Biodiversity and Traditional Knowledge

Biological resources and the knowledge of communities about them are valuable inputs for pharmaceuticals, agriculture and cosmetics. Before the Convention on Biological Diversity (CBD) 1992, genetic resources were treated as the "common heritage of mankind" and freely accessible; patents on products derived from them were granted without sharing benefits. The CBD changed this by recognising sovereign rights of states over biological resources (Article 15) and requiring prior informed consent (PIC) and mutually agreed terms (MAT) for access, and fair and equitable benefit sharing. Biopiracy means unauthorised commercial exploitation of biological resources or associated traditional knowledge (TK), usually through patents granted to foreign companies/institutions without consent or benefit sharing.

Enacted to implement the CBD (to which India is a party since 1994). The Biological Diversity Rules 2004 supplement the Act. The BD Act sets up a three-tier institutional structure:

Key provisions

• Section 3: foreign nationals, non-resident Indians and foreign-controlled companies/organisations (non-Indian participation in share capital or management) require prior approval of the NBA to obtain any biological resource occurring in India, or knowledge associated with it, for research, commercial utilisation, bio-survey or bio-utilisation.

• Section 4: prior approval of NBA for transfer of results of research relating to biological resources occurring in/obtained from India to any foreigner.

• Section 6: approval of NBA is required before applying for any IPR in or outside India for an invention based on biological resources obtained from India (the original Act allowed approval after acceptance of an Indian patent application but before sealing). Section 6(3): NBA may impose benefit-sharing conditions or royalties.

• Section 7: Indian citizens/companies must give prior intimation to the SBB before obtaining biological resources for commercial utilisation (not for local people and vaids/hakims who have been practising indigenous medicine, and exemptions for normally traded commodities).

• Section 18, 21: functions of NBA; benefit sharing may be monetary or non-monetary: joint ownership of IPR, technology transfer, research and development, capacity building, royalties.

• Section 36: Government to develop national strategies for conservation; Section 37: declaration of Biodiversity Heritage Sites (BHS) by the State Governments in consultation with local bodies; Section 38: notification of threatened species; Section 36(5): Central Government protects traditional knowledge of local people.

• Section 41: BMCs; Section 55 (as originally enacted): penalties for contravention of Sections 3, 4 and 6: imprisonment up to 5 years, or fine up to ₹10 lakh, or both.

Biological Diversity (Amendment) Act 2023. Passed by Parliament in July–August 2023 and brought into force in phases. Main changes:

• Decriminalisation: imprisonment replaced by monetary penalties for most offences (penalties ranging from about ₹1 lakh up to ₹50 lakh, higher for serious breaches; verify the exact figures); adjudication by an Adjudicating Officer.

• Exemptions for codified traditional knowledge, cultivated medicinal plants, and AYUSH practitioners and local communities (including the earlier exemption of vaids/hakims); and fast-track approvals for research, patent applications and transfer of research results.

• Prior approval for IPR now required before grant (not before application) – aimed at easing patent filings (verify exact stage).

• Benefit-sharing now tied to commercial utilisation; Indian companies (including those with limited foreign shareholding) treated more favourably; foreign-owned entities remain regulated.

• Wider definition of "access" and addition of "codified TK", and requirement for the BMCs and Local Bodies to be consulted.

Enacted under TRIPS Art. 27(3)(b) option for a sui generis system, rather than joining UPOV.

• Authority: Protection of Plant Varieties and Farmers' Rights Authority (PPVFRA), New Delhi; Registry; Plant Varieties Protection Appellate Tribunal.

• Registrable varieties: new, distinct, uniform and stable (NDUS); extant varieties and farmers' varieties are also registrable. Varieties with genetic use restriction technologies ("terminator") are not registrable.

• Term (Section 24(6)): 15 years from the date of registration for most crops; 18 years for trees and vines; 15 years from the date of notification for extant varieties.

• Breeders' rights: exclusive right to produce, sell, market, distribute, import or export the variety.

• Farmers' rights (Section 39): a farmer may save, use, sow, resow, exchange, share or sell his farm produce including seed of a protected variety, but cannot sell branded seed of a protected variety. Also: farmers are not required to pay fee in proceedings; Further: registration of farmers' varieties and recognition and reward through the Gene Fund; Section 26 and the National Gene Fund for benefit sharing; Liability: compensation if the variety fails to perform as claimed.

• Compulsory licensing of protected varieties is possible after 3 years if the seed isn't available to the public at a reasonable price (Section 47).

• Related case/current affairs: PepsiCo India Holdings v. Registrar/PPV&FR Authority (Delhi HC; FL-2027 potato variety – breeders' rights vs. farmers' rights, litigation 2021–2024; verify latest status). Monsanto Technology v. Nuziveedu Seeds (SC 2019): Bt cotton patents; Section 3(j) Patents Act and the interface with PPVFR.

Meaning. TK is knowledge, know-how, skills and practices developed, sustained and passed from generation to generation within a community, often forming part of its cultural or spiritual identity. It includes agricultural, medicinal (Ayurveda, Siddha, Unani, Yoga), ecological knowledge, and traditional cultural expressions (folklore). It is typically collective, oral, cumulative and not novel in the patent-law sense (it is already in the public domain, so the patent system tends to fail to protect it and invites misappropriation).

Biopiracy and landmark cases (very high yield)

• Turmeric (haldi) patent: US Patent No. 5,401,504 (1995) was granted to the University of Mississippi Medical Center for use of turmeric in wound healing. India's CSIR challenged it with ancient Sanskrit texts and a 1953 JAMA paper; the USPTO revoked the patent in 1997 – the first successful challenge by a developing country to a biopiracy patent.

• Neem patent: European Patent No. 436,257 (granted 1994) to the US Department of Agriculture and W.R. Grace & Co. for a fungicidal neem-oil method; opposed in Europe by Indian and international organisations (including Vandana Shiva, the Research Foundation for Science, Technology and Ecology and the European Greens); revoked by the EPO in 2000 and the revocation was upheld on appeal in 2005 for lack of inventive step (no novelty because of prior use of neem in India).

• Basmati rice: RiceTec Inc. obtained US Patent No. 5,663,484 (1997) claiming Basmati lines and grains; after India's challenge (via APEDA/Government) the USPTO narrowed the claims (2001), and RiceTec withdrew the Basmati-named claims; this led to Basmati's GI registration in India (2016).

• Others: Hoodia (San people, South Africa) and Kava, Ayahuasca, Hoodia are international examples of benefit-sharing disputes.

India's legal measures to protect TK

1. Traditional Knowledge Digital Library (TKDL): established in 2001 by CSIR and the Department of AYUSH, a searchable database of Indian systems of medicine (Ayurveda, Unani, Siddha, Yoga, Sowa-Rigpa). Information is classified using the Traditional Knowledge Resource Classification (TKRC), modelled on the International Patent Classification, and made available in English, French, German, Japanese and Spanish. Access agreements allow patent examiners at the EPO, USPTO, JPO, UKIPO and other offices to search TKDL as prior art, preventing erroneous patents.

2. Patents Act (2002 Amendment): Section 3(p) (TK is not an invention); Section 10(4)(d)(ii)(A) (disclosure of the source and geographical origin of biological material); Section 25(1)(j)–(k) and 25(2)(j)–(k) (pre-grant and post-grant opposition on non-disclosure and on anticipation by TK); Section 64(1)(p)–(q) (revocation).

3. Biological Diversity Act 2002: PIC/MAT, benefit sharing (Sections 3, 6, 21), BMCs and People's Biodiversity Registers (to document local knowledge and prevent misappropriation), Section 36(5).

4. GI Act 1999: protects collective indigenous products linked to place (handlooms, handicrafts).

5. Copyright: folklore as traditional cultural expressions is only indirectly protected (works whose authors are unknown; the Copyright Act has no sui generis TCE right, although Sections 22–23 deal with anonymous works).

6. PPVFR Act 2001: farmers' varieties and farmers' rights.

International developments

• CBD Article 8(j) (respect and maintain TK, innovations and practices of indigenous and local communities and promote their wider application with their approval and involvement, with equitable benefit sharing) and Nagoya Protocol 2010 (access to genetic resources and associated TK, benefit sharing, compliance measures).

• WIPO IGC (Intergovernmental Committee on IP and Genetic Resources, Traditional Knowledge and Folklore, established 2000): led to the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted 24 May 2024, the first WIPO treaty directly addressing TK. It requires patent applicants to disclose the country of origin or source of genetic resources, and the Indigenous Peoples or local community providing associated TK. Enters into force after ratification by 15 contracting parties (verify current status).

• TRIPS Council debate on a mandatory disclosure of origin (proposed amendment to TRIPS Art. 29bis, supported by India, Brazil and others).

• ITPGRFA 2001: a multilateral system for access and benefit sharing for plant genetic resources for food and agriculture, and farmers' rights.

Analysis points (for conceptual MCQs). (i) TK is not patentable because it lacks novelty (public domain) and an identifiable inventor. (ii) The defensive approach (databases like TKDL preventing wrongful patents) is distinct from positive protection (granting rights to communities). (iii) Disclosure of origin is a linking mechanism between patent law and the CBD. (iv) The 2023 amendment's exemption for codified TK is criticised for weakening community benefit sharing.

Quick facts for revision (Section 8). BD Act: 2002; NBA: Chennai (2003); SBBs; BMCs; PBR; Section 3 (foreigners), 4 (transfer), 6 (IPR), 7 (Indian users), 41 (BMC). Amendment: 2023. PPVFR Act: 2001; term 15/18 years; Section 39 farmers' rights. TKDL: 2001; CSIR + AYUSH. Turmeric: US patent revoked 1997; Neem: EPO revoked 2000 (upheld 2005); Basmati: RiceTec 1997 claims narrowed 2001. CBD: 1992; Nagoya: 2010; WIPO GRATK Treaty: 2024.