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Distr GENERAL

CONVENTION ON BIOLOGICAL DIVERSITY

UNEP/CBD/COP/3/Inf. 20

20 September 1996

ORIGINAL: ENGLISH

CONFERENCE OF THE PARTIES TO THE CONVENTION ON BIOLOGICAL DIVERSITY

Third meeting

Buenos Aires, Argentina

4 to 15 November 1996

BIOLOGICAL DIVERSITY AND INTELLECTUAL PROPERTY RIGHTS:

ISSUES AND CONSIDERATIONS

Submission by the Government of Australia

1. INTRODUCTION

1. Pursuant to Decision II/12 on "Intellectual Property Rights" of the second meeting of the Conference of the Parties to the Convention on Biological Diversity, Australia submits this paper on the relationship between intellectual property rights and the overall objectives of the Convention on Biological Diversity (CBD) relating to the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources.

2. The paper aims at identifying relevant issues and considerations which may need to be addressed in determining the role of intellectual property rights in advancing the CBD's overall objectives. It should be noted that the various issues and considerations set out in the paper should not be interpreted as representing an official Australian position.

3. The paper is divided into three parts: Part I sets out Australia's basic approach to intellectual property rights; Part II considers the relationship between the objectives of the CBD and the World Trade Organisation (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS); and Part III examines the possible roles of intellectual property rights in the conservation and sustainable use of biodiversity and the sharing of benefits arising from the use of genetic resources, including in relation to the contributions of indigenous and local communities.

4. The paper is not intended to exhaust all the issues which may arise in the context of biodiversity and intellectual property rights, but to provide some insight into those issues which have been or are being reviewed in Australia. Australia hopes that the paper may be of some help in identifying relevant issues and possibilities requiring further consideration so as to progress consideration of these in the CBD.

5. Intellectual property rights may be relevant to facilitating the implementation of the CBD. Areas where they appear most relevant are in relation to technology transfer and the sharing of benefits deriving from the utilisation of genetic resources. However, the issues are difficult and complex. Intellectual property rights cannot be considered in isolation. They are only one aspect of a broader inter-related fabric of political, economic, legal and social factors and may not necessarily be the most important element in achieving the successful transfer of technology or sharing of benefits. Another issue that requires acknowledgement is the fact that funding for technology transfer is primarily a matter for the commercial sector. The challenge for governments is to create the national conditions for commercial transfers of technology and private sector driven technological development.

6. It should be noted that intellectual property and environment issues are being addressed in an increasing number of international fora. Australia considers that it is important for the Parties to the CBD to be abreast of all relevant work in progress in other fora and for duplication of work to be avoided.

7. Thus, while intellectual property rights may be relevant to achieving the objectives of the CBD, the Conference of the Parties (COP) may not be an appropriate body to make decisions on the appropriateness of standards of protection afforded by intellectual property rights. An appropriate role for the COP could be to make recommendations on options for consideration at the national level or in other relevant fora.

8. In considering the role of intellectual property rights in relation to furthering the objectives of the CBD, it may be useful to set out at this point some important factors that help shape Australia's approach to the conservation and sustainable use of its biodiversity, including:

a) a large stock of biodiversity - Australia is in a unique position in being the only industrialised country among those countries to have been identified as possessing a large stock of biological resources (we are "biologically megadiverse");

b) an advanced scientific community (both domestic and international) which accesses and uses our biological resources to develop new technologies;

c) strong agricultural, pharmaceutical and other industries which use and rely on technology developed from both local and foreign biological resources; and

d) a large number of indigenous communities, all interested in protecting and benefiting from their traditional knowledge. This includes knowledge which may assist in the conservation of biodiversity in Australia. Australia's indigenous communities have an important role to play in contributing to Australia's pursuit of the CBD's objectives.

PART I: AUSTRALIA'S GENERAL APPROACH TO INTELLECTUAL PROPERTY RIGHTS

9. Australia notes that the general rationale for protecting intellectual property rights is that they provide an opportunity for owners to benefit from their intellectual activity and thus to encourage innovation, technological development and creative activities. This rationale is reflected in Australia's domestic legislative regime governing the protection of intellectual property rights.

10. Generally speaking, modern intellectual property rights laws around the world are fundamentally similar, reflecting the influence of international treaties in shaping national intellectual property rights laws. "Intellectual Property" is generally accepted to include all copyright and related rights, all rights in relation to inventions (including patent rights), plant varieties, registered and unregistered trademarks (including service marks), geographical indications , registered designs, confidential information (i.e. protection of undisclosed information in a commercial context, including trade secrets and know how) and circuit layouts, and all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields.

11. Australian intellectual property laws are based on the well-established premise that economic development and the well-being of society will be advanced through the creation and dissemination of new products, processes and services. This objective will be served, and an incentive given to invention and creativity, if the creators of intellectual property (or their employers, assignees, heirs or successors in title) are entitled to an opportunity to gain, for a limited time, exclusive economic rights, for example, the right to exploit an invention and to authorise another person to exploit the invention (patents) or the right to reproduce a work or to authorise another person to exploit a work (copyright). These rights allow creators to secure a return on their investment in original creative activity. Because intellectual property rights are personal to the owners of those rights, it is generally up to them to use, protect and enforce them, for example, by instituting infringement actions in the courts.

12. It is generally accepted that the maintenance of such a regime has served to attract state-of-the-art technology and access to overseas copyright works, which has helped enhance Australia's economic and cultural development and the fostering of Australian creative talents. Intellectual property rights can therefore be viewed as an important instrument in promoting the dissemination of new ideas, technologies and creative endeavours.

13. In a trading context, Australia's interests in intellectual property are fundamentally affected by the fact that Australia is a net importer of technology and intellectual property products. Various reviews have found that adequate protection of intellectual property rights has been a factor in Australia's ability to gain access to new technologies and overseas creative products. However, the creative activities of Australians are playing an increasingly important role in Australian exports, a trend which is expected to continue. Protection of Australian intellectual property rights, domestically and in both existing and potential export markets, is of growing significance to Australia.

14. Australia notes that it, along with the more than 120 other Members of the WTO, has accepted the intellectual property right standards set out in TRIPS as constituting an adequate degree of protection of those intellectual property rights specified in TRIPS (i.e. copyright and related rights, trademarks, geographical indications, industrial designs, patents, layout-designs (topographies) of integrated circuits, and protection of undisclosed information).

PART II: RELATIONSHIP BETWEEN THE OBJECTIVES OF THE CBD AND THE TRIPS AGREEMENT

15. The objectives of the CBD are the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources. Intellectual property rights are explicitly referred to in Article 16 of the CBD which deals with access to and transfer of technology. Article 16.5 states that the Contracting Parties, recognising that patents and other intellectual property rights may have an influence on the implementation of the CBD, "shall cooperate in this regard subject to national legislation and international law in order to ensure that such rights are supportive of and do not run counter to its objectives".

16. The TRIPS Agreement aims to provide a multilateral framework for promoting effective and adequate protection of intellectual property rights both to reduce distortions and impediments to international trade and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to trade. Article 7 of the Agreement states that "the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations".

17. A number of issues would seem to deserve consideration in looking at the relationship between the objectives of the CBD and the TRIPS Agreement:

(a) the promotion of environmentally-sound technology and access to and transfer of this technology;

(b) the provision of incentives for the conservation and sustainable use of biological resources and the equitable sharing of the benefits of this use, including in relation to the traditional knowledge, innovations and practices of indigenous and local communities;

(c) the handling of technology that may adversely affect the environment.

18. Article 16 of the CBD states that both access to and transfer of technology among Contracting Parties are essential elements for the attainment of the Convention's objectives. It provides for Contracting Parties to provide and/or facilitate access to and transfer to other Contracting Parties of technologies relevant to the conservation and sustainable use of biological diversity. Article 16 also provides for access to and transfer of technology to developing countries to be provided and/or facilitated under fair and most favourable terms. In the case of technology subject to patents and other intellectual property rights, such access and transfer "shall be provided on terms which recognise and are consistent with the adequate and effective protection of intellectual property rights".

19. Article 16.3 of the Convention addresses the issue of access to and transfer of technology which makes use of genetic resources to those countries, particularly developing countries, which provide the genetic resources. It provides for parties to take measures to provide access to and transfer of such technology on mutually agreed terms. The issue of access to genetic resources is dealt with in Article 15 which also draws attention to the aim of sharing in a fair and equitable way, and upon mutually agreed terms, the results of research and development and the benefits arising from the commercial and other utilisation of genetic resources with the party providing such resources.

20. The TRIPS Agreement seeks to balance the objectives of promoting technological innovation and facilitating access to and transfer of technology through the provision of appropriate standards of intellectual property protection. A properly functioning system protecting intellectual property rights can provide a positive environment for investment in the development and transfer of technology. TRIPS also reinforces the right of governments to adopt measures to prevent the abuse of intellectual property rights by rights holders or practices which adversely affect technology transfer (Article 8). At the same time, there is nothing in the TRIPS Agreement preventing governments or international financial mechanisms from providing financial assistance to promote technology transfer. Technology transfer is important not only for the promotion of environmentally friendly technologies but also in encouraging the development of technologies that help the conservation and sustainable use of biological diversity, as specifically prescribed in Article 16 of the CBD.

21. Provisions of the TRIPS Agreement which may be relevant in considering the relationship between it and the generation and transfer of environmentally-sound technology are Article 8 (right to adopt appropriate measures consistent with the provisions of the TRIPS Agreement to prevent the abuse of intellectual property rights or practices which adversely affect international technology transfer), Article 30 (right to provide limited exceptions to patent rights), Article 39 (obligation to protect undisclosed information) and Article 40 (right to adopt appropriate measures to protect or control restrictive practices associated with intellectual property rights which impede the transfer and dissemination of technology).

22. The CBD explicitly notes that intellectual property rights may have an influence on its implementation in respect of access to and transfer of technology. It has been suggested that intellectual property rights and the TRIPS Agreement may also be relevant to a number of other aspects of the CBD. In particular, there has been interest in the possible impact of the TRIPS Agreement on providing incentives for the conservation and sustainable use of biological diversity and in the possible role of intellectual property rights in recognising the contribution of the traditional knowledge and practices of indigenous and local communities.

23. It is important to note that the TRIPS Agreement only obliges Members to meet its minimum standards while they are free to grant more extensive protection. This means that the TRIPS Agreement would not preclude any WTO Member from developing additional intellectual property rights that it might consider appropriate means of addressing the concerns of indigenous and local communities. However, Article 3 may be relevant here as it (and the Paris (industrial property) and Berne (copyright) Conventions) generally requires that any intellectual property protection afforded to nationals in one country must be afforded to nationals of other member countries. In addition, Article 4 requires that "any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members".

24. An aspect of the TRIPS Agreement which may be particularly relevant to the objectives of the CBD is Article 27.3(b). This allows Members to exclude from patentability 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. However, Members are required to provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. These provisions are to be reviewed in 1999 and deserve careful consideration for their possible relevance to the objectives of the CBD. It is likely that this review will look at whether to maintain these existing exclusions or reduce the scope for exclusions.

25. An effective sui generis system may be a means of addressing concerns that have been raised, for example, about the possible implications of intellectual property rights for practices such as farmer-exchanged and farmer-saved seeds which may be important in promoting conservation and development of biological diversity as well as in addressing equity concerns. One possibility is that cultivated plants may be subject to a specialised form of protection, Plant Breeders Rights, established under the International Union for the Protection of New Varieties of Plants. Australia, which became a member of UPOV in 1988 and enacted the Plant Breeder's Rights Act in 1994, considers that certain rights should be given to plant breeders to encourage the genetic improvement of plant species and the release of elite varieties in Australia. However, the Australian legislation also strengthens the public interest provisions. This includes the recognition of the concept of "farmers privilege" which allows farmers to save the seeds from a protected variety for next year's crop without paying further royalties to the breeder. In 1991 the UPOV Convention was amended to, among other things, extend the rights of breeders.

26. Another issue which could be explored in examining the relationship between the objectives of the CBD and the TRIPS Agreement is the treatment of technology that may adversely affect the environment. The TRIPS Agreement does not affect the right of governments to restrict research or development or the use of technology on the grounds of protecting the environment. Article 27.2 of the Agreement specifically provides that a WTO Member may exclude from patentability inventions whose use would seriously prejudice the environment.

PART III: INTELLECTUAL PROPERTY RIGHTS AND THE OBJECTIVES OF THE CBD

27. There is general recognition that complex issues arise when examining the role of intellectual property rights in pursuing the conservation, sustainable use and equity objectives of the CBD. Intellectual property rights are only one aspect of a broader inter-related fabric of political, economic, legal and social factors and may not necessarily be the most important one. Other considerations which could affect access to and the transfer of technology, including technology relevant to the objectives of the CBD, include the extent of funding for research in the public domain, access to finance to purchase privately-owned technologies, the investment environment, and the state of technological and infrastructure facilities in the countries receiving technology. It may therefore be difficult to isolate the particular role of intellectual property rights in relation to the CBD's objectives without also examining the role that other factors may play. The full range of issues involved in facilitating and promoting the transfer of technology needs to be considered in looking at ways to advance the objectives of the CBD.

28. Effective intellectual property rights regimes, including enforcement, can make a positive contribution to facilitating technology transfer and furthering the objectives of the CBD. Further work could be aimed at identifying this contribution as well as any gaps which may exist.

29. Article 15 of the CBD, while affirming national sovereignty, requires parties to endeavour to facilitate access to their genetic resources for environmentally sound uses and allows for parties to obtain a fair and equitable share of benefits arising from the use of their genetic resources by other parties.

30. Ways in which a share of the benefits can be obtained include through access to and transfer of technology, including biotechnology developed from the genetic resource provided. Another way in which providers of genetic resources may seek benefits is through access to products derived from the provided resources, for example, an improved plant variety. Under article 27 of TRIPS Members shall provide for the protection of plant varieties by patents and/or an effective sui generis system. This raises the question as to what constitutes an effective system. The TRIPS Council is due to consider the UPOV sui generis system in 1997. Other systems are available and may more closely match the needs of indigenous peoples. This would appear to be an area where more study could usefully be done.

31. The relationship between access to genetic resources and benefits arising from their utilisation raises fundamental questions about the status and ownership of genetic resources. There have been calls for legal regimes for intellectual property rights to be extended to cover the owners of these resources in recognition of the intellectual input they have made to their conservation, sustainable use and genetic improvement. Under current intellectual property rights regimes, any ownership right to the original resource is not an intellectual

property right because there has been no intellectual input as such. Ownership could also be very difficult to establish in some cases, along with the degree to which indigenous and local communities embodying traditional lifestyles have actually contributed intellectually to genetic improvement through deliberate breeding. Intellectual property rights arise from the products and processes derived from those resources through scientific research and which may subsequently be commercialised.

32. The contribution of indigenous peoples and local communities in furthering the objectives of the CBD is recognised in CBD articles 8(j) and 10(c). Such recognition has been identified as important both on equity grounds and in view of the role which such communities have played, and continue to play, for example, in using, conserving, improving and making available biological resources.

33. The issue of recognising the contribution of local and indigenous communities in relation to the conservation and sustainable use of biological resources has been, and continues to be, considered in Australia. This has included consideration of advancing the CBD's objectives in relation to articles 8(j) and 10(c) by examining possible measures that could act as incentives for protecting and encouraging customary use of biological resources in accordance with traditional cultural practices that are compatible with conservation and sustainable use requirements.

34. Australia's experience in addressing this issue has confirmed that it is a difficult and complex issue which will require considerable time and effort to resolve. Australian Indigenous peoples' organisations have expressed a number of concerns in relation to the protection of their traditional knowledge, including:

(a) the need for recognition of both the commercial and non-commercial value of knowledge systems and innovations;

(b) inherent in that, recognition of the cultures, social life and belief systems of indigenous communities which embody the knowledge and practices supportive of biodiversity;

(c) the need to address fundamental differences in protection between innovations protectable by existing intellectual property rights and traditional knowledge of and uses of biodiversity; and

(d) the reality that, for indigenous communities, priorities include the need for equitable benefit sharing, not merely for its own sake but also to avoid the damage that results within a community where there is a sense of unauthorised use or misappropriation of knowledge.

Possible options for protecting indigenous knowledge

35. Intellectual property rights are only one of a range of mechanisms that have been raised as possible means for addressing the concerns of local and indigenous communities in relation to protecting their knowledge, innovation and practices and sharing in the benefits arising from the utilisation of such knowledge, innovation and practices. Possible mechanisms for additional protection of indigenous knowledge which have been suggested in consideration of this issue at various international fora include:

(a) operating within existing intellectual property regimes;

(b) the creation, through legislation or other means, of new forms of intellectual property rights;

(c) funding mechanisms;

(d) an equitable sharing of the benefits arising from the contributions, including elements of using traditional knowledge, made by indigenous and local communities;

(e) contractual agreements such as material transfer agreements;

(f) codes of conduct;

(g) rights in relation to cultural products and expressions, including cultural property;

(h) greater reliance on the laws of unconscionable behaviour and unjust enrichment.

36. Further work is clearly needed on exploring the relative merits or disadvantages of each of these mechanisms and any other mechanisms which may be identified. The possible role of intellectual property rights in recognising the knowledge and practices of indigenous and local communities cannot be considered in isolation from the other mechanisms that have been identified, as these may prove to be more appropriate mechanisms. It is possible that a combination of several mechanisms may be needed to recognise the contribution of indigenous and local communities in the conservation and development of biodiversity and to promote the fair and equitable sharing of the benefits arising out of the utilisation of their knowledge, innovations and practices.

37. For example, more formalised arrangements governing access to genetic resources may provide an important avenue for recognising the contribution of the knowledge, innovations and practices of indigenous and local communities, and ensuring an equitable sharing of the benefits. Such codes of conduct could be complemented by, or involve, contractual arrangements such as material transfer agreements setting out conditions for the transfer and use of genetic materials.

38. While Australia's indigenous peoples can use the existing intellectual property system to protect specific products and processes and unique works, the extent to which it can meet other concerns, such as providing protection for traditional knowledge or biological resources is limited. The main factors limiting the scope of current intellectual property right systems are:

(a) intellectual property rights are the result of creative or inventive endeavour by an individual or individuals creating an original product;

(b) there must be an identifiable creator or owner (e.g. patentee, author, etc) of the intellectual property, since the laws do not recognise collective or community ownership under customary law of a creation or product except for a corporate body under company law;

(c) intellectual property rights are of limited duration after which the work or product falls into the public domain.

39. Existing intellectual property rights would not protect traditional knowledge as such, including uses of plants and other natural resources, against unauthorised commercial exploitation (unless the knowledge was recorded in some way). Contractual law may be an appropriate mechanism to provide some level of redress. For example, indigenous communities could withhold their knowledge except under licensing contracts providing for confidentiality, appropriate use and the sharing of economic benefits with the originators of that knowledge. The viability and utility of this option has not been explored completely in Australia.

40 It may be argued that some traditional knowledge, such as the herbal remedies used by traditional healers for centuries, can be protected as confidential information. Such knowledge would be regarded as unpatentable since it lacks the requisite "new" character for patentability. This is so notwithstanding the considerable effort that indigenous communities may have made in developing traditional knowledge. This effort may have involved centuries of observation and experimentation with naturally occurring species. However, confidential information as a form of protection (e.g. the formula for Coca Cola) can often be more valuable than other forms of intellectual property rights.

41. Clearly, however, traditional knowledge can also have economic value. For example, traditional knowledge may be utilised by the biotechnology industry to select plants for laboratory analysis, in a way which significantly reduces the cost of developing new commercial products. Thus, while traditional knowledge itself may not be patentable, it can provide a significant asset for others to obtain patents for inventions based on that knowledge.

42. The TRIPS Agreement also provides for the protection of undisclosed information. While the WTO has not considered in detail whether this area of TRIPS may be relevant to the protection of indigenous knowledge, some work is being undertaken in Australia in relation to the scope of the action of confidential information. In October 1994 a paper titled "Stopping the Rip-Offs: Intellectual Property Protection for Aboriginal and Torres Strait Islander Peoples", currently under consideration, examined the copyright protection available for indigenous cultural expression in Australia. It noted a case where the publication of sacred-secret materials has been successfully prevented in Australia using a breach of confidence action, where copyright infringement was not applicable. The case involved information revealed in confidence by an Aboriginal community to an anthropologist. Such a case suggests that principles of confidential information can be used in Australia to protect indigenous knowledge, however, each situation would need to be considered in light of the strict common law principles which apply to the law of confidential information. The basic principles in brief are: the information is sufficiently confidential and not public knowledge; the information was provided in circumstances imparting an obligation of confidence; and there was an unauthorised use of that information causing detriment to the party communicating it. Many of these requirements may be difficult to establish in the case of use of indigenous knowledge.

43. It is clear that the existing intellectual property rights framework is limited and may not be the most effective way to protect indigenous knowledge and practices. Ultimately, the effective protection of this knowledge and these practices may require the creation of a new class of proprietary rights for traditional knowledge, or the creation of new classes of transfer agreements. Alternatively, or in addition, some protection could be afforded through greater reliance on common law principles of unconscionable behaviour and unjust enrichment, or other areas of law such as contract or licensing arrangements.

44. The concept of "Farmers' Rights", which is being addressed in the FAO Global System on Plant Genetic Resources for Food and Agriculture through the International Undertaking on Plant Genetic Resources for Food and Agriculture, is also of possible interest to indigenous communities. The exact nature, scope and purpose of these rights have yet to be clearly defined.

Approaches To Access To Australia's Genetic Resources

45. In 1992 a task force was established to report on the implications and manner of implementation of the CBD in Australia. In relation to access to Australia's biological resources, it found that under existing legislation and guidelines it is possible to access and export a large range and volume of genetic resources for use in overseas research and development without appropriate returns to Australia.

46. Australia is currently in the process of examining matters related to national policy on managing access to Australia's biological resources. In the Australian federal system, responsibility for the management of indigenous biological resources, including their conservation and sustainable use, is shared by the State, Territory and Commonwealth governments. This reflects the fact that under Australia's constitutional arrangements, the Commonwealth has primary responsibility in areas such as trade and commerce with other countries and intellectual property protection, while the States and Territories have traditionally managed matters relating to conservation and land management.

47. A Commonwealth-State Working Group (CSWG) on Access to Biological Resources was established in May 1994 to investigate options for a national approach to access to biological resources in Australia. The work of the CSWG is concentrating on developing a nationally consistent approach to managing access to Australia's biological, including genetic, resources. More specifically, it is required to identify the benefits for the Australian community of a national approach; to develop principles to be applied in the assessment of mechanisms and in negotiations concerning grant of access; and to develop mechanisms which may be employed to govern access to and collection, processing, development and export of Australia's biological resources.