B  U  L  L  E  T  I  N

of the American Society for Information Science and Technology       Vol. 30, No. 2      December/January  2004

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Intellectual Property and Biological Knowledge
by Gwen L. Williams

Gwen L. Williams is currently enrolled in the Master's program at the Graduate School of Library and Information Science, University of Illinois at Urbana-Champaign.

Global biological data poses particular challenges for organizing and managing intellectual property. Issues concerning the industrial property branch, such as patent protection, have generally not been the librarian's concern. However, for the librarian and information management professional specializing in the organization of biological knowledge, the knowledge domain includes intellectual resources eligible for industrial property rights protection. An intellectual resource can be deemed industrial property eligible for rights protection if the resource is a patentable invention and has an industrial application.

Traditionally, libraries and natural history museums have been concerned primarily with the copyright branch of intellectual property as it pertains to access to intellectual resources. It is primarily the first sale doctrine and the fair use of copyrighted resources that enable libraries and museums to meet the educational and information organization and dissemination goals of their charter. With respect to the organization of biological knowledge, the intellectual property issues include the traditional issues surrounding the copyright branch as well as issues pertaining to industrial property protection. Access for current and future biological knowledge management has become more complicated. This is not to say that the intellectual property questions on the immediate horizon for biological knowledge management are necessarily new questions or are necessarily unique to the library and information science discipline. But the following issues concerning access to intellectual resources are new questions for library and information management practitioners and are of particular concern for those specializing in the organization of biological knowledge.

Biological Objects: Discovery or Invention?

The definition of biological objects is important for whether an intellectual resource falls under copyright protection or is eligible for industrial property protection. In other words, is the biological object a discovery or an invention? This definitional distinction is important because it affects whether the biological object is patentable and thus eligible for industrial property protection. That is, if the biological object is considered a discovery, then the biological object is not the scientist's creation. The creation of the scientist is the publication disclosing the discovery. Hence, copyright applies to the published findings and the protection of intellectual property rights is protection of the copyright. This protection is particularly important in biology where a person's name is associated as the authority for the first published treatment of a new species.

On the other hand, if the biological object itself is considered a creation of the scientist, then the biological object is an invention and is a potentially patentable object. Whereas the scientist's publication disclosing the invention would fall under copyright protection, the issuance and protection of patents fall under the industrial property branch of intellectual property rights: the protection of intellectual property rights is protection of the industrial property, the invention.

The classification of the biological object is not simply a matter of differing epistemological positions. A May 2002 Science article, "DuPont Ups the Ante on Use of Harvard's OncoMouse," details a recent intellectual property debate between private enterprise and academic scientific research where the biological object itself is a patented "mouse engineered to develop cancers." Another Science article, "Patents, Secrecy, and DNA," published in 2001, indicates "more than 25,000 DNA-based patents were issued by the end of 2000" on various genomics inventions, including patents for gene fragments and sequences. It is, as it were, a matter of the relations between publicly supported scientific research and commercial for-profit ventures in free-market capitalist economies.

For the library and information management practitioner, the disposition of the biological object whether it be discovery or invention affects the approach to and management of access. For management of access to copyrighted creations, the first sale doctrine and fair use principle would certainly seem applicable guidelines. Although access to copyrighted creations becomes more complex when it involves property rights for physical objects in natural history museums. Museums may "own" (with caveats discussed below) the specimens in their collections but if these objects are digitized, the museums must claim copyright protection for the digital representations. Some museums may fear that even with the copyright protection regime, they may lose control over the value of their collections. In contrast, the organization of information to support patent protection of inventions would entail denying unauthorized access, as denial of access for unauthorized parties is the underlying assumption that makes patent protection possible.

Commercialization of Biological Knowledge: Findings by the Convention on Biological Diversity

The Convention on Biological Diversity's "Report on the Role of Intellectual Property Rights in the Implementation of Access and Benefit-Sharing" (www.biodiv.org/doc/meetings/abs/abswg-01/official/abswg-01-04-en.doc) is exclusively concerned with the industrial property branch of intellectual property protection. The 2001 report makes plain that for international biological information networks, the most pressing intellectual property issues revolve around patents and patent procedures, adjudicating contesting claims for rights and protection, and trade agreements. All factor into decisions about the organization and management of biological knowledge, and all pertain to the commercial potential of biological resources.

In addition, the Convention on Biological Diversity specifically focuses their attention on and makes recommendations for addressing the often-conflicting interests between developed and developing countries with respect to commercialization of biological resources. Natural history museums hold many specimens of species from around the world, as collectors from industrialized countries have aggressively gathered specimens from developing countries over the past 300 years. The potential financial consequences are enormous as many of these materials, such as botanical pharmaceuticals, are patentable. The Convention's Panel of Experts on Access and Benefit-Sharing identified four key intellectual property issues under their auspices: prior informed consent; traditional knowledge related to genetic resources; access and benefit-sharing agreements; and scope, prior art and monitoring. Library and information management practitioners would likely be concerned with all four, as each involves questions of information and knowledge organization and management.

Prior informed consent pertains to incorporating patent application procedures for documenting "identification of the source of genetic material used in the development of subject matter which is to be protected by intellectual property rights" and "proof of the prior informed consent of the competent national authority of the provider country." Essentially, the panel maintained that holders of traditional knowledge and of the rights to innovations based on traditional knowledge must give informed consent prior to granting access to genetic resources, and that such consent must be documented.

The panel's report on traditional knowledge related to genetic resources defines "traditional knowledge," discusses the limits of property protection for traditional knowledge and proposes the sui generis model for protection of traditional knowledge. Traditional knowledge related to genetic resources is defined as "manifestations of knowledge and innovation" evidenced in indigenous creative practices, classifications systems, empirical observations and environmental management practices. Because of the collective nature of and lack of systematic documentation about traditional knowledge, the panel considered whether intellectual property rights are applicable to traditional knowledge; as argued by pharmaceutical industry interests, the panel recognized that intellectual property rights, in particular patents, could be viewed as and used toward protection of traditional knowledge.

The panel recommended implementation of sui generis systems for protection of traditional knowledge rights. Among their proposals for legislation were the recognition of ancestral community rights; recognition that intellectual property rights can be collective; and the "distinction between the rights over genetic resources (where vested in the State) and rights over knowledge associated with such resources (vested in local and indigenous customs)." Components of sui generis systems for protection could include systematic documentation of traditional knowledge, traditional knowledge registries and various patent and innovation systems, all of which present opportunities for library and information science management.

The panel discusses various access and benefit-sharing agreements at length, highlighting various possible arrangements between countries, industries, ministries and legal apparatuses. Access, for the Convention's purposes, tends to mean access to the actual genetic or biological resources for cultivation, harvesting and exploitation, and benefit-sharing means the protection of and compensation for the holders of intellectual property rights to such genetic or biological resources. In other words, access and benefit-sharing agreements pertain primarily to legal and binding financial arrangements between interested parties across the globe. How such legal and financial agreements affect library and information management practitioners seems to depend upon the particular situations as determined by employers, be they governmental, non-profit or for-profit organizations.

Related to, but different than, prior informed consent is prior art. The Convention's panel and the World Intellectual Property Organization's (WIPO) Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore are both exploring and advocating recognition that traditional knowledge be viewed as prior art. The categorization of traditional knowledge as prior art affords opportunities for library and information management practitioners to compile existing traditional knowledge literature; create registries for and repositories of traditional knowledge; and examine ways to improve search and access to traditional knowledge documents, collections and databases. This information could be organized around the species descriptions used in western taxonomy or in the taxonomy assigned by the holders of traditional knowledge about the species in the native environment.

Repatriation: Data or Specimen?

One of the most interesting intellectual property problems facing current and future biodiversity knowledge management concerns relations between developed and developing countries and involves repatriation of biological intellectual resources. While international and national policy decisions regarding repatriation are beyond the scope of the individual library and information management practitioner, the practitioner should be aware that repatriation law, agreements and treaties will have ramifications for organizing and providing access to biological resources. The global mission of many biodiversity projects to identify, name and classify the world's species certainly warrants attention to repatriation issues. The emphasis Global Biodiversity Information Facility (www.gbif.org/GBIF_org/what_is_gbif) places on data repatriation suggests the issue is crucial for the successful organization and management of a global biodiversity information network.

The repatriation of biological intellectual resources differs from the repatriation of refugees, of human remains and of cultural heritage objects typically housed in developed countries' museums and libraries. Whereas the actual persons, actual remains or actual cultural heritage objects are returned to their respective countries of origin, the actual biological specimens are not. Rather, as the Organization for Economic Cooperation and Development's (OECD) working group on biological informatics points out, with respect to biodiversity resources, repatriation concerns the repatriation of data generated about the specimen. In other words, a data surrogate replaces the original biological specimen as the object repatriated. The original biological specimen is held and maintained by the natural history museum, organization or institution that generated the specimen data. In this manner, the natural history museum seems to serve a custodial role, as opposed to explicitly claiming ownership of the specimen, although claims for ownership seem implied through maintaining possession of the original biological specimen.

Data repatriation poses an intriguing problem not only for governors, ministers and administrators of state, but also for scholars interested in globalization, the world economy, geopolitics and post-colonialism as data repatriation makes evident the historical, political milieu in which the present state of biological knowledge is immersed, and perhaps, from whence it originates. For data repatriation to be successful, the data repatriated must conform to internationally recognized standards and exist in formats of demonstrable value to the country of origin. Moreover, the replacement of the original specimen with its data surrogate must be satisfactory to all international parties involved. This question will probably be asked of natural history museums in developed countries: if the data surrogate be the virtual equivalent of the specimen, why not repatriate the specimen to the country of origin, generally a developing country, and maintain the surrogate in the developed country? In principle, unlike cultural artifacts, it would be possible to gather another specimen of the same species from its native environment.

It is probably an understatement to remark that identifying, naming and classifying all of the world's species is a gargantuan, utopian goal. But that is the goal toward which many in the biological sciences devote their working lives. Achieving progress toward that goal necessitates significant contributions from many allied disciplines and practitioners, including those that organize and manage access to all of the actual current and possible future intellectual manifestations of biological knowledge. While much work remains to be done and many unknowns have yet to unfold, one thing is certain: where there are intellectual resources to organize and manage, there are intellectual property issues that affect how the work of library and information management practitioners proceed. We need to be aware of the intellectual property issues debated, the many parties and varied interests involved, and the organizational and managerial possibilities for enabling the desired type of access. This is part of our contribution toward knowledge of our vast world.

For Further Reading

Convention on Biological Diversity. (2001). Report on the role of intellectual property rights in the implementation of access and benefit-sharing arrangements. Available at www.biodiv.org/doc/meetings/abs/abswg-01/official/abswg-01-04-en.doc.

Cook-Deegan, R. M., &  McCormack, S.J. (2001). Patents, secrecy, and DNA. Science, 293 (July 13), 217.

Marshall, E. (2002). DuPont ups ante on use of Harvard's OncoMouse. Science, 296 (May 17), 1212.

OECD Megascience Forum Working Group on Biological Informatics. (1999). Final report of the OECD Megascience Forum Working Group on Biological Informatics.  Available at www.gbif.org/GBIF_org/facility/BIrepfin.pdf.

World Intellectual Property Organization. (2001). WIPO Intellectual property handbook: Policy, law, and use. Geneva, Switzerland: WIPO. Available at www.wipo.org/about-ip/en/.

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