TABLE OF CONTENTS
- INTRODUCTION
- UNITED STATES PROTECTION OF TK-DERIVED PRODUCTS
- EXAMPLES OF TK-DERIVED PRODUCTS VERSUS U.S. PATENTS
- INTERNATIONAL TREATIES, CASE STUDIES, AND MODEL PROVISIONS
- ISSUES ARISING FROM THE INTERFACE BETWEEN TK PROTECTION AND IP RIGHTS
- CONCLUSION
As appreciation of the importance of traditional knowledge and folklore, and the fruits thereof, grows on a worldwide scale, the protection of traditional knowledge and traditional knowledge-derived property as intellectual property (IP) has come under scrutiny. Nations are becoming increasingly protective of their natural resources (for example, see Appendix A). This article outlines the perspective of the United States (U.S.) on this increasingly heated debate, and advocates collaboration between holders of traditional knowledge and industry/ research institutions as a mutually beneficial solution which allows both sharing and protection of traditional knowledge. The article will explore definitions of traditional knowledge and folklore; U.S. systems of legal protection and suitability for protection of traditional knowledge and folklore; a brief overview of the U.S. patent system and case law relating to the patentability of natural products, international treaties and the establishment of model provisions and databases to protect traditional knowledge. The article concludes with a series of questions regarding protection of traditional knowledge and folklore as IP in the U.S., and incentives for collaborations between developed and developing countries.
A working concept of "Traditional Knowledge" (TK) has been defined by the World Intellectual Property Organization (WIPO) Secretariat as "tradition-based literary, artistic, or scientific works; performances; inventions; scientific discoveries; designs; marks, names, and symbols; undisclosed information; and all other tradition-based innovations and creations resulting from intellectual activity in the industrial, scientific, literary or artistic fields."[i] Traditional knowledge subject matter may include herbal classification, location and properties; geographical assets in territories, such as timber or underground deposits, animal domestication and hunting; and land management and use.
"Tradition-based" refers to "knowledge systems, creations, innovations and cultural expressions which: have generally been transmitted from generation to generation; are generally regarded as pertaining to a particular people or its territory; and are constantly evolving in response to a changing environment."[ii]
"Expressions of folklore" consist of "characteristic elements of traditional artistic heritage developed and maintained by a community... or by individuals reflecting the traditional artistic expectations of such a community, in particular:
'(i) verbal expressions, such as folk tales, folk poetry, and riddles;
'(ii) musical expressions, such as folk songs and instrumental music;
'(iii) expression by action, such as folk dances, plays and artistic forms of rituals whether or not reduced to material form; and
'(iv) tangible expressions such as productions of folk art"[iii]
WIPO notes that there are many definitions of TK and folklore, and that it may not be possible (or necessary) to develop an all-purpose term. "The definition of IP-related subject matter may also be expressed very generally when the definition does not determine or delimit the actual scope of protection to be granted under law."[iv] WIPO descriptions, as well as various national publications, suggest that Traditional Knowledge can be divided into public and non-public knowledge, and may be subject to different forms of protection. For example, secret or sacred knowledge may be a subject matter excluded from a system of publication-based protection. Subject matter and products derived from TK, such as use of medicinal plants, may be distinguished from the TK from which the subject derives, and TK and products derived from TK may be protected under similar or different statutes.
The U.S. has a range of IP protection mechanisms that may be suitable to provide legal protection for TK and Folklore, as well as products, works, and marks derived from TK or Folklore: plant variety protection certificates, plant patents, design patents, trademarks, copyrights, trade secrets, or utility patents. In addition to these IP mechanisms, if proposed, special case protections may allow for unique protection of IP which may not be protected under other laws.
New plant varieties may be protected under the Plant Patent Act (35 U.S.C. §§161-164), which protects asexually reproduced plants, or the Plant Variety Protection Act (PVPA, 7 U.S.C. 2321 et seq.), which protects sexually reproduced plants. A plant patent gives the inventor or breeder exclusive rights to exclude others from production, reproduction, sale, export, and stocking of the plant or its material. To be patentable, plants must be nonobvious and novel. A plant variety certificate gives the owner, breeder, or discoverer of a new plant variety the right to exclude others from selling, exporting, or propagating the plant, although farmers and researchers are exempt from propagation exclusion. Under PVPA, a plant must be novel, but does not have to be nonobvious. Plants cultivated by Indigenous peoples for medicinal and other uses may be protected by plant patent or plant variety certificate.
A design patent (35 U.S.C. § 171) covers the ornamental design of a manufactured article, as opposed to the article's functional design. A design is patentable provided the design, separate from the function of the product, meets novelty and nonobviousness requirements. Design patents may also be used to protect TK-derived products or folklore-based designs.
Trademarks are given to a manufacturer or merchant who adopts a mark to identify goods and services. The Lanham Trademark Act identifies four types of registerable marks:
- Trademark– a mark used on or with goods.
- Service Mark– a mark used in advertising and sale of services
- Collective Mark– indicates membership in a group, or that groups or services originate from members of that group.
- Certification Mark– used by government or private entities to certify that products or services come from a designated region, or possess certain characteristics.
Marks do not need to be new or original. Trademarks may be a way of uniquely identifying TK- or folklore-derived products; for example, the U.S. Patent and Trademark Office (USPTO) has recently started development of a database of official Native American Tribe insignia for the purposes of trademark protection.[v]
Copyright (17 U.S.C. § 102(a)) covers literary, musical, dramatic, choreographic, pictorial, graphic, sculptural works, motion picture and audio-visual works, sound recordings, and architectural works. Copyrights confer exclusive right to authorize reproductions, prepare derivative works, and publicly perform and display works (17 U.S.C. § 106). Copyright may be used to protect folklore or TK-derived expressions such as artistic works or performances.
Trade secrets are covered under common law, which has been codified in many states within the U.S. by the Uniform Trade Secrets Act. Subject matter can be any information that derives "economic value... from not being known, and not being readily ascertainable by proper means, by other persons."[vi] Some non-public forms of TK may be in the manner of a trade secret by the attachment of sacred or ceremonial significance to such knowledge. Possible examples include herbal potions, plants, fruits, geological deposits, and the like. Public traditional knowledge is unlikely to be protected by trade secret laws.
A United States utility patent gives the right to exclude others from making, using, importing, or selling in the U.S. the product or process claimed in the patent. To qualify for patent protection, an invention must meet requirements of novelty, utility, and nonobviousness over prior art. A utility patent entitles an inventor to a limited monopoly on his invention in exchange for the inventor's full disclosure of his discovery to the public. The United States patent system, therefore, rewards the inventor for his discovery by securing for the inventor the exclusive rights to his invention for a limited time and, most importantly, benefits the public by promoting the full disclosure of such inventions which can be used by anyone after the expiration of the limited monopoly afforded by the patent laws. An inventor's right to the limited monopoly defined by his patent is derived from the Constitutional grant, Article 1, Section 8 which provides:
"The Congress shall have the power . . . To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries."
Patentable subject matter is defined in Title 35, U.S.C. § 101 as "any new and useful process, machine, manufacture, or composition of matter or improvement thereof". In addition, the invention must show novelty (35 U.S.C. §102), meaning that a person shall be entitled to a patent unless (for example):[vii]
(a) the invention was known or used by others in this country, 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) the invention 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 . . .
An invention must also be nonobvious (Title 35, U.S.C. §103), meaning that the differences between the invention and the prior art are such that the subject matter to be patented would not have been obvious at the time the invention was made, to a person having ordinary skill in the art to which the subject matter pertains. In addition, the invention must be enabled (Title 35, U.S.C. §112), meaning that an invention must also be described in sufficient detail as to enable any person skilled in the art to make and practice the invention.
U.S. Case law provides examples of when natural products are patentable. The first major case to deal with the issue of patenting natural products was Funk Bros. Seed Co. v. Kalo Inoculant Co., 75 U.S.P.Q. 280 (1948). The product claimed in the patent was a composite mixture of six strains of bacteria packaged for use to inoculate leguminous plants. The Supreme Court held that claims to the mixture of bacteria, as a product, were not patentable because each of the bacteria existed in nature before, and without more, their combination was a mere discovery of nature. Thereafter, the Funk Seed case was regarded as standing for the general rule that products found in nature are not patentable.
Merck & Co. Inc. v. Olin Mathieson, 116 U.S.P.Q. 484 (4Cir. 1958) and Merck & Co. Inc. v. Chase Chemical, 155 U.S.P.Q. 139 (D.N.J. 1967) furthered the idea that products from nature but modified by man were patentable. The inventors in the Merck vitamin B-12 cases were the first to separate and purify vitamin B-12 from fermentates. The patent claimed the purified vitamin B-12 product. The court concluded that the purified vitamin B-12 was not the same as that found in nature, but a new and useful composition entitled to patent protection. In re Kratz et al., 201 U.S.P.Q. 71 (C.C.P.A. 1970) furthered the argument that purified natural products are patentable, by upholding a patent for substantially pure 2-methyl-2-pentenoic acid, the chemical responsible for the flavor and fragrance of strawberries.
Diamond v. Chakrabarty, 447 U.S. 303, 65 (1980), centered on the question of whether a living organism qualifies as a "composition of matter" which could be patentable. The invention involved bacteria which had been engineered in the laboratory to contain new genes that enabled the bacteria to degrade components of crude oil, which could be used to treat oil spills. The United States Supreme Court upheld the patentability of Chakrabarty's microorganisms and enunciated the rule that patentable subject matter encompassing a process, machine, manufacture, or composition of matter in Section 101 of the Patent Statute included "anything under the sun that is made by man." Genetically modified plants are similarly qualified subjects for utility patents, as decided in In re Hibberd, 227 U.S.P.Q. 443, 444 (BNA, 1985), in which plants genetically engineered to produce increased levels of the nutritional amino acid tryptophan were upheld as patentable subject matter. A plant can be protected simultaneously by a plant patent and a utility patent, as upheld in J.E.M. Ag. Supply, Inc. v. Pioneer Hi-Bred, Inc., 534 U.S. 124 (2001).
An examination of U.S. cases involving TK-derived products provides examples of the dilemmas involved with patenting products with traditional uses.
Turmeric, which is derived from a plant, was used for many years by the people of India for medicinal and other purposes. In 1995, the USPTO granted U.S. Patent No. 5,401,504, assigned to the University of Mississippi Medical Center, which covered the use of turmeric in wound healing. But because this use had been documented in Indian publications, the claims of the patent were ultimately cancelled during reexamination for lack of novelty.[viii] This highlights the importance of publishing traditional knowledge: by making such knowledge publicly accessible, it is maintained in the public domain to be used by anyone and can serve as prior art to prevent patentability.
Vociferous protests centered around patents involving the neem plant. Materials derived from the neem tree were used for many years by the people of India for pesticidal and other purposes. The United States has issued numerous patents for neem-related inventions. For example, U.S. Patent No. 4,946,681, assigned to U.S. company W.R. Grace & Co., covers a technique for extracting neem seeds to produce stable azadirachtin solutions. And U.S. Patent No. 5,124,349, also assigned to W.R. Grace & Co., covers a storage‑stable pesticide composition comprising a neem seed extract solution containing azadirachtin. Thus, while the inventors may have drawn upon the TK of the Indian people, the patented inventions themselves are different as to method of extraction and final product.[ix]
Basmati rice has long been produced in India and Pakistan. In 1997, the USPTO granted U.S. Patent No. 5,663,484, assigned to the United States company of RiceTec, Inc., which covers Basmati rice lines and grains (see Appendix B). Upon reexamination five years later, fifteen of the patent's twenty claims were cancelled as unpatentable over the prior art. The five surviving claims relate only to the varieties actually bred by RiceTec, Inc. The patent examiner also changed the title of the patent from "Basmati Rice Lines and Grains" to "Rice Lines Bas867, RT 117, RT1121."[x]
On a worldwide scale, there are significant differences between U.S. and international interfaces between intellectual property and traditional knowledge. The U.S. has little specific legal protection for TK-derived products, but is a signatory to the North American Free Trade Agreement (NAFTA), and the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPs). Although NAFTA contains no provisions relating specifically to TK, NAFTA has incorporated the International Convention (Union) for the Protection of New Varieties of Plants (UPOV) to protect plant breeder's rights. In the U.S., UPOV is legislated by the Plant Variety Protection Act (PVPA), as previously discussed for plant variety patents.
In the U.S., a per se rule, rather than a rule of reason, excludes foreign practice ("known or used" or "offered for sale") of an invention from being prior art in view of 35 U.S.C. §§ 102 & 104. The amended § 104 recognizes foreign practice of an invention in countries that are signatories to the NAFTA and/or the WTO agreements. These provisions may allow for the use of unpublished TK in NAFTA and WTO countries as prior art. However, foreign publications are given equal weight to U.S. publications as prior art, which suggests a way in which publication of TK can be counter-productive. Under 35 U.S.C. 119(a), the publication of TK may protect TK-derived inventions from being patented by non-TK holders; however, this also could invalidate any attempts by TK-holders themselves to obtain a U.S. patent on their TK or TK-derived inventions.
TRIPs does not make specific provisions for TK or TK-derived products, but sets international minimum standards for protecting IP. The objectives of the TRIPs Agreement include reducing impediments to international trade, protecting intellectual property rights, and ensuring that measures to enforce intellectual property rights do not themselves become barriers to legitimate trade.[xi] TRIPs recognizes "the special needs of the least‑developed country Members in respect of maximum flexibility in the domestic implementation of laws and regulations in order to enable them to create a sound and viable technological base."[xii] The TRIPs Agreement requires its Member countries to make patents available for any inventions, subject to the tests of novelty, inventive step and industrial applicability.[xiii] However, members may exclude from patentability:[xiv]
- inventions that defy ordre public or morality, the prevention of which protects human, animal or plant life or health, and avoids serious prejudice to the environment;
- diagnostic, therapeutic and surgical methods for the treatment of humans or animals;
- 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.
The last exception, in particular, may provide a mechanism to protect some forms of Traditional Knowledge from by foreign enterprises.
Several international agreements, to which the U.S. is not party, have clauses relating directly to TK. The United Nations Conference on Environment and Development established the Convention on Biological Diversity (CBD) to address major issues of biodiversity. The three main goals of the Convention are the conservation of biodiversity; the sustainable use of the components of biodiversity; and sharing the benefits arising from the commercial and other utilization of genetic resources in a fair and equitable way.[xv] Article 8 (j) of the CBD states that each party shall,
"subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices"[xvi].
In addition to the CBD, the U.N. Food and Agricultural Organization (FAO) adopted the International Treaty on Plant Genetic Resources (ITPGR) in 2001. The IPTGR provides for a multilateral approach to access and benefit-sharing of plant genetic resources, in which access to these genetic resources are provided in exchange for access to and transfer of information and technology, capacity-building, and sharing of benefits arising from commercialization.[xvii] Although little of the CBD and ITPGR treaties address IP rights directly, they may provide a framework of equitable distribution of compensation for TK-holders in the form of licensing and development opportunities.
WIPO has conducted studies on the IP needs and expectations of TK holders, and has developed case studies and suggested future possibilities involving the interfaces between TK and the IP system. In 2000, WIPO established a body, the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge, and Folklore, dedicated to this emerging issue. WIPO has also outlined several model provisions which suggest possible ways to negotiate equitable contracts involving TK. The various proposals and case studies offer essentially sui generis protection regimes for TK along with contracting and licensing rules designed to provide income to particular communities. As a case study example, WIPO describes a benefit sharing arrangement developed by the University of California at Davis (UC Davis) involving a TK-derived wild rice from Mali.[xviii] The rice strain Oryza longistaminata, which has a blight-resistance gene that was cloned and patented by researchers at the university, was used by select local Malian communities and collected by Malian and Indian scientists. UC Davis, wanting to compensate the germplasm source countries, established a Genetic Resource Recognition Fund. Royalties generated from commercialization of the disease resistance gene could then be used to provide fellowships to students from developing countries, who would return to their countries to help in nation building. The university goals for establishing the Fund were "five-fold:
- "To establish a mechanism to recognize and compensate for germplasm contributions from developing nations."
- "To provide a means for scientists to patent their inventions while maintaining productive collaborations and good relations with scientists from developing countries."
- "To encourage university/ developing nation/ industry links for commercialization of genetically engineered products."
- "To create a constructive solution that would be easy to implement and be widely accepted."
- "To create economic incentive for continued sharing of germplasm and conservation efforts."[xix]
In addition to case studies, WIPO has also published actual and model contracts. For example, a model developed by the U.S. National Cancer Institute (NCI) for collaborations between NCI and a Source Country/ Source Country Organization are available on the internet.[xx] These contracts include Memoranda of Understanding, Material Transfer Agreements, and Letters of Collaboration, which trade knowledge and drug discovery technology to the Source Country in exchange for the ability to study the Source Country's plants and organisms (see Appendix C). WIPO is also developing a database of contracts relating to IP, access to genetic resources, and benefit-sharing.[xxi]
In an effort to protect IP rights of traditional knowledge holders, some countries are developing databases to document TK and TK practices, as prior art for defense against attempts to patent TK-derived products. WIPO has published samples of TK databases from China, India, and Venezuela, to demonstrate the Knowledge available and to illustrate examples of IP issues that have arisen from TK databases.[xxii]
There are many difficulties involved in recognizing and protecting the TK and folklore IP rights of indigenous peoples. Some of the issues include:
- Is TK better protected as prior art (by publication/ establishment of searchable database) or trade secret (by limiting access to the information), or by a sui generis protection scheme (by enactment of new laws)?
- Can or should U.S. patent laws be modified to include TK, and TK-derived inventions, despite difficulties with such inventions fulfilling patent requirements relating to subject nature, novelty, and nonobviousness/ inventive step?
- If TK is known "by others" for more than one year prior to date of invention, it is not novel. Who might "others" be, for consideration of public disclosure, if for example an invention is patented by a community collective?
- When more than one community shares a common resource, or when communities share aspects of TK, who is considered the "owner" for considerations of property and compensation for use?
- Are biological species and native germplasm a nationally-owned resource?
- In an effort to compensate for access to genetic resources, how does one set a value on the potential of TK?
- How might indigenous peoples attempting to claim IP rights establish a spokesperson/ collective bargaining entity to make decisions regarding utilization of IP resources?[xxiii]
- How might indigenous peoples afford to invest in litigation to protect their IP?
- As indigenous peoples often wish to control their TK-based IP for generations rather than short-term, how might this be accomodated and enforced by existing protection schemes, and can aspects of trademarks and/ or trade secrets (which last indefinitely) be incorporated into an IP scheme?
- What ways exist to reward corporations from developed countries for recognizing, protecting, and conserving TK?
- How can IP rights be structured, alongside environmental protection and commercial laws, to promote development and conservation of resources?
- How might complicity with benefit-sharing practices, such as those outlined by the CBD, be enforced worldwide?
Incentives to industry to recognize, collaborate with, and compensate TK-holders for TK-derived IP currently exist. Commercialization of TK-derived products can be lucrative for both sides, and protection of these combined intellectual assets by patent and other IP strategies can ensure the spread of beneficial products and technologies while allowing financial remuneration for investment in such efforts. The insight provided by TK-holders can be an asset for industry: for example, by consulting with TK holders, the success ratio in trials for useful medical substances can increase from one in 10,000 to one in two.[xxiv] TK holders can also benefit from industry collaborations: by isolating drug components from medicinal plants, which are non-obvious in view of the whole plant, companies can provide the inventive step necessary for patentability.
Previous collaborations can provide guidelines for the establishment of future partnerships, and also highlight the incentives for developed nations to invest in the genetic resources of developing nations. The UC Davis Genetic Resource Recognition Fund was designed to recognize the contributions of TK holders, and to establish and maintain good relations with the developing countries in which the TK-derived product originated and was initially studied, with an eye toward future endeavors. In a similar vein, Merck Pharmaceuticals contracted with INBio, a private nonprofit biodiversity institute created by the Costa Rican governement, to "bioprospect" the species-rich Costa Rican lands. In exchange for extracts from Costa Rican plants, insects, and microorganisms, and Costa Rican screening and research services, Merck provided US$ 1.3 million as an initial sum, plus a share of any royalties on commercial products developed from these accessions.[xxv]
Although a lofty goal, the attempt to patent TK in our complex society will require an entire shift and possible revisions of our IP laws. Given that the U.S. IP system was not designed to protect the kinds of information represented by TK, and given the growing interest in recognition, conservation, and protection of cultural heritage and genetic resources worldwide, examination of mutually beneficial contracts between TK holders in developing countries, and research/ industry groups in developed countries such as the U.S., may provide a means for the simultaneous sharing and protection of TK and TK-derived resources as intellectual property.
REFERENCES
[1] I wish to acknowledge my partner Geraldine Baldwin, and my associates Lynn Ditch, T. Christopher Tsang, and Rattan Nath, who contributed to this paper.
[i]. "Traditional knowledge-- Operational terms and definitions" Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO/GRTKF/IC/3/9, p. 11 (2002)
[ii]. Id., p. 11
[iii].WIPO/GRTKF/STUDY/1
[iv]. "Traditional knowledge-- Operational terms and definitions" Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO/GRTKF/IC/3/9, 2002
[v]. "Procedures for Native Tribe Database are Finalized", 62 PTCJ 412, 2001.
[vi].Uniform Trade Secrets Act §1(4)
[vii].See 35 U.S.C. §§102(a),(b).
[viii].See U.S. Patent No. 5,401,504; S. Kumar, India wins Battle with USA over Turmeric Patent, 350 Lancet 724 (1997); D.R. Downes, How Intellectual Property Could Be a Tool to Protect Traditional Knowledge, 25 Colum. J. Envtl. L. 253 (2000).
[ix].See U.S. Patent No. 5,124,349; U.S. Patent No. 4,946,681; D.R. Downes, How Intellectual Property Could Be a Tool to Protect Traditional Knowledge, 25 Colum. J. Envtl. L. 253 (2000).
[x].See U.S. Patent No. 5,663,484
[xi].See Agreement on Trade-Related Aspects of Intellectual Property Rights (1994), Preamble.
[xii].Id.
[xiii].See TRIPs, supra note 1, at Article 27.1.
[xiv].Id.
[xv]."Sustaining life on Earth", Secretariat of the Convention on Biological Diversity, 2000
[xvi].Convention on Biological Diversity, Article 8 (j)
[xvii]. "Initial report on the technical study on disclosure requirements related to genetic resources and traditional knowledge", Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO/GRTKF/IC/4/11, 2002.
[xviii]. "The role of intellectual property rights in the sharing of benefits arising from the use of biological resources and associated traditional knowledge: selected case studies" WIPO/ UNEP joint submission, 2000.
[xix].Id., p. 14-15.
[xx].Available online (as of January 2003) at http://www.wipo.int/globalissues/databases/contracts/summaries/
[xxi]. "Structure of proposed database of contractual practices and clauses relating to intellectual property, access to genetic resources and benefit sharing", Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO/GRTKF/IC/3/4, 2002.
[xxii]. "Inventory of existing online databases containing traditional knowledge documentation data", Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO/GRTKF/IC/3/6, 2002.
[xxiii].M. Hannig, 13 Ariz. J. Int'l & Comp. L. 175, 1996
[xxiv]. N. Roht-Arriaza, 17 Mich. J. Int'l L. 919, 1996.
[xxv]. N. Roht-Arriaza, 17 Mich. J. Int'l L. 919, 1996.