The threshold of novelty under patent laws differs across countries and is especially low in countries where pharmaceutical industries are strong. TRIPS does not require the consent of communities with regard to patenting traditional knowledge and as a result large pharma companies have patented traditional knowledge. This has led to several instances of bio- piracy. Some solutions to bio-piracy include establishment of registries, sui generis systems,
benefit-sharing agreements between drug patent-holders and source countries etc.
However, the dominant paradigms of access and benefit-sharing and intellectual property rights fail to adequately protect TK because they reflect western norms and laws which are based on individualistic and negative rights. While instances of bio-piracy may have been brought to light and resulted in such patents being cancelled, the real issue is whether a slight modification or improvement to traditional knowledge will cross the novelty threshold and if it does, whether the patentee will be under no legal obligation to share the profits with the community, whose knowledge formed the basis of that invention.
Understanding Legal Implications For Traditional Knowledge
Traditional Knowledge has not been defined in The Patents Act 1970. The only references to traditional knowledge in The Patents Act 1970 is under Section 3(p) which provides that traditional knowledge cannot be patented[1], Sections 25(1)(k)[2] and 25(2)(k) which allows pre-grant and post- grant opposition on the ground that the subject matter of patent is indigenous knowledge of local community and Section 64(1)(q)[3] which recognises it as a ground for revocation. A thorough analysis of case laws reveals that Indian courts as well as courts abroad have relied on the definitions provided in the World Intellectual Property Organisation (WIPO) and by the UNESCO for determining whether traditional knowledge has been patented in a given case.
WIPO has defined traditional knowledge as the knowledge having cultural or spiritual significance, which has been passed on from generation to generation among members of a community.[4] UNESCO defines traditional knowledge as the practices and innovations transmitted among the indigenous and local communities. It recognizes that traditional knowledge is collectively owned.[5] It is interesting to note that the landmark agreement on intellectual property rights, the TRIPS does not specifically refer to traditional knowledge, a remote reference may be inferred from Article 27.3 of the TRIPS which enables members to exclude plants, animals and biological processes and plant varieties from being patented.
There is no requirement for obtaining consent from the indigenous communities under the TRIPS. The Doha Declaration[6] called upon TRIPS to address the question regarding the protection of traditional knowledge in light of its objectives specified in Articles 7 and 8 of the TRIPS.[7] In 2000, WIPO established an IGC on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore with aim to provide effective protection for traditional knowledge.[8] The 2024 WIPO Conference on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge laid down the disclosure requirements for safeguarding traditional knowledge, but it too is fraught with loopholes which can be exploited to the detriment of developing countries, especially those which have undocumented or unpublished traditional knowledge.[9] The inadequacy of international norms with regard to traditional knowledge is a result of the specific characteristics of traditional knowledge, namely that those who possess this knowledge are often citizens of developing countries which lack adequate bargaining power at international forums.
The Threshold Of Novelty
Traditional knowledge is not organised and there is no individual person who can claim to have discovered it or own it as it is held by the entire community for generations. Often, this knowledge is appropriated by large companies of developed countries, who engage in bio piracy by exploiting this knowledge for commercial gain without providing adequate compensation and recognition to these communities.[10] Patent law does not grant protection to knowledge already existing in the public domain. Any product must satisfy the criteria of novelty, inventive step and commercial exploitation.[11]
Since traditional knowledge is already in the public domain, the criteria of inventive step or novelty is not satisfied. Often big pharmaceutical companies take advantage of this by investing in research and development and satisfying the inventive step criteria to commercially exploit traditional knowledge. Further, in most developed countries, while examining whether novelty threshold is met, it is tested against prior art and the test of person skilled in the art. However, this test can be applied only when traditional knowledge has been published somewhere, which is often not the case.
National laws of most countries, including the United Stated draw a clear distinction between traditional knowledge published within the country and that which is not, implying that when there is no written record within the country, any company can proceed to patent traditional knowledge even if it is well recognised beyond the borders.[12] Further, it is problematic to apply the test of obviousness to a person skilled in the art because, such person is most likely to be someone from the community itself, hence in this case the community is both the inventor as well as person skilled in the art.
Stealing Traditional Treasures: Biopiracy
There have been several instances of biopiracy by large companies from United States and in most instances, the victim of the theft has been Indian traditional knowledge. A well-known example is the granting of patent over neem for its pesticidal properties by the United States and the European Union to a company called W.R Grace, which had appropriated the knowledge regarding neem[13] already recognized by Ayurveda and other traditional medicine in India like Unani.
Even though this was challenged before the patent office of the United States, the company was successful in obtaining the patent. Another such instance was the filing of patent for turmeric for its healing properties.[14] However, this patent could be successfully revoked after producing commentaries on ayurvedic texts and other historical texts from India which proved that turmeric’s healing properties was already well known in India since ancient times. There has also been attempts to patent India’s Basmati rice. Rice Tec, an American company had successfully obtained patent for Basmati Rice, however after opposition from APEDA, Rice Tec withdrew most of its claims.[15]
Biopiracy is not just limited to Indian traditional knowledge, the traditional knowledge of several native tribes of the Americas and Africa too have been exploited without consent. Well known examples include the patent granted to Eli Lilly and Co over periwinkle for its ability to treat leukemia and Hodkin’s disease,[16] patent over the Amazonian ayahuasco for its medicinal properties and the attempt of Colorado State University to patent quinoa, a community heritage of Andean farmers.[17] Even if bio-piracy is identified, the costs of litigation involved in fighting bio-piracy is extremely high, for example, the litigation costs involved in the basmati rice case was estimated to be around 300,000$. These instances have led to exploring several solutions to avoid bio-piracy.
Recognizing Rights Of Indigenous Communities: Confronting Bio-Piracy
Since the exclusivity of patent rights is based on individual ownership of property, a change in perspective towards collective ownership of heritage can ensure that indigenous communities can benefit from the benefits of commercial exploitation of traditional knowledge. This calls for effective sui generis systems based on a benefit-sharing model which can preserve traditional knowledge by providing incentive for its sustainable use.
Such a system is expected not just to enable benefits to be shared, but also facilitate the transfer of scientific know-how and modern technology. The first solution to biopiracy is the compilation and publication of traditional knowledge, which is best done by digitally capturing information relating to traditional knowledge. The was the first response of India to biopiracy was the establishment of the Traditional Knowledge Digital Library (TKDL) which aimed to codify, translate and publish information regarding traditional medicine recognized in Ayurveda, Unani, Siddha and Yoga in a publicly accessible database.[18]
The TKDL has successfully classified traditional knowledge in a manner similar to International Patent classification making it easier to access. The TKDL can act as a basis of facilitating benefit-sharing agreements or contracts between the communities owning the traditional knowledge and the companies that seek to exploit this knowledge. A good example of benefit sharing agreements is the Trichopus zeylanicus, traditional knowledge of the Kani Tribe whose medicinal values was recognised by researchers of TBGRI and converted into an ayurvedic drug.[19] Recognition may also be possible by the making disclosure of origins mandatory in patent filings as this would enhance accountability. However, all these solutions are not free from their own limitations, which must be addressed.
Challenges To Confronting Biopiracy
The TKDL is based on a mechanism of defensive protection rather than positive protection. It has only enabled access to traditional knowledge that was codified in local texts or that could be codified. A large part of India’s traditional knowledge continues to remain uncodified as they are transmitted orally.
Further, since all that TKDL does is to establish the traditional knowledge as prior art, it does not provide any platform for recognizing rights of those communities from whom such traditional knowledge is obtained. There is no immediate incentive for local communities to contribute to the TKDL or any database or registry. Even if the TKDL succeeds in codifying all traditional knowledge, there must be a primary change in the patent regime itself to enable the benefit sharing.
This is less likely to happen as large companies often have significant political influence and they are unlikely to compromise on their profits. Further, the TKDL would only grant more access to large companies for investing in research of already known traditional knowledge, enabling them to cross the novelty and inventive step threshold for patenting the so-called invention.
Thus, many scholars have suggested that having an accessible database may actually increase instances if bio-piracy. Further, the names used by local communities significantly differ from the names used by scientists, thus database search would prove inefficient most of the times.
Even if the TKDL enables benefit sharing agreements, it does not take any measures to balance the inequality of bargaining power between the communities and large multi-national corporations. Another problem with the idea of benefit sharing agreements is who will enter into contract on behalf of an entire community, equally entitled to the benefits of such agreement. In most cases, it is the government that enters into these benefit sharing agreements rather than representatives of the community itself.
Safeguarding Indigenous Knowledge: A Path Forward
Patent laws are territorial in nature and the recognition of prior art is territorially limited. This limitation must be removed by global agreements such as the TRIPS. Patent laws of most countries prevent patenting traditional knowledge on the grounds that they are already in public domain, however it fails to recognize that even local communities innovate their traditional knowledge and what is assumed to be in the public domain in reality, a true innovation satisfying the requirements of novelty and inventive step. An examination into whether an innovation has been made by the community must be undertaken by the patent office by applying the person skilled in the art test but ensuring that such a person is not someone who is part of the community holding the traditional knowledge and a patent may be granted to the community as a whole, if the threshold of novelty and inventive step is crossed.
It must also be recognized that there are communities who believe traditional knowledge to be sacred and hence their ethical and spiritual norms may not encourage them to patent this knowledge for commercial benefit. In such instances, there must be free and informed consent of communities for patenting such knowledge or while entering into agreements with multinational corporations. Further, in most instances, indigenous communities do not have the resources and education to be able to file a patent with the detailed specifications and claims. It must be the responsibility of the government of the State to take this initiative to help the representative of these communities to file for the patent. For this, the communities must be recognized as legal persons. This has already taken place with respect to land ownership in many jurisdictions and the same may be incorporated with respect to the patent regime.[20]
Further, when a patent has been granted to a community, it is recommended that the duration of the patent must be extended beyond twenty years so that the community may genuinely benefit from such grant of communal patent. Communal patents will enhance the bargaining power of local tribes and communities to enter into contracts with multi-national corporations. The concept of communal patents aligns with the modern inventive framework where group of scientists and researchers often work together on a given invention. Thus, a move towards communal patents is not something uniquely required for indigenous communities, rather it is a need of the modern patent regime.
Conclusion
Large companies, that have engaged in bio-piracy have benefitted at the expense of indigenous communities. This has been possible due to the framework of the current patent regime that is based on individual property rights. Our patent framework has not defined what constitutes traditional knowledge and hence has led to a situation where the threshold set for novelty is low. Further, even for traditional knowledge to be recognized as prior art, documentation has been the only recourse while no measures have been taken to address uncodified orally transmitted traditional knowledge.
Scholars have suggested various strategies to accomplish establishment of a sui generis system recognizing communal patents. It has been suggested that after a registry has been created, it must enable the grant of patents to community as a whole. In case there are competing claims, it must be resolved through local dispute resolution mechanisms. An officer of the State must be appointed to represent communities with traditional knowledge internationally and to track any appropriation of traditional knowledge at the global level.
The threshold for novelty must be increased if the prior art is traditional knowledge so that large companies do not exploit the heritage held by communities for generations. There is a need to develop national as well as international legal instruments defining traditional knowledge, explaining how the rights would be distributed and how competing claims would be addressed.
[1] The Patents Act 1970, s 3(p)
[2] The Patents Act 1970, s 25(1)(k)
[3] The Patents Act 1970, s 64(1)(q)
[4] https://www.wipo.int/edocs/pubdocs/en/wipo-pub-rn2023-5-1-en-traditional-knowledge-and-intellectual-property.pdf
[5]https://uis.unesco.org/en/glossary-term/traditional knowledge#:~:text=Definition,orally%20from%20generation%20to%20generation.
[6] Doha Declaration, World Trade Organisation, Ministerial Conference , 4th session <https://www.wto.org/english/res_e/booksp_e/ddec_e.pdf>
[7] Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)
[8] The WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, https://www.wipo.int/edocs/pubdocs/en/wipo-pub-rn2023-5-2-en-the-wipo-intergovernmental-committee-on-intellectual-property-and-genetic-resources-traditional-knowledge-and-folklore.pdf
[9] Dr Anson CJ, “WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge: Concerns of India and Developing Nations- Part I” < https://spicyip.com/2024/06/wipo-treaty-on-intellectual-property-ge…raditional-knowledge-concerns-of-india-and-developing-nations.html >
[10] John Reid, “Biopiracy: The Struggle For Traditional Knowledge Rights”, American Indian Law Review , 2009-2010, Vol. 34, No. 1 (2009-2010), pp. 77-98 <https://www.jstor.org/stable/25684263>
[11] The Patents Act 1970, s 2(1)
[12] John Reid, “Biopiracy: The Struggle For Traditional Knowledge Rights”, American Indian Law Review , 2009-2010, Vol. 34, No. 1 (2009-2010), pp. 77-98 <https://www.jstor.org/stable/25684263>
[13] Ikechi Mgbeoji, “Patents and Traditional Knowledge of the Uses of Plants: Is a Communal Patent Regime Part of the Solution to the Scourge of Bio Piracy?”, Development, Agriculture, and the Challenge of Genetically Modified Organisms (Fall, 2001), pp. 163-186 <https://www.jstor.org/stable/20643824>
[14] ibid
[15] Krystyna Swiderska, “Banishing The Biopirates: A New Approach To Protecting Traditional Knowledge,” International Institute for Environment and Development (2006) <http://www.jstor.com/stable/resrep01338>
[16] Feifei Jiang, “The Problem with Patents: Traditional Knowledge and International IP Law,” Harvard International Review , FALL 2008, Vol. 30, No. 3 (FALL 2008), pp. 30-3 <https://www.jstor.org/stable/42763596>
[17] Bosse, J. (2024). Re-examining the “wild” story of the ayahuasca plant patent. Intellectual Property Quarterly, (2), 136-162
[18] Ajeet Mathur, Who Owns Traditional Knowledge? Economic and Political Weekly , Oct. 18-24, 2003, Vol. 38, No. 42 (Oct. 18-24, 2003), pp. 4471-4481 <https://www.jstor.org/stable/4414163>
[19] Achal Gupta, Intellectual Property Rights and Protection of Traditional Knowledge: A General Indian Perspective, <https://www.scconline.com/blog/post/2020/06/22/intellectual-property-rights-and-protection-of-traditional-knowledge-a-general-indian-perspective/>
[20] Ikechi Mgbeoji, “Patents and Traditional Knowledge of the Uses of Plants: Is a Communal Patent Regime Part of the Solution to the Scourge of Bio Piracy?”, Development, Agriculture, and the Challenge of Genetically Modified Organisms (Fall, 2001), pp. 163-186 <https://www.jstor.org/stable/20643824>
Author: Sharada A Kalale is a 4th year law student at National Law University Delhi.
