Index

Intellectual Property Rights

David Vivas-Eugui and Heike Baumüller

“International discussions on traditional knowledge tend to appear in two distinct formats: one defensive and one proactive. Defensive initiatives are designed to guard against the ‘misappropriation’ of the rights of indigenous peoples and local communities while proactive initiatives tend to assign legitimate and legal rights.”

Much of the debate on environment, trade and intellectual property rights (IPRs) revolves around a basic challenge: How to balance the increasing shift of knowledge and technology from the public domain to private ownership that has occurred because of the strengthening of the global IPR regime in the 20th century?

This global regime—which includes the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), agreements under the World Intellectual Property Organization (WIPO) and a new generation of bilateral and regional trade agreements with IPR obligations—has given titleholders exclusive rights over the use and marketing of the resulting products and processes. This protection has made it considerably more profitable for business to invest in research and development. At the same time, however, many existing genetic resources and forms of traditional knowledge (TK) have been used or incorporated in “inventions or discoveries” (whether products or processes) in third country markets.

This situation has raised a variety of environmental, socio-economic and ethical concerns, including that the IPR system encourages “biopiracy” and the “misappropriation” (illegal access and use) of genetic resources and TK. Critics have warned that global IPR rules increase the monetary incentives for such actions, without imposing any corresponding obligation to promote biodiversity conservation or other social objectives.

A variety of other concerns have been voiced about unbalanced intellectual property protection, including:

• limitations placed on access to seeds for use and breeding;

• shift in research priorities in the agricultural and environmental field away from less profitable research that responds to public needs towards technologies with high marketing potential;

• increased prices for and reduced access to environmentally sound technologies;

• promotion of research into genetically modified organisms without requiring appropriate risk assessments;

• erosion of genetic diversity resulting from an increased focus on a limited number of high-yield agricultural varieties;

• the appropriateness of the IPR system to protect traditional ecological knowledge; and

• ethical considerations related to the patenting or “privatization” of life forms.

These concerns have given rise to a complex and overlapping regulatory framework at the national, regional and international levels. While some agreements seek to introduce ever-higher levels of protection for intellectual property, others seek to mitigate some of the cited environmental, ethical and socioeconomic concerns. The consequence has been a tapestry that is rich in contradictions and unanswered questions.

At the international level, the 1961 International Union for the Protection of New Varieties of Plants (UPOV) was the first instrument to reflect the philosophical shift away from national sovereignty over biological materials as a common heritage, towards a system of private ownership rights benefiting those who could manipulate new plant varieties. The 1991 version of UPOV went further in this direction, by further strengthening breeders’ rights and providing the option of protecting plant varieties through breeders’ certificates of patents.

To balance these breeders’ rights, the International Undertaking on Plant Genetic Resources for Food and Agriculture adopted under the auspices of the United Nations Food and Agriculture Organization (FAO) in 1983 was based on the principle that plant genetic resources for food and agriculture are a “heritage of mankind” and should be available without restriction. The agreement introduced the concept of farmers’ rights “arising from past, present and future contributions by farmers to the conservation and maintenance of plant genetic resources for food and agriculture,” allowing farmers to reuse, sell and exchange these resources. The agreement was revised in 2003 to become the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), establishing a multilateral system that aims to facilitate access and benefit-sharing (ABS) arising from the use of such resources.

The 1992 Convention on Biological Diversity (CBD) sought a balance between national sovereignty over biological resources and a need to respect, preserve and maintain the knowledge, innovations and practices of indigenous and local communities. Like the ITPGRFA, the Convention’s Article 8(j) highlights the critical importance of indigenous and local communities’ traditional knowledge for the conservation and sustainable use of biodiversity. The issue of IPRs has repeatedly cropped up in CBD debates amongst parties since the Convention’s adoption and plays a central role in the ongoing negotiations of the international regime on ABS which were launched in April 2004.

The TRIPS Agreement, which was adopted in 1992, offered the most radical extension of private rights to date. The TRIPS Agreement provides that patents shall be available for any invention, whether products or processes, in all fields of technology subject to certain criteria. Article 27.3(b) allows countries to exclude plants and animals from patentability as long as plant varieties are protected either by patents, or by an effective sui generis system (of its own kind), or by any combination thereof. The definition of micro-organisms for purposes of patentability remains a contested issue under the TRIPS system.

Finally, in 2001, WIPO added to the debate over intellectual property protection and the public patrimony, with the establishment of the Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. WIPO uses IPRs primarily as a tool for strengthening private ownership rather than as a means for achieving public policy objectives, such as the conservation and sustainable use of genetic resources, benefit-sharing or preserving access to commonly shared resources as embodied in the CBD and the ITPGRFA.

Some have raised the concerns that the modern IPR system might not be suitable for preserving and protecting traditional systems of knowledge sharing and genetic resource use. However, within the context of the current IPR system, efforts have also been made to take advantage of existing IPRs for the purpose of environmental and biodiversity protection. Among them, so-called geographical indications might provide a potential tool to promote the preservation and lucrative use of TK.

Interests and Fault Lines

There are multiple issues related to the debates at the intersection of trade, environment and IPRs. Three are of particular importance (a fourth area, related to environmental technologies, is discussed elsewhere).

Access and Benefit-sharing (ABS)

A central challenge for policy-makers has been to address the problem of resources that have been patented without disclosure of sources, and/or sharing of benefits. This challenge has given rise to extensive discussions and has served to highlight the different aims and objectives of the various agreements which comprise the global IPR regime.

A key concern has been that IPR filing procedures allow the granting of patents regardless of whether a particular invention uses or incorporates illegally accessed genetic material or associated TK (i.e., without prior informed consent and benefit-sharing). This concern has been most acute in cases where the transboundary movement of genetic resources or TK has circumvented national regulations designed to ensure the existence of prior informed consent and benefit sharing and to prevent the illegal access. Indeed, only a dozen countries have implemented the CBD at the national level, while only a few have introduced legal measures which target illegal access to genetic resources. In contrast, a great majority of countries have incorporated the minimum standards of intellectual property protection at the national level (in some cases, also adopting TRIPS-plus provisions).

While discussions on amending the TRIPS Agreement in light of the CBD objectives and principles have been ongoing for some time in the WTO, the Doha Ministerial Declaration gave new impetus to the debate by explicitly referring to these issues for the first time. Thus, Paragraph 19 instructs the TRIPS Council “to examine, inter alia, the relation between the TRIPS Agreement and the CBD, the protection of traditional knowledge and folklore [...]. In undertaking this work, the TRIPS Council shall be guided by the objectives and principles set in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension.” Given the linkages of these TRIPS-related issues with environmental concerns, the WTO Committee on Trade and Environment (CTE) has a mandate to give particular attention to “the relevant provisions” of the TRIPS Agreement. Discussions in the CTE have largely mirrored those in the TRIPS Council.

In an effort to bring the TRIPS Agreement into line with the CBD objectives, a group of developing countries, led by India and Brazil, have been pushing for an amendment to the TRIPS Agreement, which would require patent applicants to disclose the origin of biological resources and associated TK. The amendment would also require applicants to provide evidence of prior informed consent and benefit-sharing. These proposals have received strong support from the African Group as well as other developing countries at the WTO. The African Group has gone further by advancing a separate proposal, which calls for Article 27.3(b) to be revised so as to prohibit patenting of plants, animals and micro-organisms.

The EU has signaled its willingness to discuss mandatory origin disclosure for genetic resources and TK in the form of a “self-standing” requirement. However, the EU believes that such a requirement should not constitute a formal or substantial patentability criterion and that consequences for failure to disclose should lie outside patent law. Other countries, such as Switzerland, would prefer these issues to be dealt with outside the WTO, through an amendment to WIPO’s Patent Cooperation Treaty (PCT) allowing countries to require patent applicants to declare the source of any genetic resources and TK used.

Australia, Canada, Japan and the United States continue to oppose such proposals, arguing that the IPR system should not be used as a means to enforce ABS systems and that these types of requirements could become a legal nightmare for patent applicants. Rather, they propose the WIPO IGC as the appropriate venue. Importantly, in 2003, the WIPO General Assembly approved a new mandate for the IGC, which “will focus on its international dimension without prejudice to work pursued in other fora.” Also, “no outcome is excluded, including a possible development of an international instrument(s).”

The need for disclosure requirements in the patent filing procedure has been raised during other negotiations, including the CBD’s Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization, which were adopted in 2002. The issue was resolved by adding requirements for disclosure of the origin of the genetic resources and TK as a possible means of compliance. In addition, countries were encouraged to include disclosure requirements on genetic resources and associated TK in patent applications.

Discussions on disclosure requirements have largely focused on the appropriate forum that should deal with this issue. Given that discussions in WIPO have resulted in more emphasis on the protection of private rights of IPR titleholders than the promotion of sustainable development and the protection of developing countries’ biodiversity, many developing countries, including Brazil and the African Group, continue to question whether the IGC is the appropriate body to address disclosure requirements. They are concerned that hosting the discussions in the IGC will distract from the negotiations in the TRIPS Council.

Traditional Knowledge (TK)

Traditional knowledge refers to the knowledge, innovations and practices of indigenous and local communities, which has been developed based on experience over time and adapted to the local culture and environment. TK is often collectively owned by indigenous and local communities. Appreciation of the value of TK has increased as its use in modern industry—especially, plant based medicines— and agriculture has grown.

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International discussions on traditional knowledge tend to appear in two distinct formats: one defensive and one proactive. Defensive initiatives are designed to guard against the “misappropriation” of the rights of indigenous peoples and local communities while proactive initiatives tend to assign legitimate and legal rights. Defensive proposals may include disclosure or certification requirements as part of patent filing procedure, as well as requirements for proof of prior informed consent and the existence of mutually agreed terms. On the other hand, proactive international measures would include the setting of clear objectives, the recognition of customary law, required compensation for right holders, the grant of exclusive rights, maintenance of databases or registers on TK, and the establishment of incentives for the promotion of the use of traditional practices.

These debates, of course, take place in multiple fora. In the WTO, for example, the African Group has sought proactive measures and proposed that TK be classified as a category of intellectual property rights. Meanwhile at WIPO, the IGC agreed in 2004 to accelerate its substantive work on the protection of TK and folklore. This includes the identification of policy objectives and core principles, as well as the compilation and analysis of specific policy options. This work is expected to provide the foundations for policy-making at both the domestic and international levels, including a possible international instrument for the protection of TK and folklore.

Similar debates are also taking place in the CBD and, in particular, with respect to the development of the international ABS regime. Thus, the CBD Working Group on Article 8(j) and related provisions, dealing with indigenous issues, has been mandated to make recommendations to ensure that the ABS regime includes sui generis systems and measures for the protection of TK. The Working Group is examining several other issues, including: the role that databases and registers might play in the protection of TK; the potential for existing and new forms of IPRs to contribute to the objectives of Article 8(j) and related provisions; and non-intellectual- property-based sui generis forms of TK protection.

Groups representing indigenous peoples feel that their participation in discussions regarding protection of TK has been limited. They have cautioned that without the meaningful participation of indigenous peoples, there will be no legitimacy for any of the results of these international discussions. However, for many of these groups, TK is not on the top of the agenda. Many believe that there are more urgent needs to be addressed including customary law, self-determination, human rights, land rights, and religious and ethical issues.

At the national level, many countries have started to develop a new generation of TK laws with the aim of preserving, protecting and promoting TK. These laws have used a variety of approaches, including customary law, ABS systems, IPR-derived frameworks, and sectoral systems of protection (medicinal, agriculture, folklore).

Geographical Indications (GIs)

Indications of geographical origin—e.g., Bordeaux wine, Parmigiano Reggiano—have been historically recognized as indicators of the origin, reputation and quality (or other aspects) of a product. The TRIPS Agreement establishes new standards and norms for such indications. It introduces geographical indications (GIs) as a new category of IPRs, providing a relatively narrow definition of GIs as “indications which identify a good as originating in the territory of a Member, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin.”

Geographical indications can be linked to biodiversity conservation and sustainable use; they could be used to protect products that have a positive impact on the environment or help in the preservation of plant varieties. Cases of Cacao de Chuao or Quinoa Real show positive links with biodiversity and human development. In other cases, GIs could have a negative impact on biodiversity conservation. Mexico’s Tequila industry, for instance, relies on a single plant variety (blue agave), which has led to the promotion of genetic homogeneity and intensive land use to respond to the huge market demands. It is important to note, however, that GIs protect the name of the product but not the product itself or the know-how that might have been used in its production. Thus, anyone is free to replicate the GI-protected product outside the region as long as the name is not used.

The WTO negotiating mandate on GIs is two-fold. First, Paragraph 18 of the Doha Ministerial Declaration instructs the TRIPS Council “to negotiate the establishment of a multilateral system of notification and registration of geographical indications for wines and spirits.” While these negotiations should have been finalized by 2003, Members failed to reach an agreement and the deadline has been postponed. Second, the possibility of extending the higher level of GI protection that is currently accorded to wines and spirits to other products (“GI extension”) has been raised by developing countries as an “implementation issue”—issues were developing countries need certain adjustment in current agreements in order to generate some benefits.

Unlike most other provisions in the TRIPS Agreement, the positions on the subject of geographical indications do not reflect the usual North-South divide. Demandeurs for expanded GI protection include developing countries such as Cuba, India, Kenya, Pakistan, Peru, Sri Lanka, Thailand, as well as Switzerland and the EU. Opponents, which can be broadly categorized as “new world” countries include Argentina, Australia, Canada, Chile, Japan and the U.S. This latter group strongly resists proposals for GI extension, and favours a system that would merely serve as a database where countries are free to register their GIs.

Arguments in favour of an extension of the present system have been largely economic. The demandeurs note that there are no economic or systemic reasons for protecting GIs for wines and spirits differently from others. Extending the higher level of protection, they argue, would avoid free-riding on the reputation of a genuine GI, enhance consumer choice, provide legal certainty and market opportunities (thereby fostering the development of local rural communities), and encourage a quality agricultural and industrial policy. Opponents, however, counter that GI extension would not provide meaningful benefits and would create additional administrative burdens.

Trends and Future Directions

Significant activity is happening in each of the three areas discussed above. The trends, however, are mixed.

Access and Benefit-sharing

Creating synergies between the IPR regime and ABS systems will have to be a multi-step process. Key steps include final ratification by all signatories of the CBD and the ITPGRFA, including the main user countries of genetic resources, such as the U.S. and Japan. Subsequently, it will be important to ensure full implementation of these treaties and the TRIPS Agreement. Specific tasks and competencies will need to be assigned to the various fora—in accordance with their specific mandate— in order to promote coherence while avoiding duplication of work and “forum shopping.” Finally, measures should be incorporated into the IPR system, as well as in the future international ABS regime, to address illegal access and transboundary movement of genetic resources.

While strong opposition to all these steps remains, advances in the ratification and implementation of the CBD and the ITP-GRFA are strengthening international legal frameworks. This will make it difficult for the IPR system to ignore biodiversity-related concerns and should augment the need to find mutually supportive solutions. Even some traditionally reluctant countries, such as the EU and Switzerland, are slowly warming to the idea of bringing more coherence between the intellectual property regime and biodiversity protection systems. Developing countries can be expected to continue their pursuit of concrete results in the WTO and WIPO in order to make current IPR rules supportive of biodiversity concerns.

Traditional Knowledge

While countries might differ on the means for providing proactive TK protection at the international level, there is a growing acceptance of the need for such protection. Governments will need to reconcile divergent views on many definitional issues, including:

• scope (wide versus restricted);

• the legal nature of defensive/positive measures (binding or not);

• type of objectives (protection, promotion, preservation, commercialization);

• potential solutions (whether based on IPR/ABS systems or on customary law); and

• the means to implement those solutions (enforcement mechanisms).

Recent submissions by the African Group, Brazil and India on behalf of several developing countries in WIPO and the WTO will help to keep these issues on the agenda. However, developing countries and indigenous peoples will need to coordinate their efforts if these discussions in multiple fora are to yield solutions that are both acceptable and coherent.

Meanwhile, at the national and regional levels, the number of ABS/TK laws will likely continue to grow. Many countries have already approved legislation (sectoral or other) on the matter, including Bolivia, Brazil, China, Colombia, Costa Rica, India, Panama, Peru, the Philippines, Portugal, Thailand and Venezuela.

Geographical Indications

The debate in the TRIPS Council on GI extension remains at an impasse. Members generally agree that the hierarchy between wines and spirits and other GIs has no rational or legal foundation, but is an outcome of earlier negotiation trade-offs. Thus, a case can be made that acceding to demandeurs in the Doha Round will be balanced by concessions in other areas of the trade negotiations. It will be up to negotiators and policy-makers to assess the benefits from increased GI protection against those concessions. However, the fact that progress on other “implementation issues” appears directly linked to progress on GI extensions may complicate the debate and raise the stakes for developing countries in particular.

At the same time, countries have yet to take full advantage of the existing protection that is already provided by the TRIPS Agreement and to develop the necessary legislation to put this into practice. Nothing in the TRIPS Agreement prevents Members from designing their own national or regional GI system in such a way that takes into account human factors in a manner supportive of sustainable development. Efforts in the near future should focus on closing this gap and assessing the potential that GIs might have for achieving environmental and social goals so as to better inform the underlying legal and policy frameworks.