by US 45 Brendan Borrell, “Are patients misserved by patents
5 “Summary of the Paris Convention for the Supreme Court,” BBC World News. 21 Jun 2010, 24 on human genes?,” Los Angeles Times 12 Apr. 2010.
of approximately 2 double spaced pages per topic,
Protection of Industrial Property (1883),” World Intellectual Jun 2010 <http://news.bbc.co.uk/2/hi/world/us_and_ 46 Kyle Jensen and Fiona Murray, “Intellectual
12 point Times New Roman font. Position papers canada/10371831.stm>
Property Organization, <http://www.wipo.int/treaties/en/ property landscape of the human genome,” Science 20 Jun.
must present information in a clear, succinct manner, ip/paris/summary_paris.html >. 24 Delborne and Kinchy 2010: 239-240.
and shall not exceed 4 double spaced (12 point font) 6 “Patent Cooperation Treaty (“PCT”) (1970),” 25 Delborne and Kinchy 47 Jensen and Murray
pages. Position papers are essential to organizing one’s World Intellectual Property Organization, <http://www. 26 Helga Kuhse and Peter Singer, A companion to
wipo.int/pct/en/treaty/about.html >. 48 “Patents Block Competition, Slow Innovation in
thoughts, conducting research, and developing creative bioethics, 2nd ed. (Malden, MA: Wiley-Blackwell, 2009) 235-
7 “Summary of the Patent Law Treaty (2000),” World Gene Testing,” Institute for Genome Sciences and Policy, 14
solutions to such problems. If you have any further 244. Apr. 2010 < http://www.genome.duke.edu/press/news/04-
Intellectual Property Organization, <http://www.wipo.int/
questions on the position paper, please feel free to treaties/en/ip/plt/summary_plt.html >. 27 Gene Patenting (Nutley, NJ: Hoffman-La Roche). 15-2010/index.php>.
contact me. I look forward to reading your papers! 8 “Convention Establishing the World Intellectual 28 Kuhse and Singer 49 Schacht
Property Organization: Article 6,” World Intellectual 29 Wendy H. Schacht, Gene Patents: A Brief Overview 50
Closing Remarks
“Patents Block Competition, Slow Innovation in
Property Organization, <http://www.wipo.int/treaties/en/ of Intellectual Property Issues (Washington, D.C.: United Gene Testing”
T
convention/trtdocs_wo029.html#P87_5335>. States Congress, 2006). 51 “Sitting up and taking notice,” Nature
his has been a long document to read, I know,
9 “Convention Establishing the World Intellectual 30 Robert Cook-Deegan, “Gene Patents,” in From Biotechnology May 2010: 381.
but I hope it has been of some use to you and
Property Organization: Article 7,” World Intellectual Birth to Death and Bench to Clinic: The Hastings Center 52 White 165-173
has shown to you how complex, but interesting, Property Organization, <http://www.wipo.int/treaties/en/ Bioethics Briefing Book for Journalists, Policymakers, and
the topics we will be discussing are. As this is only 53 White 165-173
convention/trtdocs_wo029.html#P119_9691>. Campaigns, ed. Mary Crowley (Garrison, NY: The Hastings 54 “Seeds of Suicide.” Frontline. Public Broadcasting
a starting point, I highly encourage you to do and 10 “Convention Establishing the World Intellectual Center, 2008), 69-72. Service. 26 July 2005. Television.
compile additional research, especially with regards to Property Organization: Article 8,” World Intellectual 31 Katherine Hobson, “Think Gene Patents Are 55 Vandana Shiva, “From Seeds of Suicide to Seeds
your country’s involvement with the topics and some Property Organization, <http://www.wipo.int/about-wipo/ Controversial Now? Just Wait,” Wall Street Journal. 14 Apr of Hope: Why Are Indian Farmers Committing Suicide
potential solutions. The better prepared you are, the en/what_is_wipo.html >. 2010, 15 Jun 2010 <http://blogs.wsj.com/health/2010/04/14/ and How Can We Stop This Tragedy?,” Huffington Post 28
better debate will be in committee. If at any point any 11 “Decision-Making Bodies,” World Intellectual think-gene-patents-are-controversial-now-just-wait/> Apr. 2009, 14 Jun. 2010 < http://www.huffingtonpost.com/
sort of confusion arises, please do not hesitate even for Property Organization, <http://www.wipo.int/members/en/ 32 Delborne and Kinchy vandana-shiva/from-seeds-of-suicide-to_b_192419.html>.
a moment to contact me. I am incredibly excited about decision_bodies.html >. 33 Mark Sagoff, “Are Genes Inventions? An Ethical 56 White 165-173
WIPO at WorldMUN 2011, and I cannot wait to meet 12 “Core Tasks of WIPO,” World Intellectual Property Analysis of Gene Patents,” in A companion to genethics, 57 Shiva
all of you in Singapore. As I said earlier, please feel free Organization, <http://www.wipo.int/about-wipo/en/core_ ed. Justine Burley and John Harris (Malden, MA: Blackwell
58 Stifling or Stimulating: The Role of Gene Patents in
to send an email my way before we meet in Singapore tasks.html>. Publishers, 2002) 420-437.
Research and Genetic Testing, (Washington, D.C.: United
with any questions you may have, or just to say hello. 13 Yann Joly, “Open biotechnology: licenses needed,” 34 Edward White, “Gene Patenting,” in Battleground States Congress, 2007) 34-56.
Nature Biotechnology May. 2010: 417-419. science and technology, ed. Sal P. Restivo and Peter H.
Good luck with all your research, and get excited—I 59 Joseph Stiglitz and John Sulston, “The Case Against
14 Edward White, “Genetic Engineering,” in Denton (Westport, CT: Greenwood Press, 2008) 165-173.
am sure we will make this the best committee at Gene Patents,” Wall Street Journal 16 Apr. 2010.
Battleground science and technology, ed. Sal P. Restivo and 35 Cook-Deegan
WorldMUN 2011! 60 Munzer
Peter H. Denton (Westport, CT: Greenwood Press, 2008) 36 Stephen R. Munzer, “Property, Patents, and Genetic
61 Munzer
173-182. Material,” in A companion to genethics ed. Justine Burley
62 Munzer
15 C. Darkin, “What is a gene?,” Nature 25 May 2006: and John Harris (Malden, MA: Blackwell Publishers, 2002)
399-401. 438-454. 63 “Testing time for gene patents”
16 37 64 “ICSU Statement on Gene Patenting,” International
Endnotes
Random House Dictionary Robert W. Hahn, Intellectual property rights
in frontier industries: software and biotechnology. Council for Science, Jun. 2002.
17 Jason A. Delborne and Abby J, Kinchy, “Genetically
65 “TRIPS material on the WTO website,” World McManis (Sterling, VA, Earthscan, 2007) 242-243. 103 Dutfield 503 126 WIPO Seminar on Intellectual Property and
Trade Organization, 26 Jun. 2010 < http://www.wto.org/ 81 de Carvalho 242-243 104 Dutfield 503 Development
english/tratop_e/trips_e/trips_e.htm> 82 de Carvalho 246 105 Dutfield 503 127 WIPO Seminar on Intellectual Property and
66 “WTO-WIPO cooperation agreement,” World 83 Graham Dutfield, “Legal and economic aspects 106 Dutfield 504 Development
Trade Organization, 26 Jun. 2010 < http://www.wto.org/ of traditional knowledge,” in International public goods 107 Cottier and Panizzon 581 128 de Carvalho 172
english/tratop_e/trips_e/wtowip_e.htm> and transfer of technology under a globalized intellectual 108 Antony Taubman, “Saving the village: Conserving 129 de Carvalho 170
67 “Uruguay Round Agreement: TRIPS: Part II: property regime, ed. Keith E. Maskus and Jerome H. jurisprudential diversity in the international protction 130 Cottier and Panizzon 575
Standards concerning the availability, scope and use of Reichman (Cambridge, New York, Cambridge University of traditional knowledge,” in International public goods 131 “About TKDL,” Traditional Knowledge Digital
Intellectual Property Rights,” World Trade Organization, 10 Press, 2005) 501. and transfer of technology under a globalized intellectual Library, <http://www.tkdl.res.in/tkdl/langdefault/common/
Jun, 2010 <http://www.wto.org/english/docs_e/legal_e/27- 84 de Carvalho 247 property regime, ed. Keith E. Maskus and Jerome H. Abouttkdl.asp?GL=Eng>
trips_04c_e.htm#5>. 85 Daniel J. Gervais, Intellectual property, trade and Reichman (Cambridge, New York, Cambridge University 132 Rabodo Andriantsiferana, “Traditional Knowledge
68 “Uruguay Round Agreement: TRIPS: Part II: development: strategies to optimize economic development Press, 2005) 524. Protection in the African Region,” in Biodiversity and the
Standards concerning the availability, scope and use of in a TRIPS-plus era. (Oxford, New York, Oxford University 109 Biber-Klemm and Cottier 25 law: intellectual property, biotechnology, and traditional
Intellectual Property Rights” Press, 2007) 346. 110 Rosemary Coombe, “Protecting cultural industries knowledge, ed. Charles R. McManis (Sterling, VA,
69 “Uruguay Round Agreement: TRIPS: Part II: 86 Dutfield 504 to promote cultural diversity: Dilemmas for international Earthscan, 2007) 172-173.
Standards concerning the availability, scope and use of 87 de Carvalho 246 policymaking posed by the recognition of traditional 133 “Portal of Online Databases and Registries of
Intellectual Property Rights” 88 Dutfield 504 knowledge,” in International public goods and transfer of Traditional Knowledge and Genetic Resources,” WIPO, <
70 “4.2 Implications of the TRIPs Agreement on 89 Dutfield 505 technology under a globalized intellectual property regime, http://www.wipo.int/tk/en/databases/tkportal/>
Biotechnology,” World Health Organization, 2000, 20 90 Brendan Tobin, “Setting Protection of TK to ed. Keith E. Maskus and Jerome H. Reichman (Cambridge, 134 John B. Kleba, “Protection of Disseminated
Jun. 2010 <http://apps.who.int/medicinedocs/en/d/ Rights: Placing Human Rights and Customary Law at the New York, Cambridge University Press, 2005) 606. Traditional Knowledge: Learning from Brazilian Cases,”
Jh1459e/7.2.html>. Heart of TK Governance,” in Genetic resources, traditional 111 Coombe 606 in Genetic resources, traditional knowledge and the law:
71 “3.12 TRIPs Review,” World Health Organization, knowledge and the law: solutions for access and benefit 112 Coombe 606 solutions for access and benefit sharing, ed. Evanson C.
2000, 20 Jun. 2010 <http://apps.who.int/medicinedocs/ sharing, ed. Evanson C. Kamau and Gerd Winter (Sterling, 113 Coombe 609 Kamau and Gerd Winter (Sterling, VA, Earthscan, 2009)
en/d/Jh1459e/6.12.html>. VA, Earthscan, 2009) 107. 120.
114 Coombe 601-602
72 Daniel R. Peterson, “Policing future nontherapeutic 91 Dutfield 504 135 Kleba 120
115 Coombe 614
applications of genetic enhancement through international 92 Tobin 107 136 Kleba 120
116 Ikechi Mgbeoji, Global biopiracy: patents, plants
agreement,” Houston Journal of International Law 2008. 137 Kleba 120
93 Susette Biber-Klemm and Thomas Cottier. Rights and indigenous knowledge. (Vancouver, UBC Press, 2006)
73 Joseph E. Stiglitz, “Intellectual property rights and to plant genetic resources and traditional knowledge: basic 61. 138 Kleba 120
wrongs,” Project Syndicate 5 Aug. 2005. issues and perspectives. (Cambridge, MA, CABI, 2006) 26. 117 Mgbeoji 61 139 Kleba 120
74 Stiglitz 94 Weerawit Weeraworawit, “International Legal 118 Cottier and Panizzon 581 140 “Uruguay Round Agreement: TRIPS: Part II:
75 “Sitting up and taking notice” Protection for Genetic Resources, Traditional Knowledge Standards concerning the availability, scope and use of
119 Rabodo Andriantsiferana, “Traditional Knowledge
76 Joly and Folklore: challenges for the intellectual property Intellectual Property Rights,” World Trade Organization,
Protection in the African Region,” in Biodiversity and the
77 Stifling or Stimulating: The Role of Gene Patents in system,” in Trading in knowledge: development perspectives law: intellectual property, biotechnology, and traditional <http://www.wto.org/english/docs_e/legal_e/27-
Research and Genetic Testing on TRIPS, trade, and sustainability, ed. Christophe knowledge, ed. Charles R. McManis (Sterling, VA, trips_04c_e.htm#5>.
78 Marie Battiste, Protecting indigenous knowledge Bellmann, Graham Dutfield, and Ricardo Melendez-Ortiz Earthscan, 2007) 317. 141 Cottier and Panizzon 572
and heritage: a global challenge. (Saskatoon, Purich (Sterling, VA, Earthscan, 2003) 159. 120 Andriantsiferana 317 142 Y Daya and N Vink, “Protecting traditional
Publishers, 2000) 35-36. 95 Weeraworawit 159 ethno-botanical knowledge in South Africa through the
121 Andriantsiferana 317
79 Thomas Cottier and Marion Panizzon, “Legal 96 Biber-Klemm and Cottier 26 intellectual property regime,” Agrekon 45, 3 (2006).
122 WIPO: Ninth Session, Republic of South Africa:
perspectives on traditional knowledge: The case for 97 Weeraworawit 159 143 “Article 8. In-situ Conservation,” Convention on
Indigenous Knowledge Systems Policy (Geneva, 2006).
intellectual property protection,” in International public 98 Weeraworawit 159-160 Biological Diversity, <http://www.cbd.int/convention/
123 WIPO: Ninth Session
goods and transfer of technology under a globalized 99 Weeraworawit 160 articles.shtml?a=cbd-08>
intellectual property regime, ed. Keith E. Maskus and 124 Denise Nicholson, “SA Intellectual Property
100 Antony Taubman and Matthias Leistner, “Analysis Amendment Bill (Traditional Knowledge) - Going Ahead 144 Daya and Vink
Jerome H. Reichman (Cambridge, New York, Cambridge
of Different Areas of Indigenous Resources,” in Indigenous Regardless?,” ACA2K 01 Mar. 2010, <http://www.aca2k.org/ 145 Biswajit Dhar, “The Convention on Biological
University Press, 2005) 566.
heritage and intellectual property: genetic resources, index.php?option=com_idoblog&task=viewpost&id=269&I Diversity and the TRIPS Agreement: compatibility
80 Nuno Pires de Carvalho, “From the Shaman’s traditional knowledge and folklore, ed. Silke von Lewinski or conflict?,” in Trading in knowledge: development
temid=73&lang=en>
Hut to the Patent Office: A Road Under Construction,” (Frederick, MD, Aspen Publishers, 2008) 81. perspectives on TRIPS, trade, and sustainability, ed.
in Biodiversity and the law: intellectual property, 125 WIPO Seminar on Intellectual Property and
101 Gervais 346 Development, Biodiversity and Perspectives of Traditional Christophe Bellmann, Graham Dutfield, and Ricardo
biotechnology, and traditional knowledge, ed. Charles R. Melendez-Ortiz (Sterling, VA, Earthscan, 2003) 86.
102 de Carvalho 247 Knowledge in South Africa (Geneva, 2005).
146 Dhar 86
TRIPS: Part II, Section 5
147 Gervais 349
148 Gervais 349 Article 27: Patentable Subject Matter
149 Cottier and Panizzon 574 1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products
150 Cottier and Panizzon 574 or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of
151 Cottier and Panizzon 574 industrial application. (5) Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this
152 Taubman 526 Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention,
153 Taubman and Leistner 83 the field of technology and whether products are imported or locally produced.
154 Taubman and Leistner 83
2. Members may exclude from patentability inventions, the prevention within their territory of the commercial
exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or
155 “Accredited List,” WIPO, <http://www.wipo.int/
plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made
export/sites/www/tk/en/igc/ngo/accreditedlist.pdf> merely because the exploitation is prohibited by their law.
156 Joseph E. Stiglitz, “Intellectual property rights and 3. Members may also exclude from patentability:
wrongs,” Project Syndicate 5 Aug. 2005. (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
157 The URL is: <http://www.wipo.int/tk/en/igc/index. (b) plants and animals other than micro-organisms, and essentially biological processes for the production of
html> plants or animals other than non-biological and microbiological processes. However, Members shall provide
for the protection of plant varieties either by patents or by an effective sui generis system or by any combination
thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the
WTO Agreement.
Article 28: Rights Conferred
1. A patent shall confer on its owner the following exclusive rights:
(a) where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent
from the acts of: making, using, offering for sale, selling, or importing (6) for these purposes that product;
(b) where the subject matter of a patent is a process, to prevent third parties not having the owner’s consent from
the act of using the process, and from the acts of: using, offering for sale, selling, or importing for these purposes
at least the product obtained directly by that process.
2. Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing
contracts.
Article 29: Conditions on Patent Applicants

1. Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear
and complete for the invention to be carried out by a person skilled in the art and may require the applicant to
indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is
claimed, at the priority date of the application.
2. Members may require an applicant for a patent to provide information concerning the applicant’s
corresponding foreign applications and grants.
Article 30: Exceptions to Rights Conferred
Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such
exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably
prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.
Article 31: Other Use Without Authorization of the Right Holder
Where the law of a Member allows for other use (7) of the subject matter of a patent without the authorization of
the right holder, including use by the government or third parties authorized by the government, the following
provisions shall be respected:
(a) authorization of such use shall be considered on its individual merits;
(b) such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain
authorization from the right holder on reasonable commercial terms and conditions and that such efforts have
Appendix not been successful within a reasonable period of time. 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. In
situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, circumstances, that any identical product when produced without the consent of the patent owner shall, in the
be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or absence of proof to the contrary, be deemed to have been obtained by the patented process:
contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or (a) if the product obtained by the patented process is new;
will be used by or for the government, the right holder shall be informed promptly; (b) if there is a substantial likelihood that the identical product was made by the process and the owner of the
(c) the scope and duration of such use shall be limited to the purpose for which it was authorized, and in patent has been unable through reasonable efforts to determine the process actually used.
the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice 2. Any Member shall be free to provide that the burden of proof indicated in paragraph 1 shall be on the alleged
determined after judicial or administrative process to be anti-competitive; infringer only if the condition referred to in subparagraph (a) is fulfilled or only if the condition referred to in
(d) such use shall be non-exclusive; subparagraph (b) is fulfilled.
(e) such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use; 3. In the adduction of proof to the contrary, the legitimate interests of defendants in protecting their
(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member manufacturing and business secrets shall be taken into account.
authorizing such use;
(g) authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the Convention on Biological Diversity—Article 8: In-situ Conservation
persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are
unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the Each Contracting Party shall, as far as possible and as appropriate:
continued existence of these circumstances; (a) Establish a system of protected areas or areas where special measures need to be taken to conserve biological
(h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account diversity;
the economic value of the authorization; (b) Develop, where necessary, guidelines for the selection, establishment and management of protected areas or
(i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or areas where special measures need to be taken to conserve biological diversity;
other independent review by a distinct higher authority in that Member; (c) Regulate or manage biological resources important for the conservation of biological diversity whether within
(j) any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or or outside protected areas, with a view to ensuring their conservation and sustainable use;
other independent review by a distinct higher authority in that Member; (d) Promote the protection of ecosystems, natural habitats and the maintenance of viable populations of species
(k) Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use in natural surroundings;
is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. (e) Promote environmentally sound and sustainable development in areas adjacent to protected areas with a view
The need to correct anti-competitive practices may be taken into account in determining the amount to furthering protection of these areas;
of remuneration in such cases. Competent authorities shall have the authority to refuse termination of (f) Rehabilitate and restore degraded ecosystems and promote the recovery of threatened species, inter alia,
authorization if and when the conditions which led to such authorization are likely to recur; through the development and implementation of plans or other management strategies;
(l) where such use is authorized to permit the exploitation of a patent (“the second patent”) which cannot be (g) Establish or maintain means to regulate, manage or control the risks associated with the use and release of
exploited without infringing another patent (“the first patent”), the following additional conditions shall apply: living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts
(i) the invention claimed in the second patent shall involve an important technical advance of considerable that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to
economic significance in relation to the invention claimed in the first patent; human health;
(ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention (h) Prevent the introduction of, control or eradicate those alien species which threaten ecosystems, habitats or
claimed in the second patent; and species;
(iii) the use authorized in respect of the first patent shall be non-assignable except with the assignment of the (i) Endeavour to provide the conditions needed for compatibility between present uses and the conservation of
second patent. biological diversity and the sustainable use of its components;
(j) Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of
Article 32: Revocation/Forfeiture indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable
use of biological diversity and promote their wider application with the approval and involvement of the holders
An opportunity for judicial review of any decision to revoke or forfeit a patent shall be available. of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from
the utilization of such knowledge, innovations and practices;
(k) Develop or maintain necessary legislation and/or other regulatory provisions for the protection of threatened
species and populations;
Article 33: Term of Protection (l) Where a significant adverse effect on biological diversity has been determined pursuant to Article 7, regulate
or manage the relevant processes and categories of activities; and
The term of protection available shall not end before the expiration of a period of twenty years counted from the
(m) Cooperate in providing financial and other support for in-situ conservation outlined in subparagraphs (a) to
filing date (8) (l) above, particularly to developing countries.
Article 34: Process Patents: Burden of Proof

1. For the purposes of civil proceedings in respect of the infringement of the rights of the owner referred to in
paragraph 1(b) of Article 28, if the subject matter of a patent is a process for obtaining a product, the judicial
authorities shall have the authority to order the defendant to prove that the process to obtain an identical
product is different from the patented process. Therefore, Members shall provide, in at least one of the following
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UN World Intellectual Proper Ty Organization: Background Guide

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World Model United Nations 2011

UN Wor l d I nte l l e c t ual Proper t y O rganizatio n

Cover image courtesy of Singapore Tourism Board.

Reihan Nadarajah Dear Delegates of the General Assembly,

March 14 - March 18 2011

Organization international cooperation in intellectual property

T he World Intellectual Property Organization

T o understand the current systems of gene

A s discontent with the current gene patenting

W ith the whirlwind of activity surrounding

N on-governmental organizations (NGOs)

Article 29: Conditions on Patent Applicants

Article 34: Process Patents: Burden of Proof

Harvard WorldMUN 2011 World Intellectual Property Organization 48

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