- The Convention on Biological Diversity (CBD) and its Nagoya Protocol
- The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) of the United Nations Food and Agriculture Organization (FAO)
- Key Issues Around Genetic Resources and Intellectual Property
- Australian Biodiscovery Laws
- Consumerism, Genetic Resources and BioTrade
Broadly stated genetic resources contain biological materials such as genes or molecular material. Think plants, animals and microbes. The World Intellectual Property Organization (//WIPO//) defines genetic resources as:
… genetic material of actual or potential value. Genetic material is any material of plant, animal, microbial or other origin containing functional units of heredity. Examples include material of plant, animal, or microbial origin, such as medicinal plants, agricultural crops and animal breeds. [^AUTOREPLACEDhttpswwwwipointtkengeneticENDREPLACE] [^AUTOREPLACEDhttpswwwwipointtkengeneticENDREPLACE]: https://www.wipo.int/tk/en/genetic/
For millennia, genetic resources were the ‘common heritage of mankind’ [^AUTOREPLACEDSeeforexampleJamesOdekBiopiracycreatingproprietaryrightsinplantgeneticresourcesJIntellPropL21994141PaulGeptsWhoownsbiodiversityandhowshouldtheownersbecompensatedPlantphysiology1344200412951307ENDREPLACE] [^AUTOREPLACEDSeeforexampleJamesOdekBiopiracycreatingproprietaryrightsinplantgeneticresourcesJIntellPropL21994141PaulGeptsWhoownsbiodiversityandhowshouldtheownersbecompensatedPlantphysiology1344200412951307ENDREPLACE]: See, for example, James Odek, ‘Bio-piracy: creating proprietary rights in plant genetic resources’ J. Intell. Prop. L. 2 (1994): 141; Paul Gepts, ‘Who owns biodiversity, and how should the owners be compensated?’ Plant physiology 134.4 (2004): 1295-1307 . This meant that discoveries and innovations based on genetic resources often did not result in benefits returning to those communities or countries providing the material. Instead, genetic resources have regularly been a source of research and development in pharmaceutical, agricultural, cosmetic and food industries. For example, the wild rosy periwinkle from Madagascar has been used in (patented) cancer treating drugs, and the 1990s are known, in IP circles, for the neem and turmeric patent ‘controversies’ in both Europe and the United States [^AUTOREPLACEDForexampleapatentgrantedfortheuseofturmericforwoundhealingwaswithdrawnbytheUnitedStatesPatentandTrademarkOfficein1997andtheEuropeanPatentOfficewithdrewapatentforanantifungalproductderivedfromneemin2000ENDREPLACE] [^AUTOREPLACEDForexampleapatentgrantedfortheuseofturmericforwoundhealingwaswithdrawnbytheUnitedStatesPatentandTrademarkOfficein1997andtheEuropeanPatentOfficewithdrewapatentforanantifungalproductderivedfromneemin2000ENDREPLACE]: For example, a patent granted for the use of turmeric for wound healing was withdrawn by the United States Patent and Trademark Office in 1997, and the European Patent Office withdrew a patent for an anti-fungal product derived from neem in 2000 .
Perhaps the best way to illustrate some of the ways in which genetic resources and intellectual property interact is through examples:
- Plants may attract PBR or patent protection if the relevant criteria are satisfied (Link to PBR Chapter);
- Biological or natural ingredients can be the subject of patent protection; for example, the pharmaceutical, agriculture, cosmetics and food industries have all made use of biological and natural ingredients (Link to Patent Chapter). A good example of this is the use of Aloe Vera and Jojoba in the health and beauty industry;
- Trade marks, certification and geographical indications (GIs) can also be used on genetic resources. For example, cheese and alcohol (e.g. Agave) often have IP protection related to GIs and marks.
When considering the relationship between intellectual property and genetic resources there are key areas of focus including access to biological diversity; plant genetic resources for food and agriculture; traditional knowledge; and farmers’ rights. Many of these issues are addressed in some form in “IP-related” conventions and treaties.
Perhaps, then, a good starting point to address the relationship between intellectual property and genetic resources is looking at the Convention on Biological Diversity (//CBD//) and the International Treaty on Plant Genetic Resources for Food and Agriculture (//ITPGR//).
Acknowledging the importance of biological resources, in 1988, the United Nations Environment Programme (UNEP) explored the possibility of an international convention on biological diversity. After much work and negotiation an agreed text was adopted in 1992 and opened for signature on 5 June 1992.
Entering into force in 1993, the CBD (Art. 1) has three objectives:
- Conservation of biological diversity;
- Sustainable use of its components; and
- Fair and equitable sharing of the benefits arising from the use of genetic resources.
As of 1 February 2019, there were 196 parties to the CBD [^AUTOREPLACEDForaListofPartiesseehttpswwwcbdintinformationpartiesshtmlENDREPLACE] [^AUTOREPLACEDForaListofPartiesseehttpswwwcbdintinformationpartiesshtmlENDREPLACE]: For a List of Parties see https://www.cbd.int/information/parties.shtml .
In addition to the Convention itself, there are a range of supplementary protocols and guidelines that address issues and help with the implementation of the CBD.
The Cartagena Protocol is an international treaty governing the movements of living modified organisms (LMOs) resulting from modern biotechnology.
Adopted on 29 January 2000, and coming into force on 11 September 2003, Article 1 sets out the Cartagena Protocol’s objective:
In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.
In 2002, the voluntary Bonn Guidelines were developed to represent best practices for biodiscovery. The Bonn Guidelines provide the basis for national laws on biodiscovery.
In Australia, for example, a number of states and territories have incorporated these Guidelines in various pieces of legislation and regulation. For information about the raft of approaches to biodiversity in Australia see the Department of Environment and Energy website, //Access to biological resources in States and Territories// [^AUTOREPLACEDhttpwwwenvironmentgovautopicsscienceandresearchaustraliasbiologicalresourcesaccessbiologicalresourcesstatesandENDREPLACE] [^AUTOREPLACEDhttpwwwenvironmentgovautopicsscienceandresearchaustraliasbiologicalresourcesaccessbiologicalresourcesstatesandENDREPLACE]: http://www.environment.gov.au/topics/science-and-research/australias-biological-resources/access-biological-resources-states-and
The Nagoya Protocol establishes a legal framework for the effective implementation of the third objective of the CBD - the fair and equitable sharing of benefits arising out of the utilization of genetic resources. The Nagoya Protocol was adopted in October 2010 and entered into force on 12 October 2014.
Perhaps what’s most important about the Nagoya Protocol is that it addresses one of the major criticisms of the CBD – little, or no, implementation.
In addressing the issue of implementation of the CBD, the Nagoya Protocol provides various mechanisms including:
- Establishing national contact points for information, grant access or cooperate on issues of compliance;
- Setting up a clearing-house to share information, such as domestic regulatory ABS requirements;
- Developing domestic ABS legislation to implement the Nagoya Protocol;
- Awareness-raising and technology transfer.
The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR) of the United Nations Food and Agriculture Organization (FAO)
The International Treaty on Plant Genetic Resources for Food and Agriculture (//ITPGR//) was adopted on 3 November 2001 and came into force on 29 June 2004. For details of the Contracting Parties to the ITPGR see http://www.fao.org/plant-treaty/countries/membership/en/
The ITPGR’s objectives are:
- recognising the contribution of farmers to the diversity of food crops;
- establishing a global system to provide access to plant genetic materials; and
- ensuring that the benefits derived by recipients of plant genetic material are shared with the countries where they have been originated.
To achieve its objectives, the ITPGR established a Multilateral System that:
…puts 64 of our most important crops – crops that together account for 80 percent of the food we derive from plants – into an easily accessible global pool of genetic resources that is freely available to potential users in the Treaty’s ratifying nations for some uses.[^AUTOREPLACEDhttpwwwfaoorgplanttreatyareasofworkthemultilateralsystemoverviewenENDREPLACE] [^AUTOREPLACEDhttpwwwfaoorgplanttreatyareasofworkthemultilateralsystemoverviewenENDREPLACE]: http://www.fao.org/plant-treaty/areas-of-work/the-multilateral-system/overview/en/
Importantly, the 64 crops in the Multilateral System are shared for research, breeding and training for food and agriculture.
Importantly, too, the //ITPGR// prevents the recipients of genetic resources from claiming intellectual property rights over those resources “in the form received” and ensures that access to genetic resources already protected by international property rights is consistent with international and national laws.
In addition, the //ITPGR// recognises the contribution that farmers have made to the development of the plant genetic resources, and the benefits associated with these developments. Indeed, the //ITPGR// is the first binding international instrument to give formal recognition to farmers’ rights, which is discussed in more detail in part 4.3 of this Chapter.
One of the key features of the Multilateral System is the use of Standard Material Transfer Agreement (//SMTA//). More specifically transfers of ITPGR are governed according to a //SMTA// between the provider of the plant materials and the recipient of the plant materials.
The standard material transfer agreement sets out the terms and conditions of access, use and benefit sharing, and addresses a number of intellectual property matters. Generally, the //SMTA// deals with three forms of the plant material:
- Plant materials ‘in the form received’ from the Multilateral System;
- Plant materials ‘under Development’ derived from the originally provided material that is being changed up to the stage of a commercialised ‘Product’;
- Plant materials as a ‘Product’ that incorporates the plant material received, or any of its genetic parts or components ready for commercialization (excluding commodities and other products used for food, feed and processing).
An //SMTA// places obligations on the both plant material provider and recipient.
The //ITPGR// (and //SMTA//) restrict recipients from claiming intellectual property where the claim would restrict access to the plant materials (and their genetic parts or components) ‘in the form received for use or conservation for research, breeding and training for food and agriculture’ [^AUTOREPLACEDArt123dENDREPLACE] [^AUTOREPLACEDArt123dENDREPLACE]: Art. 12.3(d) .
So, intellectual property may be claimed over plant material subject to the ITPGR in limited circumstances including:
- Any materials received so long as access to the materials for research, breeding and training for food and agriculture is allowed (possibly through a non-exclusive license);
- Any developments over genetic parts or components of the plant materials received.
Importantly, recipients of any plant materials that are already protected by intellectual property must continue to respect those rights [^AUTOREPLACEDArt132bENDREPLACE] [^AUTOREPLACEDArt132bENDREPLACE]: Art. 13.2(b) .
Having briefly outlined the main treaties and conventions dealing with genetic resources, we now turn our attention to a range of issues around the intersection between genetic resources and intellectual property.
The issues highlight the complicated and contingent nature of genetic resources, innovation, development and local and indigenous communities. Perhaps at the crudest level, the relationship between intellectual property and genetic resources is seen as a zero-sum proposition: intellectual protects those who innovate and invent at the expense of local and indigenous communities and farmers. Like most things, however, the truth is much more nuanced.
In the remainder of this part of the Chapter we briefly consider three recurring issues: traditional knowledge, disclosure requirement and farmers’ rights.
Traditional knowledge (TK) possessed by indigenous peoples and local communities is not only important socially and culturally but can also provide insights for innovations and inventions. Sometimes TK is related to genetic resources. For example, a plant or its properties may have therapeutic or cosmetic effects.
TK is a contentious issue for many, and over the years it has proven difficult achieving consensus on key issues including the nature and scope of TK and the way in which it should and can be safeguarded. One of the key organisation working in this area is the World Intellectual Property Organization. With WIPO’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), considering three related texts addressing genetic resources (GRs), traditional knowledge (TK) and traditional cultural expressions and expressions of folklore (TCEs). [^AUTOREPLACEDSeehttpswwwwipointtkenigcENDREPLACE] [^AUTOREPLACEDSeehttpswwwwipointtkenigcENDREPLACE]: See https://www.wipo.int/tk/en/igc/
In terms of the conventions and treaties discussed above, there are some explicit and implicit references to TK.
|CBD| Most notably Art. 8(j) of the //CBD// requires that: 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. The //CBD// contains other provisions that deal with the interests of indigenous and local communities including Arts. 10 (c), 15.5, 17.2, and 18.4.| |Nagoya Protocol|The preamble to the Nagoya Protocol contains numerous paragraphs relevant to TK. These paragraphs include references to Article 8(j) of the //CBD//, the interrelationship between genetic resources and TK, the diversity of circumstances in which TK is owned, and the Declaration on the rights of Indigenous Peoples. The Protocol also contains significant provisions relating to TK associated with genetic resources held by indigenous and local communities. For example, the Protocol sets out obligations to seek the prior informed consent of indigenous and local communities in these situations [^AUTOREPLACEDArt155ENDREPLACE] [^AUTOREPLACEDArt155ENDREPLACE]: Art. 15(5) . It also provides for the sharing of benefits arising from the use of TK associated with genetic resources [^AUTOREPLACEDPreambleArts18j157ENDREPLACE] [^AUTOREPLACEDPreambleArts18j157ENDREPLACE]: Preamble, Arts 1, 8(j),15(7) .| |ITPGR|The //ITPGR// calls for the protection of TK of farmers, as well as increasing farmers participation in national decision-making processes and ensuring that the benefits from the use of genetic resources be shared with farmers [^AUTOREPLACEDPreambleArts5691213ENDREPLACE] [^AUTOREPLACEDPreambleArts5691213ENDREPLACE]: Preamble, Arts. 5, 6, 9, 12, 13 .|
When an invention makes use of, or incorporates, genetic resources or TK there are often issues about whether, and how, the origins of that material be disclosed. Disclosure requirements may serve a number of purposes including ensuring compliance with relevant laws, identifying rights holders and prior art, and promoting equitable benefit sharing. Disclosure of origin is central to the CBD, Bonn Guidelines and Nagoya Protocol.
- Art. 16(d) of the Bonn Guidelines suggest measures to support compliance with ABS requirements, including “measures to encourage disclosure of the country of origin of [GRs] and of the origin of [TK], innovations and practices of indigenous and local communities in applications for [IP] rights”, measures to prevent use of GRs obtained without prior informed consent, and measures discouraging unfair trade practices.
Importantly, though, disclosure of origin remains a contentious issue and has been introduced into national laws in a piecemeal way. This means that there is not a consistent approach to disclosure of origin, instead there are a range of mandatory and voluntary laws and guidelines adopted by national governments and regional organisations. For example, Belgium, Brazil, India, New Zealand and Peru have adopted disclosure laws.
Disclosure requirements often relate to one or more of the following:
- the origin and/or source of GRs and/or TK;
- evidence of prior informed consent for their use connected to research of which the claimed invention was an outcome, from the provider country (and, in some cases, from indigenous peoples and local communities, in accordance with domestic law);
- evidence of having established a contractual arrangement (mutually agreed terms) for the fair and equitable sharing of the benefit derived from such use – if so required by the national legislation of the provider country.
Originally conceived in the 1980’s to minimise the impact of plant breeders’ rights on local farmers, farmers’ rights are recognised in a variety of legal instruments regulating access to and use of genetic resources and TK. The term farmers’ rights have been primarily incorporated in the //ITPGR//, and a small number of national laws; particularly those with large farming communities such as India and Thailand.
As noted above, the //ITPGR// recognises the contribution farmers have made to the development of the plant genetic resources, and the benefits associated with these developments. Indeed, the //ITPGR// is the first binding international instrument to give formal recognition to farmers’ rights. More specifically Art. 9(1) of the //ITPGR// recognises:
…the enormous contribution that the local and Indigenous communities and farmers of all regions of the world, particularly those in centres of origin and of crop diversity, have made and will continue to make for the conservation and development of plant genetic resources which constitute the basis of food and agricultural production throughout the world.
Articles 12 and 13 of the //ITPGR// calls for protecting the TK of these farmers, increasing farmer participation in national decision-making processes and ensuring that farmers share in the benefits from the use of these resources.
However, despite these ‘calls’ in the //ITPGR//, the responsibility for realising farmers’ rights, as they relate to plant genetic resources for food and agriculture, rests with national governments. This has only been done to a limited extent.
An important intersection of farmers and intellectual property are plant breeder’ rights. Plant breeder’s rights are protected internationally by the International Convention of the Union for the Protection of New Varieties of Plants (//UPOV//) 1961. As noted in the PBR Chapter, the different version of the UPOV Convention have treated farmers differently. For instance:
- //UPOV// 1978 recognised a ‘farmer’s privilege’ allowing farmers to reuse propagating material from the previous year’s harvest. Under //UPOV// 1991 the farmers’ privilege is no longer automatic and all unlicensed multiplication of protected seed and propagating material is an infringement;
- //UPOV// 1991 provides a limited right to States to permit farmers to use farm saved seed for sowing on their own lands, but not for sale or exchange with others.
While the //CBD// (and the Bonn guidelines and Nagoya Protocol) provide a framework for the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the use of genetic resources, they need to be implemented by national governments.
While Australia signed the //CBD// in 1992, Australian governments (federal, state and territory) have taken different approaches to its implementation. In 2002, all governments endorsed a nationally consistent approach for access to, and the utilisation of, Australia’s native genetic resources. Information about relevant laws can be found http://www.environment.gov.au/topics/science-and-research/australias-biological-resources
In Queensland, for example, the //Biodiscovery Act 2004// (Qld) was introduced to:
- Facilitate access to minimal quantities of native biological resources for biodiscovery;
- Encourage the development of valued added biodiscovery;
- Ensure a fair and equitable share in the benefits of biodiscovery;
- Enhance diversity, conservation and sustainable use of native biological resources (Section 3, //Biodiscovery Act// 2004 (Qld)).
In addition to the //Biodiversity Act 2004// (Qld), the Queensland Biotechnology Code of Ethics “defines the ethical boundaries for organisations undertaking biotechnology activities in Queensland. The code covers all areas of biotechnology activity including health care, agriculture, food and the environment.”
Key features of national biodiversity laws, including the Queensland Biodiversity Act 2004 (Qld) are:
//Permit System// Collecting and using native biological material from State land or waters for biodiscovery requires a permit. To obtain a permit an application needs to be made to the relevant authority.
//Benefit sharing agreements// A Benefit Sharing Agreement must be entered into with the resource access provider. While the benefits often flow to the government, there are provisions within the Acts for the sharing of benefits with local indigenous communities. Benefits may be monetary or non-monetary.
So far, this Chapter has focused on ‘traditional’ legal frameworks. Importantly, though, not all conservation and sustainable efforts are via treaties and legislation. The legal frameworks discussed above (e.g. CBD, Nagoya) seek to promote shared goals and objectives; however, there have been concerns expressed that due to the politicised nature of treaty-making, few, or severely limited, commitments or enforcement mechanisms are provided for either in international or national law.
Consequently, the perception of added legality and bureaucracy that legal instruments may provide, has been criticised on the basis will fail to affect the //CBD//’s goals in a meaningful way. Increasingly, with genetic resources, broader regulatory frameworks need to be contemplated.
For example, in 1996, the United Nations Conference on Trade and Development (//UNCTAD//) introduced the BioTrade Initiative to support sustainable trade in a way that is consistent with the objectives of the //CBD//. See https://unctad.org/en/pages/ditc/trade-and-environment/biotrade.aspx
BioTrade refers to those activities of collection, production, transformation, and commercialization of goods and services derived from native biodiversity under the criteria of environmental, social and economic sustainability [^AUTOREPLACEDhttpsunctadorgenpagesditctradeandenvironmentbiotradeaspxENDREPLACE] [^AUTOREPLACEDhttpsunctadorgenpagesditctradeandenvironmentbiotradeaspxENDREPLACE]: https://unctad.org/en/pages/ditc/trade-and-environment/biotrade.aspx .
BioTrade serves an important role in this context. It emphasises balancing and accommodating trade and development with biodiversity and sustainability. In this way, BioTrade can fill a void in public legal frameworks, by attempting to facilitate change not solely via direct regulation or enforcement, but by encouraging complementary private-driven measures to supplement transnational approaches.
In 2017, //UNCTAD// published 20 years of BioTrade which outlines some of the key initiatives of BioTrade. Looking to the future, Executive Secretary of the Convention on Biological Diversity made it clear that:
“taking steps to strengthen markets for BioTrade and putting in place supportive policies would help leverage the contribution that BioTrade can make to meeting the objectives of the [CBD]” [^AUTOREPLACEDhttpsunctadorgenpagesPublicationWebflyeraspxpublicationid1765ENDREPLACE] [^AUTOREPLACEDhttpsunctadorgenpagesPublicationWebflyeraspxpublicationid1765ENDREPLACE]: https://unctad.org/en/pages/PublicationWebflyer.aspx?publicationid=1765 .