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INTRODUCTION
The existing and conventional intellectual property system is not able to protect TK as such it is. Each local and indigenous communities has their own distinctive and different identity, sometimes they do share similarities. These days the traditional and associated knowledge is at the risk of theft and bio piracy. Protecting and preserving this knowledge and resources is very crucial to ensure that future generations also get benefits from them. Traditional knowledge is under a threat of being misappropriated by unlawful acts, together with their disappearance with time.
Also, scientists and researchers may use this TK without prior permission of these communities to get a license of sole monopoly which affects the community’s morale. These knowledge or resources frameworks can be used to make an invention or innovation, which may obtain the benefit of patent protection or even trademark or geographical indication protection since this knowledge in its raw form cannot be protected by conventional IP systems. This all has led to a situation where the traditional knowledge and resources are being misused or lost forever. So there is a necessity to protect this knowledge and resources which led to the evolution of Intellectual Property Rights concerning traditional knowledge. If communities are empowered to control, manage and sustain their traditional knowledge and resources, they can work together with the government to protect it and leverage its value and utility.
Governments act as the competent licensing authority, are well placed to consult with and obtain the prior informed consent of communities before granting these licenses[1].
RIO DECLARATION ON ENVIRONMENT AND DEVELOPMENT, 1992[2]
The United Nations Conference on Environment and Development, held at Rio de Janerio, Brazil, did not explicitly address TK protection but it created a political framework for addressing these issues within environmental circles and mentioned the issues of intellectual property rights (IPR) in TK and innovation.[3] The indigenous and local communities have a pivotal role in development of the economy because of their traditional knowledge, skills and resources as stated in the Principal 22 of the declaration. Agenda 21[4] is a comprehensive plan of action, adopted by more than 160 states at the Earth Summit, which contains a good deal of deliberation, recommendation and protection. This focuses on the government to take appropriate actions for the protection of traditional knowledge and cultural heritage of indigenous people.
THE CONVENTION ON BIOLOGICAL DIVERSITY, 1992[5]
The traditional dependence of local and indigenous communities on the traditional knowledge, skills and genetic resources was recognized in the international arena and the Convention of Biological Diversity (CBD) was signed in 1992 at the Earth Summit in Rio de Janeiro and came into force on 29th December, 1993. It is the first international legal instrument which explicitly acknowledges the role of traditional knowledge and resources and the practices of local and indigenous communities. This is the principal instrument to protect and to conserve the rights of the state and community over their resources and sustain the diversity of life on earth. The fundamental objectives[6] of the convention are conservation and sustainable use of resources of biological diversity and fair and equitable sharing of benefits arising out the utilization of these genetic resources.
The convention focuses on the importance of prior informed consent and access and benefit sharing at the core. Biological Diversity, means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystem. CBD also discusses the access to genetic resources and each contracting party is granted with sovereign powers over these resources, shall be subject to the prior informed consent and on mutually agreed terms. Each nation has the sovereign power and responsibility to ensure that activities within their jurisdiction do not cause damage to the environment of other States or of areas beyond the limits of national jurisdiction and ensure fair and equitable utilization and benefit sharing of genetic resources.
TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS AGREEMENT (TRIPS)[7]
The TRIPS agreement was adopted during the Uruguay Round of multilateral trade in 1986-1994. It was the first document regarding Intellectual Property Rights (IPR) negotiated but it does not explicitly cover patent protection of traditional or associated knowledge, but it specifically contains several provisions which mentions disclosure of traditional knowledge while filing patent application. Articles 7, 8, 27, 29, 32 and 62 acknowledge the disclosure of traditional knowledge. Article 7 and 8 emphasize on the objectives of TRIPS agreement and underlying principles respectively.
The scope of patentability is discussed in article 27. It states that any invention can be patented, provided that they are new and involve any inventive step, novelty and industrial application.[8] It also covers certain exceptions to patentability generally in the fields of technology and bioscience and is specifically provided in article 27.2 and 27.3. The exceptions also include ‘commercial exploitation of which is necessary to protect order, public or morality, including to protect human, plant life or health or to avoid serious prejudice to the environment…’[9] However, under the mandate of article 27.3(b), two issues were reviewed, issues pertaining to patent provision and relating to the sui-generis of plant varieties. And the conflict between TRIPS-CBD was raised in Doha Declaration in 2001.
DOHA MINISTERIAL DECLARATION, 2001
Doha Declaration[10] on the TRIPS agreement and public health is a special ministerial declaration adopted by the WTO Ministerial Conference in Doha on 14th November, 2001. The conference was to clarify the ambiguities of the principles of public health related TRIPS agreement. The declaration specifically recognizes the role of intellectual property protection and rights and minimum standards of protection. The objective of the declaration is to resolve TRIPS-CBD linkage in the context of the review of article 27.3(b). It also addresses a variety of issues concerning international trade and economic development, including marginalization of least developed countries. The review of article 27.3(b) began in WTO in 1999[11] and this led to the adoption of Doha Declaration in 2001.
It specifically states that the TRIPS Council should look at the relationship between the TRIPS agreement and Convention of Biological Diversity. It was guided by the objectives[12] and underlying principles[13] and must take development issues fully into consideration. Paragraph 19 of the declaration has mandated the council to examine TRIPS-CBD linkage and to protect traditional and associated knowledge and resources. The Ministerial declaration has instructed the TRIPS Council to consider the necessity of protecting traditional knowledge in its various programs.
ISSUES RELATING TO TRADITIONAL KNOWLEDGE AND PATENT IN INDIA
TK was in public domain and individuals used to exploit them by taking unfair advantage of patent protection or any other IP protection. The incredible capacity of humankind in using the resources for their own benefit alone has indeed made human species more powerful in the world. Till the beginning of the 21st century, people used to misappropriate traditional knowledge and resources and make private economic benefits commonly known as ‘bio piracy.’ Some of the controversies relating to this issue in India were as follows:
TURMERIC PATENT[14]
The United States Patent and Trademark Office (USPTO) granted the patent on turmeric for its wound healing properties to the University of Mississippi Medical Centre in 1995. After a year-long battle with India’s Council of Scientific and Industrial Research (CSIR), USPTO revoked this patent, as it lacked the novelty criteria required for patenting. CSIR strongly argued that turmeric being a native Indian plant had been used for centuries for wounding and healing by the people. This case also highlighted the need for documenting traditional knowledge so that it can be protected.
NEEM PATENT[15]
W.R. Grace and the Department of Agriculture, USA in European Patent Office (EPO) was granted a patent for the anti-fungal properties of neem. RFTSE and others had challenged the patent on the ground that neem had been known in India and used for centuries, used by people for many purposes including diabetes to skin diseases and even used as twigs in toothbrushes. After an eleven year old dispute, EPO found that the invention lacks the novelty criteria and this patent was revoked.
DOCUMENTATION OF TRADITIONAL KNOWLEDGE
The situation of misusing traditional knowledge and genetic resources for economic benefit prompted some countries to protect and preserve their traditional forms by developing their own sui generis system for protecting traditional knowledge and resources. Documentation of TK and GR will help to provide confidential and secret records of the knowledge and resources of indigenous communities. This will prevent and anticipate bio piracy or gene piracy and help to safeguard the sovereignty of TK. The main purpose of documentation is preserving and safeguarding the traditional knowledge, resources and cultural forms rather than legal protection. Each and every country needs to identify their local and indigenous communities and the knowledge and resources associated with them through documentation. These databases will help to prevent others from misappropriation of the knowledge or resources or in obtaining IP protection.
TRADITIONAL KNOWLEDGE DIGITAL LIBRARY[16]
Traditional Knowledge Digital Library (TKDL) is a collaborative project of the Council of Scientific and Industrial Research (CSIR) in association with the Ministry of Health and Family Welfare, Government of India, to protect, safeguard and preserve the sovereignty of traditional knowledge. The Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) and the Department of Indian Systems of Medicine and Homeopathy (ISM&H) joined hands to establish the TKDL. This is an online database which would help to enhance the quality of patent examination by facilitating the database of existing TK in India in a format understandable by patent examiners at their patent offices. TKDL has also set structured international specifications and standards for setting up of online database. This will help to prevent bio piracy, illegal usage, misappropriation and to protect these IPR.
CONCLUSION: SUGGESTING A BETTER WAY
India, being a member state, has taken an active and initiative role to revive WTO discussions on issues relating to prevention of theft of TK and help to address issues relating to bio piracy. India played a major role in organizing two days International Conference on TRIPS-CBD linkage held in Geneva, Switzerland on June 7th and 8th, 2018.[17] In the absence of an international regime regulating misappropriations, misuse or theft of TK and GRs, it is different for the developing countries to protect these resources only through sui generis system or domestic laws. The adoption of a possible plurilateral framework is essential to address these setbacks.
The traditional knowledge and genetic resources are at the risk of misappropriation and misuse by individuals for their economic gains. Here comes the necessity of safeguarding and protecting the resources and associated knowledge through an international regime against misappropriation in a multilateral context. Developing substantive standards of what constitutes misappropriation is relevant to anticipate the misuse. Since the legal system prevailing in each country is different and unique, adopting a comprehensive international law reform which requires careful consideration and a good deal of deliberation and efforts. It should also help to address the limitations of the current enactments regarding the biological resources and associated knowledge.
Stringent rules and regulations should be adopted regarding the access and benefit sharing legislation and if found violated or bypassed, such as when the access took place without prior informed consent and mutually agreed terms as prescribed by national legislation, penalties should be imposed. It would be better if the new instrument facilitates recognition of judgments made in accordance with a national legislation regarding the violation of rules in a foreign country having different legislation. It will not be quite acceptable since legislation differs from where the judgement is pronounced (whose right is violated) and enforcement (who violated the rights).
Mandatory disclosure procedures in patent application will help to increase the transparency of Intellectual Property Rights and monitor the utilisation of their resources and associated knowledge and facilitate appropriate legal actions. In the absence of an international legal system capable of curbing misappropriation, cases of bio piracy will augment.
References:
[1] Catherine Jewell, “Protecting traditional knowledge: A grassroots perspective”, 1 WIPO Magazine 19 (2017).
[2] Rio Declaration on Environment and Development, Convention on Biological Diversity, available at: https://www.cbd.int/doc/ref/rio-declaration.shtml (last visited on June. 12, 2021).
[3] Mugabe J., “Intellectual Property Protection and Traditional Knowledge” 21 Biopolicy International 20-21 (1999).
[4] Agenda 21 is a comprehensive plan of action to be taken globally, nationally and locally by organizations of the United Nations, Governments and Major Groups in every area in which there are human impacts on the environment.
[5]Convention on Biological Diversity, United Nations, available at: https://www.un.org/en/observances/biological-diversity-day/convention#:~:text=The%20Convention%20on%20Biological%20Diversity,been%20ratified%20by%20196%20nations (last visited on June. 15, 2020).
[6] The Convention on Biological Resources, 1992, art. 1.
[7] TRIPS: 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) [hereinafter TRIPS Agreement].
[8] TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, art. 27.1.
[9] Id.,art. 27.2.
[10] World Trade Organization, Ministerial Conference, Fourth Session, Doha, 9-14 November 2001, Ministerial Declaration, Adopted on 14 November 2001, WT/MIN(01)/DEC/1, 20 November 2000.
[11]TRIPS: Reviews, Article 27.3(B) and Related Issues, World Trade Organization, available at: https://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm (last visited on June. 12, 2020).
[12]Supra note 10, art. 7.
[13] Id., art. 8.
[14] K.S. Jayaraman, “US patent office withdraws patent on Indian herb”, Nature, Sept. 4, 1997, available at: https://www.nature.com/articles/37838 (last visited on June. 13, 2020).
[15]India wins neem patent, The Times of India, Apr. 1, 2005, available at: https://m.timesofindia.com/business/international-business/India-wins-neem-patent/articleshow/1067104.cms (last visited on June. 15, 2020).
[16]Traditional Knowledge Digital Library, India, available at: http://www.tkdl.res.in/tkdl/langdefault/common/home.asp?GL=Eng (last visited on June. 12, 2020).
[17] International Conference on the TRIPS CBD Linkage, available at : https://www.civilsdaily.com/news/pib-international-conference-on-the-trips-cbd-linkage/ (last visited on June. 16, 2020).
