The Nagoya Protocol: A Sui Generis Approach to Traditional Knowledge Protection

On March 31, 2019, representatives from 143 universities around the globe gathered in Washington DC to participate in the 60th edition of the world’s largest international moot court competition, the Philip C. Jessup competition. Among the various public international law issues canvassed during oral proceedings, one international intellectual property issue in the moot problem raised a particularly thorny matter. On what basis can a State claim compensation from a pharmaceutical company for misappropriating an indigenous people’s traditional knowledge associated with genetic resources?

Despite years of discussion under the aegis of the World Intellectual Property Organization, States remain divided on how best to address biopiracy, that is, the exploitation of indigenous people’s traditional knowledge associated with genetic resources. For example, in 2015, a French government research institute allegedly exploited French Guianese traditional knowledge of the Quassia plant’s antimalarial properties by isolating its active ingredient Simalikalactone E. Similarly, Merck purportedly misappropriated the Brazilian Tupi-Guarani people’s traditional knowledge of the Jaborandi plant’s anti-inflammatory properties to develop the antiglaucoma drug Timpilo. Amidst the multilateral discourse, developing countries have maintained that the cultural and socioeconomic interests that indigenous peoples hold in traditional knowledge asserts the need to recognize its protection as intellectual property, especially when such knowledge is used as a lead for pharmaceutical research and development.

However, traditional knowledge stretches conventional conceptions of intellectual property, and to simply shoehorn it into the existing intellectual property framework would demand caution. Broadly, the proposals for traditional knowledge protection fall into two categories, defensive and positive. Positive protection confers indigenous people with positive rights to their traditional knowledge, while defensive protection prevents pharmaceutical companies from receiving patents claimed over traditional knowledge held by indigenous communities. One form of defensive protection entails harmonizing minimum patent standards of novelty to deter pharmaceutical companies from patenting knowledge directly based on traditional knowledge. However, most pharmaceutical companies readily surmount the novelty threshold because their inventions depart substantially from the traditional knowledge that served as an earlier point of reference during research. A more promising solution involves requiring patentees to disclose the original source material for patents associated with genetic resources, the failure of which would foreclose the grant of the patent. However, there remains no international consensus on the content of this procedural requirement and the consequences of non-compliance.

By comparison, proposals for positive protection of traditional knowledge have been more creative, ranging from trade secrecy rights over undisclosed traditional knowledge to unfair competition claims against traditional knowledge-using entities. However, the main difficulty with granting indigenous peoples a novel form of “intellectual property” is the inappropriateness of categorizing traditional knowledge as property. Fundamentally, the intergenerational, cumulative and collective nature of traditional knowledge is antithetical to a Western conception of individualized property, and international intellectual property law does not countenance perpetual rights in knowledge.

Against this backdrop, 117 States ratified the 2010 Nagoya Protocol (“the Protocol”), which grants indigenous peoples two sui generis rights in respect of their traditional knowledge: first, the right to obtain free, prior and informed consent for the use of their traditional knowledge under Article 7, and second, the right to equitably share benefits arising from the use of traditional knowledge under Article 5(5). Accordingly, pharmaceutical companies based in States that have implemented these provisions must now obtain the consent of indigenous peoples and conclude benefit-sharing agreements with indigenous peoples for the use of their traditional knowledge. Underlying these obligations is a rationale of equity and the need to remedy distributional injustices arising from a history of colonial subjugation. For example, Special Rapporteur Farida Shaheed stresses that traditional knowledge protection is fundamentally grounded in indigenous people’s right to self-determination, particularly in view of the historical oppression perpetrated against these people groups.

However, the Protocol remains a “masterpiece in creative ambiguity”.[1] For example, the expression “traditional knowledge associated with genetic resources” remains undefined, and the epistemological question arises as to the specific content of what indigenous people are required to know. Addressing a similar issue in a patent anticipation context, Lord Hoffman once remarked that an Amazonian Indian’s reference to the antiseptic qualities of tree bark would constitute adequate knowledge notwithstanding its label in animistic rather than chemical terms because the indigenous person knows the medically useful properties in the bark.[2] Another issue is whether a sophisticated scientific process such as the isolation of chemical compounds would qualify as “utilizations” of traditional knowledge that trigger the Protocol obligations, especially given the distance between the traditional knowledge and its subsequent use. Disagreements have also arisen regarding the temporal scope of the Protocol, with developing countries arguing that the obligations in respect of traditional knowledge apply to the continuing manufacture of drugs, even if the traditional knowledge was first accessed for research purposes prior to the Protocol’s entry into force in October 2014. Worse still, the Protocol does not contain a provision governing its extraterritorial applicability, thus leaving a lacuna in paradigm biopiracy scenarios where traditional knowledge in one State is utilized by a pharmaceutical company based in another State.

Concerns have also emerged in relation to the beneficiaries of traditional knowledge. Although Article 5(5) of the Protocol identifies that the holders of traditional knowledge are “indigenous and local communities”, the expression is not defined. Furthermore, a cursory understanding of anthropology informs that people groups migrate unpredictably in response to various historical events, thus dispersing traditional knowledge far and wide across regions. For example, traditional knowledge in the antimalarial properties of the Quassia plant is widely held by multiple “indigenous and local communities” across 12 States in Central America and South America.[3] Although it would appear unduly onerous for pharmaceutical companies to consult every community and negotiate benefits-sharing agreements with every group, the Protocol envisages a global benefit-sharing mechanism requiring States to cooperate internationally.[4]

Finally, the Protocol’s ramifications on healthcare and innovation policy could be enormous. Access to health is a core human right entrenched in Article 25(1) of the Universal Declaration of Human Rights, but traditional knowledge rights could impede efficient access to life-saving medicines during emergency situations. As such, the Protocol allows States to make exceptions during “imminent emergencies that threaten or damage human . . . health”.[5] Nevertheless, the Protocol does not permit exclusions of traditional knowledge protection based on a pro-patent innovation policy, since the positive protection of traditional knowledge can coexist with patents in the same way that moral rights exist alongside copyright. For example, the Protocol’s sui generis obligations requiring traditional knowledge users to obtain prior informed consent and to share benefits with indigenous peoples do not necessitate the revocation of a patent relying on traditional knowledge. Although these obligations may encumber patentees, Special Rapporteur Farida Shaheed emphasizes that intellectual property rights must be subject to indigenous people’s human right to self-determination because “the objective of intellectual property law is not to provide the maximum possible return to rights holders”.[6]

Given the Nagoya Protocol’s ambiguity on many core issues, it is no surprise that the US has not signed the treaty. But this uncertainty did not deter 397 oralists from advancing novel arguments about the Protocol’s scope during the Jessup moot competition. Though extremely contrived, the hypothetical scenario in the moot problem provided ample fodder for oral argument. The chief contention was whether the acquisition and commercial exploitation of a patent over an enzyme found in a yak gallbladder violated traditional knowledge rights guaranteed under the Protocol. But the twist was that scientists only isolated the enzyme after observing indigenous people consume the yak gallbladder as part of a religious ritual to improve longevity. New York University’s team, which had finished runners-up in the US Northeast regional rounds, enjoyed a good run during the international rounds and won three out of four preliminary rounds. But in the championship final of the 2019 Jessup Competition, Eötvös Loránd University of Hungary defeated Columbia University to clinch Hungary’s inaugural title.

Samuel Lim is an L.L.M. candidate, 2019, at NYU School of Law.

[1] International Institute of Sustainable Development, Summary of the Tenth Conference of the Parties to the Convention on Biological Diversity, Earth Negotiations Bulletin, 26 (Nov. 1, 2010).

[2] Merrell Dow Pharmaceuticals Inc. and Anr. v. H.N. Norton & Co. Ltd.(1995) RPC 76, 88.

[3] Genevieve Bourdy et. al., Quassia “biopiracy” case and the Nagoya Protocol: A researcher’s perspective, 206 Journal of Ethnopharmacology 290, 292 (2017).

[4] 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, art. 10, Oct. 29 2010, 3008 U.N.T.S 1.

[5] Ibid, art. 8(b).

[6] Farida Shaheed (Special Rapporteur in the field of cultural rights), Rep. of the Special Rapporteur in the field of cultural rights, U.N. Doc A/70/279, ¶ 64 (Aug. 4, 2015).