Introduction
Recently, WIPO Member States adopted a historic treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge (hereinafter referred to as the “Treaty”). Initiated by Columbia in 1999, the negotiations began in 2001 and the Treaty was successfully negotiated and agreed upon by more than 150 countries in the final stage negotiations from May 13-May 24 this year. It will come into force upon ratifications by at least fifteen countries. Currently, only 35 countries have disclosure related requirements for patents; majority of which have either a weak enforcement mechanism or do not attract penal action, if violated against. In the wake of such inconsistency, developing countries, including India, have been advocating for a robust regime for protecting intellectual property of indigenous communities. While the Treaty comes out as a promising step towards such protection, a thorough analysis becomes pertinent to identify the loopholes and ensure its effective implementation. This blog aims at attaining the same. It tries to trace international impetus regarding the protection of Genetic Resources (“GRs”) and Associated Traditional Knowledge (“ATK”) and also analyses the present Indian patent regime vis-à-vis the Treaty.
International Impetus and need for the Treaty
Recent years have witnessed a shift in the international community’s approach, especially from the developing countries, towards protecting GRs and ATK. International initiatives such as WIPO’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore in 2001, are testament to this changing paradigm. The Treaty, as a result of such a shift, recognises other international instruments related to genetic resources such as United Nations Declaration on the Rights of Indigenous Peoples (“UNDRIP”), United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas beyond National Jurisdiction (“BBNJ Agreement”), Nagoya Protocol and Convention on Biological Diversity (“CBD”).
UNDRIP, under Article 31, acknowledges the rights of the indigenous people to maintain, protect, control, and develop their cultural heritage, traditional knowledge and traditional cultural expressions. Moreover, the BBNJ Agreement, albeit restricted to marine genetic resources, under article 13, mandates the member states to take effective steps in taking Free, Prior and Informed Consent (FPIC) of the indigenous peoples and local communities for using the marine genetic resources beyond national jurisdiction. It also advocates for fair and equitable sharing of benefits. Similarly, Nagoya Protocol, a protocol to CBD was brought in to ensure access and benefit sharing arising from the utilization of GRs.
Despite these international instruments, a more nuanced agreement was necessary, not only to fulfil the obligations arising from these instruments but also to comprehensively address the complexities involved in according these rights to indigenous peoples. The Treaty comes in the recognition of such requirements. It, however, only deals with patent systems across the globe and fails to address other tools in the IPR regime such as copyright, GI tags, etc.
Unveiling the Flaws of the Treaty
The Treaty, through Article 3 mandates disclosure requirements for inventions ‘based on’ GRs. This indicates that there must be a causal relationship between the invention and the GR/ATK relied upon. Hence, for a GR/ATK to fall within mandatory disclosure requirements it must form an essential part of the invention claimed. However, it is to be noted that ‘based on’ criteria of the Treaty deviate from the ‘utilization’ criteria of Nagoya Protocol and CBD. This dilution of scope negates objective of the Treaty, potentially leaving out inventions not substantially based on GR/ATK.
While the Treaty, by mandating international disclosure requirements, intends to bring legal certainty, it actually seems off road in achieving this aim. For instance, while Article 3.1 and Article 3.2 of the Treaty mandates the disclosure of country of origin and indigenous peoples or communities who provide the traditional knowledge associated with the GR, Article 3.3 provides an exception and sates that in absence of such information being known to the applicant, s/he must provide a declaration with regards to the same. These stipulations, in combination, are ambiguous and problematic for two reasons.
Firstly, the Treaty provides the contracting parties liberty to formulate national legislations in compliance with the stipulations of the Treaty. In absence of clear and unambiguous language of the Treaty, the Contracting parties will adopt different standards for disclosure requirements. For instance, the USA, a non-signatory to CBD, has a pro innovation regime. India, on the other hand, has a strong regime protecting GRs and ATK of indigenous communities. Owing to the subjectivity provided by the Treaty, its implementation could result in differing national standards for disclosure requirement. This could impede effective protection of GRs and ATK.
Secondly, it provides the party with an opportunity to dodge the disclosure requirement. Allowing declarations in the absence of GR source knowledge
under Article 3.3 without any mandatory duty of due diligence poses apparent enforcement challenges. For instance, a pertinent question arises as to how would the burden of truthfulness be established and who would have the onus to do the same. The flexibility provided to countries to decide, as per Article 6, which measures are ‘appropriate, effective and proportionate’ obscures the very objective of the Treaty. Differences in ‘goals’ (discussed above) of different countries will result in inconsistent enforcement and legal uncertainty.
One must agree that there is a power imbalance between the biodiversity-rich developing countries and technologically advanced developed countries. For the same reason, the developed countries have been raising the concern of addressing biopiracy’ which refers to appropriation and exploitation of biological materials native to a particular country without providing due credit and fair compensation to the community, directly or indirectly. The concern of biopiracy, however, remains unattended in the Treaty.
However, this Treaty depicts the changing dynamics of Intellectual Property regime, where the demand of developed countries and concerns of biodiversity rich countries are increasingly being recognised and negotiated at a multilateral level. Although, the above discussion identifies certain loopholes in the Treaty, it is a promising start which is bound to grant more protection to GR/ATK as the discourse proceeds at the multilateral stage.
India’s position and Comparison
India, in its opening statement to the WIPO conference, highlighted the need for instruments addressing the problem of ‘bio-piracy’ and misappropriation of GRs and ATK. It also asserted the need for an international database for the indigenous traditional knowledge due to its ‘positive’ experience with the domestic Traditional Knowledge Digital Library (“TKDL’) established in 2001. Neither have appeared in the final act. A comparative analysis of India’s regime regarding disclosure of GRs and ATK and that created by WIPOs treaty suggest a legal incompatibility between the two such that implementation of the Treaty might be antithetical to India’s regime.
The Indian Patents Act (“Act”), through section 3 (p), does not recognise as invention a product which is either duplication of traditional knowledge or the known properties of traditionally known components. Moreover, the Act complements the Biological Diversity Act, 2002 which, under section 6(1) states that no person shall apply for any IP rights without taking permission from the National Biodiversity AuthorityThe patent applicant has to mandatorily submit a declaration under Form-1 (Application for Grant of Patent) of the Patent Rules, 2003, acknowledging that s/he has taken all the permissions required from other authorities. Moreover, the Biological Diversity Act also mandates a penalty for INR 10 lakhs or an imprisonment of five years in case of not fulfilling or violating the obligations under section 3, 4 and 6.
Overall, the Indian regime is better suited to protect GRs and ATK as it allows retroactive cancellation of patents if found in violation of the provisions of the Act. Since the Treaty neither allows retroactivity nor allows cancellation of the patent, in the absence of disclosure, except in case of fraudulent conduct, its implementation will present an apparent clash with the Indian regime. It, thus, becomes pertinent to strategise the implementation of this Treaty in India.
Conclusion
While this is a historic step in protecting the GRs and ATK, a directed step toward protection is required. Stipulations of the Treaty appear to be falling short of the objective of the Treaty. As discussed above, just like CBD, an unambiguous and effective instrument is required to address the much-needed reforms for the protection of indigenous communities and traditional knowledge protectors. While this Treaty marks a significant step in the area, it is riddled with loopholes that compromise its objectives.
Nonetheless, this Treaty will form the basis of much needed discourse in the field of the protection of the rights of indigenous communities while providing certain relief from the concerns of ‘piracy’. India, however, is much ahead of the Treaty in providing protection to indigenous communities and their knowledge and there is a need to develop strategies to implement the Treaty in India.
The post is written by Suryansh Pandey, 4th year student of B.A. LL.B. (Hons.), DNLU Jabalpur.