A small first step in the protection of Indigenous traditional knowledge
The World Intellectual Property Organisation (WIPO) in May 2024, after almost 25 years of negotiations, approved a historic new treaty on intellectual property, genetic resources and associated traditional knowledge. In particular, the new treaty seeks to import a requirement on prospective patent applicants to disclose the country of origin or source of genetic resources or traditional knowledge on which an invention disclosed in a patent application is based. In this article, we examine the operation of this new treaty, including a review of the issues that it seeks to address.
The treaty will come into force once there are 15 contracting parties. The provisions of the treaty will only affect Australian intellectual property rights if and when Australia signs and ratifies the treaty and imports the requirements into Australian domestic law. There is currently no indication of a time frame within which Australia will seek to undertake these actions. Nevertheless, Australia’s Minister for Foreign Affairs, Senator the Hon Penny Wong, issued a media release welcoming the conclusion of the treaty and stated that the “treaty enables Australian First Nations peoples to benefit from their cultural heritage, promote their unique and diverse export offerings, and is an important step toward further protection for Aboriginal and Torres Strait Islander peoples’ traditional knowledge within Australia”.
Protection of Traditional Knowledge and Traditional Cultural Expressions
The adequate protection of traditional knowledge (TK) and traditional cultural expressions (TCE) of first nations peoples around the world has long been a topic of discussion at both national and international levels.
Existing intellectual property regimes are often not properly adapted to protect TK and TCEs because:
- TK and TCEs are not usually “owned” by any single person or entity, but are held by groups of people who are the custodians of such knowledge;
- there are customary laws around the appropriate use and dissemination of such knowledge, which is not usually recognised in existing intellectual property rights;
- the knowledge may have been publicly known and used for thousands of years, meaning that it is not sufficiently “novel” to qualify for protection such as patent rights; and
- the duration of rights for existing intellectual property regimes are not consistent with timeframes for TK and TCE which have been and will continue to be practiced for thousands of years.
A range of different proposals to protect TK and TCEs have been raised over the years, which can generally be grouped into two types – positive protection and negative protection. Positive protection seeks to use existing intellectual property mechanisms and new types of rights to protect the content of TK and TCEs themselves. Negative protection seeks to prevent outside users of TK and TCEs from acquiring intellectual property rights through the misappropriation of such information and knowledge.
The issue of “biopiracy”
Negative protection has focused on a range of issues, including the problem of “biopiracy”, which is where outsiders utilise TK associated with natural resources (such as knowledge about the medicinal properties of native plans) without obtaining consent from the custodians of that TK and without any proper compensation for access to that knowledge. This information can form the platform for a patent application, creating numerous problems including:
- that the invention may not actually be new or inventive in light of the known TK (of which the patent examiner may not be aware or be able to identify through orthodox patent searches);
- the outsider may achieve an economic benefit by commercialising the invention without compensating the traditional custodians of the knowledge who contributed to the invention; and
- any granted patent rights themselves may then limit the ways in which custodians can commercially exploit their TK or control the way in which it is used.
Disclosure as a mechanism to tackle biopiracy
One suggestion for tackling biopiracy is through the introduction of a disclosure requirement in patent law which would require patent applicants to disclose any TK or natural resources on which their invention is based as a pre-condition to the grant of a patent.
Several disclosure mechanisms have been suggested over the years, including disclosure of:
- the country of origin or source of the relevant natural resources;
- the identity of the custodians of the relevant TK;
- the content of that TK;
- whether there has been prior informed consent from the custodians of the TK to use and commercialise the TK; and
- whether appropriate access and benefit sharing agreements have been entered into with the custodians of the natural resources/TK to ensure that they have been properly compensated for providing access to the natural resources and TK, and can share in the commercial success of any resulting inventions.
The suggested consequences for a failure to disclose the above matters range from merely being optional, through to being a mandatory requirement whereby failure to disclose (or false declarations) can result in invalidation or unenforceability of patent rights.
Traditionally, developed nations such as the US and Japan have opposed strong disclosure requirements on the basis that they introduce uncertainty into the patent system and that disclosure may lead to significant administrative burdens for patent offices. Developing nations such as India and Brazil have long supported a strong disclosure requirement particularly because of the wealth of TK amongst first nations peoples in those countries, combined with significant biodiversity.
The New WIPO Treaty
The new WIPO treaty, once it comes into effect, will introduce disclosure requirements that seek to balance these competing views.
Disclosure Requirements
The treaty will require new patent applicants to disclose:
- the country of origin of any “genetic resources” (or if not known, the source of the genetic resources) and/or
- the identity of the Indigenous Peoples or local community that provides TK associated with genetic resources (or if not known, the source of the TK),
where the invention is based on the genetic resources or TK associated with genetic resources.
“Genetic resources” refers to materials of plant/animal/microbial or other origin which contain “functional units of heredity” (such as DNA). The treaty therefore does not apply to naturally derived resources that do not include genetic material and TK associated with those resources.
The treaty only imports a disclosure obligation where the invention is “based on” the TK or genetic resources. The treaty defines “based on” to mean that the TK/genetic resources “must have been necessary for the claimed invention” and that the invention must “depend on the specific properties” of the genetic resources or TK.
Where the relevant information is not known to the patent applicant, the applicant will be required to make a declaration to that effect.
The treaty does not require national patent offices to verify the authenticity of the disclosure, and the treaty requires that patent applicants be given an opportunity to rectify any failure to properly disclose information (unless the failure was fraudulent, in which case an opportunity to rectify need not be provided).
Consequences for non-compliance
If a patent applicant is found not to have complied with the requirements, the treaty provides that appropriate sanctions must be put in place, however (unless the failure was fraudulent), the patent will not be able to be revoked, invalidated, or rendered unenforceable solely on the basis of an applicant’s failure to disclose the required information.
Information Systems
The new treaty also provides that contracting parties may establish systems such as databases of genetic resources and associated TK in consultation with indigenous peoples and local communities, and other stakeholders. These databases can then be made available to patent offices for the purposes of search and examination of patent applications (though access to the information can be subject to authorisation).
Conclusion
The effect of the new treaty may improve the quality of patents by ensuring that underlying genetic resources and associated TK are considered in the course of examination, and that patents are not awarded if they merely seek to patent known TK. Disclosure of these matters, particularly in conjunction with databases of TK can assist patent offices in better assessing whether a claimed invention is in fact novel and inventive over known TK in the field. It remains to be seen how these provisions will apply in circumstances where the TK is confidential (and thus not relevant for novelty and inventive step), but nevertheless may form the basis of the invention.
The new treaty also does not require any disclosure as to whether the genetic resources or TK were accessed and used with the prior informed consent of the traditional custodians, or whether any benefit sharing agreements were entered into. Therefore, the treaty does not address whether the relevant TK was ethically accessed and used by the patent applicant.
Such matters are the subject of a separate international instrument, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (Nagoya Protocol), which entered into force on 12 October 2014. However, the Nagoya Protocol does not include any provisions for a disclosure requirement in applications for intellectual property protection – it relates (in this context) only to the implementation of measures to ensure prior informed consent and mutually agreed terms with relevant indigenous and local communities where access to genetic resources and associated TK is sought by third parties for any reason. Australia is a signatory to this instrument, but has not yet ratified it, which means that these provisions do not yet have legal effect domestically in Australia.
The new WIPO treaty has been drafted using relatively broad language, which will provide each contracting party a degree of latitude in terms of how it chooses to specifically implement it in its respective domestic laws. One area ripe for varied interpretation is the the nature of the nexus required between the genetic resources/TK and the invention as claimed in order to enliven the disclosure requirement.
Further, it remains to be seen which countries will ratify the treaty. Given the position of certain countries such as the US in relation to disclosure mechanisms, these requirements may not be implemented in those countries domestically.
Nevertheless, given the extended period of negotiations, the conclusion of the treaty does represent an important first step in the recognition of the role and unique nature of TK in the context of existing intellectual property systems, though the new treaty will need to supported by a range of other measures to provide adequate protection. The issues raised during the discussions to date during the negotiation period will no doubt also inform debate in other forums, both internationally and domestically in relation to both positive and negative forms of protection for TK and TCEs moving forward.