4. Māori and the Patenting of Biotechnological Inventions
Background
75. As discussed in section 2, in 1989 the then Ministry of Commerce began a review of the Patents Act 1953 as part of a general review of New Zealand's intellectual property legislation. Submissions received in response to a 1992 discussion document indicated concern within the Māori community that the proposed reforms did not address the following issues: the patentability of biotechnological or "life-form" inventions, and the protection of traditional remedies and other inventions based on traditional knowledge. As a result the review of the Patents Act was postponed to allow further consultation with Māori to occur.
76. Submissions to the then Ministry of Commerce from Māori in 1994 and 1999 indicated that Māori are in general opposed to any reform of the Patents Act that might either "extend" patentability in the area of biotechnology, or that might not prevent the granting of patent rights to inventions based upon living organisms.
77. Many Māori are concerned about the application of patent rights to life forms, including indigenous flora and fauna. These concerns are wide ranging. First, there is concern that a patent for an invention derived from indigenous flora and fauna may, through the grant of exclusive rights in relation to the invention, infringe what Māori consider to be their rights under the Treaty of Waitangi to maintain control over their resources, and may also limit the rights of Māori themselves to develop new uses of those resources. Second, there is concern about the cultural and spiritual implications of the alteration of life forms, and the encouragement given through the patents system to continue innovation in this field.
78. Māori have also raised concerns about the application of the patents system to inventions based on traditional knowledge. There is a concern that traditional remedies, or their active ingredients, may be patented by individuals from outside the iwi from which the knowledge is obtained, and that Iwi would then be denied access to their traditional remedies during the patent term without either informed consent or arrangements for benefit sharing. Conversely, the requirement for inventions to be "novel" and to involve an "inventive step" may prevent Māori themselves from obtaining patent protection for traditional knowledge (which is typically passed on from generation to generation and evolves incrementally).
79. Another concern is that, while the Patents Act permits some collective ownership of patent rights, the system does not as a whole sit well with the concept of collective ownership of knowledge. It is also argued that the patents system allows and promotes the commercial exploitation of knowledge, whereas the objective for Māori is more often the protection of traditional knowledge against inappropriate use and possible loss. In many instances the commercial exploitation of traditional knowledge is culturally offensive.
80. In addition, many Māori share the same concerns as other New Zealanders about the possible social and environmental effects of genetic modification, and oppose the patenting of genetically modified products and processes on these grounds. Others, however, welcome genetic modification as a means of ensuring reliable supplies of valuable medical supplies such as insulin. In any event, it is important to note that patents, while they may provide an incentive to further research and development in this field, will not operate to prevent research and development in that area. The Patents Act essentially deals with the granting of rights over the "end product" of what is often a long process of research and development.
Consultations to Date
81. Four consultation hui were held in 1994 to discuss Māori concerns raised about proposed changes to intellectual property legislation. In 1995, in response to Māori concerns, the then Ministry of Commerce established the Patenting of Life Forms Focus Group ("the Focus Group"). Its purpose was to identify for the Ministry some issues of probable concern to Māori in relation to the patenting of life forms. The Focus Group engaged in wide consultations in developing its report.
82. The Focus Group's report and the Ministry's discussion paper on the patenting of biotechnological inventions were released for public discussion in February 1999. Consultation hui and workshops on these papers took place between April and June 1999. Submissions were also received on both papers from New Zealand scientific and research organisations and the patent attorney profession.
83. Responses to the Focus Group's report and the Ministry's discussion paper included a wide range of views. Some respondents were against any exclusions to patentability, or any amendments to the Patents Act to accommodate specific Māori concerns. Others argued strongly that Māori should be consulted when decisions are being made on the patenting of life form inventions, and that the Act should be amended to ensure that Māori have standing to raise issues of concern to them in patent opposition or revocation proceedings.
Issues to Be Considered
84. This document does not seek to re-examine the issues raised comprehensively in the report of the Focus Group and the Ministry's discussion paper. Rather, its purpose is to assist in exploring the extent to which Māori concerns about the patents system might be accommodated within the existing regime while still permitting the system to function effectively in promoting innovation, competition and New Zealand's overall economic interests. There is a broader set of concerns relating to the protection of traditional knowledge and cultural heritage which conventional intellectual property mechanisms, such as the Patents Act, do not address because of the underlying objectives and values on which they are based. These concerns could be addressed by the development of a stand-alone system to protect traditional knowledge (this issue is discussed further below in paragraphs 107 - 112).
85. The Focus Group also noted that many of the concerns raised by Māori, although seen as very much related to the discussion of Patents Act reforms, were more appropriately dealt with in some other forum. These concerns included:
- the use of the research material involved, including indigenous flora and fauna;
- controlling access to such resources; and
- the exercise of rangatiratanga over indigenous life forms.
86. As mentioned in section 2, there is a currently a claim before the Waitangi Tribunal ("WAI 262") which alleges that the Crown has breached its obligation to protect the cultural and intellectual property of Māori. This claim arises from Article II of the Treaty.
87. Article II of the Treaty of Waitangi preserves the rights of Māori to exercise te tino rangatiratanga ("their full chiefly authority") over their taonga (literally "treasures"- rendered in the English version of the Treaty as natural resources including lands, forests, fisheries and other properties).
88. The Wai 262 claim may be seen, at least in part, as a response to the tension between what are understood by Māori to be Article II rights and obligations, and the proprietary rights granted under intellectual property rights legislation, including the Patents Act 1953. The claim asserts that the Treaty guarantees rights of ownership, control, and authority over the genetic resources of indigenous flora and fauna, and cultural and intellectual heritage and traditional knowledge. The concept of "ownership" would cast Māori in the role of guardians of their heritage, while "control" suggests the possibility of commercial exploitation. The claim also asserts that the Crown is in breach of Article II of the Treaty through the enactment of legislation, including the Patents Act, which is inconsistent with those rights.
89. The Wai 262 inquiry is some way from completion. Meanwhile the government is proceeding with legislative reform that may go some way towards addressing the issues raised by the claim. For example, the new Trade Marks Bill introduced in June 2001, will, once enacted, require the Commissioner of Trade Marks to refuse to register a trade mark where the Commissioner considers that its use or registration would be likely to offend a significant section of the community, including Māori. The Bill goes some way towards addressing some of the concerns raised in the Wai 262 claim by ensuring that the Crown is not inappropriately registering trade marks containing Māori text and imagery.
Māori Concerns and the Review of the Patents Act
90. In considering potential changes to the Patents Act it is necessary to take account of the implications for Māori in granting intellectual property rights to inventions which may be perceived to conflict with Māori rights and interests in traditional knowledge, native plants and animals. The Crown also has an obligation to consult with Māori on matters affecting their interests under the Treaty.
91. Traditional knowledge, and Māori interests in indigenous flora and fauna, could be given some protection through amendments to the Patents Act while continuing to comply with New Zealand's international obligations.
92. These might include, for example, providing for consultation with Māori when making decisions on patents based on traditional knowledge or indigenous genetic material (see below paragraphs 98 - 106). The Act might also be amended to provide that Māori will have standing to seek revocation or re-examination of a patent.
93. Some Māori also assert a special interest in the genetic integrity of non-indigenous flora and fauna (in the context of genetic modification) on the basis of their spiritual connection to all living things. Māori concerns in this regard could be examined along with other similar claims based on religious or cultural grounds. These might not be the subject of specific consultation with Māori, but could be considered in the context of any public morality type exceptions to patentability.
94. Māori may be concerned that a patent, through its grant of an exclusive right to use and commercially exploit an invention, may both prevent Māori from continuing to use their own traditional knowledge, and may not result in any appropriate compensation for the knowledge contributed. It is important to note however, that a patent gives rights only in respect of the specific invention being claimed and nothing more. A patent on an invention derived from traditional knowledge does not prevent the continued use of that knowledge by the relevant community (but it may affect the future patentability of traditional knowledge based inventions by the owners of that knowledge). It should also be noted that before a patent can be granted for a traditional knowledge based invention, the examining office, in this instance IPONZ, must be confident that the invention is new, that is, that details of the invention have not been previously published.
95. In Stage 2 of the review of the Patents Act, a change is proposed that which would require that an invention involve an inventive step (not be obvious) before a patent can be granted. This would also reduce the likelihood of a patent being granted for an invention based on traditional knowledge. Whether an invention involves an inventive step is determined having regard to the information already known and used in the relevant field - the invention must not simply be a natural consequence of something already known.
96. Where traditional knowledge has contributed to the development of a new invention, ideally questions of benefit sharing would be managed by the parties concerned and would not be a matter for legislation. In the absence of legislative requirements, it is possible that this may not occur equitably or at all. The issue of access to genetic resources and benefit sharing for indigenous peoples is currently being considered at the international level by organisations such as the World Intellectual Property Organisation and the Convention on Biological Diversity. New Zealand has signalled its intention to participate actively in these discussions.
97. Providing for Māori input into the patent process could assist in addressing inequalities that may result from the situations described above.
Māori Input into the Patent Process
98. The Patents Act could be amended to ensure that consultation with Māori occurred when applications are made for patents for inventions based on traditional knowledge or indigenous genetic material. Such consultation could take place on examination of the patent application, or in the course of revocation or re-examination proceedings.
99. Proposals to require consultation have been criticised by stakeholders for imposing uncertainty on the patent process. Patents, however, should not be granted without rigorous examination and will always be subject to challenge at any time during the patent term. In this respect, the system could already be said to be "uncertain" and the introduction of possible mechanisms to, in effect, reduce future uncertainty, can only contribute to its over-all soundness.
100. The nature of any consultation process would need to be carefully determined to ensure both its effectiveness and over-all fairness to all interested parties. It would be advisable to impose some time limits on any proposed consultation process to ensure it did not result in undue delays for users of the system. One proposal that has been put forward by Māori groups is that patent applicants be required to provide clear evidence of the source of any genetic material concerned or, in the case of inventions which may be based on traditional knowledge, of "prior informed consent" of the owners that knowledge.
101. Even if patent applicants were required to provide evidence of the source of genetic material and obtain "prior informed consent", it will still be important to ensure that patent examiners are able to recognise patents based on traditional knowledge or indigenous genetic resources, independently of information provided by the applicant. The ability to recognise traditional knowledge is important to enable patent examiners to determine whether an invention is new and is eligible to be patented.
102. It is difficult to identify how and what consultation should take place at the examination stage, when examiners become aware that a patent is based on traditional knowledge or indigenous genetic resources. One option could be the formation of a committee to represent Māori interests in this context, and to advise the Commissioner of Patents as to the nature of the interest and the particular communities or persons with whom the Commissioner should consult. Alternatively, the patent applicant could be directed to undertake consultation. It may be difficult, however, for applicants to arrange adequate consultation before filing a patent application, particularly if the applicant is from outside New Zealand.
103. The Royal Commission on Genetic Modification has recommended (recommendation 10.4) that a Māori Consultative Committee be established to develop procedures for assessing applications, and to facilitate consultation with the Māori community where appropriate. In its response to the Royal Commission's recommendations, the government agreed that:
a Māori consultative committee be established, but that its scope and role be confirmed following public consultation as part of Stage 3 of the review of the Patents Act 1953.
104. The functions of this committee in relation to "assessing applications" would be limited by New Zealand's international obligations in respect of Article 27 of the TRIPS agreement, which deals with patentable subject matter and permits limited specific exclusions to patentability. The exclusions are set out in section 3 of this discussion document, and include exclusions necessary to protect ordre public or morality, to protect human, animal or plant life or health or to avoid serious prejudice to the environment. Article 27 does not expressly allow parties to refuse the grant of a patent on cultural grounds, although such a refusal may fit within the ordre public and morality exception.
105. The Royal Commission on Genetic Modification also recommended (recommendation 10.5) that New Zealand pursue an amendment of the TRIPS agreement which would allow the avoidance of cultural offence as a specific ground of exclusion. In its response to the Royal Commission's recommendation, the Government has directed officials from the Ministry of Economic Development, Te Puni Kōkiri and the Ministry of Foreign Affairs and Trade to:
- support the concept of exclusion or reservation on the basis of cultural offence through work currently being progressed through the World Intellectual Property Organisation, and the development of a new system for the protection of Māori "cultural and intellectual property"
- be alert for opportunities which may arise in the World Trade Organisation TRIPS context.
106. Another possibility might be to include provision in the legislation for Māori to participate in the application process as interested parties. For example applications for re-examination (both pre and post grant) or revocation of particular patents could be made by Māori groups or individuals where they considered their interests had in some way been contravened.
Sui Generis Mechanisms of Protection of Traditional Knowledge
107. An alternative to adapting existing intellectual property legislation to protect traditional knowledge is to develop a "sui generis" (stand alone) system. The development of a sui generis system will address the broader concerns raised about the protection of traditional knowledge which cannot be adequately achieved by adapting existing intellectual property mechanisms.
108. The importance of developing mechanisms to protect traditional knowledge has been recognised internationally. Work is being undertaken in a number of international fora including the World Intellectual Property Organisation, which has recently established an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. New Zealand has signalled its support for work by the Committee on sui generis systems to protect elements of traditional knowledge not covered by existing intellectual property systems. This is consistent with recommendation 10.4 of the Royal Commission on Genetic Modification, that:
New Zealand be proactive in pursuing cultural and intellectual rights for indigenous peoples internationally.
The government has agreed with this recommendation, and has directed officials ot implement it. New Zealand has also stated that this approach should not preclude the development of country or region-specific alternative approaches to protecting the knowledge and practices of indigenous communities.
109. Sui generis protection for traditional knowledge could be developed in conjunction with mechanisms governing access to genetic resources and benefit-sharing, as well as other measures such as registries of traditional knowledge, which would be used by patent examiners when considering patent applications. Such protection might include registers recording traditional knowledge and prior informed consent.
110. The development of registers of traditional knowledge is a contentious issue. Such registers would to some extent prevent the commercial exploitation of traditional knowledge by preventing third parties from obtaining patents for traditional knowledge based inventions where it could be shown that the invention was not new or obvious. There is, however, considerable concern among indigenous peoples about the public disclosure of traditional knowledge in this way.
111. Some countries, including the members of the Andean11 community and the Philippines, have already introduced sui generis systems at the national level. International agreement on a sui generis system is, however, likely to take some time, as is the development of any sui generis system within New Zealand. Meanwhile it is appropriate to explore ways in which the existing regimes for intellectual property rights, including patents, can be adapted to address some Māori concerns while still meeting its overall objective to promote innovation and competition.
112. The New Zealand Biodiversity Strategy, released in February 2000, acknowledged the need to encourage Māori participation in managing biodiversity and in developing a framework for the retention and promotion of Matauranga Māori.12 It also recognised the need to take Māori interests into account in developing access to and use of New Zealand's indigenous genetic resources and the sharing of benefits of their use. Implementation of the Strategy (which is the responsibility of several government departments, including the Department of Conservation and the Ministry of the Environment) will complement any amendments to the Patents Act to take account of Māori interests in these areas.
Questions for Consideration in Relation to the Review of the Patents Act 1953
- Should applicants for patents be required to provide evidence of the source of any genetic material? If so, what sort of evidence would be required?
- Where inventions are based on traditional knowledge, should applicants be required to provide evidence of the prior informed consent of the holders of that knowledge. If so, what form should that evidence take? What process would be required?
- How might patent examiners be made aware that patent applications are based on Māori traditional knowledge or indigenous flora and fauna?
- Should there be specific consultation with Māori during the patent examination process?
- If so, what sorts of applications should Māori be consulted about? Applications based on Māori traditional knowledge and indigenous flora and fauna? Anything else? Why?
- What should the role of the Māori consultative committee be? How would it be constituted? Should applicants be required to consult with Māori, or should the onus be on the Crown, or a combination of both?
- How else might Māori interests be taken into account in the patent process?
Other Questions You May Wish to Consider (Although They Are Outside the Scope of the Patents Review)
- Is a sui generis (stand alone) system for the protection of traditional knowledge and cultural heritage needed? Is international protection of traditional knowledge necessary? Why?
- If so, what should a sui generis system protect, and how?
- Should a sui generis system be limited to the protection of traditional knowledge, or should it also provide for the commercial exploitation of the knowledge by the holders of that knowledge?
- Should registers of traditional knowledge, to assist patent examiners in the search of prior art, be developed? What are the advantages and disadvantages? What sort of information might be contained on registers? Who would be responsible for the compilation and maintenance of such registers?
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