(Posted January 2006)
 

THE U.S. APPROACH:
GENETIC RESOURCES, TRADITIONAL KNOWLEDGE, AND FOLKLORE
By Jeanne Holden

Anthony Morales of the Gabrieleno Native-American tribe, at a powwow in California. (AP/WWP)

A variety of herbal remedies, some of which have been traditional healing therapies for centuries. (Getty Images (RF))

The National Dance Company of Korea in the traditional dance Janggochum. (AP/WWP)

A Cambodian troupe that performs Khmer classical and folk dance and music. (AP/WWP)

A worker near Trombetas, Brazil, with new sprouts of native vegetation that will be used to reforest and replenish the country's rich genetic resources. (AP/WWP)

Students from the Beijing Shaolin Kung Fu School. The Shaolin monastery -- considered the cradle of Chinese martial arts -- is trying to protect the Shaolin trademark. (AP/WWP)

The National Museum of the American Indian in Washington, D.C. (AP/WWP)

A U.S. agency negotiates a collaborative agreement with a university research organization in Brazil to study plants in that country as potential sources of drugs to fight cancer.

Members of a Native-American tribe create a digital database in which they record all of their community's cultural knowledge, history, practices, and arts.

A U.S. corporation seeking to study microorganisms in Yellowstone National Park enters a Cooperative Research and Development Agreement with the U.S. government, stating that any benefits of commercialization will be shared.

Though these situations may seem unrelated, they have something in common: All are mechanisms aimed at protecting the value of genetic resources, traditional knowledge, and folklore, three elements that are often intertwined in daily life in indigenous communities. A traditional healing remedy, for example, may involve preparing a local plant according to a recipe passed down from generation to generation and consuming it as part of a cultural ceremony.

The United States respects and recognizes the importance of protecting genetic resources, traditional knowledge, and expressions of folklore by facilitating equitable benefit sharing, eliminating erroneously issued patents, eliminating misappropriation of traditional knowledge, and preserving expressions of folklore, says Linda Lourie, an attorney with the U.S. Patent and Trademark Office's (USPTO) International Relations Office.

As a country composed of people from all over the globe, as well as more than 560 Native-American tribes, the U.S. government has had to handle a myriad of concerns regarding these often-complex matters. "We've resolved these issues by national means," Lourie stressed. Some of these solutions utilize existing U.S. intellectual property laws, while others do not. Tribal businesses, for example, use established intellectual property laws, while Native-American expressions of folklore are protected by other types of laws, programs, and even museums.

In the international arena, the United States is at the forefront in developing benefit-sharing agreements with source countries regarding their genetic resources. "We have consistently led the world in negotiating these kinds of arrangements," she said, "and we certainly would encourage other countries to do so."

The United States is eager to share its experiences with other countries in international fora, said Lourie. "But," she cautioned, "each country has different issues that need to be resolved differently. One size does not fit all."

WHAT ARE THE ISSUES?

In 1993, the Convention on Biological Diversity (CBD) came into force. It represents a commitment by nations to conserve biological diversity, to use biological resources sustainably, and to share the benefits arising from the use of genetic resources fairly and equitably. Article 8(j) of the convention draws a connection among traditional knowledge, folklore, and genetic resources by calling on nations to "respect, preserve, and maintain knowledge, innovations, and practices of indigenous and local communities" and to promote wider application with the approval of the holders of such knowledge and practices.

Since 1993, the international community has been working to better understand and implement Article 8(j) within the framework of the World Trade Organization (WTO) and the World Intellectual Property Organization (WIPO), among others. In these discussions, several developing countries have advocated creating new forms of legal protections for these resources at WIPO. In response, WIPO member states established an Intergovernmental Committee (IGC) as an international forum for discussing the relationship between intellectual property and genetic resources, traditional knowledge, and folklore.

But what is meant by these three terms? Ultimately there is no uniformity in definitions. The term "genetic resources" is defined in the Convention on Biological Diversity, Article 2, as "genetic material of actual or potential value." Genetic material refers to any material of plant, animal, microbial, or other origin containing functional units of heredity.

According to the International Bureau of WIPO, "traditional knowledge" refers to systems of knowledge, generally passed from generation to generation, pertaining to a particular people or territory, and including their creations, innovations, and cultural expressions. By definition, some form of traditional knowledge has existed for a long time. However, such knowledge is not static and can be constantly evolving in response to a changing environment. Traditional knowledge may focus on natural elements such as mineral deposits, location of salmon, healing properties of local plants, land management practices, or agricultural technologies.

The term "expressions of folklore" has also been defined by WIPO for purposes of its discussions. WIPO says this term refers to characteristic elements of "traditional artistic heritage" developed and maintained by a community or by individuals who reflect the traditional artistic expectations of such a community. Expressions of folklore may be oral, as in folktales; musical, as in songs; actions, as in folk dances, plays, or rituals; or tangible expressions, such as drawings, paintings, carvings, sculptures, pottery, woodwork, metal ware, jewelry, basket weaving, needlework, textiles, carpets, costumes, musical instruments, and architectural forms, among others.

The concerns of traditional knowledge holders within the United States and other countries include: loss of traditional knowledge; lack of respect for traditional knowledge; the misappropriation of traditional knowledge, including use without benefit sharing and offensive use; and the need to preserve and promote the use of traditional knowledge. Indigenous communities have many similar concerns regarding their traditional artistic expressions.

Holders of genetic resources worldwide also are largely focused on the issues of "protection," "preservation," and "equity," although even those terms have not been defined uniformly.

There have been calls for the creation of new international legal protections for these resources, but many questions remain unanswered. Who would be the beneficiaries of any protection measures created for genetic resources, traditional knowledge, or folklore? No country, international intergovernmental organization, or person has been able to identify the intended beneficiaries of these sought-after protection measures. Similarly, none has determined what the scope of such protection might be, what would constitute "fair use" or other exceptions of limitations, or even what enforcement mechanisms could be applied. How would an expatriate of an indigenous community from one country profit from, or have the right to use, genetic resources, traditional knowledge, or folklore from her past in her new home? How would combinations of traditions be protected? What about traditions or knowledge that span borders or continents or are universally practiced?

Some countries want to prevent others from using their traditions while others want to commercialize or profit from such use. How could any one system encompass all these interests? And, to make matters even more complex, there is no agreement as to what actual harm would be remedied by new means of protection.

In the United States, tribal enterprises can and do avail themselves of U.S. intellectual property laws, said Eric Wilson, an international program analyst with the U.S. Department of the Interior. The Mississippi Band of Choctaw, for example, holds annual seminars for tribal government and tribal industry managers on intellectual property. The tribe is engaged in manufacturing enterprises and wants to be able to avail itself of relevant intellectual property rights (IPR), he explained.

The current laws of intellectual property rights are not enough to cover all the concerns of indigenous peoples, and such laws alone cannot be expected to do so, Wilson stressed. "Indigenous values," as they are sometimes called, are quite broad and vary among the tribal communities, with some interests belonging to an entire tribe, a clan, or an individual.

In order to achieve protection of intellectual interests, Wilson suggested that some of the solutions will need to come from the indigenous communities themselves. He said that it would be appropriate for national governments to give legal recognition to customary indigenous law.

TRADITIONAL KNOWLEDGE

One approach taken to respond to traditional knowledge holders, said Linda Lourie, consists of ensuring that patents are not granted on known products or processes, including those that are considered traditional knowledge.

A patent is a grant by a national government to an inventor for the right to exclude others from making, using, or selling his or her invention. To qualify for patent protection in most countries, an invention must be new, it must be useful, and it must not be a trivial extension of what is already known. Some holders of traditional knowledge fear that others will seek patents based on their long-held knowledge and reap the benefits from it. But an applicant trying to patent traditional knowledge likely cannot meet the three necessary requirements, Lourie said. "Traditional knowledge is already known, so if it has been documented, it's no longer new."

According to the U.S. Patent Act (Title 35 U.S. Code, Section 102), if an invention a) was known or used by others in the United States, or patented or described in a printed publication in this or a foreign country before the invention thereof by the applicant for patent, or b) was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, then it is not entitled to a patent.

"However," Lourie explained, "if our patent examiners in Virginia do not know about traditional practices overseas, they cannot protect them."

Lack of information about a traditional remedy led to a problem in 1995 when a U.S. patent covering the use of the turmeric plant in healing wounds was mistakenly granted to Indian nationals from the University of Mississippi Medical Center. Turmeric has been used for a long time in India to heal wounds, and this had been documented in Indian publications. The Indian Council for Scientific and Industrial Research requested a reexamination of the patent, and the U.S. Patent and Trademark Office revoked the patent for lack of novelty. The ability of a third party to request reexamination and the eventual cancellation of the claims when a mistake has occurred demonstrate that the current patent system works well to correct itself.

The importance of publishing traditional knowledge and making that information available to patent examiners internationally cannot be overemphasized, said Lourie. "If traditional knowledge is documented, that knowledge may not be the subject of a patent, even if it is not widely known in an industrialized country."

The United States is encouraging other countries to create digital databases to catalog their traditional knowledge and protect it from patent attempts. Digital databases would allow patent examiners all over the world to search and examine traditional knowledge. Several developing countries are working toward this end. India and China have been very involved in developing searchable digital libraries of their traditional knowledge, Lourie said. U.S. patent examiners regularly check the international databases that are already in use.

Lourie acknowledged that some traditional knowledge holders might want to keep certain aspects of their knowledge secret or limited to specific individuals or groups. If so, she said, they may want to take steps to guard their knowledge as a trade secret. In the United States, infringement of a trade secret is considered a type of unfair competition.

Within the United States, some Native-American tribes are cataloging their tribal values in a way that fulfills the need for documentation and the need to limit outsiders' access to information. According to Eric Wilson, the Tulalip Tribes in the U.S. state of Washington, for example, have developed a sophisticated digital computer inventory, named "Cultural Stories," that delineates who is to have access to what traditional information about their knowledge, history, culture, or practices. Some users have unlimited access, while others, such as U.S. patent examiners, may have limited access.

Some holders of traditional knowledge want to be sure that any new discoveries derived from their traditional knowledge include an equitable sharing of benefits. These communities may want to negotiate contractual benefit-sharing agreements regarding new products or processes created through research using their traditional knowledge. Lourie cautioned, however, that it could be a mistake to expect a windfall from such contracts; to date, very few financial benefits have accrued from commercialization of traditional knowledge.

FOLKLORE

In the United States, expressions of folklore are protected in a variety of ways, ranging from standard U.S. intellectual property laws to laws and programs specifically designed to protect and preserve the cultural heritage of its indigenous peoples.

One mechanism is the Indian (Native American) Arts and Crafts Act, a federal law enacted in 1935 and amended in 1990. This truth-in-advertising law prohibits the marketing of products misrepresented as Native American-made. It covers all Indian and Indian-style traditional and contemporary arts and crafts, such as baskets, jewelry, masks, and rugs. An individual or business violating the act can face civil penalties or criminal penalties or both.

The Database of Official Insignia of Native-American Tribes was established at the USPTO in 2001 in response to Native-American concerns about the preservation of expressions of folklore. Official insignia are not trademarked designs; they are insignia that various federally and state-recognized Native-American tribes have identified as their official tribal emblem. Inclusion of official insignia in the database ensures that an examining attorney will be able to identify any official insignia that may preclude registration of a mark where the mark suggests a false connection with the tribe.

In addition, all trademark applications containing tribal names, recognizable likenesses of Native Americans, symbols perceived as being Native American in origin, and any other application that the USPTO believes suggests an association with Native Americans are examined by an attorney at the USPTO who has developed expertise and familiarity in this area.

The U.S. government has taken several other steps to protect and preserve its peoples' expressions of folklore. The American Folklife Center in the Library of Congress was created in 1976 by the U.S. Congress "to preserve and present American folk life" through programs of research, documentation, archival preservation, live performance, exhibition, public programs, and training. The center incorporates the Library's Archive of Folk Culture, established in 1928 as a repository for American folk music. The center holds more than 1,000,000 photographs, manuscripts, audio recordings, and moving images.

The U.S. government also maintains the Smithsonian Center for Folklife and Cultural Heritage to promote the understanding of grassroots cultures in the United States and abroad. Its collection includes many thousands of commercial discs, audiotapes, compact discs, still images, videotapes, and motion picture film. It produces annual folklife festivals, recordings, exhibitions, documentary films, and educational materials.

The newest U.S. effort to protect and preserve Native-American culture is the Smithsonian Institution's National Museum of the American Indian, which opened in Washington, D.C., on September 21, 2004. It is the first national museum in the United States dedicated to the preservation, study, and exhibition of the life, languages, history, and arts of Native Americans.

GENETIC RESOURCES

Throughout the world, many communities are focusing on issues of equity as well as protection and preservation of resources. Those communities have expressed their concern that industrialized-country companies could utilize source-country natural resources for agricultural and pharmaceutical products and assert intellectual property rights claims.

Many others believe that such concerns have been overstated. Where the U.S. government, including the National Cancer Institute (NCI), is involved in genetic resource research in other countries, it enters into benefit-sharing agreements with those countries to gain fair access to genetic resources and/or traditional knowledge, said Linda Lourie. "There are many success stories" involving collaborative agreements and contracts for cooperation negotiated on mutually beneficial terms.

"NCI was ahead of the Convention on Biological Diversity by about three or four years" in negotiating agreements with source countries regarding their resources, says scientist Dr. Gordon Cragg.

Cragg, chief of the Natural Products Branch of NCI's Developmental Therapeutics Program, explained that, in the 1980s, NCI started developing policies for collaborating with source countries on the use of their genetic resources in research aimed at finding more effective treatments for cancer. These agreements provided the source countries with short-term benefits that would accrue without having to wait and see whether promising discoveries were derived from their resources. The benefits included training source-country scientists in NCI laboratories or U.S. universities' laboratories and technology transfer, he said.

"The chances of a discovery becoming a commercial product is usually said to be one in 10,000," said Cragg, adding, "I think that is optimistic."

NCI, part of the U.S. National Institutes of Health, one arm of the U.S. Department of Health and Human Services, functions much like a non-profit pharmaceutical company. Established in 1937, NCI had evolved by the 1950s into a drug research and development center, collecting plants mostly in the United States, Mexico, Canada, and parts of Africa and Europe. In the 1980s, NCI began a collection program for plants and marine organisms in tropical regions.

This was the program in which NCI first developed policies for benefit-sharing with source countries. "We began letting out contracts to high-quality research organizations in the United States for collections overseas," explains Bjarne Gabrielsen, senior advisor for drug discovery and development in NCI's Technology Transfer Branch. "The Missouri Botanical Garden collected plants in Africa, the New York Botanical Garden collected in Latin America, the University of Illinois in Chicago collected in South Asia," he said. "The collections were done mainly in tropical and subtropical countries, mainly developing countries."

At this stage, Cragg's program started using Letters of Collection, agreements among NCI, a U.S. contractor organization, and a collecting organization in the source country. "The U.S. contractor goes into an area, obtains the necessary permits, and collects plants and marine organisms for us" with the source country organization, said Gabrielsen. "The NCI does the extraction and testing." In addition to short-term benefits, NCI requires that, if a promising potential drug is discovered and licensed to a pharmaceutical company, the company must negotiate an agreement so that benefits, such as part of the royalties, will be returned to the country.

Over time, in response to the Convention on Biological Diversity and to greater awareness on the part of source countries about the value of their resources, research organizations and pharmaceutical companies increasingly have adopted policies of equitable collaboration and compensation.

In this, too, NCI has been a leader. In the 1990s, NCI de-emphasized its collections in its plant-derived drug discovery program in favor of expanding closer collaboration with qualified source-country scientists and organizations under agreements called Memoranda of Understanding.

"Where source-country organizations have the skills, expertise, and knowledge and some reasonable infrastructure in their labs, we support them by helping them further their own drug discovery research programs," said Cragg. For example, he said, NCI's Developmental Therapeutics Program has provided a research organization at the Federal University of Ceara in Fortaleza, Brazil, with the training and cancer cell lines to establish their own cancer drug discovery program. This group is now screening materials from research programs all over Brazil.

"We have five such agreements in Brazil," said Cragg, as well as collaborations with organizations in Australia, Bangladesh, China, Costa Rica, Fiji, Iceland, South Korea, Mexico, New Zealand, Nicaragua, Pakistan, Panama, Papua New Guinea, South Africa, and Zimbabwe.

Through this type of collaboration, the developing-country organization may make a promising discovery in-country, said Cragg. Even if they send NCI a sample for more extensive testing, such testing is regarded as routine and NCI makes no intellectual property claim, he said. "The results are sent back to them and the source-country organization can take out the patent, if appropriate.

"To our minds," stressed Cragg, "it is an ideal process. ... If a pharmaceutical company wants to use the discovery and the source-country organization has the patent, it must negotiate a licensing agreement and the source-country organization can dictate [the] terms.

"By establishing these close collaborations aimed at developing promising treatments for the U.S. and global cancer population, we achieve NCI's mission and also the goals of the Convention on Biological Diversity," said Cragg. "The source country is deriving significant benefit."

Linda Lourie pointed out that the U.S. government also requires a contract when companies want to collect genetic resources from federally owned lands or from the approximately 56 million acres of land the federal government holds in trust for U.S. tribes and individual Native Americans. For example, in order to study unique microorganisms in the hot springs of the U.S. government-owned Yellowstone National Park that can withstand great heat, researchers must enter into a Cooperative Research and Development Agreement (CRADA) with the U.S. government that includes benefit sharing, with milestone payments if the results are commercialized, she said.

"The U.S. view of protection of genetic resources," Lourie said, "is to encourage other countries to establish appropriate access and benefit-sharing regimes that provide benefit sharing on mutually agreed terms." Some countries develop policies limiting access by creating so many barriers as to almost prohibit collaboration, thus ruling themselves out of the potential benefits of collaboration, said Cragg.

CONCLUSION

The United States has developed a wide variety of mechanisms to respond to concerns regarding the protection of traditional knowledge, folklore, and genetic resources. In the U.S. view, intellectual property laws are and should continue to be available to indigenous individuals and peoples who meet the appropriate criteria for such legal protection.

The U.S. government supports the exchange of views on traditional knowledge, expressions of folklore, and genetic resources in international fora, particularly in WIPO, which has the necessary expertise and resources to tackle these complex and technical issues. WIPO activities have included fact-finding missions, case studies and surveys, sample contractual clauses, and examples of databases.

U.S. experts agree that intellectual property protections do not offer a solution for all of the issues involved in the protection, preservation, promotion, and use of traditional knowledge, expressions of folklore, and genetic resources worldwide. In the U.S. view, however, the key to resolving these issues satisfactorily is a solutions-oriented approach rooted in each country's national context.