WORLD IN REVIEW

The Problem with Patents
Traditional Knowledge and International IP Law
staff writer FEIFEI JIANG

W

ith attractive pinkish-white flowers and lush green foliage, the Madagascar rosy periwinkle appears atfirstto be an iniKiciious, decorative plant. Belying its appearance, the plant has incredibly potent qualities. In the early 1950s, the pharmaceutical giant F.li Lilly <k (>)nipany hegan conducting research on the periwinkle, until then grown largely hy poverty-stricken indigenous communities. Inspired by its use traditional medicine, researchers at Eli Lilly eventually isolated two extracts—vin bias tine and vincristine. Both extracts have become powerful drugs, one to treat childhood leukemia, and the other to treat Hodgkins' Disease. Together, these drugs generate over US$20() million in revenue for Eli Lilly each year, no part of which is seen or even heard of hy the people of Madagascar.

from an original plant sample, might have a completelely different purpose than the original status ofthe plant in tnuiitional knowledge. At the ver}' least, however, benefit-sharing agreements l)etw een drug patent-holders and source countries is not only a moral issue in terms of uniform protection of rights, but at a more fundamental level, is necessarx' for protecting and promoting tlie livelihoods ofthe worlds poor.

The story of Eli Lilly and the rosy periwinkle is one example that relevant NGOs label as "biopiracy," a term used to describe the appropriation, by outside f"()rces, ot legal rights over indigenous knowledge. This type of traditional knowledge (TK), including but not limited to native lore about plants by Eli Lilly. and animals, is scantily protected under existing international intellectual property (IP) regimes. Furthermore, indigenous communities tend to be located in poorer countries in tlie "Global Soutli," where governments cannot easily afford to reguiate or protect local rights to indigenous biodiversitj'. In order to protect the rights ot the governments and peoples of tliese countries, the current system must be adapted, with new laws created that recognize value of traditional knowledge. The question arises, however, of whether or not knowledge about indigenous biodiversity can be considered intellectual proj>erty; The end product, a compound developed
HARVARD I N T E R N A T I O N A L REVIEW

International Standards: The West and the Rest The current basis for international intellectual property law resides in a treaty signed by \VTO member states, the Agreement on Trade-Relatcti Aspects of Intellectual Propert)- Rights (TRJPS). The TRIPS agreement is a basic framework that protects the intellectual property rights of individuals and corporations across W T O nations. However, the standarils of TRTPS stem from those of richer, developet! nations. Pushed through the W T O by the US, European countries, and japan, the agreement as a whole is generally viewed by atlvocates of developing countries as a forcetl concession to the developed world. Though fought and tlehated tor a Floating periwinkle blossoms.The rosy periwinkle blossom is nadecade, by the beginning tive to Madagascar and has been used in pharmaceutical products
of 2005, all developing

countries were bound to comply to TRIPS intellectual property standards. The agreement, thus far, has mostly sen'ud tt) protect the interests of large, multinational corporations based in the developed world. Particularly with regard to prescription drugs, TRIPS has protected large pharmaceutical countries to the detriment of the citizens of poorer nations, who in many cases have the most need for such drugs but are the least able to afford them. The irony, then, comes full circle. In some cases, such as that ot the rosy periwinkle, the indigenous people who provided the initial source of knowledge

• Fall 2 0 0 8

no effective legal niechanisms yet exist that proactively provide support for holders of TK. R K V I K . this admirable goal seems far in the future for many poor and developing nations. This type of general disrespect tor TK from developed countries and developing country governments alike often stems from the inabiiit

of indigenous people to fight for the effective protection ot traditional knowledge. even though governments to not revert to comMerck currently holds the patent for the drug. R N A T I ( ) N A I. it woukl cost a poor country roughly US$2 million just to build a basic infrastructure for administering intellectual property rights. something tliat is generally identified with the economies oí much more developed Western nations. However. it becomes diflicult TRIPS appears here to stay. two sides of the coin to this forced acceptance of international intellectual property' rights by poor countries. then. With many other more pressing development needs at present. the current regime could aid people in the Global South as opposed to harming them. much less even hear about them or reap any monetär)' benefits at all. 74 percent of which were "discovered pursuing claims from native fables. Western countries. ideas. In the context of this realit}'. An "owner" or "inventor" Many academics are optimistic about the answer to this cannot be determined. UC Davis Law Professor Madhavi Sunder cites do not necessarily conform to more community-oriented the example of one Indian farmer in Kerala who patented TK. Because current standards of property' are Western seems detrimental to the development of poor countries. protecting his ideas when others tried to use them. is knowledge that has been rights can be made to work for developing nations. It no documentation of an original inventcir. In fact. since Western standards ot ownership question. President of Brazil Luiz Inacio Lula da Silva speaks at a ceremony in 2007 after signing are putting pressure on other a decree authorizing Brazil to import a generic version of an AIDS drug. pharmaceutical c(tmpanies profiting from TK often protest against patent-hrcaking by nations where they might have obtained the plants or inspirations for some of their patented drugs. the United States still refuses to sign. experts have pondered how today's intellectual property Traditional knowledge. In addition. legal scholar ctoria Spier estimates that around 121 patented drugs globally are made from plants. However. the issue of protecting traditional knowledge has risen in prominence among lawyers und activists alike. activists hope that increased recognition of intellectual property rights will help to eliminate biopiracy and patent pirating in general. A Paradox for the Poor Furthermore. pulsory licensing unless circumstances are beyond dire. Though in recent years. the issue of traditional knowledge is often treated as just another bargaining chip by developing countries in international trade discussions. a major hurdle that protectors of traditional knowledge must overcome is the question of authorEven if the entorcement of intellectual property rights ship. Phocos Courtesy Reuters Fnll :(I()S • I [ A R \ ' A R D I N T I-. drugs that are currently covered by patents owned by large pharmaceutical companies. Ironically. it is unlikely the governments ot poor countries will be able to dedicate resources for an intellectual property regime. his own method of planting nihher trees to produce higher and even more often knowledge is passed down orali\. it individuals in indigenous communities are educated on how is unclear if TK has a status as "intellectual propert)'^" or to work within the TRTPS framework to protect their knowledge. notably." Hypocritically.WORLD IN REVIEW about a medicine are among the least likely to benefit from the resulting drugs. One major area of concern is the right of access to affordable drugs—especially the important ones which fight epidemics such as AIDS and malaria. There are. On the other hand. with yields. in a conununity for generations. Oftentimes knowledge is collectively shared and o\ ncd. Though TRTPS provides an exception for compulsory licensing. and. typically. wherein poor countries unable to afford crucial drugs to fight diseases may produce generic versions of drugs locally. to fit traditional knowledge into international standards. based upon individual ownership. spurred by the outciy from pharmaceutical companies. The 1^92 C!onvention on Biological Diversity is the one treaty that came close to recognizing the rights of traditional knowledge holders by declaring that "traditional lifestyles" must be protected. there are no effective enforcement measures built into the treat

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. According to economists.

and to ensure that holders of traditional knowledge are compensated accordingly.the developer must reach a benefit-sharing agreement to suitably compensate the source country. these lawsuits and eftbrts at documentation are only defensive and preventa- Finding Solutions T he Convention on Biological Diversity (CBD). if poor countries saw even a fraction of that money. are considered "prior art. especially in the United States where only paper documents. In an effort to aid poor countries in the fight against biopiracy. protect traditional knowledge. F.ven with all ot the hurdles activists view an international IP framework as potentially beneficial not just for the holders of traditional knowledge. poor countries lose US$5 billion in royalties each year due to the unauthorized outside use of traditional knowledge. The CBD describes possessors of traditional knowledge as "resource managers. and not oral evidence.WORLD IN REVIEW whether it should be treated as a more general form of property." in most cases some sort of documentation that the knowledge existed prior to the patent holder's appropriation of it. but not as authors of knowledge in their own right." The effect is that poor people may be seen as the guardians of valuable information. Bronwyn Parry . compensation. but also to innovators in botli developed and developing countries. it also created an obstacle that impedes possessors of TK from gaining status as owners of intellectual property. in their own right. The NCI's Letter of Collection has become a guiding example of an agreement that benefits all parties involved. 1985-1995 Since the l960's. the National Cancer Institute (NCI) has funded a Natural Products research program. attempts to recognize and formalize the value of traditional knowledge. the plaintiff or plaintiffs must provide evidence of "prior art. Current lines of redress for T K holders wrongfully affected by lack of intellectual propert)' protection are defensive measures that do not establish ownership of TK. and should be compensated accordingly." However. or created—something that would detinitively fall under the category of intellectual property. This documentation aims to protect local people from pirating companies. in such cases. they must also be recognized. Even it holders of TK receive compensation for the use of their traditions and work. it is often difticult to provide evidence that fits the exacting standards of the courtroijm. In fact. it does not expressly define T K as something original. The CBD does not go far enough to achieve this goal. and patented. They are the possessors of raw material. which might be refined and marketed. as holders of legitimate intellectual property. by others. According to UN estimates. Possessors of TK may file claims and lawsuits against Western corporations that may have appropriated their knowledge without consent. It is clear from this map that the vast majority of these source countries are in the southern hemisphere. VVTiile the CBD's goal was to legitimize and Sampling the South The National Cancer Institute's Natural Products Collection Sites Around the World. NGOs all over the world are working with local people to create documentation for innovations and traditional knowledge. Because traditions are often passed down orally. culling samples from biodiversity-rich countries around the world. It mandates that if any Western company develops a sample taken from the NCI repository. or acknowledgement of any rights that the traditional knowledge holders may have had. or are generally accepted within indigenous cultures as communal knowledge. it could go a long way towards both development and creating a standard legal infrastructure to protect traditional knowledge in the future. drafted in 1992.32 H A R V A R D IN TE R X A PI ÜN AL R E V I E W Fall :()08 . However. Though it recognizes the existence ot traditional knowledge.

But are they not productive not in compliance with these laws would forfeit their patent. In addition to national legislation protecting traditional knowledge. but instead in the forfeiWilliam Fisher instead describe it as something dynamic. ture of lucrative and exclusive intellecuial property rights. given the obstacles. Champagne. Whether traditional knowledge in an unconventional way. the plant. not knowledge. Had the rosy periwinkle been the importance and value of traditional knowledge as intelestablished as a GI. Tn fact. In them meaning—traditional knowledge is not raw or passive this way. international IP regime would not be easy to implement. of Goods Act of 1999 gives protection to any product that is linked to a specific region and produced using a specific Traditional knowledge that indigenous conuiiunities process. However. even one new clause in the TRIPS agreement recognizing IP rights and IP law in poor countries would be a step in the right direction. would be detennined by the laws of knowledge are not seen as authors of that knowledge. If developing countries must work within the TRIPS framework to recoup the losses created by biopirac>s they must start by building the capacity to protect IP rights at home. Furthermore. was being used for its medicinal qualities TRIPS itself. the solutions to these problems must begin in developing countries themselves. The Geographical Indication interaction. Possessors of traditional The Big Change Alternatives With enough political solidaruy and initiative from developing countries. Hanard Law profesChancellor of Germany Angela Merkel speaks at the UN Convention on Biological sor William Fisher suggests one Diversity in May 2008. a new structure for international intellectual property law could be inijilcniented—one that would give individual countries more autonomy in determining IP rights. Florida oranges. in the case of the rosy periwinkle. then Fli Lilly might have had to give lectual propert\. any new model of an Photo Courtesy Reuters Fall2OÜ8 « H A R V A R D I N T E R N A T I O N A L REVIEW . traditional knowledge must be legally considered. most GIs are for established rated and accepted in some way into the international intelWestern products. Legal scholars such as Madhavi Sunder and by any direct monetary punishment. echoes of Western colonialism still disturbingly resound. GI status should have pro-active means by which to protect their could be expanded across W T O member states to protect interests instead of the existing defensive measures. In fact. and Feta cheese are have developed over centuries of practice nnist be inc(trp(ijust a few examples. forward in the economic development of the third world. inventors also? They have modihed their protlucts and given trademark. which does exist in several develi)ping countries. however. any entity using IP who is instead as passive guardians. Though the current problems facing the protection of traditional knowledge are mostly international ones. corresponding national infrastructure and legitimate enforcement mechanisms are needed. 03 Admittedly. or copyright rights tor any consequent product. In order to fully protect such innovation. as valid intellectual property. native by strengthening and reinforcing the CBD. recognizing the rights of poor and the people of Madagascar just compensation for the use of indigenous peoples would be a significant and crucial step their intellectual property. from the outset. ample. Possessors of traditional knowledge existing GTs are vehemently opposed to the idea. or by revising imly to Madagascar. an international framework protecting IP in individual countries would be more politically viable. it is knowledge that has been transformed by indigenous Another interesting and promising solution may lie in peoples and is still changing and evolving with continued geographical imlications (GIs). For exit is by defining traditional knowledge in a Gl-like context. Redefining Standards At the intersection of the realms of traditional knowledge and intellectual propert)' law. where T K is a valuable natural resource. Though Western nations.The UN conference aimed to address some of the issues sursuch structure in which IP rights rounding the use and preservation of traditional knowledge. and makers of lectual property regime. If poor countries had laws recognizing traditional knowledge. the international community shoulil recognize by the natives to the island.WORLD IN REVIEW cive measures. but an individual nation. compliance could be ensured in a powerful way.

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of indigenous people to fight for the effective protection ot traditional knowledge. even though governments to not revert to comMerck currently holds the patent for the drug. R N A T I ( ) N A I. it woukl cost a poor country roughly US$2 million just to build a basic infrastructure for administering intellectual property rights. something tliat is generally identified with the economies oí much more developed Western nations. However. it becomes diflicult TRIPS appears here to stay. two sides of the coin to this forced acceptance of international intellectual property' rights by poor countries. then. With many other more pressing development needs at present. the current regime could aid people in the Global South as opposed to harming them. much less even hear about them or reap any monetär)' benefits at all. 74 percent of which were "discovered pursuing claims from native fables. Western countries. ideas. In the context of this realit}'. An "owner" or "inventor" Many academics are optimistic about the answer to this cannot be determined. UC Davis Law Professor Madhavi Sunder cites do not necessarily conform to more community-oriented the example of one Indian farmer in Kerala who patented TK. Because current standards of property' are Western seems detrimental to the development of poor countries. protecting his ideas when others tried to use them. is knowledge that has been rights can be made to work for developing nations. It no documentation of an original inventcir. In fact. since Western standards ot ownership question. President of Brazil Luiz Inacio Lula da Silva speaks at a ceremony in 2007 after signing are putting pressure on other a decree authorizing Brazil to import a generic version of an AIDS drug. pharmaceutical c(tmpanies profiting from TK often protest against patent-hrcaking by nations where they might have obtained the plants or inspirations for some of their patented drugs. the United States still refuses to sign. experts have pondered how today's intellectual property Traditional knowledge. In addition. legal scholar ctoria Spier estimates that around 121 patented drugs globally are made from plants. However. the issue of protecting traditional knowledge has risen in prominence among lawyers und activists alike. activists hope that increased recognition of intellectual property rights will help to eliminate biopiracy and patent pirating in general. A Paradox for the Poor Furthermore. pulsory licensing unless circumstances are beyond dire. Though in recent years. the issue of traditional knowledge is often treated as just another bargaining chip by developing countries in international trade discussions. a major hurdle that protectors of traditional knowledge must overcome is the question of authorEven if the entorcement of intellectual property rights ship. Phocos Courtesy Reuters Fnll :(I()S • I [ A R \ ' A R D I N T I-. drugs that are currently covered by patents owned by large pharmaceutical companies. Ironically. it is unlikely the governments ot poor countries will be able to dedicate resources for an intellectual property regime. his own method of planting nihher trees to produce higher and even more often knowledge is passed down orali\. it individuals in indigenous communities are educated on how is unclear if TK has a status as "intellectual propert)'^" or to work within the TRTPS framework to protect their knowledge. notably." Hypocritically.WORLD IN REVIEW about a medicine are among the least likely to benefit from the resulting drugs. One major area of concern is the right of access to affordable drugs—especially the important ones which fight epidemics such as AIDS and malaria. There are. On the other hand. with yields. in a conununity for generations. Oftentimes knowledge is collectively shared and o\ ncd. Though TRTPS provides an exception for compulsory licensing. and. typically. wherein poor countries unable to afford crucial drugs to fight diseases may produce generic versions of drugs locally. to fit traditional knowledge into international standards. based upon individual ownership. spurred by the outciy from pharmaceutical companies. The 1^92 C!onvention on Biological Diversity is the one treaty that came close to recognizing the rights of traditional knowledge holders by declaring that "traditional lifestyles" must be protected. there are no effective enforcement measures built into the 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. According to economists.

and to ensure that holders of traditional knowledge are compensated accordingly.the developer must reach a benefit-sharing agreement to suitably compensate the source country. these lawsuits and eftbrts at documentation are only defensive and preventa- Finding Solutions T he Convention on Biological Diversity (CBD). if poor countries saw even a fraction of that money. are considered "prior art. especially in the United States where only paper documents. In an effort to aid poor countries in the fight against biopiracy. protect traditional knowledge. F.ven with all ot the hurdles activists view an international IP framework as potentially beneficial not just for the holders of traditional knowledge. poor countries lose US$5 billion in royalties each year due to the unauthorized outside use of traditional knowledge. The CBD describes possessors of traditional knowledge as "resource managers. and not oral evidence.WORLD IN REVIEW whether it should be treated as a more general form of property." in most cases some sort of documentation that the knowledge existed prior to the patent holder's appropriation of it. but not as authors of knowledge in their own right." The effect is that poor people may be seen as the guardians of valuable information. Bronwyn Parry . compensation. but also to innovators in botli developed and developing countries. it also created an obstacle that impedes possessors of TK from gaining status as owners of intellectual property. in their own right. The NCI's Letter of Collection has become a guiding example of an agreement that benefits all parties involved. 1985-1995 Since the l960's. the National Cancer Institute (NCI) has funded a Natural Products research program. attempts to recognize and formalize the value of traditional knowledge. the plaintiff or plaintiffs must provide evidence of "prior art. Current lines of redress for T K holders wrongfully affected by lack of intellectual propert)' protection are defensive measures that do not establish ownership of TK. and should be compensated accordingly." However. or created—something that would detinitively fall under the category of intellectual property. This documentation aims to protect local people from pirating companies. in such cases. they must also be recognized. Even it holders of TK receive compensation for the use of their traditions and work. it is often difticult to provide evidence that fits the exacting standards of the courtroijm. In fact. it does not expressly define T K as something original. The CBD does not go far enough to achieve this goal. and patented. They are the possessors of raw material. which might be refined and marketed. as holders of legitimate intellectual property. by others. According to UN estimates. Possessors of TK may file claims and lawsuits against Western corporations that may have appropriated their knowledge without consent. It is clear from this map that the vast majority of these source countries are in the southern hemisphere. VVTiile the CBD's goal was to legitimize and Sampling the South The National Cancer Institute's Natural Products Collection Sites Around the World. NGOs all over the world are working with local people to create documentation for innovations and traditional knowledge. Because traditions are often passed down orally. culling samples from biodiversity-rich countries around the world. It mandates that if any Western company develops a sample taken from the NCI repository. or acknowledgement of any rights that the traditional knowledge holders may have had. or are generally accepted within indigenous cultures as communal knowledge. it could go a long way towards both development and creating a standard legal infrastructure to protect traditional knowledge in the future. drafted in 1992.32 H A R V A R D IN TE R X A PI ÜN AL R E V I E W Fall :()08 . However. Though it recognizes the existence ot traditional knowledge.

But are they not productive not in compliance with these laws would forfeit their patent. In addition to national legislation protecting traditional knowledge. but instead in the forfeiWilliam Fisher instead describe it as something dynamic. ture of lucrative and exclusive intellecuial property rights. given the obstacles. Champagne. Whether traditional knowledge in an unconventional way. the plant. not knowledge. Had the rosy periwinkle been the importance and value of traditional knowledge as intelestablished as a GI. Tn fact. In them meaning—traditional knowledge is not raw or passive this way. international IP regime would not be easy to implement. of Goods Act of 1999 gives protection to any product that is linked to a specific region and produced using a specific Traditional knowledge that indigenous conuiiunities process. However. even one new clause in the TRIPS agreement recognizing IP rights and IP law in poor countries would be a step in the right direction. would be detennined by the laws of knowledge are not seen as authors of that knowledge. If developing countries must work within the TRIPS framework to recoup the losses created by biopirac>s they must start by building the capacity to protect IP rights at home. Furthermore. was being used for its medicinal qualities TRIPS itself. the solutions to these problems must begin in developing countries themselves. The Geographical Indication interaction. Possessors of traditional The Big Change Alternatives With enough political solidaruy and initiative from developing countries. Hanard Law profesChancellor of Germany Angela Merkel speaks at the UN Convention on Biological sor William Fisher suggests one Diversity in May 2008. a new structure for international intellectual property law could be inijilcniented—one that would give individual countries more autonomy in determining IP rights. Florida oranges. in the case of the rosy periwinkle. then Fli Lilly might have had to give lectual propert\. any new model of an Photo Courtesy Reuters Fall2OÜ8 « H A R V A R D I N T E R N A T I O N A L REVIEW . traditional knowledge must be legally considered. most GIs are for established rated and accepted in some way into the international intelWestern products. Legal scholars such as Madhavi Sunder and by any direct monetary punishment. echoes of Western colonialism still disturbingly resound. GI status should have pro-active means by which to protect their could be expanded across W T O member states to protect interests instead of the existing defensive measures. In fact. and Feta cheese are have developed over centuries of practice nnist be inc(trp(ijust a few examples. forward in the economic development of the third world. inventors also? They have modihed their protlucts and given trademark. which does exist in several develi)ping countries. however. any entity using IP who is instead as passive guardians. Though the current problems facing the protection of traditional knowledge are mostly international ones. corresponding national infrastructure and legitimate enforcement mechanisms are needed. 03 Admittedly. or copyright rights tor any consequent product. In order to fully protect such innovation. as valid intellectual property. native by strengthening and reinforcing the CBD. recognizing the rights of poor and the people of Madagascar just compensation for the use of indigenous peoples would be a significant and crucial step their intellectual property. from the outset. ample. Possessors of traditional knowledge existing GTs are vehemently opposed to the idea. or by revising imly to Madagascar. an international framework protecting IP in individual countries would be more politically viable. it is knowledge that has been transformed by indigenous Another interesting and promising solution may lie in peoples and is still changing and evolving with continued geographical imlications (GIs). For exit is by defining traditional knowledge in a Gl-like context. Redefining Standards At the intersection of the realms of traditional knowledge and intellectual propert)' law. where T K is a valuable natural resource. Though Western nations.The UN conference aimed to address some of the issues sursuch structure in which IP rights rounding the use and preservation of traditional knowledge. and makers of lectual property regime. If poor countries had laws recognizing traditional knowledge. the international community shoulil recognize by the natives to the island.WORLD IN REVIEW cive measures. but an individual nation. compliance could be ensured in a powerful way.

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