Traditional Knowledge, Biodiversity and Plant Varieties

1. The problem

Traditional knowledge (TK) is the knowledge, practices and innovations of indigenous and local communities, developed over generations and often tied to genetic resources: medicinal uses of plants, farming methods, crop varieties. It does not fit the IP system because it is held collectively, it is old (so not novel), it is often oral, and it evolves without a single author or inventor. Firms and researchers can therefore take TK, add a modest step, and patent the result. This is called biopiracy. The holders get nothing, and may even be accused of infringing when they use their own knowledge.

2. The biopiracy cases

• Turmeric: in 1995 the US Patent and Trademark Office granted a patent to two researchers at the University of Mississippi Medical Center for the use of turmeric powder to heal wounds. The Council of Scientific and Industrial Research (CSIR) requested re-examination, citing ancient Sanskrit texts and an Indian medical journal article of 1953. The patent was revoked in 1997 for lack of novelty.
• Neem: the European Patent Office granted W.R. Grace and the US Department of Agriculture a patent for a method of controlling fungi on plants with neem oil. An opposition led by Vandana Shiva, Magda Aelvoet and the International Federation of Organic Agriculture Movements succeeded: the patent was revoked in 2000 and the revocation upheld on appeal in 2005, on evidence of prior public use in India.
• Basmati: RiceTec’s 1997 US patent on rice lines described as Basmati, whose broad claims were withdrawn after India’s challenge (see the GI note).
• Hoodia (South Africa): the San people’s appetite-suppressing plant was patented by the CSIR of South Africa and licensed abroad; a benefit-sharing agreement with the San followed in 2003, and is the standard example of what the CBD aims at.

The US cases show a structural problem: US law at the time did not treat foreign unwritten prior use as prior art, so knowledge known for centuries in India counted only once it appeared in print.

3. The international instruments

• Convention on Biological Diversity, 1992 (signed at Rio, in force 1993): affirms the sovereign rights of states over their natural resources (Article 3), so access to genetic resources is subject to national legislation and the prior informed consent of the providing state on mutually agreed terms (Article 15). Article 8(j) requires respect for and preservation of the knowledge, innovations and practices of indigenous and local communities and equitable sharing of benefits from their use. The United States has not ratified the CBD.
• Nagoya Protocol on Access and Benefit-Sharing, 2010 (in force 2014): detailed obligations on access, benefit-sharing and compliance, including checkpoints to monitor use of genetic resources. India ratified it.
• International Treaty on Plant Genetic Resources for Food and Agriculture, 2001 (FAO): a multilateral system of access for listed food crops, and recognition of farmers’ rights (Article 9).
• TRIPS: says nothing on TK. India and other developing countries have proposed an Article 29bis requiring disclosure of origin of biological resources and TK in patent applications, with evidence of prior informed consent and benefit-sharing, to reconcile TRIPS with the CBD. The proposal has not been adopted.
• WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (May 2024): the first binding international rule requiring patent applicants to disclose the country of origin or source of genetic resources and associated TK on which the claimed invention is based. It does not itself require prior informed consent, and failure to disclose may not by itself lead to revocation except in cases of fraud. Supporters call it a start; critics call it a minimal outcome after twenty-four years of negotiation in the IGC.

4. India’s defensive protection

• Patents Act, 1970 (as amended in 2002 and 2005): section 3(p) excludes TK and the aggregation or duplication of known properties of traditionally known components; section 10(4)(ii)(D) requires disclosure of the source and geographical origin of biological material; and sections 25(1)(j) and (k) and 25(2) allow opposition for non-disclosure or wrongful mention of the source, and for anticipation by knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere. This last ground answers the turmeric problem.
• Traditional Knowledge Digital Library (TKDL), set up in 2001 by the CSIR and the Ministry of AYUSH: it records formulations from Ayurveda, Unani, Siddha, Sowa Rigpa and yoga, translated into English, French, German, Japanese and Spanish and classified according to the patent classification system. Patent offices that have signed access agreements, including the EPO and USPTO, search it, and Indian submissions have led to many applications being withdrawn or refused.
• People’s Biodiversity Registers maintained by Biodiversity Management Committees at the local level.

5. The Biological Diversity Act, 2002

The Act implements the CBD through a three-tier structure: the National Biodiversity Authority at Chennai, State Biodiversity Boards and local Biodiversity Management Committees. Foreign persons and entities need the NBA’s approval for access to biological resources and associated knowledge; Indian entities must give prior intimation to the State Board. Under section 6, a person applying for any IP right based on research or information on a biological resource obtained from India needs the NBA’s approval. The Biological Diversity (Amendment) Act, 2023 made several changes: approval is now required before the grant of the IP right rather than before the application, codified and cultivated medicinal plants and AYUSH practitioners were given relief from some benefit-sharing requirements, and many offences were decriminalised and made subject to penalties. Critics argue the amendment favours industry over communities; supporters argue it removes obstacles to research and to the AYUSH sector.

6. Plant varieties

TRIPS Article 27(3)(b) requires protection of plant varieties by patents, an effective sui generis system, or both. The model sui generis system is the UPOV Convention (International Union for the Protection of New Varieties of Plants, 1961; revised 1972, 1978 and 1991). The 1991 Act gives breeders strong rights over propagating material and essentially derived varieties, and makes the “farmers’ privilege” to save seed optional. India chose not to join UPOV and enacted its own law.

The Protection of Plant Varieties and Farmers’ Rights Act, 2001:

• registers new varieties (novel, distinct, uniform and stable), extant varieties, and farmers’ varieties;
• gives breeders the exclusive right to produce, sell, market, distribute, import or export the variety, for fifteen years for annual crops and eighteen years for trees and vines;
• recognises farmers’ rights in section 39: a farmer may save, use, sow, re-sow, exchange, share or sell farm produce including seed of a protected variety, as before, but may not sell branded seed of a protected variety; farmers are protected against innocent infringement; and farmers who conserve landraces may be rewarded from the National Gene Fund;
• provides for benefit sharing, compulsory licences where seed is not available at a reasonable price, and disclosure by breeders of the geographical origin of genetic material.

How this is examined

Questions: “Protection of traditional knowledge,” “Biopiracy,” “CBD and TRIPS,” or “Farmers’ rights.” Explain why TK does not fit IP; give the turmeric and neem cases; the CBD, Nagoya and the 2024 WIPO treaty; India’s defensive provisions (section 3(p), section 25, TKDL); the Biological Diversity Act with the 2023 amendment; and the PPV&FR Act with section 39 and the PepsiCo case.