2010 Guest Article: The Biological Patent Predicament
Traditional Knowledge and Biological Product Derivative Patents: Benefit-Sharing and Patent Issues Relating to Camu Camu, Kakadu Plum and Açaí Plant Extracts
By Dr Daniel F. Robinson (1)
Published online 30 April 2010
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Summary: Concerns about the patenting of biological materials and the extracts of plants, microbial or animal products has heightened in recent years as the life science industries expand and as international legal agreements condone the intellectual property protection of these materials across the globe. This article discusses benefit-sharing and patent issues related to three different plants and their fruits: Camu Camu, Kakadu Plum and Açai. Access and benefit-sharing regulations, with a specific focus on Australia, are also addressed. | .
Contents: Introduction | The Camu Camu Patents | The Kakadu Plum and Açaí Patent Application | Previous Research and Intellectual Property Rights Relevant to Kakadu Plum | Brazilian Açaí Berry | Conclusions | References | Acronyms | Footnotes
This paper is based on an extract from Daniel Robinson’s book: Confronting Biopiracy: Challenges, Cases and International Debates published in 2010 by Earthscan, London.
Concerns about the patenting of biological materials and the extracts of plants, microbial or animal products has heightened in recent years as the life science industries expand and as international legal agreements condone the intellectual property protection of these materials across the globe. While much of the early ‘biopiracy’ protest in the 1990s was raised by NGOs such as RAFI (now the ETC Group) and inspired by activists like Vandana Shiva, there are now fairly mature debates surrounding biological product patents in international fora including the World Trade Organization (WTO) Council on Trade-Related Aspects of Intellectual Property Rights (TRIPS Council), the World Intellectual Property Organization (WIPO), and the Convention on Biological Diversity (CBD). In particular, many bio-diverse ‘developing’ countries have been seeking to minimize the opportunity for grant of spurious patents, or patents that are based on traditional knowledge without obtaining prior informed consent and/or establishing benefit-sharing arrangements.
One of the main approaches favoured by these developing countries has been a patent requirement that applicants disclose the source and country of origin of biological materials that they obtain and seek to patent. Submissions in the WTO TRIPS Council have made some progress on the development of such a requirement, but there still appears to be some way to go, and there are also a few key ‘developed’ countries like the US and Japan which are opposed to the idea. In the meantime there have been some improvements to the international patent system in WIPO, with the inclusion of traditional knowledge journals and databases in the scope of examiner searches for Patent Cooperation Treaty (PCT) international patent applications.
Despite these measures, there is still considerable scope for patent offices to grant patents that may seem spurious to people in other countries due to a number of factors: poor quality examination procedures, ‘national novelty’ criteria, and narrow breadth of prior art searches conducted by examiners. This ultimately means that patents which attract the ire of NGOs, academics and even government authorities with the label ‘biopiracy’, are still likely to emerge as an issue in the near future (see Robinson, 2010). The following section discusses a number of specific patents and a patent application, which together refer to three different plants and their fruits: Camu Camu, Kakadu Plum and Açai. I also discuss issues relating to access and benefit-sharing regulations, with a specific focus on Australia.
The Camu Camu Patents
Peru is a ‘megadiverse’ country and is one of the world’s centres of origin for agriculture. It is also a multiethnic and multicultural country consisting of 14 linguistic families and 72 ethnic groups, with an estimated one-third of the population considered Indigenous who reside mostly in rural areas. These Indigenous peoples are the heirs to the former Peruvians who domesticated and diversified many plant and animal species, and who are now a repository of traditional knowledge regarding the uses of these species (Peru, WTO Doc. IP/C/W/493, 2007).
In recent years a number of patents have been sought and, in many cases, granted on products that are essentially derived from biological products with their origins in Peru. The majority, if not all of these patents have been granted in foreign jurisdictions by foreign researchers and companies. In addition, Peruvian authorities are concerned that the patents have been granted for so-called ‘innovations’ that are based on pre-existing traditional knowledge that is held by Indigenous communities in Peru.
In response to these patents, the Government of Peru has enacted a law establishing the National Commission for the Protection of Access to Peruvian Biological Diversity and to the Collective Knowledge of the Indigenous Peoples (known as the National Anti-Biopiracy Commission; Law No. 28216 of 1 May 2004). The National Anti-Biopiracy Commission is chaired and coordinated by INDECOPI – the Peruvian national institute for competition and intellectual property protection – and is made up of representatives of a number of other relevant government bodies, NGOs, Indigenous peoples and business associations. The commission has the task of ‘developing actions to identify, prevent and avoid acts of biopiracy with the aim of protecting the interests of the Peruvian State’ (Peru, WIPO/GRTKF/IC/8/12, 2005a, p3). Its main functions are to:
Establish and maintain a register of biological resources and traditional knowledge;
Provide protection against acts of biopiracy;
Identify and follow up patent applications made or patents granted abroad that relate to Peruvian biological resources or collective knowledge of the Indigenous peoples of Peru;
Make technical evaluations of the above-mentioned applications and patent grants;
Issue reports on the cases studied;
Lodge objections or institute actions for annulment concerning the abovementioned patent applications or patent grants;
Establish information channels with the main intellectual property offices around the world;
Draw up proposals for the defence of Peru’s interests in different forums.
The National Anti-Biopiracy Commission has been the most directly active of any national organization in the world in terms of documenting and addressing biopiracy. It has actively sought to identify and highlight acts of biopiracy in international forums, including submissions on maca (Lepidium meyenii) and camu camu (Myrciaria dubia). By documenting these cases of spurious patents, the commission has sought to pressure inventors to withdraw patents where appropriate and have also put pressure on foreign patent offices to improve their patent-examination procedures (Robinson, 2010). Of particular relevance in this paper is their submission in the WTO TRIPS Council (Peru, WTO Doc. IP/C/W/458, 2005b) on a plant known as camu camu which has been identified by Peruvian authorities in several foreign patents.
Camu camu is a plant native to Amazonia and is believed to be particularly concentrated in the Peruvian Amazon. The fruit of the camu camu shrub is of particular interest because it has very high levels of ascorbic acid (vitamin C) when compared to other common natural sources such as lemons or oranges. An FAO report from 1993 notes that the main potential use of camu camu as a source of vitamin C, representing one of a number of documents of prior art (Chávez and Wanders, 1993; Peru, 2005a, p4). Another earlier document by Alvarado (1969), although in Spanish, also notes the use of camu camu as a juice and flavouring for ice cream. It seems that there is some limited documentation of the uses of camu camu in the English language, although the Peruvian researchers note that it has been used traditionally as a food by Indigenous Peruvians.
The Peruvian submission to the TRIPS Council analyses a series of patents, most of which have been granted in the Japanese Patent Office for cosmetic extracts and food additives that utilize camu camu. Relating to cosmetic extracts and lotions the following patents granted in Japan are of particular interest:
Patent number 3431383, filed 14 February 1996: ‘Melanogenesis suppressing agent’;
Publication number 11–246336, filed 27 February 1998: ‘Activated oxygen scavenger and skin beatifying cosmetic composition’;
Publication number 2000–327549, filed 17 May 1999: ‘Cosmetic comprising extract of camu camu’;
Publication number 2000–327550, filed 19 May 1999: ‘Skin preparation for external use’;
Publication number 2000–327552, filed 19 May 1999: ‘Skin preparation for external use’;
Publication number 2000–327525, filed 19 May 1999: ‘Skin preparation for external use’;
Publication number 2001–031558, filed 20 January 2000: ‘Skin lotion’;
Publication number 2001–031580, filed 19 January 2000: ‘Preparation for external use for skin’.
In most of these patents the claims refer to cosmetic properties and products such as ‘melanin inhibitors’, ‘an agent that eliminates activated oxygen’ and ‘a make-up base’ that use extracts of camu camu. The Peruvian researchers indicate that the existing prior art refers mostly to the use of the camu camu fruit as a juice and not in cosmetics, so the applications can probably be described as novel. However, they indicate that ‘there is evidence of lack of an inventive step’ because ascorbic acid or vitamin C is known as an antioxidant and a compound that can prevent mottling and skin-ageing. Thus, it is obvious that camu camu, which is high in ascorbic acid, would have the same effect. This finding is consistent with numerous papers from the field of dermatology which note the benefits that vitamin C provides for the maintenance of healthy-looking skin in humans. For example, Hata and Senoo (1988) note that L-ascorbic acid derivatives of vitamin C “promotes reorganization of a three-dimensional tissuelike substance from skin fibroblasts in culture by stimulating collagen accumulation in the fibroblasts.” Similarly, Geesin et al (1988) note that “in cultured human fibroblasts, ascorbic acid stimulates collagen production with no apparent change in the intracellular degradation of newly synthesized procollagen” (see also Murad et al, 1983). In a study on healthy female volunteers, a topically applied cream containing 5% vitamin C “led to a clinically apparent improvement of the photodamaged skin and induced modifications of skin relief and ultrastructure, suggesting a positive influence of topical vitamin C on parameters characteristic for sun-induced skin ageing” (Humbert et al. 2003; see also Traikovich, 1999; Phillips et al, 1994). These existing studies make a strong argument supporting the Peruvian claim that it is obvious to someone trained in the art (dermatology), that high levels of vitamin C or ascorbic acid promotes healthy looking skin. The actual fruit used to provide the high levels of vitamin C content should not matter – it is the same active molecule that is found in other fruits. The concentration of the molecule is the variable factor, unless the patent applicant can prove synergistic effects caused by the existence of other molecules.
In some cases, such as patents 2000–327552 and 2001–031558, the inventors have included camu camu extracts in ‘compositions’. For these patents, the Peruvian researchers have conceded that despite prior knowledge about the effects of ascorbic acid, and without further information available, the synergistic effects involved in the combination could constitute an inventive step. Indeed, the combination of two or more ingredients could have a cumulative or cooperative effect. On the other hand, the inventors may have simply combined two ingredients so that they can argue they have achieved something inventive – a common tactic used by patent applicants. Depending upon the knowledge of the patent examiner and the level of description in the patent, it would be quite difficult for an examiner to disprove novelty and non-obviousness involving synergistic effects – this is something more likely to be achieved in patent appeals where additional evidence is brought in to support or disprove the claims in a patent. But if the predominant or only active skin whitening/smoothing agent in the cosmetic is the camu camu extract, then the patents should be regarded as obvious.
Additionally, the Peruvian submission lists a number of patents related to juices or preserves which contain camu camu. A number of these have been rejected, presumably because of the existing prior art on camu camu as a juice (patent publication numbers 09–140341 and 09–215475) and in some cases because of the obvious nature of the patents as flavour enhancements (patent publication numbers 09–140357 and 09–140358).
Apart from these specific technical problems relating to these patents, the Peruvian researchers also noted a number of problems with patent transparency. These concerns relate to the lack of English translations for some Japanese patent documents; the lack of literal clarity in the English translations of others: and, in some cases, the poor descriptions of what is being protected. Of relevance to novelty and prior art, the Peruvian researchers also noted the difficulty in finding documentation of traditional uses of camu camu, particularly where traditional knowledge of the uses of a plant has been transmitted verbally from generation to generation.
Finally, they noted issues whereby biological resources have been exported overseas as commodities (in the case of camu camu, as fruit or juice), but have ended up being researched for their genetic resources and then potentially patented (Robinson, 2010). This last point highlights the limitations of the CBD notion of national or ‘sovereign control’ over biological resources, for which a strict interpretation is likely to be virtually impossible to enforce. Indeed, when it comes to crop genetic resources, there is a historical interdependence between nations for supply of germplasm, particularly in modern times, but also through ancient trade routes. For this reason, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) is likely to play a very important role in regulating the transfer of genetic resources used strictly for food and agricultural purposes. Regarding biological resources that are used for other purposes: medicines, cosmetics, fibres and others; CBD rules for access and transfer are shaping up to be more difficult to achieve a binding agreement on. The CBD Working Group on ABS has reached a milestone with the Draft Nagoya Protocol on ABS in March 2010. However there are still some substantial disagreements between biodiverse developing countries and a number of developed countries.
The Kakadu Plum and Açaí Patent Application
The cosmetics company Mary Kay Inc. has applied for WIPO PCT patent application number WO/2007/084998 on ‘Compositions comprising kakadu plum extract or açaí berry extract’ on January 19, 2007. Because this is an international patent application (now in the national phase of examination as at April 2010), it also corresponds with national application numbers such as:
Australian patent application number 2007205838,
US patent application number 11/624985,
European Patent Office application number EP20070710236, and others.
The Kakadu plum (Terminalia ferdinandiana) has been used as a food for hundreds and possibly thousands of years by Indigenous Australians in the Northern regions of Australia. It has also been well documented by Gorman et al (2006), Woods (1995) and Brand et al (1982) that the Kakadu Plum has a history of traditional use as both a food and medicine by Indigenous Australians. These details are also noted in US patent number 7,175,862 on a method of preparing Kakadu Plum powder. These documents and others like them, arguably provide evidence of prior art with regards to the high levels of ascorbic acid or vitamin C found in the Kakadu Plum . Even with the US’ problematic ‘national novelty’ interpretation (see Kadidal, 1998, p29; Bagley, 2002–3, p680), it is arguable that some of the primary claims of the patent can be dismissed because of the existence of US patent descriptions regarding effects of the high vitamin C content of Kakadu Plum. It could be construed that the application of Kakadu Plum extract in a cosmetic is novel, however Kakadu Plum suppliers in Australia have noted the use of the fruit in cosmetic products for some time, although in commercial products which are not under patent (Forbes, Pers. Comm, 30 March 2010). If these products have been on sale for over a year prior to the patent application, then this negates the novelty claims according to S.102 of the US Patent Law. This would have the same effect on the Australian patent application by Mary Kay Inc and presumably the other foreign applications.
An even stronger argument can be made with regards to the obviousness of the patent application. As discussed in the previous section, given the considerable prior knowledge of the effects of vitamin C on skin within the dermatology field, many of the claims in Mary Kay Inc’s patent applications should be considered obvious to those trained in the art. In this regard, an International Preliminary Patent Report made under the Patent Cooperation Treaty of WIPO has been filed in July 2008 ‘for further action’ regarding the obviousness of most of the patent claims 1-33. In other words, the inventors were asked to submit further evidence to prove that the invention is not obvious. An International Application Status Report (current 31 March 2010), did not provide further information about these requirements or clarify the status of the application, however the PCT database does indicate that the application has entered the national phase, for further examination. Under the Australian Patents Act a Section 27 submission has been made making statements regarding the obviousness of many of the claims. This discussion paper will also be filed as a S.27 submission.
Concern has been raised about the patent application in the Australian Senate, with Question 1172 raised by Senator Rachel Siewert of Western Australia on the 10th March 2009. The Senator raised concerns that current development plans for commercial activities utilising the plant will be stopped by the patent. The Minister for Innovation, Industry, Science and Research (Senator Carr, 10 March 2009) has responded:
The fact that a patent may refer to, claim compositions of, or be to a method involving Kakadu Plum does not necessarily mean that such a patent would prevent commercialisation by Indigenous communities. The breadth and value of patents varies greatly, and hence interpretation and understanding of each patent is required. It may mean that advice should be sought by Indigenous communities as to which aspects of the use of Kakadu Plum may become, or are, under patent. Commercialisation may be able to occur and co-exist with patented aspects of the Kakadu Plum – much depends on what is to be commercialised, and the breadth of any patented use or extracts.
This response is accurate in its assertion that the patent ‘does not necessarily’ mean the prevention of commercialisation activities by Indigenous groups. Food products that utilize Kakadu Plum are unlikely to be affected. However, the patent, if granted, is likely to mean that ventures for the commercialisation of dermal cosmetic products containing Kakadu Plum run the risk of litigation, or may be forced to enter into a licencing arrangement with Mary Kay Inc including the payment of royalties.
Senator Carr’s suggestions for the protection of traditional knowledge, however, are less likely to be useful. Senator Carr cites only formal intellectual property laws with legislative requirements that are likely to be completely incompatible with the protection of traditional knowledge. For example, traditional knowledge generally cannot be protected under the Patents Act because it is often not new/novel. Trademarks may present an option for the protection of product names, but this type of protection is quite limited. Plant breeder’s rights may rarely be useful where new, distinct, uniform and stable varieties are bred by Indigenous communities. But in many cases, Indigenous knowledge relates to existing varieties of plants rather than new cultivars. Last, confidential information or trade secrets are unlikely sources for the protection of traditional knowledge because these laws essentially replicate a more formal or codified version of customary laws or protocols for the secrecy of certain aspects of traditional knowledge. More likely to be helpful for the protection of traditional knowledge are sui generis laws or systems that are designed by Indigenous communities and which correspond to, or refer to, Indigenous customary laws that already exist. These systems are currently being discussed in the Article 8(j) Working Group of the CBD, for which the Secretariat has requested papers and case studies from state Parties, Indigenous communities and interested parties.
Irrespective of the tenuousness of the patent claims by Mary Kay Inc for this composition (the national patent offices will resolve this one way or the other), there is also the question of access and benefit-sharing (ABS) relating to the plant genetic resources. Given civil society and Indigenous concern over bioprospecting and ‘biopiracy’, Mary Kay Inc in Australia and the US were contacted by phone, email, and post to clarify any arrangements that may have been made with local suppliers, authorities and Indigenous communities in Northern Australia. They have not yet replied in detail to any enquiries made by the author in March and April 2009. Two Australian Kakadu Plum harvesting and supply companies were also contacted – Wild Harvest and Coradji. Both denied supplying Mary Kay Inc with materials and expressed serious concern about the patent application (Boehme, Per. Comm, 24 and 27 March 2010; Forbes, Pers. Comm, 30 March 2010). There were also suspicions that past research on Kakadu Plum had been sold onto Mary Kay Inc by Access Business Group and/or Cognis, however this seems unlikely as they are direct competitors (See Box 1).
Box 1: Previous Research and Intellectual Property Rights Relevant to Kakadu Plum
There are many US and Australian patents and patent applications which mention Kakadu Plum (see the official response to Australian Senate Question 1172, 10 March 2009). However, most of these do not make extensive claims over derivatives or extracts of the plant which could inhibit further commercialization of similar products. Many of them cover processes, which are benign from the perspective of free competition. In other cases they cover food compositions that optionally contain Kakadu Plum (e.g. Australian Innovation patent application 2008100919) which are also unlikely to affect commercial freedom to operate.
One particular US patent around which there has been some concern is US Patent Number 7175862, which is assigned to Access Business Group International LLC (ABG) on a method of preparing dried powder from Kakadu Plum. While the patent itself has not been of major concern – it is a process patent – the activities of ABG (a business of Alticor Group and sister company to Amway) have been scrutinized for allegedly taking their research offshore, along with biological materials obtained in Australia. ABG, in partnership with Cognis Australia, took a strong interest in the high vitamin C content of Kakadu Plum and began conducting research, cultivation and processing from 1994. Horticultural development occurred at a site near Darwin in the Northern Territory where production techniques were trialed and an orchard of 6000 trees were planted (Cunningham et al., 2009). According to a recent paper on Kakadu Plum:
Confidence in the product had evolved to a point of commercialization and Amway sent a team to Australia to develop a film based on T. ferdinandiana and Australian Indigenous uses. This was released globally on the Discovery Channel in 2004. Although there was always the intention that benefit-sharing with Aboriginal people would occur, no model for this was ever developed or discussed with any Aboriginal Group (Cunningham et al., 2009, p24).
In 2004, ABG are reported to have exported tissue cultures to Amway facilities in Brazil. Because of the transferral of plant tissue culture (and associated knowledge), an Australian running the research farm in the NT withdrew his services from the project in protest (Boehme, Pers. Comm. 24 March 2010).
An application for plant breeder’s rights (PBRs) on a Kakadu plum variety named ‘DD26’ in Australia was received on 4 March 2004 and provisionally accepted on 25 March 2004. The title holder for this provisional PBR is Cognis Australia and ABG. A researcher from Cognis Australia indicated that the individual applicant for PBRs has since retired from Cognis and so the application has sat idle since 2004. An official from the PBR Authority in Australia has indicated that ‘the applicant has reported a number of logistical issues relating to the siting and ownership of the comparative trial. As a consequence, the agent is currently in the process of confirming their intentions with the possibility of withdrawing the variety from the PBR scheme’ (Jodie Boyd, Pers. Comm. 18 March 2009). Currently it is unclear if these companies will pursue further research and commercialization of products relating to Kakadu Plum. Whilst their research in Australia appears to have halted, it is unclear if ABG or Amway are continuing their research in Brazil.
The Convention on Biological Diversity requires that parties seek prior informed consent for access to biological resources and traditional knowledge (as detailed by the Bonn Guidelines, and soon to be formalized under an International Regime on Access and Benefit-Sharing if/when the CBD parties can agree on a text). The Convention also requires that those who commercialise these products establish benefit-sharing arrangements with the original providers. Mary Kay Inc is a US-based multinational. Because the US has not ratified the CBD it is not bound by commitments under the Convention with regards to its operations in the US. However, subsequent Mary Kay Inc offices around the world are bound to national laws in the countries in which they operate. In Australia, where Mary Kay Inc also has an office, the CBD has been ratified and there are regulations regarding access and benefit-sharing under the Commonwealth (federal) Environmental Protection and Biodiversity Conservation (EPBC) Act 1999, as well as through state laws in Queensland, the Northern Territory and Western Australia where Kakadu Plum can be found in its natural state.
Access and benefit-sharing (ABS) obligations are dealt with under Part 8A of the EPBC Regulations (2000), but this refers specifically to Commonwealth Areas (e.g. Kakadu National Park) and specifically refers to the ‘taking of biological resources and native species for research and development’ (EPBC Regs. 2000, 8A.03(1)). For non-Commonwealth areas, the Natural Resource Management Ministerial Council has endorsed a “Nationally consistent approach for access to and utilisation of Australia’s native genetic and biochemical resources”, which should ensure that there are consistent approaches to ABS across the states and territories of Australia. Specific laws in each of the relevant States and Territories deal with ABS accordingly, and these include the Queensland Biodiscovery Act (2004), the Northern Territory Biological Resources Act (2006) and the Western Australian Conservation and Land Management Act (1984, as amended).
Under the Commonwealth system there are specific requirements for permits to be obtained prior to access (EPBC Regs. 2000, 8A.06(1), for Commonwealth areas), for an access permit to be contingent on a benefit sharing agreement with provider parties (including with Indigenous peoples where appropriate) (EPBC Regs. 2000, 8A.07(1)), and for informed consent if the biological resources are on Indigenous owned land of native title held land (EPBC Regs. 2000, 8A.10(1)), including consultations with Indigenous land councils. Access to biological resources for non-commercial purposes can be sought with written permission from the access provider, provided a statutory declaration is made asserting non-commercial use, the sharing of research results, and prevention of transfer to third parties (EPBC Regs. 2000, 8A.13).
A few of the state/territory laws are quite similar, but use slightly different terminology, such as the NT Biological Resources Act (2006), which specifies the resource access provider (S.6) by land tenure type, requires permits for ‘bioprospecting’ (i.e. research) activities from the relevant parks or fisheries agency (Part 3), and requires benefit-sharing agreements with resource access providers (Part 4). There are also interesting provisions for establishment of retrospective benefit sharing agreements where biological resources are originally taken for other purposes, but are then researched for biodiscovery purposes (S.30).
These laws and regulations do not cover biological resources that are publically available on a commercial basis – this is a considerable legal loophole. Many plants, plant tissues, seeds or genetic materials are commercially available from nurseries, as foodstuffs, or otherwise. This is problematic from a biodiscovery perspective because researchers can purchase biological materials commercially without obtaining permits from the relevant Australian authorities, and can then take them away for further research. If they are taken offshore it is likely to be very difficult to establish retrospective benefit sharing arrangements.
A representative of the Commonwealth Department of Environment, Heritage, Water and the Arts (DEWHA) has indicated that they believe that Mary Kay Inc have obtained Kakadu Plum plant genetic resources commercially through nurseries and possibly before the EPBC Act was effective (Harvey, Pers. Comm. 30 March 2010). This is problematic, because it may represent a lost opportunity to ensure benefit-sharing with appropriate providers in northern Australia (including relevant Indigenous communities that are providers), unless a retrospective arrangement can be made. It could also hamper domestic commercialization of similar products in this specific field. Despite the patent application, it is not clear if Mary Kay Inc have yet commercialized their cosmetic product that uses Kakadu Plum – it would inevitably have to pass clinical trials, US Food and Drug Administration (FDA) approvals, and equivalent approvals in other countries. Therefore, there is still a chance that Mary Kay Inc could be persuaded to enter into a benefit-sharing agreement if Australian state/territory or Commonwealth authorities pursue this. Additionally, non-government and academic pressures may help persuade Mary Kay Inc to demonstrate corporate social responsibility, if not strict legal obligations under the Australian regulatory framework for biodiversity.
If benefit-sharing arrangements were made at this stage, there are no known ‘providers’ as such. Nevertheless, retrospective benefit-sharing arrangements have been made in other cases such as the Phytopharm patent on hoodia from southern Africa. In 1995, following some detailed spectroscopic analyses, a patent application (patent number 983170) was filed in South Africa by the Council for Scientific and Industrial Research (CSIR) for use of the active components of the plant which were responsible for suppressing appetite. After much negative press and NGO pressures, CSIR responded by negotiating a memorandum of understanding in 2001 and by establishing a ‘San Hoodia Benefit-Sharing Trust’ in 2003 that should ultimately see milestone payments and royalties with traditional knowledge-holders (Dutfield, 2004, p53). Wynberg (2004; 2008, p88-90) explains the compexities involved in the establishment of this benefit-sharing agreement, including questions about which groups specifically should be the beneficiaries and how San knowledge and culture can be protected. This trust is now accruing funds and representatives from different communities regularly meet to determine how to split the funds between local groups that reside across southern Africa who conserve and use hoodia (Bavikatte, et al., 2009). A centralised fund such as this has the benefit that it is non-exclusive and relevant groups may apply to receive funding. The drawbacks may be that a trust is seen as overly bureaucratic and there may be concern about who is the decision-maker regarding applications. Such a system could ultimately be of relevance in Australia where a number of Indigenous groups across northern Australian could be considered ‘traditional knowledge-holders’ regarding various uses of Kakadu Plum.
Brazilian Açai Berry
With regards to the açai fruit, there are similar issues. Açai (Euterpe oleracea, Mart.) is a common name in Brazil for a small dark blue or black fruit that has been traditionally used as a food and possibly a medicine in the Amazon (see Lévi-Strauss, 1952, for an early study). The fruit has been described as a ‘superfood’ with various claims made over its antioxidant content, mineral content and ability to improve sexual performance; it is now commonly used in fruit juices as well as dietary supplements. Again, the high ascorbic acid content is well known and so there is a strong argument regarding the obviousness of the claims which mention açai in the Mary Kay Inc patent application. Brazil has formally indicated their concern about both patents and trademarks on plants, including specific mention of the açai berry in submissions to the WIPO Standing Committee on Trademarks, Industrial Designs, and Geographical Indications in November 2006, as well as in negotiations in the WTO TRIPS Council. This paper will also be sent to the Permanent Mission of Brazil to the UN in Geneva, where delegates can raise the issues in these fora.
The Camu Camu patents raised by the Peruvian Anti-Biopiracy Commission illustrate issues associated with the patent examination process internationally, particularly in cases where the so-called ‘innovation’ is based on traditional knowledge. Where it is difficult to prove prior art because of a lack of clear documented use of plants and other biological resources, then many patents based on traditional knowledge are likely to be granted as ‘novel’. In a number of these cases, patents have been granted for products that should have been interpreted as obvious to someone skilled in the science of dermatology.
The Mary Kay Inc patent applications raise the same concerns. Although the applications may still be refused due to the obviousness of the claims, this example demonstrates issues that exist regarding the transfer of biological resources for research purposes. It seems likely that researchers at Mary Kay Inc have obtained Kakadu Plum plant materials through commercial sources and have then conducted research on the plant. This contravenes the spirit, if not the word, of the CBD and of Australian biological diversity or biodiscovery laws. Currently, negotiators to the CBD Ad Hoc Working Group on ABS are seeking to close this loophole between international and national laws by establishing an International Regime on ABS, to which Australia has been a contributing Party. Although progress has been made with the Draft Nagoya Protocol on ABS, there are still significant disagreements between Parties as to some of the exact terms in the Protocol. Another approach that the Australian government should seriously consider is support for a ‘disclosure of source and/or origin’ patent requirement in the WTO TRIPS Council (or alternatively, in the less favoured WIPO Intergovernmental Committee).
Due to the recent stalemate in the Doha Development Round Work Programme as reported by the director general of the WTO (WT/GC/W/591 and TN/C/W/50, 9 June 2008), a number of countries have put forward a ‘Draft Modalities’ text to steer negotiations on outstanding implementation issues in the TRIPS Council. Several developing countries, as well as the African, Caribbean and Pacific group, Switzerland and the EC amongst others, have suggested parallel modality texts and negotiations on: TRIPS, the CBD and the disclosure issue; a register for geographical indications (GIs); and an extension of protection on GIs for products other than wines and spirits (under Article 23 of TRIPS). This compromise appears to have been made by finding mutual ground between the EC’s desire to improve the international protection of GIs and the possibility that GIs might be used to protect product-based traditional knowledge. This breakthrough in the negotiations now sees the majority of countries supporting a disclosure of origin requirement (with the US and Japan being the main antagonists). Australia has not taken a strong position on the issue, but should consider protecting its biological resources through the disclosure mechanism. Australia should also consider the relevance of GIs for the protection of food, agricultural and related products. Although it does not have the same long history as the EC for developing reputation in relation to specific regional products, GIs may have some relevance for premium foods and ‘exotic’ regional or Indigenous products in the future.
These are relatively technical and legal measures relating to the protection of biological resources and commercial products. There is also additional need for the protection and promotion of Indigenous and traditional knowledge. The most appropriate way of doing this would be to fully engage Indigenous communities for the development of sui generis systems, laws or protocols relating to their customs surrounding knowledge of biodiversity. This sort of approach has been encouraged by the United Nations Environment Programme (UNEP) through the development of bio-cultural community protocols (BCPs). As Bavikatte and Jonas (2009) indicate:
A BCP is a protocol that is developed after a community undertakes a consultative process to outline their core ecological, cultural and spiritual values and customary laws relating to their TK and resources, based on which they provide clear terms and conditions to regulate access to their knowledge and resources.
This sort of approach has particular relevance to Indigenous Australian communities, whose customary norms, protocols and laws are not adequately recognised by Native Title laws and other relevant intellectual property laws. BCPs could be developed for specific Indigenous communities across bio-geographical zones.
Last, it is worth making a note about the ethical obligations on corporations. Given that Mary Kay Inc promotes its social responsibility on its websites and reports, this incident surrounding the patent application may in fact turn into a positive situation if the right steps are taken by the company from these early stages. If action is taken quickly to engage the appropriate authorities and Indigenous communities, the patent application and commercialisation process may not end up with the same controversial circumstances which have surrounded a number of other patents that has been much maligned by NGOs such as the ETC Group, and which have received extensive negative international press (see Robinson 2010 for a number of examples).
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Acronyms and Abbreviations
ABG: Access Business Group International LLC
ABS: Access and Benefit Sharing
BCP: Bio-cultural Community Protocol
CBD: Convention on Biological Diversity
CSIR: Council for Scientific and Industrial Research (South Africa)
DEWHA: Department of Environment, Heritage, Water and the Arts (Australia)
EPBC Act: Environmental Protection and Biodiversity Conservation Act Cth. (1999) (Australia)
ETC Group: Erosion, Technology and Concentration
FAO: Food and Agriculture Organization
FDA: Food and Drug Administration (US)
GIs: Geographical Indications
ITPGRFA: International Treaty on Plant Genetic Resources for Food and Agriculture
PBR: Plant Breeder’s Rights
PCT: Patent Cooperation Treaty
TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights
WIPO: World Intellectual Property Organization
WTO: World Trade Organization
(1) Lecturer at the Institute of Environmental Studies at the University of New South Wales (UNSW), Sydney. This paper is based on an extract from Daniel Robinson’s book: Confronting Biopiracy: Challenges, Cases and International Debates published in 2010 by Earthscan, London.
(2) Section 102 of the US Patent Law S102 outlines the conditions for patentability; novelty and loss of right to patent: “A person shall be entitled to a patent unless – (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country more than one year prior to the application for patent in the United States.”
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