Can extracts from local flora be patented in Malaysia? And how do intellectual property rights (IPRs) apply in traditional knowledge (TK)?
Malaysia's rich biodiversity
Malaysia is renowned for its rich tropical forests and diverse flora and fauna, and ranks highly in the National Biodiversity Index, which is used by the Convention on Biological Diversity (CBD) to estimate a country's richness and endemism in four terrestrial vertebrate classes and vascular plants. Therefore it comes as no surprise that there is an overwhelming interest, among local and foreign researchers, to tap into the vast goldmine that is the Malaysian tropical forest, and discover naturally-occurring compounds, substances and materials within the tens of thousands of plant species in Malaysia.
The "Tongkat Ali" patent
Eurycoma longifolia is a plant colloquially known amongst the locals in Malaysia as Tongkat Ali. It is a plant native to Malaysia, and is traditionally used as an aphrodisiac, a cure or relief for a number of illnesses or as a health tonic for vitality, vigour and improved blood circulation.
Recently, it was reported in certain Malaysian media outlets that a Malaysian company, jointly with a US institute, had obtained a patent relating to bioactive fractions of Eurycoma longifolia. This Malaysian patent no: MY 134867 A (the 867 Patent) had raised the eyebrows of certain parties when the sole licensee of the patent published a notice in a local daily, warning the public against committing any possible acts that would infringe the said patent. Certain sections of the public had the impression that the plant per se had been patented, and that therefore no one else could legally use the plant for medicinal purposes unless granted permission to do so. The licensee subsequently issued a press statement, clarifying that the patent was granted in relation to "new scientific uses relating to Tongkat Ali" and not Tongkat Ali itself.
Patent protection in Malaysia
Patents in Malaysia are governed by the Patents Act 1983 (PA 1983) and the accompanying Patents Regulations 1986 (PR 1986).
Section 11 of the PA 1983 allows an invention to be patented if it is new, involves an inventive step, and is industrially applicable.
Under Section 13, inventions that are non-patentable include:
i) discoveries, scientific theories and mathematical methods;
ii) plant or animal varieties or essentially biological processes for the production of plants or animals, other than man-made living microorganisms, microbiological processes and the products of such microorganism processes;
iii) methods for the treatment of human or animal body by surgery or therapy, and diagnostic methods practised on the human or animal body.
Under Section 13, products used in the methods described in (iii) do not fall under the ambit of non-patentable inventions. Whilst plant varieties are non-patentable subject matter, they may be protected in Malaysia under the Protection of New Plant Varieties Act 2004.
It can be argued that bioactive compounds naturally present in plants are "discoveries" under Section 13 of the PA 1983 and therefore are non-patentable. However, methods of extracting these bioactive compounds, compositions comprising the bioactive compounds and other constituents, and new uses of the bioactive compounds, or new uses of the compositions, are not excluded under Section 13 and may therefore be patentable subject matter.
The inventors of the 867 Patent reportedly state that while prior art indicates the effects of crude Eurycoma longifolia extracts on sexual physiology, there has been no research on the physical properties of the compounds in the plant which confer aphrodisiac benefits, nor has there been literature on the effects of the extracted compounds on sexual physiology at the cellular level. The inventors further reportedly state that the inventions contain features related to, inter alia, the composition of the extract for use in the treatment of sexual dysfunction or male infertility.
Protection of traditional knowledge in Malaysia
While the novelty of the invention in the 867 Patent would have been scrutinised by the examiners prior to granting the patent, one may argue that the Eurycoma plant has long been used by the indigenous and local people in Malaysia for its medicinal properties. The World Intellectual Property Organization (WIPO) defines Traditional Knowledge (TK) as "a living body of knowledge passed on from generation to generation within a community. It often forms part of a people's cultural and spiritual identity".
There is nothing contained within the PA 1983 that explicitly protects the intellectual property rights (IPR) of TK. Further, Section 14 of the PA 1983 defines prior art as "everything disclosed to the public, anywhere in the world, by written publication, by oral disclosure, by use or in any other way, prior to the priority date of the patent application claiming the invention". This would make TK prior art and non-patentable. However, providing evidence of TK to challenge the novelty or inventiveness of a granted patent may be a gargantuan task due to TK often existing in its original form as undocumented oral knowledge.
Traditional knowledge documentation (TKD) functions to make information regarding traditional knowledge prior art. Information contained in the TKD will serve to aid patent examiners during the search for prior art, and help control the grant of patents which contain subject matter derived from TK.
TKD also assists with the identification of the indigenous communities with whom the benefits of the commercialisation of such knowledge is to be shared. This could help said TK providers to assert their rights over the information provided.
Interestingly, the state of Sarawak has been pioneering efforts to document TK through the Sarawak Biodiversity Centre (SBC). Among its duties, the SBC functions to document the application of TK by its local communities when using biological resources. If such a system of documentation can be set up in all other parts of Malaysia, this can go a long way towards not only conserving valuable inherited knowledge for present and future generations, but towards the creation of a prior art database which may be referred to when assessing the novelty and inventiveness of a patent application. Such a database would also help in the advancement of science, particularly medical science as it contains information which helps in medical research while at the same time ensuring that the legal and moral rights of the indigenous people who provide the TK are protected as there would be documented evidence that said information is obtained from them.
Access to genetic resources and sharing of benefits
The Convention on Biological Diversity (CBD), of which Malaysia is a member, does set out principles governing access to genetic resources and the knowledge associated with them, and the sharing of benefits arising from such access.
The Malaysian Government in 2017 gazetted the Access to Biological and Benefit Sharing Act 2017 (ABS 2017). Although the act has yet to be implemented, of particular interest is the requirement under the act for parties interested in gaining access to a biological resource to obtain prior informed consent from the relevant indigenous and local communities. The act also compels the interested party intending to use the biological resource or TK for commercial purpose to enter into a benefit sharing agreement with the relevant indigenous community and local community.
In East Malaysia, Section 25 of Sarawak Biodiversity Centre Ordinance 1997, among others, provides for regulations to be made in respect of the terms and conditions for access to and use of the biological resources of the state or such resources, data, exhibit, information or material kept, stored or maintained in the Biodiversity Centre, and permits to be issued under the ordinance. In Sabah, the Biodiversity Enactment 2000 came into force in 2002.
The steps discussed above should be taken and the legislation enforced as expeditiously as possible to ensure conservation and sustainable use and equitable sharing of our rich biodiversity and genetic resources whilst ensuring that the IPRs of those deserving are protected.
|Zaraihan Shaari||Pravind Chandra|
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