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ausip:genetic_resources [2019/09/08 13:39]
jessiej_87 Footnotes
ausip:genetic_resources [2019/09/08 14:00] (current)
jessiej_87
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 Perhaps the best way to illustrate some of the ways in which genetic resources and intellectual property interact is through examples: Perhaps the best way to illustrate some of the ways in which genetic resources and intellectual property interact is through examples:
  
-  * Unordered List ItemPlants ​may attract PBR or patent protection if the relevant criteria are satisfied (Link to PBR Chapter);+  * 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;   * 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.+  * 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. ​ 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. ​
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 Entering into force in 1993, the CBD (Art. 1) has three objectives: Entering into force in 1993, the CBD (Art. 1) has three objectives:
  
-  - Ordered List ItemConservation ​of biological diversity;+  - Conservation ​of biological diversity;
   - Sustainable use of its components; and   - Sustainable use of its components; and
   - Fair and equitable sharing of the benefits arising from the use of genetic resources.   - Fair and equitable sharing of the benefits arising from the use of genetic resources.
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 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 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//​[http://​www.environment.gov.au/​topics/​science-and-research/​australias-biological-resources/​access-biological-resources-states-and]+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// ​((http://​www.environment.gov.au/​topics/​science-and-research/​australias-biological-resources/​access-biological-resources-states-and))
  
 ### The Nagoya Protocol ​ ### The Nagoya Protocol ​
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 In addressing the issue of implementation of the CBD, the Nagoya Protocol provides various mechanisms including: In addressing the issue of implementation of the CBD, the Nagoya Protocol provides various mechanisms including:
-  ​Unordered List Item Establishing national contact points for information,​ grant access or cooperate on issues of compliance;+ 
 +  ​* 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;​   * Setting up a clearing-house to share information,​ such as domestic regulatory ABS requirements;​
   * Capacity-building;​   * Capacity-building;​
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   * Awareness-raising and technology transfer.   * 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) 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 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: The ITPGR’s objectives are:
-  ​Unordered List Item recognising the contribution of farmers to the diversity of food crops;+ 
 +  ​* recognising the contribution of farmers to the diversity of food crops;
   * establishing a global system to provide access to plant genetic materials; and   * 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.   * ensuring that the benefits derived by recipients of plant genetic material are shared with the countries where they have been originated.
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 To achieve its objectives, the ITPGR established a Multilateral System that: 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.((1?))+…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.((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,​ the 64 crops in the Multilateral System are shared for research, breeding and training for food and agriculture. ​
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 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: 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:
-  ​Unordered List Item Plant materials ‘in the form received’ from the Multilateral System;+ 
 +  ​* 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 ‘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).   * 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).
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 ### Intellectual property protection and the ITPGR ### Intellectual property protection and the ITPGR
  
-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’ ((Art. 12.3(d))).+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’ ((Art. 12.3(d) )).
    
 So, intellectual property may be claimed over plant material subject to the ITPGR in limited circumstances including: So, intellectual property may be claimed over plant material subject to the ITPGR in limited circumstances including:
-  * Unordered List Item 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 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.   * 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 ((Art. 13.2(b)).+Importantly,​ recipients of any plant materials that are already protected by intellectual property must continue to respect those rights ((Art. 13.2(b)).
  
-## Key issues around genetic resources ​and intellectual property+## Key Issues Around Genetic Resources ​and Intellectual Property
  
 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. 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.
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 In terms of the conventions and treaties discussed above, there are some explicit and implicit references to TK. 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: +|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.| 
-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.+|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 ((Art. 15(5) )). It also provides for the sharing of benefits arising from the use of TK associated with genetic resources ((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 ((Preamble, Arts. 5, 6, 9, 12, 13)).|
  
-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.| +### Disclosure ​Requirements
-|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 ((Art. 15(5))). It also provides for the sharing of benefits arising from the use of TK associated with genetic resources ((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 ((Preamble, Arts. 5, 6, 9, 12, 13)).| +
- +
-### Disclosure ​requirements+
  
 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. ​ 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. ​
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 For example: For example:
  
-  * Unordered List Item 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.+  * 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. 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: Disclosure requirements often relate to one or more of the following:
-  * Unordered List Item the origin and/or source of GRs and/or TK; +  * 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 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.   * 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.
  
-### Farmers’ ​rights+### Farmers’ ​Rights
  
 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. 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.
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 For instance: For instance:
  
-  * Unordered List Item 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// 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.+  *  ​//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.
  
-## Australian ​biodiscovery laws+## Australian ​Biodiscovery Laws
  
 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 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.
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 In Queensland, for example, the //​Biodiscovery Act 2004// (Qld) was introduced to: In Queensland, for example, the //​Biodiscovery Act 2004// (Qld) was introduced to:
-  ​Unordered List Item Facilitate access to minimal quantities of native biological resources for biodiscovery;​ + 
-  *  Encourage the development of valued added biodiscovery;​ +  ​* Facilitate access to minimal quantities of native biological resources for biodiscovery;​ 
-  *  Ensure a fair and equitable share in the benefits of biodiscovery;​ +  * Encourage the development of valued added biodiscovery;​ 
-  *  Enhance diversity, conservation and sustainable use of native biological resources (Section 3, //​Biodiscovery Act// 2004 (Qld)).+  * 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)).
  
  
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 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. 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.
  
- ## Consumerism,​ Genetic Resources and BioTrade+ 
 +##​Consumerism,​ Genetic Resources and BioTrade
  
 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. 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.+ 
 +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 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
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