Traditional knowledge (TK) is seen as the cultural identity of a particular community, which is generally developed, sustained, passed on to generations and shared within members of that community. Research today has become highly competitive as well as exploitative and researchers always look towards the traditional knowledge as an important resource. Often, traditional indigenous knowledge is utilized, without authorization by or reimbursement to the communities, to either gain profit by commercialization or by patenting. This is termed as biopiracy.  Many such biopiracy cases have been reported from all over the world and even a book is published to document some of those (Daniel Robinson, Confronting Biopiracy: Challenges, Cases and International Debates, 2010, Taylor and Francis, DOI: 10.4324/9781849774710). 

The Trigger

There have been many biopiracy attempts in case of Indian traditional medicinal knowledge. In 1995, United States Patent and Trademarks Office (USPTO) awarded a patent on the use of Turmeric powder for wound healing to two scientists of Indian origin – Soman K. Das and Harihar P. Kohli of the University of Mississippi Medical Center. There was a lot of uproar in India about how multinational companies have started to poach traditional Indian knowledge. India applied for a reexamination of the patent, through the Council for Scientific and Industrial Research (CSIR), and produced 32 references in Sanskrit, Urdu, and Hindi to support the fact that the patent lacked ‘novelty.’ After spending $15,000 and a year-long battle, the USPTO revoked the patent on the ground that the claims were obvious and anticipated based on traditional information in India. 

India’s response to Biopiracy

India has been responding in many ways to deal with such potential loss of intellectual property available in traditional knowledge through:

a. Documenting the traditional knowledge by preparing Traditional Knowledge Digital Library (TKDL)

b. Protecting traditional knowledge through incorporating relevant clauses in The Patent (amendment) Act 2005

c. Enacting relevant laws such as The Biological Diversity Act, 2002, Protection of Plant Varieties and Farmers Rights Act 2001, Geographical Indication of Goods (Registration and Protection) Act 1999, and Scheduled Tribes and other Traditional Forest Dwellers (Recognition of Forest Rights) Act, 2006

d. Raising the issue at International level

Traditional Knowledge Digital Library

India has enormous traditional medicinal knowledge in Ayurveda, Unani and Siddha systems written in languages such as Sanskrit, Hindi, Urdu, Tamil, etc. While dealing with the Haldi patent, India realized that our documentation on traditional knowledge is poor and this knowledge needs to be protected to prevent biopiracy attempts. Subsequently, in 2001, Department of Ayush, Government of India, in collaboration with CSIR, launched an initiative to digitize the traditional knowledge of India to create Traditional Knowledge Digital Library (TKDL). Presently, the library has 34 million pages of text, in major languages such as English, German, French, Spanish and Japanese, and has documented about 3.6 lakh formulations mentioned in books of traditional medicine systems of India. The library is made available to thirteen patent offices (with which access agreement has been signed) removing the barrier created by language. Patent examiners can evaluate the patent applications for novelty aspect and can prevent exploitation of traditional knowledge. This has resulted in several patent applications being rejected by the examiners and successful pre-grant oppositions of about 239 patent applications on the ground of available prior art in six major patent offices.

Modification in patent law of India

The Patent (amendment) Act 2005 has several provisions to protect traditional medicinal knowledge from being exploited. Major protecting provisions are:

• The patent application form must mandatorily identify the source of geographical origin of any biological material used in the Specification, wherever applicable.
• If the patent application is related to a biological material obtained from India, then it is necessary to submit the permission from the National Biodiversity Authority.
• If the biological material is sourced from traditional knowledge of a community, one has to submit evidence of informed consent and benefit sharing model with that particular community.
• Section 3 of the Indian Patent Act, which indicates inventions which are not patentable, has following clauses that directly or indirectly relate to protection of traditional knowledge:

1. Section 3(c) states that mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature cannot be patented. Thus, any patenting of any biological material or its naturally occurring components such as enzymes, chemical constituents, nucleic acids, etc. is prohibited.

2. Section 3(e) prohibits patenting of a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance. Most of the traditional medicines are mixtures of various components. Thus, formulation of a medicinal admixture wherein each component functions independently is not allowed.

3. Section 3(j) forbids patenting of life forms such as plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. This is in consonance with section 3(c) and the words “any part thereof” here in 3(j) include all parts of plants and animals such as genes, enzymes, proteins, cells, cell lines, tissues, organs, would not be patentable.

4. Section 3(p) is more specific to traditional knowledge, wherein it bars patenting of an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.

Relevant laws in India

a. The Biological Diversity Act, 2002: It regulates the access to, and use of, traditional biological resources and knowledge as well as provides a mechanism for benefits sharing. Section 2 (c) of the Act defines "biological resources" as plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value-added products) with actual or potential use or value but not including human genetic material. Under this Act, a statutory autonomous body called The National Biodiversity Authority (NBA) under the Ministry of Environment and Forests, Government of India was established in 2003. Under it, State Biodiversity Boards (SBB) in all Indian states and 31,574 Biological management committees (for each local body) across India have been created. As per the Act, before obtaining any biological resource or associated knowledge from India for the purpose of research, bio-survey, commercial utilization, applying for intellectual property, and transferring the research results, prior permission from NBA (or SBB) is required. Also, it does not permit transfer of results of research using biological resources from India to any non-citizen or foreign company without approval of NBA.

b. Protection of Plant Varieties and Farmers Rights Act 2001:

c. Geographical Indication of Goods (Registration and Protection) Act 1999: Geographical indicators (GIs) associate a product with a particular place. Because the product gets more commercial value by its association with a particular place and a particular quality, they are important intellectual property. It is well known that geographical environment affects the specific quality and characteristics of the product. Thus, the ‘geo-authentic’ material is useful in traditional medicine and not the ‘introduced’ one (For example, Tinnevelly senna, Alleppey green cardamom, Mysore Sandal, etc.). This act provides for registration of biological material as GI by any association of persons or producers or any organization or any authority established by or under any law and prevent its misappropriation and infringement.

d. Scheduled Tribes and other Traditional Forest Dwellers (Recognition of Forest Rights) Act, 2006: It is also called as the Forest Rights Act, the Tribal Rights Act, the Tribal Bill, and the Tribal Land Act. Section 3(1) of the Act includes various rights, one of which is right of access to biodiversity and community right to intellectual property and traditional knowledge related to biodiversity and cultural diversity.

International recognition of the problem

Internationally, it is now well recognized that there has been significant growth in trade of medicinal preparations based on TK and exploitation of TK as lead for biomedical research and product development. Thus, there has been a policy debate about the misappropriation of TK, benefit sharing models, and use of TK in various international bodies. Some key steps have been taken in recent decades.

a. The Convention on Biological Diversity (CBD), also known as the Biodiversity Convention, is an international multilateral treaty to which 196 states are party, was established in 1992. The Convention has three main goals viz. conservation of biodiversity, sustainable use of components of biodiversity, and sharing of benefits arising from genetic resources. CBD asserts the sovereign rights of member states over their biological resources through Article 8 (j) irrespective of whether or not it can be protected by IPRs.

b. In 2000, World Intellectual Property Organization (WIPO) members established an Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). Many member states of WIPO favour an international legal instrument providing sui generis protection to Traditional knowledge, as it cannot be patented as per existing laws. In 2009, the IGC agreed to develop an international legal instrument (or instruments) to award protection to traditional knowledge, genetic resources and traditional cultural expressions (folklore). However, no final agreement has been reached although debates are still ongoing. However, WIPO has numerous capacity building initiatives such as seminars, workshops, practical training, and distance learning programs. It also has several books available online covering varied areas such as on intellectual property management of traditional knowledge, how to document, etc. (www.wipo.int).

c. United Nations Conference on Trade and Development (UNCTAD), through its work on trade environment and development, addresses the issue of the protection of Traditional Knowledge.

d. The World Health Assembly (WHA), which has 194 member states and governs the World Health Organization (WHO), in 2009, passed a resolution called the Beijing Declaration. This resolution urges national governments of member states to respect, preserve and widely communicate traditional medicine knowledge while formulating national policies and regulations to promote appropriate, safe and effective use; to further develop traditional medicine based on research and innovation; and to consider the inclusion of traditional medicine in their national health systems.

e. In 2007, the United Nations Declaration on the Rights of Indigenous Peoples states that “Indigenous people have the right to their traditional medicines and to maintain their health practices, including the conservation of their vital medicinal plants, animals and minerals”.

f. The International Regulatory Cooperation for Herbal Medicines (IRCH) established in 2006 a global network of regulatory authorities responsible for the regulation of herbal medicines. It works along with the WHO with a mission to protect and promote public health and safety through improved regulation of herbal medicines. Since internationally, the traditional medicinal knowledge has been used in a broad sense that includes herbal medicines, this cooperation is very important.

g. India, time and again, has communicated with WTO (World Trade Organization) to harmonize the provisions of Trade-related aspects of Intellectual Property Rights (TRIPS) with CBD and to include in TRIPS agreements, the rights of holders of TK and benefit sharing if innovation is associated with bioresources of member states.

Future direction

Although global attention has been drawn, a lot needs to be done nationally and internationally to protect the traditional medicinal knowledge of India. Some suggestions are as follows:

a. There is lack of clarity in the interpretation of legal definitions such as ‘biological resources’, ‘benefit sharing’, etc. and there is also lack of compliance. A suitable manual may be prepared to explain, exemplify and remove ambiguity.

b. Since traditional knowledge has been in public domain through oral or book based knowledge, it becomes prior art and hence cannot be patented directly. Slight modification can make it patentable invention and hence laws also need to address this loophole. Due to increase in acceptance of traditional medicines globally, more incidences of exploitation will occur.

c. Indian traditional medicinal systems such as Ayurveda consider holistic healing aspects and cannot be applied like allopathy. Therefore, possible patenting of these as nutraceutical or cosmeceuticals can provide newer prospects. AYUSH has notified new categories of Ayurvedic products as Balya/Poshak (nutritional products) and Soundarya Prasadhak (Ayurvedic cosmetics) for license and export purpose. Patent laws can be amended to include their patentability.

d. Evidence based validation of claims of quality, safety and efficacy of traditional medicines is required if it has to be globalized. There are challenges to standardize the raw material including its authentication, harvesting at an appropriate time to give best quality, and assessment of intermediate and finished product. AYUSH has done a wonderful job of standardization and preparing guidelines for development of traditional medicines. Still much more is waiting to be done and hopefully it will be taken up.

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