HMUN Study Guide

1 Specialized Agencies
World Intellectual
property organization
GENERAL ASSEMBLY
History of the Problem
Current Situation
Past UN Actions
Proposed Solutions
Questions a Resolution Must Answer
Key Actors and Positions
Suggestions for Further Research
6
15
15
17
18
18
19
Topic Area A:
Gene Patenting
Topic Area B:
History of the Problem
Case Studies
Past UN Actions
Proposed Solutions
Questions a Resoultion Must Answer
Key Actors and Positions
Suggestions for Further Research
21
26
29
30
31
32
32
Protection of indigenous, ancient,
and traditional knowledge

Introduction 4
History of the Committee 4
Topic Area A 5
Topic Area B 20
Position Paper Requirements 33
Closing Remarks 33
Bibliography 39
TABLE OF CONTENTS
World Intellectual Property Organization
2 Specialized Agencies Harvard Model United Nations India 2011 A2
The harvard Team
Hunter M. Richard
SecreTary-General
Matthew J. Chartier
direcTor-General
The india Team
Anmol Soin
PreSidenT
Purav Shah
BuSineSS
Ameya Naik
leGal affairS
Ankiti Bose
finance
Dheer Bhatnagar
naTional coordinaTion
Conrad Norohna
loGiSTicS
Raahil Rai
recruiTmenT
59 ShePard STreeT, Box 205
Cambridge, MA 02138
Voice: (617)-398-0772
Fax: (617) 496-4472
Email: info@hmunindia.org
www.hmunindia.org
harvard model uniTed naTionS india 2011

Dear Delegates of HMUN India 2011,
Welcome to the frst-ever Harvard Model United Nations India 2011! It is our great pleasure to welcome you
as delegates to the vibrant city of Mumbai to simulate one of the Worlds most important international bodies,
the United Nations. Harvard Model United Nations is currently entering its 59th session in Boston and has
joined with the Indian Model United Nations Society and Alter Ego Creations to bring 59 years of dedication,
excellence, and knowledge to Mumbai for HMUN India 2011. Since the coneption of HMUN India in 2010,
our staff has been innovating topics and committees, researching and writing, and planning all of the excite-
ment that you will experience this August.
Harvard Model United Nations India is excited to simulate 10 of the organizations most important commit-
tees from the General Assemby, Economic and Social Council, and Specialized Agencies, as well as impor-
tant regional bodies. One committee will take on the intellectual property law, while another will discuss the
weaponization of space. The Special Political and Decolonization Committee will convene to discuss the
destabilizing effects of drug traffcking, while NATO will contemplate expansion and its relationship with the
Shanghai Cooperative Organization. The United Nations Environmental Programme will convene to protect
our planets rainforests while the Security Council will discuss the dangers of nuclear weapons.
As you embark on your journey toward HMUN India, we strongly encourage you to go beyond this study
guide in your research and preparation. The sources cited and recommended by your director are excellent
jumping-off points. Additionally, your school or public library and reputable websites will serve you well as
you prepare to assume the role of a country or person with whom you may be unfamiliar or whom you may
never have heard of before. Nevertheless, equal measures of preparation, enthusiasm, and creativity will go a
long way to making your committee and experience at HMUN India an outstanding one.
What can you expect in return? Our entire staff at HMUN India hope to provide you with the chance to learn
about the world, past, present, and future, while having a fun and memorable weekend. Take advantage of
everything our conference and the city of Mumbai has to offer and do not hesitate to contact our staff and
your director if you have any questions. Check our website frequently for conference and committee updates.
UN Secretary-General Kof Annan once advised, We have the means and the capacity to deal with our prob-
lems, if only we can fnd the political will. I hope you will bear these words in mind as you approach HMUN
India with an open mind and the determination to solve some of the worlds greatest problems.
Sincerely,
Hunter Richard Anmol Soin
Secretary-General President
Harvard Model United Nations India 2011 Harvard Model United Nations India 2011
secgen@hmunindia.org president@hmunindia.org
hmun india iS a collaBoraTive ProjecT BeTween The indian model uniTed naTionS SocieTy and
harvard model uniTed naTionS
3 Harvard Model United Nations India 2011
Dear Delegates,
It is my pleasure to welcome you to the frst session of HMUN India and to the World
Intellectual Property Organization! My name is Varun Bansal, and I am thrilled to be your
Chair this year. I am especially excited about our committee, which is a one-of-a-kind MUN
committee that is crucial to global trade, innovation, and international relations.
I am a junior at Harvard, concentrating in Applied Mathematics (with a focus in economics).
I grew up around Washington, D.C., and frst participated in Model UN in my ninth grade,
making this my seventh year of involvement with MUN. Beyond academics and HMUN
India, I also run committees for the Boston HMUN conference and for WorldMUN. I am
also involved with the Harvard International Review, a magazine on international afairs,
and EnviroEd, a volunteer group that teaches underprivileged students in Boston about
environmental issues.
Tis year, WIPO will be debating gene patenting and the protection of traditional knowledge.
Tough 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 patenting. Similarly,
though various international agencies have, for decades, repeatedly stated their commitment to
protecting traditional knowledge, there is still no single global system for protecting traditional
knowledge and determining how it fts into the current system (if at all). Tus, for each topic,
the goal is to create a comprehensive framework that, for the frst time, unifes and clearly sets
out global standards on gene patenting and traditional knowledge.
Debate will be shaped not only by your countrys position, but also by your personal opinions.
While our topics are certainly difcult, I am confdent that you are more than capable of
handling them, and will come prepared to discuss these issues. Te best way to ensure your
success in committee is to put in the time to prepare for conference through thorough research
and by writing a well-formed position paper. In the mean time, until we meet, please feel free to
email me with any questions or just to introduce yourself. I look forward to meeting each of you
in Mumbai!
Sincerely,
Varun Bansal
Chair, World Intellectual Property Organization
The harvard Team
Hunter M. Richard
SecreTary-General
Matthew J. Chartier
direcTor-General
The india Team
Anmol Soin
PreSidenT
Purav Shah
BuSineSS
Ameya Naik
leGal affairS
Ankiti Bose
finance
Dheer Bhatnagar
naTional coordinaTion
Conrad Norohna
loGiSTicS
Raahil Rai
recruiTmenT
59 ShePard STreeT, Box 205
Cambridge, MA 02138
Voice: (617)-398-0772
Fax: (617) 496-4472
Email: info@hmunindia.org
www.hmunindia.org
harvard model uniTed naTionS india 2011
World Intellectual
ProPerty organIzatIon
INTRODUCTION
As I mentioned in my letter, the topics our
committee will deal with are gene patenting and
the protection of traditional knowledge. Te goals
for this committee are deceptively simple: to create
a unifying, global framework for each topic. Tese
goals directly follow WIPOs strategic goals for the
millennium, including the balanced evolution of the
international normative framework for IP [intellectual
property], coordination and development of global IP
infrastructure, international cooperation on building
respect for IP, and addressing IP in relation to global
policy issues.
1
Solving the issues of gene patenting and
traditional knowledge would be a huge step forward
for WIPO and for IP in general across the world.
HISTORY OF THE COMMITTEE
Te World Intellectual Property Organization
(WIPO) has a long history, by UN standards. Te
precursor to WIPO was founded in 1883, when the
two international bureaus administering the Paris
Convention for the Protection of Industrial Property
(the Paris Convention) and the Berne Convention
for the Protection of Literary and Artistic Works
merged to form the United International Bureaux for
the Protection of Intellectual Property (BIRPI). In
1967, due to the Convention Establishing the World
Intellectual Property Organization, BIRPI became
WIPO, and in 1974, WIPO became a specialized
agency of the United Nations. Today, as WIPO itself
puts it, WIPO is a dynamic entity with 184 member
States, a staf that now numbers some 938, from 95
countries around the world, and with a mission and a
mandate that are constantly growing.
2
Today, WIPO
summarizes its core mission as dedicated to developing
a balanced and accessible international intellectual
property (IP) system, which rewards creativity,
stimulates innovation and contributes to economic
development while safeguarding the public interest.
3
Of the two founding agreements of WIPO,
the Paris Convention is more relevant to the topics
our committee will discuss. In a very real way, modern
international cooperation in intellectual property
and patents was pioneered with the adoption of the
Paris Convention, which crafted a broad set of rules
regarding industrial property. Te most signifcant
outcome of the Paris Convention was the provision
that each contracting member state had to grant the
same protection [of intellectual property] to nationals
of the other contracting States as it grants to its own
nationals.
4
Te Convention was revised and amended
numerous times since then, most recently in 1979, has
173 member states party to it, and is administered by
WIPO.
5
Tere are two other major, milestone treaties
that have had a signifcant bearing upon WIPO and
our debates this session, as both have laid the modern
system for a synchronized global patenting system.
Te frst is the Patent Cooperation Treaty (PCT),
concluded in 1970, which makes it possible to obtain
patent protection in many nations by flling out just a
few formsthe frst major step towards international
harmonization of patenting procedures.
6
Te second is
the Patent Law Treaty (PLT), concluded in 2000, which
went a step beyond PCT and formally harmonized
and simplifed various patenting procedures in many
nations, to increase the ease of obtaining patent
protection.
7
WIPO itself is organized into various bodies.
On the highest level, WIPO is composed of three
organs (the three governing bodies), the WIPO
General Assembly, the WIPO Conference, and the
WIPO Coordination Committee. Tese three organs
are of equal sizeeach is composed of one delegation
per member stateand are the highest decision-
making bodies of WIPO. Te WIPO General Assembly
largely deals with logistical issues, such as budgeting,
fnances, and status and approval of member states.
8

Te WIPO Conference, among other duties, discusses
and adopts recommendations for matters dealing with
IP and adopts amendments to the WIPO Convention
itself.
9
Finally, the WIPO Coordination Committee
creates the agenda and drafts recommendations for
the operations of the other two organs.
10
After the
governing bodies come the standing and permanent
committees, groups of experts convened for specifc
purposes by the governing bodies. Tese standing and
permanent committees can then further create working
groups, convened to examine specifc questions in great
detail. Behind all this organization is the International
Bureau, or WIPO Secretariat, which takes care of
budgeting, implementation, and other administrative
functions.
11
Today, everything WIPO does is in the spirit
of its fve core tasks: developing international IP laws
and standards, delivering global IP protection services,
encouraging the use of IP for economic development,
promoting a better understanding of IP, and providing
a forum for debate. WIPO also administers 24
international treaties (16 on industrial property; 7
on copyright; as well as the convention establishing
WIPO).
12
Unlike other UN committees, which may
depend on external factors for their power or success,
WIPOs powers derive from the agreement of member
nations. If enough member nations agree to, ratify, and
participate in a system, its successful implementation is
assured.
GENE PATENTING
Statement of the Problem
Intellectual property protection is a widely
implemented reality around the world. Whether it takes
the form of a patent or a copyright, the ideas and principles
behind intellectual property protection are generally well
understood; when someone creates something, be it a
new light bulb or a new book, they receive protection
under the government. Tis very clear system begins to
break down, however, when genetic engineering enters
the question.
At its most basic, genetic engineering is a type
of biotechnology that involves the modifcation of an
organisms genes to change what the genes do. Already,
genetically modifed products are readily available in
global markets. Entire industries, such as corn and soy
production, have been reshaped by genetically modifed
crops. New medicines are being developed that are grown
and created in living laboratories, tailored through genetic
engineering. Animal species are being changed, fused,
and spliced by human researchers. Genetic engineering,
with all its stunning technological advances, is nothing
short of a revolution that is changing the nature of
our interaction with living organisms. Tis revolution
pervades every facet of life for every human on the planet.
Food agriculture, novel medicines, and even humans are
now potential candidates for genetic engineering.
With this whirlwind of advancement, however,
has come a time of incredible uncertainty. Humanity has
embarked on a journey with no clear end and no clear
paths. Genetic engineering has the potential to open
incredibly benefcial advances for humanity, solving
issues ranging from disease to world hunger. But it also
opens the possibility of irreversible damage to the Earth
and to its people, damage so large and so unanticipated
that we would be helpless, as we watch our creations
ravage the Earth and the systems on which we depend.
Our notions of how ethics, law, and economics
apply to these situations are not yet as advanced as the
science is. It is still unclear when and if it is morally
permissible to modify an organism, and to what
extent. Nor are we sure of when it is ethical to patent a
genetically modifed organism, if at all. Even in the more
dispassionate realm of economics, we are still engaged in
a ferce debate on whether gene patents will hamper or
assist research.
As a result, there is also no unifed, global policy
or agreement on genetic engineering and gene patents,
posing a major problem to international cooperation and
trade. Tere are currently a large number of agreements,
many of which briefy mention and briefy touch upon
the issue of genetic engineering and gene patenting.
Tese agreements range from the powerful Agreement
on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) to many smaller agreements, such as
International Treaty on Plant Genetic Resources for
Food and Agriculture. Of greatest signifcance, however,
is TRIPS, which is administered by the World Trade
Organization (WTO) and efectively rules the global
patenting regime. Tere are also many points of discord
between national or regional patent laws, most notably
between United States patent law and the law set under
the European Patent Convention in Europe.
Even the existing gene patenting systems in
individual nations, all of which are largely based on
older systems of patenting, are coming under heavy
criticism from scientifc researchers, ethicists, and
lawyers. Among other criticisms, the current system of
gene patents has been characterized as unsuited for the
fast-paced biotechnology industry, restrictive to scientifc
innovation, harmful to patients and consumers, and as
an obstacle to scientifc progress.
13
Despite our doubts and uncertainties, however,
advances in genetic engineering are racing on at an
ever-accelerating pace. It is no longer feasible to simply
ignore the feld, hoping that a discovery or breakthrough
in the future will provide the crucial insight needed
to formulate guidelines. For a feld with such huge
potentialboth for good and badto be so unregulated
is alarming and untenable. Tus, WIPO is tasked with
the duty of formulating a comprehensive, international
agreement covering all aspects of gene patenting. In
other words, WIPO will have to debate the moral
controversies, overhaul the archaic patenting system
regulating genetic engineering, and address the legal
technicalities that surround patenting genes.
Te establishment of these guidelines will
certainly be challenging, but appropriate,
modernized international guidance tailored
to the radically diferent feld of genetic
engineering is crucially needed in todays
world.
hIStory and dIScuSSIon of the Problem
IntroductIon to and HIstory of
GenetIc enGIneerInG
As stated earlier, genetic engineering
is the manipulation of genes using
recombinant DNA techniques to modify
what the gene does, either by itself or in
combination with other genes. [DNA,
short for deoxyribonucleic acid, carries
genetic information, is made of simple
building blocks, encodes for all the features
of a living organism, and is passed from
generation to generation.] Recombinant
means combining genes from diferent
sources in a diferent manner than occurs
naturally. Genes are the units formed
by combinations of the nucleotides G
(guanine), A (adenine), T (thymine), and
C (cytosine), which lie in two equally long
and twisting strings (the famous double
helix) that are attached to each other
throughout their length. G, A, T, and C
nucleotides combine in pairs, across the
space between the two strings. About three billion pairs
form the human genomethe string of genes that make
up each individual humans genetic structure. A gene is
a stretch of A-T and C-G pairs that, by their complex
arrangement, lay out the instructions for a cell to produce
a particular protein. Proteins are the basic agents, formed
from amino acids, that determine the chemical reactions
in the cell.
14
For the purposes of this study guide, a
gene will be defned as the complete DNA sequence that
encodes the instruction to build a protein.
15
Some may say that genetic engineering is a
natural extension of ancient agricultural practices, such
as burning brush to encourage the growth of specifc
fora, domestication of animals, and most important, the
selective breeding of plants and animals to extinguish
Simplifed structure of DNA showing nucleotide combinations and double-helix
structure.
http://www.stkate.edu/physics/Astrobiology/DNA Structure.jpg
undesirable traits and promote desirable characteristics.
Most scientists, however, draw a contrast between these
practices and genetic engineering, as these older practices
indirectly altered the genes of living beings, while genetic
engineering directly alters the genes.
16
Genetic engineering, as understood today, began
in the early 1970s, when scientists in the United States
managed to have bacteria take up foreign DNA segments
and add it to their genomes. In 1976, the frst true
application of genetic engineering was created; insulin, a
human protein, was produced inside a genetically altered
bacterium. For the next twenty years, the technology
was further perfected until 1994, when the frst large-
scale genetically engineered animal product entered the
market: bovine somatotropin (BST), a growth hormone
that, when given to cows, induces them to produce more
milk. In 1996, genetically modifed Roundup Ready
soybean crops were introduced to the market, introducing
genetically modifed organisms (GMOs) into agriculture.
A GMO is a plant, microbe, or animal whose genetic
material has been intentionally altered through genetic
engineering.
17
Since these landmark beginnings, genetic
engineering has found its way into a wide variety of
applications. Genetically modifed (GM) animals are
routinely used in research, such as GM mice. A variety
of domesticated animals have also been engineered for
various purposes. For instance, milk and egg producing
animals have been altered to make their products contain
medicines and nutrients, and salmon have been modifed
to grow faster. Food cropsmost notably, soybean, corn,
and canola cropshave been modifed to grow faster, be
resistant to herbicides, pesticides, and various diseases,
and produce medicines. Non-food plants, such as cotton,
have also been modifed with commercial success.
18
Although genetic engineering has been largely
limited to non-human genetic engineering, human
genetic engineering is a reality already in motion. Gene
therapy, the deliberate insertion of foreign genes into a host
(human) to cure disease, is still in its infancy, though the
feld is rapidly developing and holds great promise. Tere
are two forms of gene therapy: germ line gene therapy
and somatic gene therapy. Germ line gene therapy is the
modifcation of gametes (sperm and eggs) to alter the next
generation of humans. Such gene therapy holds promise
to edit out inheritable diseases or predispositions
forever. Somatic gene therapy is the modifcation of the
somatic cells (all cells in the body besides of gametes and
undiferentiated stem cells) in order to cure the subject
human of a disease without afecting, either positively
or negatively, the next generation of ofspring. Current
research has been limited to somatic gene therapy due to
ethical qualms within the scientifc community, but as
advances continue, germ line gene therapy may be the
logical next step in research. As the reasoning goes, once
this generation has been cured, why not eliminate the
disease from the next generation as well?
19
sources of controversy reGardInG GenetIc
enGIneerInG
Tough the controversies surrounding genetic
engineering are many, the vast majority are rooted in
two fundamental uncertainties. First, the largest source
of controversy stems from the great doubt surrounding
the future implications of this feld. No one is entirely
sure what the efects of genetically engineered products
will be on human health, the environment and global
ecosystems, and the economy. Te second largest
source of controversy pertains to the ethics of genetic
engineering. Te frontiers being explored by genetic
engineering are so novel that our ideas of ethics have yet
to catch up with the feld. It is not yet clear when it is
permissible to genetically modify an organism, to what
extent, and for what purposes. Tis guide will attempt
to briefy discuss a few, but certainly not all, of the issues
currently being debated.
Te earliest signifcant concerns were voiced by
Paul Berg, who received the Nobel Prize in Chemistry
1980, for his fundamental studies of the biochemistry
of nucleic acids, with particular regard to recombinant-
DNA.
20
As one of the pioneers of the genetic engineering
revolution, Berg was among a group of scientists who
called for a moratorium on recombinant DNA research
until the risks and potentials could be more fully
evaluated. His statements were among the frst seeds
that grew into a philosophy known as the precautionary
principle, which states that dramatically new advances
not be allowed to take place in research until their
potential safety has been conclusively demonstrated.
Unfortunately, the application of such a principle
would greatly hinder advances in critical science and
technology. For instance, the vast majority of insulin for
diabetics is now produced in recombinant bacteria. Had
the precautionary principle been applied at the time of
the creation of this process, would this new process of
synthesizing insulin ever have been created? How many
8 Specialized Agencies Harvard Model United Nations India 2011 A 8
diabetics around the world would have seen their lives
cut short as a result?
21
On the other hand, the application of some form
of the precautionary principle could be a critical safeguard
against horrifying mistakes and accidents. Tere is so
much uncertainty, that many feel that mistakes are bound
to happen. For instance, if a human heart is grown in a
pig and is then transplanted into a human, is the human
now susceptible to pig diseases? (And what happens if
the disease evolves in the human into a dangerous human
disease?) What if, in the process of adding a gene to a cell,
an unintended consequence arises? What if a previously
unknown, devastating disease is created in a lab, either
intentionally or unintentionally? And what happens if
this disease makes its way into the general population
either by accident, due to terrorists, biological warfare,
or some other means? Already, we are seeing indications
of this possibility; Australian scientists recently caused
alarm when they announced they had created a disease
that was lethal to mice. More frighteningly, a group of
British scientists, while working on a vaccine, accidentally
spliced together genes from hepatitis C and dengue fever,
sparking fears that a super-hybrid would be formed.
22
Furthermore, there are vast concerns regarding
the products of genetic engineering, GMOs, as well.
Practically speaking, people are unsure of issues such as
the health efects of GMOs (e.g. allergies to new food
substances or creation of new toxins due to genetic changes),
biological contamination (also called biopollution, or
the mixing of genetically engineered plants with native
plants, resulting in new, unnatural strains, such as
superweedsweeds contaminated by pesticide-tolerant
Cattle and other livestock are often genetically engineered to conform to human tastes and desires for meat and animal products, the ethics
of which are disputed. Above, a standard cattle feedlot in the U.S.
http://specialtyfabricsreview.com/repository/1/638/full_0808_sw7_1.jpg
genetically engineered crops), antibiotic resistance (as a
result of the research techniques used to create GMOs),
and gene transfers (bacteria naturally swap genes with
each other, giving rise to the possibility that genetically
modifed genes passing through the human digestive
system may afect the bacteria naturally living there,
causing harm to the human host). In addition, many
people argue that we do not yet know the long-term efects
of GMOs on human health, and argue that the negative
secondary efects of GMOs on other species of animals
(e.g. cows) have already been demonstrated. And as an
indicator of the future of regulation, in June 2010, the
United States Supreme Court ruled that biotechnology
companies could sell their genetically modifed products
before safety tests were completed.
23
On the ethical side,
many people harbor concerns stemming from the idea of
the intrinsic value of life; is it ethical to modify the genes
of, say, a dog? Is that a violation of the integrity of the
dog?
24
Human genetic engineering, of course, carries
with it a vast set of ethical concerns. To what extent can
humans be altered? When can we declare a disease as cured?
It is one thing to use gene therapy on someone to cure
Alzheimers disease, but can a scientist use gene therapy
on a persons reproductive cells to prevent Alzheimers
in future generations? Can a doctor genetically engineer
a fetus in a womb to enhance certain traits? If a fetus
is exhibiting signs that it will develop Down syndrome,
can a doctor engineer its DNA to prevent it? When gene
therapy moves out of the treatment and into the realm
of enhancement, the situation becomes even less clear.
What if this is taken a step further; if genetic tests reveal
that a baby may be of below-average intelligence, can a
doctor change the DNA of the fetus to make it smarter?
25
Te line between treatment and enhancement
is not as clear as it might seem, though. Consider the
following scenario, as proposed by Nils Holtug. Jane is
infected with HIV. Her immune system is starting to give
in and she is about to develop AIDS. Fortunately, there
is a new kind of gene therapy availablecall it therapy
Athat will boost her immune system, and bring it back
to normal, such that she will in fact never develop AIDS.
By performing the therapy, we are providing her with a
treatment. Now consider Helen. She has not yet been
infected with HIV, but she is a hemophiliac and, since
blood reserves at the hospital have not been screened
for HIV, we know it is only a matter of time before
she is infected, unless she receives a new kind of gene
therapycall it therapy Bthat will make her immune.
[] By performing the therapy, we are enhancing
her (or her immune system), since we are giving her a
desirable property, where her present condition does
not constitute an adverse departure from species-typical
normal functioning.
26
Should this be allowed? Tere is
no clear answer to this question, yet, it fgures into the
calculus of the ethics of genetic engineering.
IntroductIon to and evolutIon of Gene
PatentInG
To understand the current systems of gene patenting
that exist across the world, it is important to briefy
examine the history of intellectual property (IP) and the
patent systems in place to protect IP, as modern gene
patenting systems are based upon these older models.
A patent is an exclusive, but temporary right granted
to an inventor or to their successors. It prevents others
from exploiting the invention unless they have the
patent owners consent. Exploiting an invention includes
making, using, selling, or importing it. Patents provide
protection only for a limited time (normally 20 years).
Te patent owner also can let others use it. For example,
he or she can grant a license for an appropriate fee.
27
It is
important to note that a patent does not necessarily allow
the license-holder to create, use, or sell the invention him/
herself; it simply bars anyone else from making, using, or
selling it.
28
Te new invention being patented must be
useful, novel, and non-obvious.
29
Generally, gene patents are understood to be
patents on whole genes. However, a variety of other
inventions are also classifed under gene patents. Tese
include not only the specifc DNA sequence that encodes
a protein, but also DNA sequences that regulate other
genes. Tey can also cover the links between specifc
DNA code and the ultimate outcome of the code.
Gene patents may also cover RNA sequences. RNA
(short for ribonucleic acid) is a molecule very similar to
DNA; when a cell wants to read DNA for instructions,
it creates a copy of the DNA to work of of, similar to
how someone writing a report may make a copy of their
original fle and use the duplicate copy as their working
draft. Tis working copy of the DNA is made of RNA.
Beyond the molecular level, gene patents can also cover
newly invented cells, treatments, diagnostics, transgenic
animals, and novel diseases.
Most legal scholars agree that the patent
system, when applied to established sectors, encourages
innovation and investment. When applied to genetics
and biotechnology, however, controversy erupts, and
has been faring since the inception of gene patenting
three decades ago. Te situation will only become more
controversial as time goes on, due to more sophisticated
and advanced genetic engineering breakthroughs. Te
title of an April 2010 article discussing the grim future
of gene patenting aptly summarizes the situation: Tink
Gene Patents Are Controversial Now? Just Wait.
31
Te early history of gene patenting largely played
out in the United States, a country strongly concerned
with protection of intellectual property. In the past,
granting patents was fairly straightforward. If an invention
was created by a human, it was patentable. Otherwise, it
was not. Patent applications for new breeds of animals
and plants, for instance, were repeatedly rejected on the
grounds that these breeds were natural, not man-made,
and belonged to nature. It was not until 1970 that, in
the United Statesthe leading proponent of intellectual
property rightsgranted new breeds patent protection.
32
Te turning point came in 1980, once again
in the United States, in the Supreme Court case
Diamond v. Chakrabarty (1980). Anand Chakrabarty,
a microbiologist, had created hybridized bacteria, new
types of bacteria formed as a result of the combination
of various other bacteria. Under the old patent system,
his patent was rejected. But this was overturned in the
Chakrabarty decision, which ruled that anything under
the Sun made by man could be patented, and thus, a life
form could be patented. When Chakrabarty was given
the patent for his bacteria, the foodgates opened for
gene patenting.
33,34
Just six months later, the frst patent
on recombinant DNA was granted.
35
Since then, gene patenting has gone in diferent
directions in diferent parts of the world. In the United
States, courts treat genetic material as a composition of
matter and typically use the rules that have developed
for the patentability of smaller, less complicated chemical
compounds Te EPO [European Patent Ofce]
wrestles with, among other issues, what morality forbids
and whether technical intervention renders a process no
longer essentially biological
36
and thus unpatentable.
Laws regarding the manipulation of human genes become
even more complex; for example, the United States has
one set of laws, the European Union has another, and
France and Germany each have even more specifc laws.
German law goes even further and places restrictions on
the manipulation of primate genes as well. A common
thread unifying all patent laws, though, is the incredible
controversy and uncertainty surrounding it.
Courts and patent ofces have continually tried
to cut through the haze and develop clear-cut guidelines
for patents, but to date, none have been successful.
Te 1995 In Re Deuel case in the United
States made it harder to reject a patent as
obvious.
37
In 1997, courts in the United
States attempted to simplify the matter by
declaring that if a patent could provide a
nucleotide sequence of the gene (i.e. the
G, A, T, C sequence) then it could be
patented.
38
After intense criticism, the
guidelines were updated such that although
a product of nature may not be patentable,
a product of nature may be patentable if
signifcant artifcial changes are made. By
purifying, isolating, or otherwise altering
a naturally occurring product, an inventor
may obtain a patent on the product in its
altered form.
39
In Britain, it was decided
that a naturally occurring human gene or
protein in people cannot be patented, but
human genetic material removed from an
individual and then refned or reproduced
in the laboratory can be patented.
40

Tough these guidelines constitute the
essence of the current methods of evaluating
Gene patents are highly fragmented and split among a variety of patent holders, often
causing delays and obstacles to research.
Source: Science Magazine: Intellectual Property Landscape of the
Human Genome
patents, these systems have been criticized, by a range of
individualsscientists, ethicists, lawyers, and the general
publicfor a variety of reasons. Among the criticisms
are that the simplifcations have created guidelines
unft for the industry, that the new guidelines are actually
more confusing than the old, and that it is now too easy
for a discovery to be patented, even if it does not merit
protection.
One of the more signifcant rulings took place
in the United States in 2002. In the past, although
unauthorized use of intellectual property was illegal, the
research exemption always held. Tis exemption allowed
scholars and academics at universities to liberally use
intellectual property in the pursuit of scholarly research,
and generally applied to all university research. However,
the 2002 Madey v. Duke University decision ruled that
the unlicensed use of intellectual property was illegal
even in university research, efectively striking down the
research exemption. As a result, research at universities
around the world became hampered, as universities
now had to deal with patents and royalties they were
previously exempt from. Although the decision sparked a
ferce backlash by the scientifc and academic community,
it was never overturned.
41
Te most recent evolution in this issue may also
be one of the most signifcant. In March 2010, a court
in the United States shocked the biotech community by
invalidating patents covering mutations in the BRCA1
and BRCA2 genes that are used to assess the risk of
breast and ovarian cancer. Myriad Genetics, a company
based in Salt Lake City, Utah, holds exclusive licenses
on these patents and has aggressively defended them.
In 2009, a group of patients, researchers and clinicians
sued Myriad, asserting, among other complaints, that
the patents hamper medical research.
42
Te results
of this case (hereafter referred to as the 2010 Myriad
case) are far-reaching, as the court ruled that genes and
human genetic sequences could not be patented because
they are naturally occurring things, not inventions.
Tough experts agree that this specifc case is likely to
be overturned when it is appealed to higher courts, the
case is incredibly revealing. It is indicative of the growing
discontent among academics, scholars, researchers,
scientists, consumers, and medical patients of the current
gene-patenting regime. If the next few years do not bring
meaningful changes to the gene patenting system, it
is possible that the entire industry may grind to a halt,
entangled in a web of patents.
Map showing legality of genetically modifed crops across the world. Banned means either a full ban or a ban on everything but scientifc
research.
http://upload.wikimedia.org/wikipedia/commons/0/07/Gm_accept_map.png
Issues reGardInG Gene PatentInG
Despite the potential of genetic engineering, the
current system of gene patenting is drawing more
criticism than ever. As summarized in an article in Nature
Biotechnology in May 2010, In the last few decades, the
application of the patent system to the feld of biotech has
faced an increasing amount of criticism from scientifc
researchers, ethicists and lawyers alike. According to
these critiques, the broad utilization of the patent system
in this scientifc feld leads to counterproductive results,
is unethical, and of dubious legal validity.
43
Te problems surrounding gene patenting begin
from the very defnitions of gene and gene patent
themselves. Although this study guide defned a gene as
the DNA sequence needed to create a protein, there is
no set defnition of a gene, even in the scientifc world.
Conventional wisdom held that genes were like discrete
beads sitting on the long wire of the DNA. But the
reality, it turns out, is far more complex. Some DNA
sequences, when combined in certain ways with other
sequences, encode a vast array of proteins. Some genes
overlap. Some genes lie within genes.
44
Te complexity is
staggering. Tese problems themselves stem from a more
fundamental fact: gene patents are dealing with living
organisms. Whereas past patents dealt with immutable,
unchanging objectslight bulbs, microprocessors,
enginesgene patents deal with organic, changing
organisms. As David Ledbetter, director of the division of
medical genetics at Emory University School of Medicine,
said, Legally, I also think there are faws with patenting
genes, which are substances that occur in nature. One
purpose of the patent system is to stimulate people to
invent in areas not covered by patents that already exist.
However, it is not possible to invent an alternative to
a gene because there is no alternative substance. Tis
suggests to me that it is something fundamental in nature
and that it shouldnt be patented.
45
As a result, gene patents are a tangle as well. A
paper published in June 2010 found that over 20% of
the human genome is explicitly patented as intellectual
property, of which 63% are patented to private frms.
More confusingly, BMP7, an osteogenic factor, and
CDKN2A, a tumor suppressor gene, were each
claimed in 20 patents.
46
And in a worrying sign for
researchers wanting to work with certain genes, some
gene patents were so fragmented that they were near
impossible to work with; PSEN2, a sequence relating to
neurological disorders and arthritis, was split into nine
patents licensed to eight diferent assignees, and BRCA1,
a breast cancer gene, was split into 14 patents licensed to
12 diferent assignees. As a result, research in these areas
may be greatly inhibited, as such fragmentation raises
the possibility that innovators may incur considerable
costs securing access to genes via structuring complex
licensing agreements.
47
Another study examined one
of the most important gene patents, the Myriad BRCA
patent, that claimed 15-letter stretches of DNA in the
Map showing countries party to the WTO and to TRIPS. Dark green signifes a founder member of the WTO, and light green a
subsequent member.
http://upload.wikimedia.org/wikipedia/commons/thumb/b/be/WTO_members.svg/1000px-WTO_members.svg.png
patent. Te study found that 15-letter stretches of DNA
claimed in the Myriad patent are common throughout
the human genome and could be found in 80 percent
of the gene sequences placed in a publicly accessible
databaseGenBankthe year before Myriad sought
patent protection. GenBank is database of the human
genome created by the Human Genome Project that is
available for free to anyone with access to the Internet.
48

Te current system of gene patenting has grown so
complex and so dense that scientists often complain of
having to hack their way through a patent thicket in
order to do even the smallest bit of research.
Traditionally, industrial leaders have defended
gene patents on the basis of the need to protect
innovation. A report by the United States Congress
notes that, patents are particularly important in this
sector [biotechnology] because of the relative ease of
replicating the fnished product. Costs associated with
imitating a product ...are extremely low relative to the
innovators costs for discovering and developing a new
compound.
49
Te economic arguments traditionally
used in favor of patenting are being called into question,
however. A study published in April 2010 in Genetics
in Medicine found that, Exclusive licenses to gene
patents do more to block competition in the gene
testing market than to spur the development of new
technologies for gauging disease risk.
50
Many researchers also criticize the traditional
patenting model, upon which the current system of
gene patenting is based, as incapable of handling the
incredible speeds of innovation taking place. An editorial
published in Nature Biotechnology in May 2010 explains,
Broader concerns about gene patents, exclusive licensing
and aggressive IP infringement strategies are fnding
an echo within research. It often seems unfair that the
patent system rewards only the last inventive stepthe
small breakthrough that enables a concept to be realized.
Te research enterprise, which continually renews
itself, especially in rapidly moving areas like genetics, is
increasingly at odds with the commercial conservatism
of patent monopolies based on gene fndings that are
obsolescent compared with current art. Despite both
cultural and economic incentives for innovation, the
difculty in dislodging incumbent approaches is
reinforced by a patent system that insists that any use,
however small, of a protected method is infringement.
Is it so outrageous to expect that a properly functioning
IP system could provide an unobstructed path to the
market both for the initial innovators and for subsequent
improvers?
51
Some also criticize the gene patenting system
for distorting incentives away from the most benefcial
research. Tey argue that patents create a concentration
of wealth for the patent holders, and thus, researchers
and universities are compelled to do research in areas
that will make them money, as opposed to areas that will
have the most beneft for people and science. Studies
examining the situation have been inconclusive and
contradictory, and there is no clear conclusion. Seeing
as patents can be enormously lucrative, are publicly
funded researchers going to ignore ethical, moral, and
social concerns in a desire to make money for themselves
or their employers?
52

Further issues arise when considering how to
enforce patents and determining when patents have been
violated. A case highlighting the problems is Monsanto
Canada Inc. v. Schmeiser, which was debated in front of
the Canadian Supreme Court in 2004. Monsanto sued
Percy Schmeiser, a farmer, for infringing its parent to
a genetically engineered form of canola by deliberately
growing the crop in his felds without having paid a
license fee for doing so. Schmeiser claimed that the
genetically engineered crop had ended up in his feld by
accidentby the wind blowing pollen, by seeds blowing
of trucks, and by other paths Te Federal Court of
Canada judge found that it did not matter whether
Schmeiser had deliberately planted the genetically
engineered canola and did not bother to determine
whether Schmeiser was telling the truth about how his
felds became seeded by the legally-protected crop. Te
judge determined that Schmeiser was guilty of infringing
on Monsantos patent because he knew that the crop he
grew was mostly of the type covered by the Monsanto
patent.
53
Te controversial case drew criticism around
the world.
Additionally, gene patenting has drawn criticism
for the powers it gives the patent-holder, particularly
concerning genetically engineered crops and gene
therapy. Te rash of farmer suicides reported in India
over the past few years has thrown the issue into the
international spotlight, highlighting the efects that are
possible. In these cases, farmers were forced to purchase
genetically engineered cotton, known as Bt cotton, from
the multinational corporation Monsanto in order to
compete with other farmers in the global market. Bt
cotton was genetically engineered to be resistant to pests
and have higher yields, and was covered by patents held
by Monsanto. Earlier, indigenous cotton seeds were sold
on the market for roughly US$0.15 per kilogram, and
reproduced themselves. In other words, the seeds only
needed to be bought once. Te indigenous cotton crops
could also be grown with other crops, to ensure farmers
had a varied crop yield. Monsantos Bt cotton, however,
cost roughly US$369.50 per kilogram. Bt cotton has a
terminator sequence engineered into it, meaning that
unlike indigenous cotton, the Bt cotton grown does
not produce seeds, forcing farmers to purchase new
seeds every year. And Bt cotton is engineered to be a
monoculture; in other words, farmers could grow no
other crops but Bt cotton. When the Bt cotton crops
began to fail due to various reasonsthe emergence
of new pests, for instancefarmers were thrown into
debt so severe that 25,000 farmers have taken their lives
since 1997.
54,55
Whether patent-holders should be given
this kind of power, backed by the current international
system, is certainly a matter of debate that needs to be
considered.
Some critics, particularly those with heavy
anti-globalization sentiments, take this argument even
further, and say that gene patents have the potential
to perpetuate the current world order. Tey argue
that gene patents, inevitably held by companies based
in wealthy countries such as the United States and
Western European nations, have the potential to control
developing and underdeveloped nation development
with the use of said patents. Access to critical medicines,
for instance, or access to much-needed crops, could be
controlled by corporations. Critics point to the Indian
farmer suicide epidemic, and note that farmers were
forced to buy Bt cotton due to trade policies forced
onto the Indian agricultural market by the World Trade
Organization, a body often accused of perpetuating a
Western hegemony.
56,57
On the medical side, gene patents have been
criticized for restricting competition and thus reducing
the quality of healthcare available to patients, increasing
the cost of healthcare, and stifing medical advances in
the feld. When a single company holds the patent to
a gene, they also, efectively, control any procedures
using that gene, and can thus charge high rates for these
procedures. As described by Marc Grodman, CEO
of Bio-Reference Laboratories, Te frst example [of
the problem with gene patents] concerns one of our
societys most dangerous killers, breast cancer, and the
related breast cancer genes BRCA1 and BRCA2. Te
patent holder has granted an exclusive license to one
company to do the diagnostic testing for these genes. Not
surprisingly, over the course of time, quality issues arose.
for about 10 years the tests of breast cancer genes was
not as comprehensive as it might have been . Te
second example involves long QT genes that can cause
sudden death from heart arrhythmias. Tese genes were
patented and an exclusive license was granted to a single
laboratory. For 2 years, the exclusive licensed laboratory
went into bankruptcy and no other laboratory could test
for this gene. During this hiatus, Abigail, a 10-year-old
child with long QT syndrome, died. [Tere were
also] persistent problems with a test performed by this
exclusive laboratory, including long delays in getting
results, indeterminant fndings, high costs, and just the
basic lack of improvement . We can make a better
test, but under the existing system, we cannot.
58
On
the fip side, however, it could be argued that the initial
research done in the feld may not have been conducted
without the incentive of patents to protect the resulting
breakthroughs.
Te recent 2010 Myriad case ruling invalidating
the Myriad BRCA1 and BRCA2 gene patents, though
likely to be overturned, has been widely hailed within the
scientifc community for the benefts it may bring. Nobel
Prize-winning economist Joseph Stiglitz called the ruling
a major victory to science and medical innovation.
59
Te
overwhelming support the ruling has had in the scientifc
and academic community is a prescient indicator of the
direction gene patents ought to head in, and is an acute
indication of the shambles the current system lies in.
On the more ethical side of the argument, under
both American and European guidelines, part of the
patent application must show that the invention being
applied for is moral.
60
But we have no guidelines by which
to judge this. An interesting example of the fragmentation
of the patent system came to fruition in 1992, with the
invention of the Harvard mouse, or the onco-mouse.
As detailed by Stephen R. Munzer, Scientists at Harvard
University engineered transgenic mice that are highly
likely to develop malignant tumors early in life. Te mice
are useful in research on cancer. Harvard obtained a US
patent in 1988, and sought European patents on both
the process of genetic manipulation and the transgenic
mice themselves. Te EPO Examining Division refused
a patent on the animals in 1989 [on moral grounds], but
the Technical Board of Appeal remitted the case in 1990.
the Examining Division issued a patent on the onco-
mice in 1992, but stressed that the patent gave Harvard
only the right to exclude others rather than a positive
right to use the invention.
61
Legal wrangling over the
patenting of the onco-mouse continued until 2006 in
Europe, and until 2002 in Canada.
Although the patent was granted for this
signifcant alteration of a mouse, many ethicists
argue where we draw the line. Would it be permissible
to grant a patent for a new, cancer-prone dog? How
about a chimpanzee? As Philip Grubb, Professor at the
Franklin Pierce Law Center, stated in 1999, Given that
the genome of a human is 98 per cent identical with that
of a chimpanzee, how many genes does it take to really
make a diference?
62
Te ethics of gene patenting are
intrinsically related to the ethics of genetic engineering
itself, as explained in an earlier section of this guide.
current SItuatIon and PreSent relevance
As discontent with the current gene patenting system
increases, there is more pressure than ever to reform the
system. Te recent 2010 Myriad case is just a taste of
what is to come, and will likely open the door for a food
of court cases, objections, and reforms to the system. As
a result, like the genetic engineering industry itself, the
feld of gene patenting is likely to rapidly evolve over the
next few years.
Tis evolution has the potential to be a welcome
relief from the current situation. At the moment, genetic
engineering is a powerful industrial and scientifc
research area, but it is being burdened with a patent
system designed for non-living inventions from the
previous millennium that was slightly modifed to ft
biotechnology. Te job of patents should be to protect
and spur forward an industry, not be the obstacle to
development. It can provide a moral check, but it should
not hamper progress.
Despite the controversies and moral questions
surrounding genetic engineering itself, it is important
to remember that there is vast potential for human
betterment in the feld. Tere are many systems in place
to ensure that genetic engineeringor any cutting-edge
feldgoes in a direction that benefts humanity. One
of these systems is supposed to be the patenting system,
which is intended to monitor the ethics of research
being done. An ideal patenting system should accelerate
advancements by ofering incentives and protection. But
the current gene patenting system does not do this. As
summarized in an editorial in Nature in April 2010, As
the biotech industry inches closer to the long-anticipated
era of personalized medicine, genetic tests promise to
exert increasing infuence in the clinic. But fully realizing
that promise will require a view of gene patenting that is
considerably more sophisticated than the one-size-fts-all
standard that now prevails. Genetic testing is undergoing
a revolution. Classic tests relying on mutations in one or
two genes, such as the BRCA1 and BRCA2 tests, [the
same tests stripped of their patents in the April 2010
court decision], are giving way to complex analyses
involving many genetic signatures. Tests for a genetic
heart condition called long QT, for example, now assay
a dozen genes. Moreover, these complex analyses will
themselves give way to whole-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 would have to be negotiated
before a given test could be performed. Such a situation
threatens to hinder innovation.
63

Genetic engineering has the potential to alleviate
world hunger, provide highly-efective personalized
medicine at low costs, cure diseases that we could
only think of curing now, and provide solutions for
environmental remediation. But it also has the potential
to introduce unforeseen tragedies into human health,
unleash novel diseases upon humanity, and wreak
environmental destruction. For over a decade, scientists
have been calling for an international gene patenting
system with harmonized regulations.
64
Without a
properly functioning, international patent system in place,
global genetic engineering research cannot function. Te
sooner a well-functioning system is put in place to allow
international cooperation and competition and to guide
genetic engineering, the better of humanity will be.
PaSt un actIonS
History of the Committee discussed various treaties
that were pivotal in the creation of WIPO and directly
infuence this topic. Despite the groundbreaking work of
the Paris Convention, however, the single most important
agreement relating to this subject is the Agreement on
Trade Related Aspects of Intellectual Property Rights, also
known as the TRIPS agreement. Negotiated at the 1994
Uruguay Round of the General Agreement on Tarifs
and Trade (GATT), TRIPS was the frst international
intellectual property (IP) agreement, and remains the
most comprehensive and expansive set of rules governing
global IP.
65

TRIPS derives part of its power from the intimate
link that it has with the World Trade Organization
(WTO); countries cannot join the WTO without
ratifying TRIPS, and countries that violate the TRIPS
agreement can be punished by the WTOs Dispute
Settlement Body. As a result, all 153 WTO members are
also party to the TRIPS agreement. Te link that TRIPS
established between trade and IP was a major triumph
for developed nations, notably the United States, who
had been pushing for the hyphenation of trade and
IP for years. Te culmination of these eforts was the
creation of the 1995 Agreement Between the World
Intellectual Property Organization and the World Trade
Organization.
66
Te most relevant portion of TRIPS is Part II,
Section 5. Article 27 of this section states, that:
patents shall be available for any inventions,
whether products or processes, in all felds of
technology, provided that they are new, involve
an inventive step and are capable of industrial
application. [P]atents shall be available and
patent rights enjoyable without discrimination as
to the place of invention, the feld of technology
and whether products are imported or locally
produced.
67
Tis strongly-worded section single-handedly
demands that countries patent any new
inventions. Te agreement goes on to broadly
state, however, that [m]embers 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 plant life or health or to avoid
serious prejudice to the environment.
68
Te
agreement then specifes that certain other items
can be exclude[d] from patentability, notably,
diagnostic, therapeutic and surgical methods for
the treatment of humans or animals and plants
and animals other than micro-organisms, and
essentially biological processes for the production
of plants or animals other than non-biological
and microbiological processes.
69
Te full text
of Part II, Section 5 of the TRIPS agreement is
available in the appendix to this study guide. Tis
portion, however, indicates that although TRIPS
demands a strong patenting system, it also allows
broad and imprecise exceptions to the rule that
everything must be patentable.
Although TRIPS clearly sets the need for a strong
patenting system, it is, in the words of the World Health
Organization (WHO), deliberately ambiguous, which
gives countries some freedom to interpret this in their
national legislation as they deem ft.
70
Te wording is
so vague that it specifes very little. Te exceptions that
it grants to patentability are vague; WHO notes that
countries could consider to specify in their national
legislation that the following 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 its elements, in whole or in
part.
71
As a result, the enormous discrepancies created
are not conducive to international-level research.
An additional problem with TRIPS is that, as it
is over a decade old, it does not appropriately deal with
the advanced genetic engineering and biotechnology
that we face today, creating a need for a more updated
agreement.
72
In addition, TRIPS itself has become
an enormously polarizing agreement, and has been
plagued by many of the accusations levied against the
WTO. Many developing nations have accused developed
nations of forcing harmful IP laws upon them by
bundling them all together in one agreement and forcing
countries to adopt the agreement in order to join the
WTO. Economist and Nobel laureate Joseph Stiglitz
warns that, Intellectual property is important, but the
appropriate intellectual-property regime for a developing
country is diferent from that for an advanced industrial
country. Te TRIP[S] scheme failed to recognize this.
In fact, intellectual property should never have been
included in a trade agreement in the frst place an
international organization [WIPO] already exists to
protect intellectual property.
73
Stiglitz also issued a harsh
condemnation of TRIPS, saying that, I [Stiglitz] served
on the Clinton administrations Council of Economic
Advisors at the time [that TRIPS was created], and it
was clear that there was more interest in pleasing the
pharmaceutical and entertainment industries than in
ensuring an intellectual-property regime that was good
for science, let alone for developing countries.
74
Despite these criticisms, TRIPS has lasted for
over a decade, serving as virtually the only source of
international guidance on gene patenting. Tough it
has worked well enough in the past despite not being
revised or replaced thus far, international agitation for
a new gene patenting system is on the rise. Tis makes
it more likely that additional agreements regarding
gene patenting must be negotiated by WIPO to either
supplement or entirely replace TRIPS.
ProPoSed SolutIonS
With the whirlwind of activity surrounding gene
patenting, it is imperative that solutions be implemented.
Two popular solutions among the scientifc community
are patent pooling and clearinghouse mechanisms.
A patent pool is formed when many companies,
academic institutions, and other inventors give their
patents to a central organization, a patent pool. When
other inventors want to use the patent, they go to the
patent pool and pay a fee. Part of this fee goes back to
the original inventors who fled the patent, and a small
portion goes to maintaining the patent pool. In this
way, the patent thicket is cleared, work is streamlined,
researchers no longer need to deal with multiple
companies, and novel treatments, agricultural practices,
and other genetically engineered products critical to
human development are no longer monopolized. Many
companies can pay the fee for the patent for, say, pesticide-
resistant soybeans, keeping prices low. In addition, most
research today needs multiple patents to work, as it builds
upon many previous discoveries. An entire project can be
destroyed if one company rejects an application for the
use of its patent. A patent pool would allow researchers
to build upon previous achievements unhampered.
Despite the potential of a patent pool, there
has not yet been a successful one. As explained in an
editorial in Nature, Patent pooling and clearinghouse
mechanisms are probably not going to emerge in biotech
of their own accord. It will therefore probably take
some form of government or legal coercion to get things
moving for gene tests. As we move from single-gene tests
to multiple-gene signature testing and whole genome
sequencing, it might also be possible to assign rights
according to the importance of any specifc gene sequence
in the utility of the test. Such a principle, instead of
rewarding companies that managed to surround the early
gene mutant discoveries (which now look rather trivial)
with an impenetrable wall of IP, would incentivize those
who continue to develop tests of high medical value with
commensurate fnancial remuneration.
75
Other scientists call for an open biotechnology
movement, inspired by the open source movement in
the feld of information technology (IT), as well as by the
already existing open science ideal within the academic
community. Similar to open source projects within
computing, where a large pool of researchers can rapidly
contribute to an invention without being hampered by
IP restrictions, an open biotechnology project would
be open for contribution by a large pool of scientists.
76

While open source IT projects have fourished because
of copyright laws though, open biotechnology is not
possible due to the nature of patent laws. Tis is an
extremely promising idea, however, and the open source
software movement has shown it to be possible. Tis
idea could be taken further, and perhaps its ideals and
implementation can be written into an agreement that
comes out of this committee.
In 2006, a group of American university-
afliated researchers who were concerned about the
current patenting system gathered to create nine points
to aspire towards when creating a new licensing system.
Tese nine points, as summarized by Jon Soderstrom of
the Ofce of Cooperative Research at Yale University,
are:
77
Point 1: Universities should reserve the right to
practice licensed inventions and to allow other
non-proft and governmental organizations to do
so
Point 2: Exclusive licenses should be structured in a
manner that encourages technology development
and use
Point 3: Strive to minimize the licensing of future
improvements
Point 4: Universities should anticipate and help to
manage technology transfer related conficts of
interest
Point 5: Ensure broad access to research tools
Point 6: Enforcement action should be carefully
considered
Point 7: Be mindful of export regulations
Point 8: Be mindful of the implications of working
with patent aggregators
Point 9: Consider including provisions that address
unmet needs, such as those of neglected patient
populations or geographic areas, giving particular
attention to improved therapeutics, diagnostics and
agricultural technologies for the developing world
Tese nine recommendations would occur in an
ideal world, as described by the academic community.
Tey are included as guidelines to consider when creating
additional solutions, and are not solutions in and of
themselves. However, the more of these recommendations
that can be included and incorporated into the solution,
the better the fnal outcome will be. At the very least,
these nine points should guide the work being done in
committee.
QueStIonS a reSolutIon muSt anSWer
Te goal of this committee is to create a comprehensive,
unifying, international treaty on genetic patenting. When
creating this agreement, the following points should be
considered and/or incorporated into the fnal agreement:
Will this new treaty supplement or entirely replace the
few guidelines in the TRIPS agreement?
If any new bodies, organizations, or agencies are
created, who will administer them? WIPO, or the
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 with
the WTO, if at all, to administer a properly thought-
out and implemented gene patenting system?
How will issues of morality be dealt with? What is
considered moral and immoral? Are there limits
to what can be engineered, based on these concepts
of morality?
What exactly can be patented? Will patenting of animal
inventions and plants be allowed? Will patenting
of the human body and its parts be allowed? How
do you deal with human ownership of genes (i.e. a
company owning a certain gene sequence from your
cells)?
Where do we draw the line between naturally-
found genes and biological products (and thus
unpatentable) versus man-made and invented
products (and thus patentable)?
Which genes can be licensed? Do we draw distinctions
between broad and specifc genes?
How do we deal with the two aspects of a patentthe
right to exclude others from using an invention and
the right to use inventionin international gene
patenting law?
How powerful and exclusive are the patents? How
do we deal with the interface of patent law and
academic research (i.e. how do we deal with the
traditional research exemption)? How do we keep
the free and open fow of information so cherished
by academics without destroying incentives?
Will an international agreement set up coordinated
eforts, such as patent pools and clearinghouses?
Will inventions made at an early stage of research and
development, upon which entire felds may rely,
be treated diferently from those made later in the
process?
What are the repercussions for violating the agreement?
What constitutes a violation?
Key actorS and PoSItIonS
nGos, unIversItIes, and corPoratIons
Non-governmental organizations (NGOs)
representing various groups of people will have a vested
interest in the issue. NGOs representing scientists and
academics may push for increased ease of access to patents
to facilitate research, the creation of international patent
pools and other cooperative mechanisms, safeguards
against egregious patenting practices by corporations,
and increased safeguards over research based patents.
NGOs representing environmentalists may argue for
a morals-based patenting process, emphasizing that
new innovations are not good just because they are
new. Tey will likely emphasize the many harms of
genetic engineering, and argue for a patenting system
that allows contemplation over each new process in
order to deem whether the benefts outweigh the risks.
NGOs representing animal rights activists might argue
for the full ban of genetic engineering involving sentient
creatures, arguing that altering the genetic makeup of an
animal violates its biological integrity, and that creating
genetically modifed animals to test genetic engineering
on is akin to a gruesome, more sophisticated form of
animal testing. NGOs representing farmers and those
involved in agriculture may push for looser patent laws
with a clearer set of guidelines and procedures, in order
to reduce the hold biotechnology corporations have on
global farming practices.
Various companies may also take a keen interest
in our proceedings, as the new agreement would afect
the bounds by which these corporations can operate.
Companies involved in biotechnology and in the
pharmaceutical industry would be most interesting,
though genetic engineering has a broad impact. For
instance, manufacturers may be interested, since
genetically modifed bacteria can make plastic, farmers
would be interested in how their seeds may be afected,
and energy companies may be interested since bacteria
may be able to split water into hydrogen and oxygen for
energy.
Curiously enough, the WTO itself may take an
interest in our proceedings. When TRIPS was passed,
the WTO imposed itself into the world of intellectual
property, leveraging its power in global trade to try and
police global intellectual policy as well. When it did this,
it stepped into the jurisdiction of WIPO. If WIPO were
to pass a new, more powerful, comprehensive intellectual
property agreement dealing with genetic engineering,
the WTO would likely be concerned about whether the
power they transferred to themselves via TRIPS might
fow back to WIPO.
Universities, as major hubs of international
research, will also have a strong say, as they wish
to protect their ability to do research in the feld of
biotechnology. Tey may push for a strong inclusion of
the research exemption. Tey will advocate on various
fronts, pushing for increased ease of access to patents and
a clearer set of guidelines for patenting novel innovations.
Tey may also push for easier patenting laws, to make it
easier for universities to retain credit for research; this is
likely to be tempered by their desire for easy access to
patent rights. Universities may also push for a royalties
program to ensure that they make profts from the
research done in their laboratories.
Bloc PosItIons
Tis 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 possible
that the blocs that you will form will be driven by
personal biases, prevailing attitudes in each nation, and
other non-political factors.
A potential divide may arise based on
governmental regulation within each country. If you are
representing a country that favors strong government
regulation, such as one from the European Union, you
may favor a patenting system 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 States, you may be in favor
of a less involved patenting system that dictates less and
leaves moral issues to the market.
Another divide may emerge based on the
activities of multinational corporations. Countries that
are home to various multinationals may pursue policies
favorable to these corporations, such as strong patenting
rights for license holders and easy patenting procedures
to make obtaining patents easy. If you represent a country
that may be the victim of multinational activitiesbe it
through unfair sales of seeds, increased medicine prices,
etc.you may be in favor of a patenting system that
emphasizes consumer rights, and tries to limit the power
patent license holders have over their products. Tis very
well could result in the usual divide of developed nations
versus developing nations.
In many cases, you will have to balance various
interests when representing your country: your countrys
commitment to regulation versus the free market,
importance placed on consumer protection versus
advancing corporate interests, etc. Te best way to get
a feel for where your country stands is to look into
national laws. Keep in mind, however, that just because
your country currently uses a certain patenting process,
it does not mean it will argue strictly for this process
on an international level. What matters more are the
values, ideals, and interests represented in your nations
patenting procedures, not the specifc details. By going
into negotiations with an open mind and the knowledge
that the new agreement will be a radical change from
the status quo for all nations, hopefully a high-quality,
comprehensive international agreement can be crafted.
SuggeStIonS for further reSearch
I would like to briefy re-emphasize that there is no
need to do further research into the science of genetic
engineering. If you are interested in more specifcs, I
certainly do not want to discourage you from pursuing
the science. However, all the science that you need to
know has been included in this study 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 of the issue.
Everyone should be familiar with the Part II,
Section 5 of TRIPS, as it directly lays out the framework
for the current global patenting system. Te full text can
be found in the appendix. Scientifc publications, such as
Nature, also publish many useful articles and editorials
on the issue that provide specifc details that may prove
useful. Tese articles can be found in the features section
of the magazine, and are written in plain English and are
easily understandable by a non-scientifc audience. Many
governments have held proceedings in front of their
legislative bodies or in committees to explore reforms
in patent law. Tese proceedings often bring in experts
from the feld that give lengthy, very useful testimony
on the subject. Many of these proceedings make their
transcripts available for free online, and are excellent
resources as well.
It may also be useful to follow the news regarding
the latest developments in this feld. For instance, there
will likely be many updates on the court cases ongoing
in the United States regarding the 2010 Myriad case,
which will in turn open up a food of new court cases. A
growing coalition against the current patenting system is
also forming, which may also create newsworthy items.
Tere may also be editorials and opinion pieces by well-
known scholarsgeneticists, lawyers, and economists
that could be useful. Tese scholars often bring a new,
eye-opening perspective to the table and are worth
examining. Following reputable international news
sources will keep you informed of the evolution of the
feld.
Protection of indigenous, ancient,
and traditional knowledge
Statement of the Problem
For almost a decade, international bodies have been
struggling with the issue of the protection of traditional
knowledge (TK). Instances of biopiracy, situations
when TK is commercially exploited without the consent
of the community it originated in, provoked public
outrage throughout the 1990s and early 2000s. And
even today, TK is slowly being pilfered from traditional
and indigenous communities around the world and
being used for commercial purposes. It
is clear to most people and nations that
such cases are wrong, and ought to be
addressed. But the mechanism by which
this can be done is yet to be negotiated.
At stake is a vast collection of
knowledge. TK represents the sum of
thousands of years of organic evolution
of human thought and accomplishments.
Most of the food we eat, medicines we
use, and cosmetics we apply today were
developed from plants and techniques
frst found from TK. In fact, many
modern advances in the pharmaceuticals
industry and the material sciences are
based on information gleaned from
TK. and But the communities this TK
originated from have received virtually
no compensation, compared to the
massive profts reaped by those who used
the TK.
Te challenge this committee
faces is to create a system that protects
TK from exploitation, but does not
stife it and prevent future development
of TK. Tis system will have to weigh
many considerations: it must allow TK
Ingredients used in traditional Chinese medicine for sale
in a market in China.
http://www.absolutechinatours.com/UploadFiles/ImageBase/Chinese%20Herbal%20Medi-
cine%201.jpg
to do good for as many people as possible, but not at the
expense of the community it originated from. It must
protect TK by bringing it into the intellectual property
system, but it must not impose the system upon these
traditional and indigenous communities. It must reform
the current system, but the resulting product must be
adopted by enough nations to be useful. Te task is
difcult, but by sharing the knowledge and experience
of each nation, and through measured and deliberate
conversation and compromise, a solution can surely be
found.
hIStory and dIScuSSIon of the Problem
defInInG tradItIonal KnowledGe
Te difculty and failure of integrating traditional
knowledge (TK) into global thought and protection
manifests itself from the starting point of the discussion:
the defnition of TK. To date, no one has created a
non-controversial, working defnition of TK. Tough
the reasons are complex, there are a few overarching
reasons for the difculty. Much TK, such as indigenous
knowledge, is very diferent from the Eurocentric point
of view that dominates global forums. For instance, TK
is often intricately intertwined with ideas of the natural
elements, making it difcult to isolate and defne. In
addition, TK is extraordinarily diverse, and has few
unifying features. TK ranges from ancient surgical
techniques to farming practices. Also, TK is often
so much a part of the community it comes from that
it is often impossible to extract what one may call the
traditional knowledge and defne it.
78
Given these limitations, some scholars have made
attempts at defning TK. For instance, Tomas Cottier,
of the University of Bern, defnes TK as the ways and
means by which individuals or communities identify
and improve genetic resources over time, including
processes related to their extraction from nature and
their preparation for human usage. Also implicated by
the term are methods and techniques for preserving
the communities accumulated information about
genetic resources for future generations.
79
Tis inclusive
defnition categorizes not just the knowledge itself, but
the methods by which the knowledge is practiced and
disseminated as well. Tis is further explained by Nuno
Pires de Carvalho, head of the TK program at WIPO,
who notes that, TK comprises two main (and to some
extent, distinct) categories: on the one hand, TK consists
of knowledge itself, that is, ideas developed by traditional
communities and indigenous peoples, in a traditional
and informal way, as a response to the needs imposed by
their physical and cultural environments and that serve as
a means of cultural identifcation. Tis contrasts with
expressions of TK, also named expressions of folklore
or expressions of traditional culture, such as verbal
expressions (tales, poetry, riddles), musical expression
(songs and instrumental music), , tangible expressions
etc.
80
Tankfully, the difcult issue of the defnition is
not a major obstacle for discussions. WIPO has spent
much of the past decade struggling with the defnition of
TK, and concluded that although it is critical to have a
grasp of what TK entails, there is little need for a precise
and universal defnition of TK in order to develop a
legal system for its protection. Many patent laws that are
currently in place are also based on undefned concepts;
for instance, most patent laws do not defne inventions.
Instead, these laws set out the characteristics necessary for
something to be an invention. In the same way, a defnition
of TK can contain the integral characteristics needed for
something to qualify as TK, such as a defnite link to
a traditional community. Tis would be a more practical
strategy that trying to create a lengthy and universal
defnition of what TK actually is, something that has
proven to be a fruitless endeavor.
81
While reassuring, this
conclusion is also incredibly revealing. Although WIPO
has not yet created any sort of framework for bringing TK
into the global intellectual property (IP) system, WIPO
has, in the past, leaned towards the creation of a system
Tribes in the American Southwest make approximately US$800
million per year selling traditional goods. Above, pots for sale in
the American Southwest.
http://www.zanzibartrading.com/images_0-f/talaveracatrinaclay-
potplant71023_small.jpg
that creates a set of criteria to qualify something as TK,
rather than create a defnition to encompass all TK.
tHe ImPortance of tK
Te impacts of TK are enormous. To fully understand
the need to protect TK, it is important to clear a
misconception: TK is not necessarily old, and therefore,
not necessarily automatically in the public domain. TK
continues to be created by traditional and indigenous
communities, building on itself. Tus, by protecting
TK against exploitation, additional resources may fow
back into the communities where TK originates, further
stimulating the creation of TK.
82
Traditional simply
refers to the sharing and learning methods by which
TK is created. As clear examples that TK is still evolving
and advancing, one needs to look no further than the
traditional medical systems of many South and East
Asian societies, all of which are based upon ancient texts.
Yet, each country continues to publish advancements
and refnements of their traditional medical systems, for
example, through the Chinese Academy of Traditional
Medicine, or the Indian Central Council for Research in
Ayurveda and Siddha.
83
It is also important to dispel the
misconception that TK is primitive. TK encompasses
a broad range of felds, and includes areas from refned
surgical techniques to complex perfume-making processes.
Too often, people associate TK with scientifcally corrupt
techniques, and fail to see the massive contributions that
TK continues to make to modern science.
In economic terms, as knowledge already present
in nations, TK has the potential to pull underdeveloped
nations up, by jumpstarting their economies. Nuno de
Carvalho, head of WIPOs TK division, explains,
some indigenous peoples and traditional communities
live in the direst poverty, and yet they are potentially rich
in intangible assets; however, assets (intangible or not)
can only be capitalized and become tools of economic
development upon their formalization and recording.
[Indigenous peoples and traditional communities]
could formalize their intangible assets, , which would
permit their transformation into capital.
84
As a tangible
example, TK can be converted into an attraction for
tourism, providing a major boost for least developed
countries. For instance, it is estimated that the TK of
various Native American tribes in the Southwest United
States produced approximately US$800 million in
annual sales, primarily through the sale of traditional
pottery and earthenware.
85

Te economic impact of TK is also immense. Te
feld where TK has probably made the greatest impact
is medicine. Traditional and indigenous communities
have discovered and recorded knowledge of a vast range
of medicinal plants and herbs, as well as combinations
and preparations of these plants to boost health. TK
also possesses a wealth of information on agricultural
and forest products that now generate massive fows of
revenue worldwide. Additionally, TK is used as leads
for the development of new medicines, and is used in
various industries, such as pharmaceuticals, cosmetics,
agriculture, and biotechnology.
86
In fact, de Carvalho
writes that, Te relevance of TK as a useful source
of information for researchers in the pharmaceutical
feld who seek to identify new chemical and biological
elements, as well as new approaches to disease treatments,
is generally undisputed.
87
For instance, in 1990, the
estimated market value of plant-based medicines sold in
OECD countries was [US$]61 billion, an extremely
conservative estimate in light of the fact that of the 119
plant-based compounds used in medicine worldwide, 74
percent had the same or related uses as the medicinal
plants from which they were derived.
88
It has been
further estimated that rice strains derived from TK in
India alone account for US$400 million worldwide.
89
Recent scholarship has also linked the protection
of TK to human rights. Tese arguments stem from
the Universal Declaration on Human Rights and the
International Covenant Economic Cultural and Social
Rights, which recognize the rights of everyone to
protection of the moral and material interests resulting
from any scientifc, literary, or artistic production of
which he [or she] is the author, and to share in scientifc
advancement and its benefts.
90
Considering that over
80% of the worlds population depends on traditional
medicine for health needs,
91
and that much of the
worlds diet is based on TK, depriving a culture of its TK
also robs the people of their capability to lead a higher
quality life.
92
Moreover, TK plays an integral part in the
social and spiritual well-being of global traditional and
indigenous communities, which could be jeopardized by
exploitation of TK.
93

tK and Intellectual ProPerty
Te issue of TK and IP fully emerged onto the
international scene in 1999, when issues of TK
were formally integrated into the ofcial WIPO
agenda, and further in 2001, with the creation of the
Intergovernmental Committee on Intellectual Property
and Genetic Resources, Traditional Knowledge, and
Traditional Cultural Expressions (previously called
folklore) of WIPO. Progress on the issue has been slow
and disjointed since then; in other words, almost a decade
has passed without signifcant movement in bringing TK
to the world of IP.
94
According to Weerawit Weeraworawit, Minister
of Commercial Afairs of Tailand, Patents [and the
current IP system] aford protection to something new
without giving regard to the sources of research and
development giving rise to such new invention. Tis
emphasis on protection of novelty while ignoring the
sources has become more pronounced with the progress
of biotechnological innovations making use of genetic
resources and giving rise to complaints by developing
countries about biopiracy.
95
Another issue driving
biopiracy is that TK is extremely open. If someone visits
a community and realizes a certain plant has medicinal
benefts in their TK system, (s)he can take the plant back
home and patent it without the next inventive step that
is usually needed. And since TK is not in the current
IP regime, biopiracy has consistently worked in the past
(though that has quickly changed in recent years, in
large part due to major pushes by various countries and
NGOs). Te holder of the patents now reaps the benefts
without the consent of the original
community, and has no obligation
to share the economic value of the
knowledge.
96
On a fundamental level,
TK poses a new challenge for the
existing IP regime. It is important
to remember that the tradition in
traditional knowledge does not
connote old, but, in the words of
the Bern convention, the manner
of producing such knowledge,
and not to the date on which
the knowledge was produced.
Tus, TK is knowledge that has
been developed based on the
traditions of a certain community
or nation.
97
At the moment,
international agreements on IP are
based entirely on individual rights.
Tus, to provide international legal
protection for TK is a signifcant
departure from this individual-
rights system to a system that
recognizes and protects communal rights. A communal
patent on TK would beneft no single person, but an
entire community, since it takes a community to keep the
TK relevant, intact, and accurate.
98
Te departure from
a highly individualistic to a community-based approach
is unprecedented. But it is possible that the international
legal framework will shift towards a new system. Finding
a way to harmonize and keep these systems cooperating
may prove to be a challenge.
99
Te communal rights versus individual rights
debate has created major factions, each radically diferent
from the other. One group of advocates says that since
communal rights are so diferent from individual rights,
an entirely new system must be created for IP protection
of TK. Another group says that since TK is a communal
good, it has no right to be protected as IP, and thus
should not be protected. A third group argues that TK,
while diferent, can be accommodated into the current
IP system with slight modifcations to the current IP
protection regime. While the various sides argue over the
issue, TK is left unattended to, and becomes a de facto
public good, resulting in its exploitation.
100
Closer examination, however, reveals that
traditional communities themselves do not see TK
as a public good. Many indigenous and traditional
Te periwinkle, a plant from Madagascar with anti-leukemia applications that fell victim to
biopiracy.
http://www.biolib.cz/IMG/GAL/54089.jpg
communities already have systems in place to regulate
and share TK. Jean Homere, of the U.S. Patent and
Trade Ofce, shares that, For instance, local shamans
view shamanic knowledge as a commodity that can be
lent, sold, exchanged, and stolen. Similarly, locals from
Melanesia trade their secret knowledge for food and/or
money.
101
Due to the fact that much TK is so easy to
replicate, traditional cultures have in the past created
indigenous systems to deter knowledge theft. Social
barriers (e.g. ceremonies), rituals, secrecy (e.g. shrouding
experimentally-proven herbal remedies with magical
preparations) have all served as methods to prevent others
from easily duplicating TK. In much of the world, the
legal system has been created to serve this very function,
giving hope of the potential to merge the two systems.
102
Given this protective nature of TK, it is important
not to take the communal versus individual rights aspect
of the issue too far. Although it is certainly true that
many indigenous and traditional societies are more
community-based than those currently in the global
IP system, concepts of ownership exist in most of these
societies, as evidenced by careful study of anthropological
literature. Furthermore, many of these societies have
actual systems of IP in place, though these systems vary
widely from each other and from the Western IP regime
currently in place. Te biggest diference between these
traditional IP protection systems and Western ones is that
these societies consider each member of the community
as having individual rights and collective responsibilities
that are linked inextricably.
103
Individuals in these
societies think in terms of the freedom to be what
they were created to be, rather than being free from
certain kinds of state encroachments,
104
but are aware
that along with this comes a sense of unique personal
responsibilities to kin, clan and nation.
105
A well-crafted
IP system will take into consideration the current systems
of IP protection present in traditional communities, and
rather than trying to replace these systems, will expand,
strengthen, and build upon them.
As a result of such a broad and fexible mindset,
the resulting IP protection systems are also very diverse.
Some traditional communities fnd it presumptuous
to attribute certain knowledge to any human. Instead,
they attribute the knowledge to pre-human creators and
spirits. But another study conducted by the Honeybee
Network found that many of the 10,000 innovations
they had documented were attributed to and claimed
by individuals.
106
And in an entirely diferent realm, a
recent study showed that IP protection is not feasible
for many crops because their origins cannot be properly
traced to a particular source. Te same study noted,
however, that TK created in the past 50 years could, in
general, be traced and attributed.
107
IP also has the potential to serve a crucial function
unrelated to economic and property dilemmas.
As traditional ways of life are being eroded
worldwide, external legal recognition of TK
will make the learning and development of
such knowledge a more attractive prospect for
the younger members of such communities,
thus perpetuating its existence.
108
In
addition, it is a known fact that most TK is
passed on and preserved via oral transmission,
from generation to generation. Tere are, of
course, major exceptions. For instance, much
knowledge from African, Latin American, and
Asian civilizations were written thousands
of years ago and thus, persist today. In
general, however, TK is orally transmitted,
and therefore not written or recorded in any
permanent way. Part of TK itself depends on
the context and community in which it exists,
and on the language it is told in. Unfortunately,
around 90% of the more than 6000 currently
spoken languages are projected to go extinct
in the next 10 years.
109
Addressing the reasons
Turmeric has been used for its medical and culinary applications for millennia in
India, but was patented in the United States in the 1990s.
http://www.allbestindiarecipe.com/blog/wp-content/uploads/2009/04/turmeric.jpg
behind this is beyond our scope. However, a thoughtfully
created IP system will also serve as a way for TK to be
archived and retained for perpetuity, despite the loss of
the original languages they were transmitted in.
Other scholars are concerned that TK will be
forced to be integrated into the current IP system, and
that TK will be molded and warped to ft into the
current system, resulting in a loss of TK. Tis worry
stems from the fact that the current system in place is
highly compartmentalized; science and religion do not
mix, humans and the environment they live in are highly
disconnected. Most traditional societies, however, live
in a connected world, and the TK coming out of these
communities is extremely holistic. Western observers
often believe that TK has both a scientifc and a religious
component, and are compelled to strip the TK of the
spiritual elements and leave only the science. But such
practices are misguided and destructive, for leaving just
the practical core will destroy much of the value of TK
that is embedded in the religious context in which it was
developed.
110
In fact, the traditional approach has yielded
advantages over the current system. For instance, there
are a group of plants in Mexico that scientists had always
regarded as belonging to the same species. But traditional
communities in the area realized that each plant actually
possessed very diferent biochemical properties that
are indicated by indigenous categorical systems and
local knowledge.
111
Had this TK been forced into the
current IP protection system, it is very likely that the
current system would have prevailed over the traditional.
Te Western categorization of these plants as a single
species would have overridden the TK that realized the
diferences, and this TK would have been lost.
112
Fears
of such a scenario replicating itself across the world have
driven some activists to urgently warn that the status quo
may be better than a misguided and improperly created
IP system for TK. But a larger plurality of NGOs and
activists warn that, Te claim that we should just leave
them alone is simply a recipe for the continuing loss of
languages, livelihoods, and the resources that the worlds
poor rely on.... It is also a recipe for undermining the
continued survival of modern medicine and agriculture,
which are crucially dependent on the genetic resources
produced with the knowledge held by the worlds poor.
113

dIlemmas reGardInG tK and tHe need for
reform
Te complex interplay between TK and IP protection,
as outlined in the previous section, brought about many
dilemmas regarding TK that were discussed. Among these
were the fundamental diferences between community-
based versus individual-based property rights, the
fact that traditional communities have extraordinarily
diverse and disparate customs surrounding IP protection
and mindsets about ownership and IP, and that forced
integration into a poorly-created IP protection system
could backfre and destroy TK.
As briefy mentioned earlier, the Western way of
thought has a tendency to look at TK and separate it
into rational and irrational parts, valuing only what
is deemed rational and scientifc. Although this may at
frst seem like an easy obstacle to overcome, it has broad
implications. A common solution to biopiracy and theft
of TK has been to create databases of TK. If patents were
fled in ofces in other countries attempting to patent TK,
a country could present the information in the database
as evidence that the knowledge was already known.
Although this solution has worked for some countries,
some traditional healers have begun to object to the use
of databases on the grounds that the databases document
only the technical expertise and not the complex social
customs surrounding the techniques.
114
Another major issue has to do with the protection
of TK itself. How do we protect TK without stifing its
further creation? By its very nature, TK builds upon itself.
Te IP protection system currently in place efectively
locks out others from using knowledge that is patented. If
this were applied to TK, then TK would fail to evolve. As
WIPO itself recognized, Challenges of multiculturalism
require cultural policies that maintain a balance between
the protection and preservation of cultural expressions
traditional or otherwiseand the free exchange of
cultural experiences. Mediating between the preservation
of cultural heritage and cultural distinctiveness on the
one hand, and nurturing and nourishing of living
culture as a source of creativity and development on the
other, is another challenge.
115
An additional dilemma arises when questions
of enforcement are considered. It is important to
remember that TK encompasses a range of knowledge,
including agricultural knowledge. Te examples cited
in previous sections of cosmetics, herbs, and even the
pharmaceutical industry pale in comparison to the
most stunning example of the infuence of TK. Ikechi
Mgbeoji, Assistant Professor of Law at the Osgoode Hall
Law School, writes, of the twenty major food crops,
none originated in North America or Australia and only
tworye and oatsoriginated in the Euro-Siberian
area. Virtually all of the developed countries foodstuf
originated in the tropical countries [where the majority
of the worlds traditional communities are located].
116

Jack Kloppenburg, Professor of Community and
Environmental Sociology at the University of Wisconsin,
goes even further to say that, Of crops of economic
importance, only sunfowers, blueberries, cranberries,
pecans, and the Jerusalem artichoke originated in what is
now the United States and Canada. Northern Europes
original genetic poverty is only slightly less striking; oats,
rye, currants, and raspberries constitute the complement
of major crops indigenous to that region. Australia has
contributed nothing at all to the global ladder.
117
Almost
all the major crops of the world originated in traditional
communities currently mired in debt. How are we to
compensate them for their past knowledge, if at all? How
do we integrate knowledge so fundamental to humanity,
so deep, and so profound, into a global system? When
the current inequities between the global South and
the global North are also brought into the picture, it
becomes clear why negotiations are so difcult. Progress
on TK and IP become entangled in a web of other
considerations.
Te last major dilemma that will be mentioned
in this guide is a difculty that plagues any system of IP
protection: the need for international cooperation, and
more importantly, the need for high levels of cooperation
between developed, developing, and underdeveloped
nations. Countries acting independently cannot achieve
the goals this committee is trying to achievenamely,
economic, environmental, and social equality and
fairness. Protection of TK will only work if a critical mass
of both developed and developing countries sign onto
an agreement and are bound by it. Only such a widely
accepted and followed agreement can protect traditional
and indigenous communities from the exploitation of
their TK.
118

caSe StudIeS
Tere have been various attempts in communities
around the world to try and secure their TK from being
exploited and biopirated by others. Almost all of these
actions have been defensive measures, put into place after
a portion of the countrys or peoples TK was exploited;
very few, if any, of the measures were proactive. As a result,
the measures implemented should be seen as stepping
stones and events to learn from in working towards a
more unifed, strengthened, international system for
TK IP protection, not as stand-alone solutions in and of
themselves.
CASE STUDY 1: SOUTH AFRICA
Te continent of Africa is the birthplace of humanity,
where modern humans frst evolved and formed
communities. As a result, the terms indigenous or
native peoples are for the most part inapplicable in
Africa.
119
Issues relating to the protection of TK are
still major issues in Africa, however. Various African
nations and tribes have fallen victim to biopiracy and
other illegitimate uses of their TK, such as the patenting
of periwinkle (a traditional medicine from Madagascar
used in anti-leukemia applications).
120
To combat these, in 2002, the WHO convened a
special meeting in Africa on TK. Te outcome was a new
system of classifcation, by which all medicines would
be classifed into three categories: traditional medicine,
traditional medicine with commercial applications,
and products from research and academic institutions.
Tough this is a good frst step, comprehensive and
unifying actions to protect TK across the continent
have, unfortunately, been unable to be agreed upon and
implemented.
121
Within the larger African framework, South
Africa has made additional progress in TK protection. In
2004, the Indigenous Knowledge Systems (IKS) Policy
was passed. Tis policy is described in the legislation
as an enabling framework to stimulate and strengthen
the contribution of indigenous knowledge to social
and economic development in South Africa.
122
Te
IKS created various bodies within the government to
protect and develop TK, increased funding for research
and development of TK, created a system to record TK
and their holders and to attempt to secure IP rights, and
various structures for holders of TK to convene and
discuss the issues.
123
Tis legislation was the frst major
milestone in TK protection in South Africa. Since then,
attempts at furthering TK have largely been unsuccessful;
the most recent bill, designed to amend the current South
African IP system to better accommodate TK, failed in
May 2010.
124
Te most interestingand controversial (and
thus instructive)case to come out of South Africa
involves the San peoples. Te San have been identifed,
using genetic studies, to be the frst humans; they
carry the oldest genes known to humankind. In the
1930s, the San provided a Dutch anthropologist detailed
information on Hoodia gordonii (henceforth referred
to as Hoodia), a plant they utilized for its appetite
suppressing qualities. In the 1990s, these accounts
were rediscovered, Hoodia patented, and licensed to
Phytopharm, a company based in the UK, for millions
of dollars, all without the consent of the San. In 2001,
an international NGO found out about and alerted the
San of the patent. Te San had previously created the
Working group of Indigenous Minorities in Southern
Africa (WIMSA), which although previously reluctant
to get involved, was mobilized to action when the head
of Phytopharm claimed that the San were extinct. In
2003, all involved parties announced the completion of a
deal through which the San would receive eight percent
of all milestone payments and six percent of all future
royalties. Te payments would go to a trust established
for this purpose, the South African San Council (SASC),
which was run by elected members from the
various San communities. All involved parties were
satisfed with the agreement and lay the issue to
rest.
125
International observers, NGOs, activists,
and researchers were far from satisfed, however.
Some criticized the deal for not providing the San
with enough compensation. Others criticized the
deal for monetizing a life form, an idea alien to the
San way of life. Others criticize the agreement for
the burden placed on the San peoples. To operate
within this new framework, the San had to rapidly
educate themselves on the global IP regime and
had to learn how to defend their rights in this
unknown feld. But some say this was actually a
blessing; whereas the San were once one of the most
studied and exploited communities, WIMSA used
its newfound knowledge to create an entire system
to protect San TK. Te SASC created media and
research policies and began to carefully monitor and
control access the media and researchers had to the
San community, to prevent the exploitation seen
in the past. Te SASC also took up the protection
of San heritage, ensuring that San art, history, and
rich cultural traditions were not plundered. A vivid
example of their progress was demonstrated when
the San insisted on participating in the planning of a
museum of rock art, whereas previous plans neglected to
contact or consult the San community at all, despite the
contents of the museum.
126
Whether you view these outcomes as positive or
negative, it is clear that the San have progressed a long
way since the 1990s, and are now capable players in the
current global IP regime, something that would not have
been possible without the massive support given to the
San people by NGOs in its earliest stages. Tough the
global IP protection system did not change, the San were
able to protect their TK by learning the system. Whether
the result destroyed some of their fundamental values,
such as the non-commercialization of life forms, is still a
matter of debate.
127

CASE STUDY 2: INDIA
As a country with various types of traditional
knowledge (indigenous, agricultural, medical, etc.), India
has developed a variety of techniques that may prove
illustrative to other countries. In addition, as one of the
few countries with a continuous history dating to an
A member of a San tribe from South Africa.
http://www.cosmosmagazine.com/fles/imagecache/news/fles/news/20070926_san.
jpg
ancient civilization, most Indian people are themselves
holders of and creators of TK. India is also home to
various tribes, which are groups of people who have
had little to no interaction with the rest of the world for
millennia, resulting in highly distinctive cultures. Tese
tribes possess additional indigenous knowledge that calls
for protection.
Much TK has been integrated into the
mainstream. Traditional Indian Systems of Medicine
(ISM) are part of the formal medical system, are overseen
by various government agencies, and are taught in
universities. Indigenous peoples, who are primarily forest
dwelling, create and maintain sacred groves in forest
areas that they deem to have signifcance. Tese areas
have been found to have extraordinarily high levels of
biodiversity, and have been turned into national parks
and biosphere reserves. Much of Indian agriculture
is also based upon TK, which has often proven more
successful than conventional techniques. As a result,
traditional agricultural techniques have been given
priority over other considerations with the adoption
of farmers rights in Indias legislation. Tese farmers
rights include the right of farmers to save the harvested
seed of protected varieties, and also to sell it. Tis
seemingly ordinary right has given farmers power over
multinational biotechnology frms that would otherwise
entirely control the farming process. In addition, a
national gene fund has been created for farmers to
share their knowledge, especially traditional strains of
crops, such as rice. Agricultural products of TK, such as
Darjeeling tea, basmati rice, and alphonso mangos have
been trademarked, and products must pass inspection to
be certifed as products allowed to carry these names.
128
Tere are, however, many aspects of TK that have
not been brought into the system. Many indigenous and
traditional societies in India have extensive knowledge
of sustainable hunting, farming, fshing, veterinary
techniques for domesticated animals, and maintaining
crop diversity. Unlike other TK, such as traditional
medicine, this TK has yet to be brought into the system.
To fll the void, NGOs (such as Samata and Mulnivasi
Mukti Manch) have been extremely active, documenting
the knowledge, making manuals on TK for distribution to
tribal peoples, and educating indigenous and traditional
populations on their IP rights. Infuenced by NGOs,
certain states have established Community Biodiversity
Registers to document environmental TK at a local level.
Other states have also created systems to create networks
of village councils to promote organization and action.
129
Te most signifcant accomplishment, from
WIPOs perspective, was passed in 2000 with the
assistance of WIPO: the Indian Biological Diversity
Bill, the frst legislation of its kind. Te bill set up an
authority whose approval is now needed before frms
can apply for IP protection for any invention based on
any biological source or TK that originated in India. Te
authority has the power to impose benefts sharing in the
form of royalties, technology transfer, payments, or other
methods. Tis type of legislation was later introduced in
other nationsnotably, Brazil, which will be examined
in greater detail in the next case study.
130

Perhaps Indias most famous contribution
to international TK protection has been the defense
of its TK through the intensive use of databases and
knowledge libraries. When turmeric (anti-cancer and
anti-Alzheimer properties), neem (anti-fungal properties
and a pesticide), and basmati rice (an aromatic rice of
India) were patented in the United States and Europe,
the international outrage that followed resulted in the
invalidation of the patents. As a result, in 2001, India
announced the Traditional Knowledge Digital Library
(TKDL), a database of Indian TK that (as of June 2010)
contains a staggering 34 million pages of information on
TK, compiled by government scientists. By partnering
with patenting ofces across the world, the system has
been successful so far in preventing additional acts
of biopiracy, but many note that the system is simply
a defensive response to biopiracy, and not a system to
actively protect TK before exploitation.
131,132

Whether the strategies being pursued by India
suit your nations problems or your nations view of
the issue will vary. For instance, after the creation of
the TKDL, China, Korea, and various African nations
created similar databases of their traditional medicines.
133

Yet, as stated earlier, some NGOs and activists warn that
databases must be used with caution and with prudence,
to ensure that TK is recorded in its entirety, and not
simplifed and placed into databases.
CASE STUDY 3: BRAZIL
With a large portion of the Amazon rainforest and
many indigenous peoples located within its borders, Brazil
has a wealth of TK. As a result, Brazil has developed an
approach to TK that is fairly diferent from those seen in
other nations. Under the law, access to TK (whether it is
for research or commercial purposes) must be approved
by the government and requires prior informed consent
forms with the traditional or indigenous community in
question and a beneft sharing form detailing the shared
benefts that will arise. Both providers and users must
sign all forms. Due to the legal uncertainties, however,
few applications are fled, and as a result, from 2002 to
2008, only two applications for commercial purposes
were approved.
134
Despite the proactive approach taken by the
Brazilian government to protect TK, there have been
some notable controversies. In 2003, Natura Company, a
Brazilian cosmetics company, interviewed various women
selling herbs at the traditional Ver-o-Peso market, an area
known for its history and culture, for the production of
a documentary. Natura then created a line of fragrance
products created with these herbs and began selling them.
When the women heard of this, they felt as if their rights
had been violated; they had given permission to be flmed
for a documentary, not for the creation of commercial
products to be sold based on their knowledge of the
herbs. In subsequent legal wrangling, Natura claimed
that it thought that the herbs were widely known TK
and thus public knowledge, while the women claimed
it was protected TK. In the end, the government ruled
in the womens favor, and they were awarded royalty fees
and compensation.
135
Partially in response to the Natura case,
the government began to pursue the novel idea of
disseminated traditional knowledge (DTK), TK that is
widely known across the nation, and not just in certain
communities. Legislation currently being drafted
and debated says that DTK would be usable by all
Brazilians (but not by those outside Brazil), including
for commercial purposes. Te idea of DTK, in efect,
transfers the rights of certain widely known TK from
communities (if applicable) to the national government.
Although the motivation behind the idea is admirable
namely, to promote open access to TK and allow TK to
build upon itself unhinderedthe idea of DTK raises
concerns. For instance, it is possible that a certain piece
of TK may be widely disseminated in society, but at the
same time be directly and recently connected to a certain
community.
136
How disseminated must the knowledge
be to become DTK, and what happens to the original
communitys rights? It is also conceivable that a company
desiring to use a piece of TK might purposely disseminate
the knowledge, then use it for its own means to avoid
legal issues and royalties.
137

A potential solution to part of the problem is
to create diferent types of TK and DTK. John Kleba,
Professor of Political Science and Sociology at the
Aeronautics Technology Institute in Brazil, has proposed
a four-category system: community-based
TK, trade and urban TK, DTK of
national custodianship, and TK in the
worldwide public domain.
138
Community-
based TK and trade and urban TK would be
restricted, and would be under the control
of the communities in which they originated.
Te other two types would be under looser
control, under national or no protection.
However, although the system is compelling,
it still leaves open the question of where the
lines are drawn between diferent types of
TK.
139

PaSt un actIonS
Te two dominating international
instruments on the issue are the Agreement
on Trade Related Aspects of Intellectual
Property Rights (TRIPS) and the
Convention on Biological Diversity (CBD).
General background information on TRIPS
Te Natura Company created a line of products, above, derived from breu branco, a
traditional Brazilian herb.
http://naturaconsultorasandra.fles.wordpress.com/2008/09/prod_breubranco.jpg
is provided in Section IV (Gene Patenting), Part C (Past
UN Actions) of this study guide. Section 27.1 of TRIPS
calls for patenting of all inventions, but Section 27.3(b)
of TRIPS explicitly states that:
Members shall provide for the protection of
plant varieties either by patents or by an efective
sui generis system or by any combination
thereof.
140
Te full text of this portion of TRIPS is available
in the Appendix. Unfortunately, the sui generis system
that TRIPS allows has created many problems, as it is
extremely vague and open to interpretation, causing
much legal trouble. Tis is exacerbated by the fact that
TRIPS does not explicitly refer to TK.
141,142
In fact, the CBD, adopted in 1993, is the only
major international treaty that explicitly calls for the
protection of TK and indigenous communities. Section
8(j) of the text states that member parties will,
respect, preserve and maintain knowledge, innovations
and practices of indigenous and local communities
and promote their wider application with the approval
and involvement of the holders of such knowledge,
innovations and practices and encourage the equitable
sharing of the benefts arising from the utilization of
such knowledge, innovations and practices.
143
Te full
text of Section 8 of the CBD is provided in the Appendix.
Te CBD also reasserted each individual countrys
sovereignty over their TK and natural resources, and
formally introduced the ideas of access and beneft-
sharing and prior informed consent into international
lawmaking. However, these ideas never became the fully
formed systems that were intended.
144
Unfortunately, there are signifcant disparities
between the CBD and TRIPS relating to the protection
of TK, which poses a conundrum to nations party to both
agreements, as both are binding. For instance, the CBD
states that communities have to be recognized for their
contribution to certain inventions, while TRIPS says that
corporations and individuals alone can be assigned IP
protection, and has limited scope in granting collective
rights. Additionally, the CBD says that any use of TK
(via biological material) requires informed consent of the
communities who are custodians of the biodiversity,
145

while TRIPS says that the patent holder need not disclose
the source. Furthermore, the CBD says that these two
parties (patent holder and community) must share the
benefts, but TRIPS says that the patent holder would be
the sole benefciary. Te list of contradictions continues,
but these major points are illustrative of the dilemma.
146
It is has been speculated, and later proven to be
possible, that countries can create IP protection systems
within their nations that fulfll the major terms of TRIPS
(the most powerful of the relevant agreements) and protect
TK. Te key is that the language in TRIPS is incredibly
broad. For instance, TRIPS says that a patentable
invention should meet three basic requirements: industrial
application (patent eligibility), novelty, and the inventive
step (non-obviousness).
147
Tese terms are never defned,
though, so countries are free to defne them on their own
terms, so as to include TK and protect them. Such a
system would allow nations to remain members of the
WTO, protect TK, and potentially commercialize TK (if
permitted by the communities) to fnancially enrich the
traditional communities themselves.
148
WIPO itself has, of course, attempted to make
progress on the matter. As described earlier the creation
of the Intergovernmental Committee on Intellectual
Property and Genetic Resources, Traditional Knowledge,
and Traditional Cultural Expressions in 2001 was a
milestone in the area. Since then, WIPO has helped
countries create databases to assist with the creation of
laws friendly to TK and to combat biopiracy. WIPO has
also devoted considerable efort to seeking a consensual
defnition of TK. As a result, regional model laws based
on the WIPO initiatives are full of defnitions but rather
devoid of operational language.
149
At long last, perhaps
it is time for WIPO to create legislation that actually
creates a system that can be used.
ProPoSed SolutIonS
Various intergovernmental bodies have sketched
rudimentary approaches to the issue of the protection
of TK. WIPO advocates a bottom-up approach,
150

recommending that countries evaluate how national
systems of IP protection can be used to protect TK,
expand their systems, and then bring their acquired
knowledge to the international level. Te WTO
recommends the opposite, proposing that nations should
frst decide on an international approach, then implement
the systems nationally. In the middle lies the approach
espoused by the United Nations Conference on Trade
and Development (UNCTAD), which recommends that
minimum standards be set worldwide for a sui generis
(literally, of its own kind) system, after which the
system could be implemented at the national level.
151
At the most fundamental level, there are also
three diferent viewpoints on what the framework of
the actual solution should be. Te frst side believes that
the current IP system has the capability and tools to
accommodate TK, and can be slightly modifed to work
fne. Te second side believes that the current system is
designed such that no matter what is done, TK cannot
be accommodated. Te second side advocates what is
called a sui generis system for TK. But there is a third
group of people who say that the incredible diversity of
beliefs and ideas, and the fact that TK is fundamentally
local, requires that an IP protection that come into place
be based upon a suorum genorum, an heterogeneous
network of mutual recognition that does not confne
TK to one distinct genus, but recognizes that divergent
knowledge traditions, integrated with customary law,
warrant recognition as distinct genera, under the aegis of
a general set of core principles.
152
Finally, there are two diferent ideological
positions on the protection of TK: positive protection and
defensive protection. Positive protection is the creation
or recognition of positive rights [authors note: positive
rights are rights that permit or oblige action by one
party against another] over how TK, or protected aspects
of it, are to be used, it at all, by others.
153
Defensive
protection consists of the steps taken to ensure that third
parties do not obtain IP rights over TK subject matter, or
that once obtained such rights are revoked or rendered
unenforceable.
154
Te vast majority of laws enacted so
far for TK protection have been defensive protection,
but some say that positive rights are the best, and most
efective, way of protecting TK.
In discussing the many issues surrounding
the protection of TK, various solutions have already
been surfaced. Te most basic solution concerned the
defnition of TK. WIPO has, in the past, suggested
that pursuing a complete, universal defnition of TK is
a wasteful task. Instead, a list of characteristics should
be created that qualifes something as TK. Once this has
been addressed and it is clear what exactly will fall under
this new system, other solutions can be examined.
Te solution most implemented worldwide is
the use of databases, led by Indias TKDL. A solution
that comes out of this committee must fnd a way to
ensure that TK is properly stored in databases, however,
and is not just stripped down to its practical parts.
An ideal solution would also fnd a way to preserve TK
for posterity, even if misfortunes such as fading away,
integrating with the larger population, or losing their
language struck the original communities. Finally, the
best system would build upon the diverse systems of
IP protection currently in place in diferent traditional
and indigenous communities around the world. Te
mechanism by which this is done will vary, but whatever
comes out of this committee should enhance the cultures
of traditional and indigenous peoples, not replace them.
QueStIonS a reSolutIon muSt anSWer
Te overarching goal of these committee sessions
will be to create a document that creates an international
framework to deal with the protection of TK. Tus,
the main question is: What treaty can be created that
efectively protects TK and is acceptable to most nations?
Within this question there are other points to take into
consideration.
How, if at all, do legal systems allow for the
commercialization of TK without adversely afecting
the communities possessing the TK? Consider, for
example, the case of the San peoples of South Africa.
Is the overall outcome positive or negative?
How does one enforce the protection of TK, should a
party or government violate the treaty?
Should the new system created penalize nations
or regions for past injustices against traditional
and indigenous communities? Tis includes both
biopiracy and larger issues like agricultural crops.
How do we balance individual versus community-
based IP rights?
How does a system both protect TK, but allow it to
continue to evolve, since TK is created through a
dynamic, living process?
How are issues like DTK integrated into the agreement
and addressed?
How will this new agreement interact with existing
ones, especially TRIPS (which has powerful
economic sanctions behind it to penalize violators)?

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