hmun study guide

1 Specialized Agencies

World Intellectualproperty organization

General assembly

History of the ProblemCurrent SituationPast UN ActionsProposed SolutionsQuestions a Resolution Must AnswerKey Actors and PositionsSuggestions for Further Research

6151517181819

Topic Area A:

Gene Patenting

Topic Area B:

History of the ProblemCase StudiesPast UN Actions Proposed SolutionsQuestions a Resoultion Must AnswerKey Actors and PositionsSuggestions for Further Research

212629

30313232

Protection of indigenous, ancient, and traditional knowledge

Introduction 4History of the Committee 4Topic Area A 5Topic Area B 20Position Paper Requirements 33Closing Remarks 33Bibliography 39

TABLE OF CONTENTS

World Intellectual Property Organization

2 Specialized AgenciesHarvard Model United Nations India 2011A2

The harvard Team

Hunter M. RichardSecreTary-General

Matthew J. ChartierdirecTor-General

The india Team

Anmol SoinPreSidenT

Purav ShahBuSineSS

Ameya Naik leGal affairS

Ankiti Bosefinance

Dheer Bhatnagar naTional coordinaTion

Conrad NorohnaloGiSTicS

Raahil RairecruiTmenT

59 ShePard STreeT, Box 205Cambridge, MA 02138Voice: (617)-398-0772

Fax: (617) 496-4472Email: [email protected]

www.hmunindia.org

harvard model uniTed naTionS india 2011

Dear Delegates of HMUN India 2011,

Welcome to the first-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 World’s 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 organization’s 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 trafficking, while NATO will contemplate expansion and its relationship with the Shanghai Cooperative Organization. The United Nations Environmental Programme will convene to protect our planet’s 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 Kofi Annan once advised, “We have the means and the capacity to deal with our prob-lems, if only we can find 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 world’s greatest problems.

Sincerely,

Hunter Richard Anmol SoinSecretary-General PresidentHarvard Model United Nations India 2011 Harvard Model United Nations India [email protected] [email protected]

hmun india iS a collaBoraTive ProjecT BeTween The indian model uniTed naTionS SocieTy and harvard model uniTed naTionS

3Harvard Model United Nations India 2011


Dear Delegates,

It is my pleasure to welcome you to the first 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 first 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 affairs, and EnviroEd, a volunteer group that teaches underprivileged students in Boston about environmental issues.

This year, WIPO will be debating gene patenting and the protection of traditional knowledge. Though research into gene patenting has been ongoing for many years now, there is still no global agreement that sets forth the rules, limits, and procedures of gene 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 fits into the current system (if at all). Thus, for each topic, the goal is to create a comprehensive framework that, for the first time, unifies and clearly sets out global standards on gene patenting and traditional knowledge.

Debate will be shaped not only by your country’s position, but also by your personal opinions. While our topics are certainly difficult, I am confident that you are more than capable of handling them, and will come prepared to discuss these issues. The 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 BansalChair, World Intellectual Property Organization

The harvard Team

Hunter M. RichardSecreTary-General

Matthew J. ChartierdirecTor-General

The india Team

Anmol SoinPreSidenT

Purav ShahBuSineSS

Ameya Naik leGal affairS

Ankiti Bosefinance

Dheer Bhatnagar naTional coordinaTion

Conrad NorohnaloGiSTicS

Raahil RairecruiTmenT

59 ShePard STreeT, Box 205Cambridge, MA 02138Voice: (617)-398-0772

Fax: (617) 496-4472Email: [email protected]

www.hmunindia.org

harvard model uniTed naTionS india 2011



World Intellectual ProPerty organIzatIon

INTRODUCTIONAs I mentioned in my letter, the topics our

committee will deal with are gene patenting and the protection of traditional knowledge. The goals for this committee are deceptively simple: to create a unifying, global framework for each topic. These goals directly follow WIPO’s 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 COMMITTEEThe World Intellectual Property Organization

(WIPO) has a long history, by UN standards. The 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 staff 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. The most significant 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 The 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

There are two other major, milestone treaties that have had a significant bearing upon WIPO and our debates this session, as both have laid the modern system for a synchronized global patenting system. The first is the Patent Cooperation Treaty (PCT), concluded in 1970, which makes it possible to obtain patent protection in many nations by filling out just a few forms—the first major step towards international harmonization of patenting procedures.6 The second is the Patent Law Treaty (PLT), concluded in 2000, which went a step beyond PCT and formally harmonized and simplified 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. These three organs are of equal size—each is composed of one delegation per member state—and are the highest decision-making bodies of WIPO. The WIPO General Assembly largely deals with logistical issues, such as budgeting, finances, and status and approval of member states.8 The 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 specific purposes by the governing bodies. These standing and permanent committees can then further create working groups, convened to examine specific 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 five 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, WIPO’s 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. This 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 modification of an organism’s genes to change what the genes do. Already, genetically modified products are readily available in global markets. Entire industries, such as corn and soy production, have been reshaped by genetically modified 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. This 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 beneficial 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 modified organism, if at all. Even in the more dispassionate realm of economics, we are still engaged in a fierce debate on whether gene patents will hamper or assist research.

As a result, there is also no unified, global policy or agreement on genetic engineering and gene patents, posing a major problem to international cooperation and trade. There are currently a large number of agreements, many of which briefly mention and briefly touch upon the issue of genetic engineering and gene patenting. These 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 significance, however, is TRIPS, which is administered by the World Trade Organization (WTO) and effectively rules the global patenting regime. There 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 scientific 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 scientific



innovation, harmful to patients and consumers, and as an obstacle to scientific 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 field, hoping that a discovery or breakthrough in the future will provide the crucial insight needed to formulate guidelines. For a field with such huge potential—both for good and bad—to be so unregulated is alarming and untenable. Thus, 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. The establishment of these guidelines will certainly be challenging, but appropriate, modernized international guidance tailored to the radically different field of genetic engineering is crucially needed in today’s 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 different sources in a different 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 genome—the string of genes that make up each individual human’s 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 defined 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 specific flora, domestication of animals, and most important, the selective breeding of plants and animals to extinguish

Simplified structure of DNA showing nucleotide combinations and double-helix structure.http://www.stkate.edu/physics/Astrobiology/DNA Structure.jpg


World Intellectual Property Organizationundesirable 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 first 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 first 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 modified Roundup Ready soybean crops were introduced to the market, introducing genetically modified 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 modified (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 modified to grow faster. Food crops—most notably, soybean, corn, and canola crops—have been modified to grow faster, be resistant to herbicides, pesticides, and various diseases, and produce medicines. Non-food plants, such as cotton, have also been modified 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 field is rapidly developing and holds great promise. There are two forms of gene therapy: germ line gene therapy and somatic gene therapy. Germ line gene therapy is the modification 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 modification of the somatic cells (all cells in the body besides of gametes and undifferentiated stem cells) in order to cure the subject

human of a disease without affecting, either positively or negatively, the next generation of offspring. Current research has been limited to somatic gene therapy due to ethical qualms within the scientific 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

Though 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 field. No one is entirely sure what the effects of genetically engineered products will be on human health, the environment and global ecosystems, and the economy. The second largest source of controversy pertains to the ethics of genetic engineering. The frontiers being explored by genetic engineering are so novel that our ideas of ethics have yet to catch up with the field. It is not yet clear when it is permissible to genetically modify an organism, to what extent, and for what purposes. This guide will attempt to briefly discuss a few, but certainly not all, of the issues currently being debated.

The earliest significant 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 first 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



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. There 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 effects 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

“superweeds”—weeds 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


World Intellectual Property Organizationgenetically 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 modified genes passing through the human digestive system may affect 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 effects of GMOs on human health, and argue that the negative secondary effects 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 modified 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 Alzheimer’s disease, but can a scientist use gene therapy on a person’s reproductive cells to prevent Alzheimer’s 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

The 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 available—call it therapy A—that 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 therapy—call it therapy B—that 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? There is no clear answer to this question, yet, it figures 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 briefly 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 owner’s consent. Exploiting an invention includes making, using, selling, or importing it. Patents provide protection only for a limited time (normally 20 years). The 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 The 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 classified under gene patents. These include not only the specific DNA sequence that encodes a protein, but also DNA sequences that regulate other genes. They can also cover the links between specific 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 off of, similar to how someone writing a report may make a copy of their original file and use the duplicate copy as their “working draft.” This “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 flaring since the inception of gene patenting three decades ago. The situation will only become more controversial as time goes on, due to more sophisticated and advanced genetic engineering breakthroughs. The title of an April 2010 article discussing the grim future of gene patenting aptly summarizes the situation: “Think Gene Patents Are Controversial Now? Just Wait.”31

The 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 States—the leading proponent of intellectual property rights—granted new breeds patent protection.32

The 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 floodgates opened for gene patenting.33,34 Just six months later, the first patent on recombinant DNA was granted.35

Since then, gene patenting has gone in different directions in different 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… The EPO [European Patent Office] 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 specific 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 offices have continually tried to cut through the haze and develop clear-cut guidelines for patents, but to date, none have been successful.

The 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 significant artificial 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 refined or reproduced in the laboratory can be patented.”40 Though 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”


World Intellectual Property Organizationpatents, these systems have been criticized, by a range of individuals—scientists, ethicists, lawyers, and the general public—for a variety of reasons. Among the criticisms are that the “simplifications” have created guidelines unfit 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 significant 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. This 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, effectively 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 fierce backlash by the scientific and academic community, it was never overturned.41

The most recent evolution in this issue may also be one of the most significant. 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 The 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. Though experts agree that this specific 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 modified crops across the world. Banned means either a full ban or a ban on everything but scientific 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 field of biotech has faced an increasing amount of criticism from scientific researchers, ethicists and lawyers alike. According to these critiques, the broad utilization of the patent system in this scientific field leads to counterproductive results, is unethical, and of dubious legal validity.”43

The problems surrounding gene patenting begin from the very definitions of “gene” and “gene patent” themselves. Although this study guide defined a gene as the DNA sequence needed to create a protein, there is no set definition of a gene, even in the scientific 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 The complexity is staggering. These problems themselves stem from a more fundamental fact: gene patents are dealing with living organisms. Whereas past patents dealt with immutable, unchanging objects—light bulbs, microprocessors, engines—gene 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 flaws 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. This suggests to me that it is something fundamental in nature and that it shouldn’t 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 firms. 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 different assignees, and BRCA1, a breast cancer gene, was split into 14 patents licensed to 12 different 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 signifies 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


World Intellectual Property Organizationpatent. The 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 database—GenBank—the 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 The 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 finished product. Costs associated with imitating a product ‘...are extremely low relative to the innovator’s costs for discovering and developing a new compound.’”49 The 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 finding an echo within research. It often seems unfair that the patent system rewards only the last inventive step—the small breakthrough that enables a concept to be realized. The 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 findings that are obsolescent compared with current art. Despite both cultural and economic incentives for innovation, the difficulty 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 beneficial research. They 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 benefit 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 fields without having paid a license fee for doing so. …Schmeiser claimed that the genetically engineered crop had ended up in his field by accident—by the wind blowing pollen, by seeds blowing off trucks, and by other paths… The 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 fields became seeded by the legally-protected crop. The judge determined that Schmeiser was guilty of infringing on Monsanto’s patent because he knew that the crop he grew was mostly of the type covered by the Monsanto patent.”53 The 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. The rash of farmer suicides reported in India over the past few years has thrown the issue into the international spotlight, highlighting the effects 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. The indigenous cotton crops could also be grown with other crops, to ensure farmers had a varied crop yield. Monsanto’s 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 reasons—the emergence of new pests, for instance—farmers 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. They 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 stifling medical advances in the field. When a single company holds the patent to a gene, they also, effectively, 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, “The first example [of the problem with gene patents] concerns one of our society’s most dangerous killers, breast cancer, and the related breast cancer genes BRCA1 and BRCA2. The 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 … . The second example involves long QT genes that can cause sudden death from heart arrhythmias. These 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. … [There were also] persistent problems with a test performed by this exclusive laboratory, including long delays in getting results, indeterminant findings, 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 flip side, however, it could be argued that the initial research done in the field may not have been conducted without the incentive of patents to protect the resulting breakthroughs.

The recent 2010 Myriad case ruling invalidating the Myriad BRCA1 and BRCA2 gene patents, though likely to be overturned, has been widely hailed within the scientific community for the benefits it may bring. Nobel Prize-winning economist Joseph Stiglitz called the ruling

“a major victory to science and medical innovation.”59 The overwhelming support the ruling has had in the scientific 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. The 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. The 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


World Intellectual Property Organizationright 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 significant 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 difference?”62 The 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. The recent 2010 Myriad case is just a taste of what is to come, and will likely open the door for a flood of court cases, objections, and reforms to the system. As a result, like the genetic engineering industry itself, the field of gene patenting is likely to rapidly evolve over the next few years.

This evolution has the potential to be a welcome relief from the current situation. At the moment, genetic engineering is a powerful industrial and scientific research area, but it is being burdened with a patent system designed for non-living inventions from the previous millennium that was slightly modified to fit biotechnology. The 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 field. There are many systems in place to ensure that genetic engineering—or any cutting-edge field—goes in a direction that benefits humanity. One of these systems is supposed to be the patenting system, which is intended to monitor the ethics of research being done. An ideal patenting system should accelerate advancements by offering 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 influence in the clinic. But fully realizing that promise will require a view of gene patenting that is considerably more sophisticated than the one-size-fits-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-effective 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. The sooner a well-functioning system is put in place to allow international cooperation and competition and to guide genetic engineering, the better off humanity will be.

PaSt un actIonS

History of the Committee discussed various treaties that were pivotal in the creation of WIPO and directly influence 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 Tariffs and Trade (GATT), TRIPS was the first 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 WTO’s Dispute Settlement Body. As a result, all 153 WTO members are also party to the TRIPS agreement. The 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. The culmination of these efforts was the creation of the 1995 Agreement Between the World Intellectual Property Organization and the World Trade Organization.66

The 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 fields 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 field of technology and whether products are imported or locally produced.”67

This strongly-worded section single-handedly demands that countries patent any new inventions. The 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 The agreement then specifies 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 The full text of Part II, Section 5 of the TRIPS agreement is available in the appendix to this study guide. This

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 fit.”70 The wording is so vague that it specifies very little. The 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 different from that for an advanced industrial country. The TRIP[S] scheme failed to recognize this. In fact, intellectual property should never have been included in a trade agreement in the first 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 administration’s 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. Though it


World Intellectual Property Organizationhas 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. This 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 scientific 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 filed 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 specific 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 financial remuneration.”75

Other scientists call for an “open biotechnology” movement, “inspired by the open source movement in the field 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 flourished because of copyright laws though, open biotechnology is not possible due to the nature of patent laws. This is an extremely promising idea, however, and the open source software movement has shown it to be possible. This 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-affiliated researchers who were concerned about the current patenting system gathered to create nine points to aspire towards when creating a new licensing system. These nine points, as summarized by Jon Soderstrom of the Office of Cooperative Research at Yale University, are:77

Point 1: Universities should reserve the right to practice licensed inventions and to allow other non-profit 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 conflicts 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 These nine recommendations would occur in an

ideal world, as described by the academic community.



They 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 final outcome will be. At the very least, these nine points should guide the work being done in committee.

QueStIonS a reSolutIon muSt anSWer

The 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 final 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 specific genes?

How do we deal with the two aspects of a patent—the right to exclude others from using an invention and the right to use invention—in 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 flow of information so cherished by academics without destroying incentives?

Will an international agreement set up coordinated efforts, such as patent pools and clearinghouses?

Will inventions made at an early stage of research and development, upon which entire fields may rely, be treated differently 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. They 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 benefits 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 modified 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.


World Intellectual Property Organization Various companies may also take a keen interest

in our proceedings, as the new agreement would affect 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 modified bacteria can make plastic, farmers would be interested in how their seeds may be affected, and energy companies may be interested since bacteria may be able to split water into hydrogen and 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 flow 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 field of biotechnology. They may push for a strong inclusion of the “research exemption.” They will advocate on various fronts, pushing for increased ease of access to patents and a clearer set of guidelines for patenting novel innovations. They 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 profits from the research done in their laboratories.

Bloc PosItIons

This 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 activities—be 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. This 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 country’s commitment to regulation versus the free market, importance placed on consumer protection versus advancing corporate interests, etc. The 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 nation’s patenting procedures, not the specific 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 briefly re-emphasize that there is no need to do further research into the science of genetic engineering. If you are interested in more specifics, 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. The full text can be found in the appendix. Scientific publications, such as Nature, also publish many useful articles and editorials on the issue that provide specific details that may prove useful. These articles can be found in the features section of the magazine, and are written in plain English and are easily understandable by a non-scientific audience. Many governments have held proceedings in front of their legislative bodies or in committees to explore reforms in patent law. These proceedings often bring in experts from the field 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 field. 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 flood of new court cases. A growing coalition against the current patenting system is also forming, which may also create newsworthy items.

There may also be editorials and opinion pieces by well-known scholars—geneticists, lawyers, and economists—that could be useful. These 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 field.

Protection of indigenous, ancient, and traditional knowledgeStatement 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 first 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 profits reaped by those who used the TK.

The challenge this committee faces is to create a system that protects TK from exploitation, but does not stifle it and prevent future development of TK. This 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


World Intellectual Property Organizationto 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. The task is difficult, 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

The difficulty and failure of integrating traditional knowledge (TK) into global thought and protection manifests itself from the starting point of the discussion: the definition of TK. To date, no one has created a non-controversial, working definition of TK. Though the reasons are complex, there are a few overarching reasons for the difficulty. Much TK, such as indigenous knowledge, is very different 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 difficult to isolate and define. 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 define it.78

Given these limitations, some scholars have made attempts at defining TK. For instance, Thomas Cottier, of the University of Bern, defines 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 This inclusive definition categorizes not just the knowledge itself, but the methods by which the knowledge is practiced and disseminated as well. This 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 identification. This … 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

Thankfully, the difficult issue of the definition is not a major obstacle for discussions. WIPO has spent much of the past decade struggling with the definition 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 definition of TK in order to develop a legal system for its protection. Many patent laws that are currently in place are also based on undefined concepts; for instance, most patent laws do not define ‘inventions’. Instead, these laws set out the characteristics necessary for something to be an invention. In the same way, a definition of TK can contain the integral characteristics needed for something to “qualify” as TK, such as a definite link to a traditional community. This would be a more practical strategy that trying to create a lengthy and universal definition 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 definition to encompass all TK.

tHe ImPortance of tK

The 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. Thus, by protecting TK against exploitation, additional resources may flow 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 refinements 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 fields, and includes areas from refined surgical techniques to complex perfume-making processes. Too often, people associate TK with scientifically 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 WIPO’s 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

The economic impact of TK is also immense. The field 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 flows 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, “The relevance of TK as a useful source of information for researchers in the pharmaceutical field 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. These 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 scientific, literary, or artistic production of which he [or she] is the author, and to share in scientific advancement and its benefits.”90 Considering that over 80% of the world’s population depends on traditional medicine for health needs,91 and that much of the world’s 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

The issue of TK and IP fully emerged onto the international scene in 1999, when issues of TK were formally integrated into the official 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 significant movement in bringing TK to the world of IP.94

According to Weerawit Weeraworawit, Minister of Commercial Affairs of Thailand, “Patents [and the current IP system] afford protection to something new without giving regard to the sources of research and development giving rise to such new invention. This 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 benefits 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). The holder of the patents now reaps the benefits

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.’ Thus, 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. Thus, to provide international legal protection for TK is a significant departure from this individual-rights system to a system that

recognizes and protects communal rights. A communal patent on TK would benefit no single person, but an entire community, since it takes a community to keep the TK relevant, intact, and accurate.98 The 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

The communal rights versus individual rights debate has created major factions, each radically different from the other. One group of advocates says that since communal rights are so different 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 different, can be accommodated into the current IP system with slight modifications 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

The periwinkle, a plant from Madagascar with anti-leukemia applications that fell victim tobiopiracy.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 Office, 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. The biggest difference 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 flexible mindset, the resulting IP protection systems are also very diverse. Some traditional communities find 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 different 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. The 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. There 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


World Intellectual Property Organizationbehind 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 fit into the current system, resulting in a loss of TK. This 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 scientific 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 different 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. The Western categorization of these plants as a single species would have overridden the TK that realized the differences, 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, “The claim that ‘we’ should just leave ‘them’ alone is simply a recipe for the continuing loss of languages, livelihoods, and the resources that the world’s 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 world’s poor.”113

dIlemmas reGardInG tK and tHe need for reform

The 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 differences 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 backfire and destroy TK.

As briefly 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 scientific. Although this may at first 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 filed in offices 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 stifling its further creation? By its very nature, TK builds upon itself. The IP protection system currently in place effectively 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 otherwise—and 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. The examples cited in previous sections of cosmetics, herbs, and even the pharmaceutical industry pale in comparison to the



most stunning example of the influence 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 two—rye and oats—originated in the Euro-Siberian area. Virtually ‘all of the developed countries’ foodstuff originated in the tropical countries [where the majority of the world’s 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 sunflowers, blueberries, cranberries, pecans, and the Jerusalem artichoke originated in what is now the United States and Canada. … Northern Europe’s original genetic poverty is only slightly less striking; oats, rye, currants, and raspberries constitute the complement of major crops indigenous to that region. Australia 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 difficult. Progress on TK and IP become entangled in a web of other considerations.

The last major dilemma that will be mentioned in this guide is a difficulty 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 achieve—namely, 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

There 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 country’s 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 unified, strengthened, international system for TK IP protection, not as stand-alone solutions in and of themselves.

CASE STUDY 1: SOUTH AFRICAThe continent of Africa is the birthplace of humanity,

where modern humans first 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. The outcome was a new system of classification, by which all medicines would be classified into three categories: traditional medicine, traditional medicine with commercial applications, and products from research and academic institutions. Though this is a good first 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. This 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 The 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 This legislation was the first 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



The most interesting—and controversial (and thus instructive)—case to come out of South Africa involves the San peoples. The San have been identified, using genetic studies, to be the “first 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. The 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. The 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 satisfied with the agreement and lay the issue to rest.125

International observers, NGOs, activists, and researchers were far from satisfied, 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 field. 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. The 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. The 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. Though 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: INDIAAs 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/files/imagecache/news/files/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. These 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 significance. These 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 India’s legislation. These farmers’ rights include “the right of farmers to save the harvested seed of protected varieties, and also to sell it….” This seemingly ordinary right has given farmers power over multinational biotechnology firms 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 certified as products allowed to carry these names.128

There 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, fishing, 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 fill 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. Influenced 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

The most significant accomplishment, from WIPO’s perspective, was passed in 2000 with the assistance of WIPO: the Indian Biological Diversity Bill, the first legislation of its kind. The bill set up an authority whose approval is now needed before firms can apply for IP protection for any invention based on any biological source or TK that originated in India. The authority has the power to impose benefits sharing in the form of royalties, technology transfer, payments, or other methods. This type of legislation was later introduced in other nations—notably, Brazil, which will be examined in greater detail in the next case study.130

Perhaps India’s 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 offices 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 nation’s problems or your nation’s 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 simplified and placed into databases.

CASE STUDY 3: BRAZILWith 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 different 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


World Intellectual Property Organizationforms with the traditional or indigenous community in question and a benefit sharing form detailing the shared benefits that will arise. Both providers and users must sign all forms. Due to the legal uncertainties, however, few applications are filed, 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 filmed 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 women’s 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. The idea of DTK, in effect, 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 unhindered—the 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 community’s 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 different 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. The 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 different types of TK. 139

PaSt un actIonS

The 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

The Natura Company created a line of products, above, derived from breu branco, a traditional Brazilian herb.http://naturaconsultorasandra.files.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 effective sui generis system or by any combination thereof.”140

The 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. This 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 benefits arising from the utilization of such knowledge, innovations and practices.”143 The full text of Section 8 of the CBD is provided in the Appendix. The CBD also reasserted each individual country’s sovereignty over their TK and natural resources, and formally introduced the ideas of “access and benefit-sharing” and “prior informed consent” into international lawmaking. However, these ideas never became the fully formed systems that were intended.144

Unfortunately, there are significant 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 benefits, but TRIPS says that the patent holder would be

the sole beneficiary. The 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 fulfill the major terms of TRIPS (the most powerful of the relevant agreements) and protect TK. The 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 These terms are never defined, though, so countries are free to define 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 financially 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 effort to seeking a consensual definition of TK. As a result, regional model laws based on the WIPO initiatives are full of definitions 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. The WTO recommends the opposite, proposing that nations should first 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


World Intellectual Property Organization(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 different viewpoints on what the framework of the actual solution should be. The first side believes that the current IP system has the capability and tools to accommodate TK, and can be slightly modified to work fine. The second side believes that the current system is designed such that no matter what is done, TK cannot be accommodated. The 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 confine 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 different ideological positions on the protection of TK: positive protection and defensive protection. Positive protection is the “creation or recognition of positive rights [author’s 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 The 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 effective, way of protecting TK.

In discussing the many issues surrounding the protection of TK, various solutions have already been surfaced. The most basic solution concerned the definition of TK. WIPO has, in the past, suggested that pursuing a complete, universal definition of TK is a wasteful task. Instead, a list of characteristics should be created that qualifies 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.

The solution most implemented worldwide is the use of databases, led by India’s TKDL. A solution that comes out of this committee must find 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 find 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 different traditional and indigenous communities around the world. The 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

The overarching goal of these committee sessions will be to create a document that creates an international framework to deal with the protection of TK. Thus, the main question is: What treaty can be created that effectively 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 affecting 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? This 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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