Regulation of Access to Biological Diversity — Intellectual Property Rights II Notes

Regulation of Access to Biological Diversity

Everything in this unit ultimately turns on one gate: who may take India’s biological resources, and on what terms? Sections 3 to 7 are that gate. Master them and you can answer any access problem in the paper.

The access-control provisions — ss.3–7

The Act divides access-seekers into two groups and sends them to two doors:

A. Foreigners — NBA approval (s.3)

Non-citizens, NRIs, and bodies corporate/associations not incorporated in India (or with foreign shareholding/management) must obtain prior approval of the NBA to obtain any biological resource or associated knowledge for research, commercial use or bio-survey.

B. Transfer of research results — NBA approval (s.4)

No one may transfer the results of research on Indian bio-resources to a foreigner/foreign entity without NBA approval.

C. Patents on bio-resources — NBA approval (s.6)

No one may apply for any IP right for an invention based on an Indian biological resource without prior NBA approval (may be obtained before grant).

D. Indians — prior intimation to the SBB (s.7)

Indian citizens and Indian companies must give prior intimation to the SBB before obtaining any biological resource for commercial utilisation or bio-survey. (Local people, vaids and hakims using resources traditionally are exempt.)

E. Exemptions — s.5

Collaborative research projects conforming to Central Government-approved guidelines are exempt from s.3/s.4.

In Simple Terms: Two doors. Foreigners and foreign patents → NBA (ss.3, 4, 6). Indians for commercial use → SBB (s.7). Everyday traditional use by local people is free; approved collaborative research is exempt (s.5).

🧩 WORKED EXAMPLE — mapping a person to the right door

Facts. (i) A foreign university wants to collect microbes in Kerala; (ii) an Indian firm wants to sell a herbal extract.

Rule. s.3 (foreigner → NBA) and s.7 (Indian commercial user → SBB).

Apply. (i) The foreign university needs prior NBA approval (s.3); (ii) the Indian firm needs prior intimation to the SBB (s.7).

Conclusion. Correctly matching the seeker to the authority is the answer — foreigner to NBA, Indian to SBB.

flowchart TD
    ROOT["Access to biological resources"]:::root
    ROOT --> Q{"Who is seeking access?"}:::dec
    Q -->|"Foreigner / foreign entity"| N["NBA prior approval (s.3)"]:::leaf
    Q -->|"Patent on bio-resource"| P["NBA prior approval (s.6)"]:::leaf
    Q -->|"Indian, commercial use"| S["SBB prior intimation (s.7)"]:::leaf
    Q -->|"Collaborative approved research"| E["Exempt (s.5)"]:::exempt
    classDef root fill:#FFF8DC,stroke:#000,stroke-width:1px,color:#000;
    classDef dec fill:#FDECC8,stroke:#B7791F,color:#000;
    classDef leaf fill:#E6F3FF,stroke:#1E3A8A,color:#000;
    classDef exempt fill:#E6FFF3,stroke:#1E7A54,color:#000;
    linkStyle default stroke:#888,stroke-width:1px;

Case Laws

Divya Pharmacy v Union of India (2018) — access and benefit-sharing obligations apply to Indian entities as well.

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