State Sovereignty Over Genetic Resources.

1. Introduction

State sovereignty over genetic resources is an important principle of international environmental law, biodiversity law, biotechnology regulation, intellectual property law and international economic law.

Genetic resources include biological materials containing genetic information that have actual or potential value. They may include:

Seeds, plants, crops and agricultural varieties.

Animals, microorganisms, bacteria and fungi.

Forest and marine genetic materials.

Genetic materials derived from medicinal plants.

DNA, RNA and other biological substances.

Genetic resources used in pharmaceutical research, biotechnology and industrial development.

The principle of state sovereignty over genetic resources means that a country has sovereign authority over the natural resources found within its territory and can regulate access to those resources, subject to its international obligations.

For example, India may regulate access to its medicinal plants, indigenous crop varieties, forest biodiversity and microorganisms for commercial biotechnology research.

However, sovereignty does not mean that a state automatically owns every genetic sequence or has unlimited control over all biological materials. The rights of indigenous communities, local communities, researchers, private holders and other states must also be considered.

The central legal challenge is balancing three interests:

National sovereignty over biological resources.

Scientific research and international cooperation.

Fair and equitable sharing of benefits arising from genetic-resource utilisation.

2. Meaning and Nature of State Sovereignty

State sovereignty over genetic resources has two important dimensions.

A. Territorial sovereignty

A state exercises authority over genetic resources located within its territory, including forests, agricultural land, inland waters and territorial marine areas.

B. Regulatory sovereignty

A state can establish laws governing:

Collection and extraction of biological materials.

Access to genetic resources.

Export and import of biological specimens.

Commercial biotechnology research.

Genetic-resource utilisation.

Intellectual property arising from genetic resources.

Benefit-sharing agreements.

Protection of traditional knowledge.

For example, if a foreign pharmaceutical company collects an Indian medicinal plant and uses its genetic properties to develop a commercial medicine, applicable access, approval and benefit-sharing requirements may arise.

3. International Legal Framework

A. Convention on Biological Diversity, 1992

The Convention on Biological Diversity (CBD) is the principal international instrument recognising national sovereignty over genetic resources.

Article 3 recognises the sovereign right of states to exploit their own resources pursuant to their environmental policies, together with their responsibility to ensure that activities within their jurisdiction do not damage the environment of other states or areas beyond national jurisdiction.

Article 15 is particularly important.

It establishes the following principles:

States have sovereign rights over their natural resources.

Authority to determine access to genetic resources rests with national governments and is subject to national legislation.

Access should be based on mutually agreed terms.

Access generally requires prior informed consent of the providing country, unless that country determines otherwise.

Benefits arising from research and commercial utilisation should be shared fairly and equitably.

Scientific research should be facilitated on mutually agreed terms.

Legal significance: The CBD shifted the international approach away from treating genetic resources as freely accessible resources and towards regulated access and benefit-sharing.

B. Nagoya Protocol, 2010

The Nagoya Protocol supplements the CBD by establishing a more detailed framework for access and benefit-sharing (ABS).

Its important provisions include:

Article 5: Fair and equitable benefit-sharing.

Article 6: Access to genetic resources.

Article 7: Traditional knowledge associated with genetic resources.

Article 12: Traditional knowledge and indigenous and local communities.

Article 15: Compliance with domestic access legislation.

Article 16: Compliance concerning traditional knowledge.

Article 17: Monitoring utilisation of genetic resources.

Article 18: Compliance with mutually agreed terms.

Benefits may include monetary payments, royalties, research collaboration, technology transfer, training and sharing of scientific results.

C. International Treaty on Plant Genetic Resources for Food and Agriculture, 2001

The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) recognises national sovereignty over plant genetic resources while creating a Multilateral System of Access and Benefit-Sharing for specified food and agricultural crops.

Its provisions balance national control with the need to facilitate agricultural research, food security and crop improvement.

Article 10 recognises the sovereign rights of states over their plant genetic resources, while Article 11 identifies the crops covered by the Multilateral System.

D. United Nations Convention on the Law of the Sea, 1982

The United Nations Convention on the Law of the Sea (UNCLOS) is relevant to genetic resources found in marine environments.

Different legal regimes apply depending on the location:

Territorial sea: coastal-state sovereignty, subject to UNCLOS.

Exclusive economic zone: sovereign rights over natural resources under Article 56.

Continental shelf: sovereign rights over seabed and subsoil resources under Article 77.

Areas beyond national jurisdiction: the international regime for marine genetic resources is relevant, including the 2023 BBNJ Agreement.

The BBNJ Agreement addresses marine genetic resources in areas beyond national jurisdiction and entered into force in January 2026.

4. Indian Legal Framework Governing Genetic Resources

India has a particularly important role in genetic-resource governance because of its biological diversity, agricultural heritage, medicinal plants and traditional knowledge.

A. Biological Diversity Act, 2002

The Biological Diversity Act, 2002 is India's principal legislation for implementing the CBD.

Its main objectives are:

Conservation of biological diversity.

Sustainable utilisation of biological resources.

Fair and equitable sharing of benefits arising from their utilisation.

Protection of associated traditional knowledge.

Prevention of unauthorised commercial exploitation of biological resources.

Important provisions include:

ProvisionLegal significance
Section 3Regulates access by certain foreign individuals, entities and organisations.
Section 4Regulates transfer of research results relating to biological resources covered by the Act.
Section 5Provides for certain collaborative research projects.
Section 6Regulates intellectual property applications based on covered biological resources.
Section 7Regulates access by Indian entities, subject to statutory exceptions and conditions.
Section 18Specifies functions of the National Biodiversity Authority.
Section 21Provides for equitable benefit-sharing.
Section 36Concerns conservation, sustainable use and biodiversity-related policy measures.
Section 37Provides for biodiversity heritage sites.
Section 41Provides for Biodiversity Management Committees.
Section 52AProvides for appeals to the National Green Tribunal under the specified provisions.

The National Biodiversity Authority (NBA) plays an important role in regulating access, approving specified activities and determining benefit-sharing arrangements.

The Act was amended in 2023, and the Biological Diversity Rules, 2024 subsequently replaced the earlier 2004 Rules. The 2025 amendment to the Rules came into force on 1 November 2025.

National Biodiversity Authority+1

 

B. National Biodiversity Authority

The National Biodiversity Authority is established under Section 8 of the Biological Diversity Act.

Its responsibilities include:

Regulating specified access to Indian biological resources.

Reviewing applications relating to intellectual property rights.

Facilitating benefit-sharing arrangements.

Advising the Central Government on biodiversity conservation.

Protecting the interests of benefit claimers.

Supporting conservation of biological resources and associated knowledge.

C. State Biodiversity Boards

State Biodiversity Boards perform regulatory and advisory functions at the state level.

Their functions include:

Regulating activities covered by Section 7.

Advising state governments on biodiversity conservation.

Monitoring biological-resource utilisation.

Supporting local benefit-sharing mechanisms.

D. Biodiversity Management Committees

Biodiversity Management Committees (BMCs) operate at local-body levels under Section 41.

They are important because genetic resources are frequently connected with the knowledge and practices of farmers, forest communities, indigenous groups and traditional healers.

They also contribute to the preparation of People's Biodiversity Registers, documenting locally available biological resources and associated knowledge.

5. Important Case Laws and Judicial Principles

An important qualification is that there is no single universally controlling judgment that comprehensively defines state sovereignty over all genetic resources. Courts have instead developed relevant principles through biodiversity, environmental protection, traditional knowledge, patents and access-and-benefit-sharing disputes.

Case 1: Divya Pharmacy v. Union of India (2018)

Court: Uttarakhand High Court.

Subject: Access and benefit-sharing obligations under the Biological Diversity Act.

Facts and issue:

Divya Pharmacy challenged the applicability of benefit-sharing requirements to Indian companies using biological resources obtained from India.

The dispute concerned whether Indian commercial entities could be required to share benefits arising from the utilisation of biological resources under the statutory framework.

Judgment and significance:

The Uttarakhand High Court upheld the applicability of the benefit-sharing framework to domestic commercial entities under the relevant statutory provisions.

The Court recognised the importance of protecting biological resources and ensuring that benefits from their commercial utilisation are not appropriated without consideration of the interests of communities contributing to their conservation and traditional knowledge.

Legal principles:

Biological resources are subject to statutory regulation.

Commercial utilisation can attract benefit-sharing obligations.

Domestic companies cannot automatically claim exemption merely because they are Indian entities.

Local communities and traditional knowledge holders have an important place in biodiversity governance.

Relevance: This is one of the most directly relevant Indian judgments for understanding sovereignty over biological resources and benefit-sharing.

Case 2: Intellectuals Forum, Tirupathi v. State of Andhra Pradesh (2006)

Citation: (2006) 3 SCC 549.

Court: Supreme Court of India.

Subject: Public trust doctrine and environmental conservation.

Facts:

The dispute involved the protection of public water bodies and the conversion of environmentally valuable land for development purposes.

Judgment:

The Supreme Court emphasised that natural resources are held by the state in trust for the public and that the state must protect ecological resources for present and future generations.

Legal principles:

The state has fiduciary responsibilities concerning natural resources.

Environmental protection is an important governmental obligation.

Development must be balanced against ecological sustainability.

Public resources cannot be treated merely as assets available for unrestricted exploitation.

Relevance: Although this case did not directly concern genetic resources, its public trust reasoning is relevant to state responsibility for protecting biodiversity and biological wealth.

Case 3: T.N. Godavarman Thirumulpad v. Union of India (1997)

Citation: (1997) 2 SCC 267.

Court: Supreme Court of India.

Subject: Forest conservation and governmental responsibility.

Facts:

The proceedings concerned extensive forest degradation and the need to enforce forest conservation laws.

Judgment:

The Supreme Court adopted a broad understanding of the term forest and emphasised the importance of effective implementation of forest conservation legislation.

Legal principles:

Forest resources require legal protection.

Governmental authorities have duties to prevent environmental destruction.

Conservation must be treated as a continuing responsibility.

Ecological interests cannot be disregarded merely for commercial exploitation.

Relevance: Forest ecosystems are important repositories of genetic diversity. The case supports the conservation responsibilities underlying state sovereignty over genetic resources.

Case 4: Vellore Citizens' Welfare Forum v. Union of India (1996)

Citation: (1996) 5 SCC 647.

Court: Supreme Court of India.

Subject: Precautionary principle and polluter-pays principle.

Facts:

The litigation concerned pollution caused by tanneries in Tamil Nadu, including contamination of water and agricultural land.

Judgment:

The Supreme Court recognised the precautionary principle and polluter-pays principle as essential components of Indian environmental law.

Legal principles:

Environmental harm should be prevented where serious risks exist.

Polluters must bear the cost of environmental restoration.

Sustainable development requires balancing economic activity and environmental protection.

Relevance: Genetic resources depend on functioning ecosystems. Environmental degradation can destroy valuable biological material and reduce national genetic diversity.

Case 5: Turmeric Patent Dispute (USPTO, 1997)

Authority: United States Patent and Trademark Office.

Subject: Traditional knowledge and biopiracy.

Facts:

A US patent was granted for the use of turmeric in wound healing.

The Council of Scientific and Industrial Research (CSIR), India, challenged the patent by producing historical evidence demonstrating that turmeric's wound-healing properties were already known in traditional Indian practice.

Outcome:

The patent was revoked after the patent authority accepted that the claimed invention lacked novelty in light of the prior art.

Legal principles:

Traditional knowledge can constitute prior art.

Existing knowledge cannot legitimately be monopolised through an invalid patent.

Documentation of traditional knowledge is important for preventing biopiracy.

Countries need mechanisms to protect their biological and intellectual heritage.

Relevance: The dispute illustrates why national sovereignty must be accompanied by effective documentation and protection of traditional knowledge.

Case 6: Neem Patent Dispute (European Patent Office, 2000)

Authority: European Patent Office.

Subject: Traditional biological knowledge and patent protection.

Facts:

A European patent relating to fungicidal properties of neem was challenged by parties including Indian organisations.

Evidence was presented that neem's pesticidal properties had long been known and used in India.

Decision:

The European Patent Office revoked the patent following opposition proceedings, finding that the claimed invention lacked the required inventive step in light of the evidence.

Legal principles:

Traditional knowledge must be considered during patent examination.

Biological knowledge developed and maintained by communities deserves protection against misappropriation.

Patent rights cannot be used to monopolise subject matter that does not satisfy patentability requirements.

Relevance: The dispute demonstrates the relationship between genetic-resource governance, traditional knowledge and international patent law.

Case 7: Basmati Rice Patent Dispute – RiceTec Inc. (1997–2001)

Authority: United States Patent and Trademark Office (USPTO).

Subject: Agricultural genetic resources and traditional crop varieties.

Facts:

RiceTec obtained a US patent in 1997 relating to rice lines and breeding methods associated with Basmati-type rice.

India challenged several patent claims, arguing that Basmati rice had a long history of cultivation and that the claimed characteristics were not genuinely new.

Outcome:

Following India's challenge and submission of evidence, several important patent claims were withdrawn or cancelled in 2001.

Legal significance:

Traditional crop varieties require appropriate legal protection.

Patent rights must not improperly monopolise existing biological knowledge.

States have legitimate interests in protecting their agricultural heritage.

International patent systems must recognise relevant prior art.

IP Helpdesk+1

Case 8: Costa Rica v. Nicaragua (Certain Activities Carried Out by Nicaragua in the Border Area), 2015

Court: International Court of Justice.

Subject: Territorial sovereignty and environmental protection.

Facts:

Costa Rica alleged that Nicaragua had violated its territorial sovereignty through activities in a disputed border area, including excavation of channels and environmental damage.

Judgment:

The ICJ examined territorial sovereignty, environmental obligations and the consequences of environmental damage.

It recognised that a state must respect the territorial sovereignty of another state and may incur international responsibility for unlawful environmental conduct.

Relevance to genetic resources:

Although this was not a genetic-resource dispute, the judgment is relevant to protecting biological resources situated within national territory and preventing unlawful interference with another state's natural environment.

Case 9: Pulp Mills on the River Uruguay (Argentina v. Uruguay), 2010

Court: International Court of Justice.

Subject: Environmental impact assessment and transboundary environmental obligations.

Facts:

Argentina challenged Uruguay's authorisation of industrial pulp mills on the River Uruguay, alleging breaches of environmental obligations under a bilateral treaty.

Judgment:

The ICJ recognised the importance of environmental impact assessment where proposed industrial activities may create significant adverse transboundary environmental effects.

Relevance:

States exercising sovereignty over biological resources must also consider the environmental consequences of activities that may affect ecosystems and biodiversity in neighbouring countries.

6. Legal Relationship Between State Sovereignty and Indigenous Communities

State sovereignty does not mean that governments can disregard indigenous communities and traditional knowledge holders.

Genetic resources are frequently conserved through generations of traditional agricultural practices, medicinal knowledge, seed preservation and forest management.

The CBD and Nagoya Protocol recognise the importance of indigenous and local communities.

Important legal considerations include:

Protection of traditional knowledge.

Recognition of customary practices.

Fair and equitable benefit-sharing.

Participation in decisions concerning biological resources.

Protection against unauthorised commercial exploitation.

Recognition of applicable community rights.

For example, if a pharmaceutical company uses traditional knowledge about a medicinal plant to develop a commercial drug, the applicable legal framework may require benefit-sharing with the country providing the resource and with the relevant knowledge-holding communities.

Important distinction: National sovereignty over genetic resources and community rights over associated traditional knowledge are related but separate legal questions. Governmental permission does not automatically eliminate the rights of communities.

7. Biopiracy and Protection of National Genetic Resources

Biopiracy generally refers to the unauthorised or inequitable appropriation of biological resources and associated traditional knowledge, particularly through commercial research or intellectual property claims.

Common examples include:

Patenting traditional medicinal uses.

Commercial exploitation of indigenous plant varieties.

Unauthorised collection of rare microorganisms.

Misappropriation of traditional agricultural knowledge.

Commercial development of products without appropriate benefit-sharing.

India has adopted several protective mechanisms.

Traditional Knowledge Digital Library (TKDL):

The TKDL documents traditional medicinal knowledge and makes it accessible to patent examiners to help prevent inappropriate patent grants.

People's Biodiversity Registers:

These registers document local biological resources and associated knowledge.

Access and Benefit-Sharing Mechanism:

This mechanism provides a legal framework for ensuring that benefits from the utilisation of biological resources are shared with eligible benefit claimers.

8. Digital Sequence Information and Genetic Sovereignty

One of the most important emerging issues is Digital Sequence Information (DSI).

DSI refers broadly to digital information derived from genetic sequences, such as DNA and RNA sequence data.

Modern biotechnology companies can use genetic sequence information without necessarily obtaining physical biological samples.

For example:

A researcher may collect a microorganism from an Indian forest, sequence its genome, upload the sequence to an international database and allow pharmaceutical companies elsewhere to use that information for drug development.

This creates several legal questions:

Does national access legislation cover the digital information?

Can a country claim benefits from commercial utilisation of sequence information?

How should traditional knowledge holders be compensated?

Can genetic sequence databases be accessed without restrictions?

How should international research collaboration be regulated?

The CBD process has developed a multilateral benefit-sharing mechanism for DSI, including the Cali Fund established following COP16 in 2024.

This is significant because conventional access-and-benefit-sharing arrangements were principally developed around physical genetic resources.

9. Marine Genetic Resources and State Sovereignty

Marine genetic resources create additional legal difficulties because biological materials may be found both within national maritime jurisdiction and in areas beyond national jurisdiction.

Maritime areaLegal position
Territorial seaCoastal-state sovereignty, subject to international law.
Exclusive economic zoneCoastal-state sovereign rights over natural resources.
Continental shelfCoastal-state sovereign rights over seabed and subsoil resources.
High seasNo national sovereignty; international legal rules apply.
International seabed areaGoverned by the applicable international seabed regime.

The BBNJ Agreement entered into force on 17 January 2026. It establishes an international framework addressing marine genetic resources, benefit-sharing, marine conservation and scientific cooperation in areas beyond national jurisdiction.

United Nations Treaty Collection+2

 

This distinction is important: a state cannot simply extend its national sovereignty to genetic resources found in international waters.

10. Limitations on State Sovereignty Over Genetic Resources

Although states possess sovereign rights over genetic resources, these rights are subject to international and domestic legal limitations.

A. International treaty obligations

States must comply with applicable obligations under the CBD, Nagoya Protocol and other relevant international instruments.

B. Environmental protection

Governments cannot exercise resource sovereignty without considering environmental protection and sustainable utilisation.

C. Indigenous and community rights

Traditional knowledge and community interests must be protected in accordance with applicable laws.

D. International trade obligations

Domestic restrictions must be considered alongside applicable international trade obligations.

E. Intellectual property rights

A state cannot automatically invalidate a patent granted in another country merely because the invention uses a biological resource originating within its territory.

F. Scientific cooperation

Unreasonable restrictions on scientific research may conflict with international cooperation objectives and applicable treaty commitments.

11. Major Legal Challenges

ChallengeLegal issue
BiopiracyUnauthorised exploitation of genetic resources
Digital sequence informationRegulation of genetic information without physical samples
Patent disputesConflict between patents and traditional knowledge
International researchAccess, consent and benefit-sharing
Indigenous rightsCommunity participation and compensation
Marine biodiversityResources beyond national jurisdiction
Genetic databasesCross-border data access and control
Biotechnology tradeBalancing sovereignty and international commerce
Climate changeConservation and exchange of genetic resources

12. Suggestions for Legal and Regulatory Reform

States should strengthen their genetic-resource governance systems through:

Comprehensive national genetic-resource inventories.

Transparent access and benefit-sharing procedures.

Effective protection of indigenous and local knowledge.

International cooperation against biopiracy.

Better monitoring of cross-border biological material transfers.

Clearer rules for digital sequence information.

Stronger scientific and institutional capacity.

Effective penalties for unauthorised commercial exploitation.

Greater participation of local communities in decision-making.

Improved coordination between biodiversity, patent, environmental and biotechnology authorities.

13. Conclusion

State sovereignty over genetic resources is a fundamental principle of contemporary international biodiversity law. The Convention on Biological Diversity and the Nagoya Protocol establish that states have authority to determine access to genetic resources under their national legislation and that utilisation should operate within an appropriate benefit-sharing framework.

Indian legislation, particularly the Biological Diversity Act, 2002, provides an institutional mechanism for regulating access, protecting biodiversity and recognising the interests of benefit claimers.

The judgment in Divya Pharmacy v. Union of India is particularly important because it demonstrates that benefit-sharing obligations can extend to Indian commercial entities using biological resources, subject to the applicable statutory framework.

Ultimately, genetic sovereignty is not simply about governmental ownership or control. It involves conservation, sustainable development, scientific cooperation, protection of traditional knowledge and equitable distribution of benefits arising from biotechnology.

The central legal objective is to ensure that a country's biological wealth is not commercially exploited without appropriate legal safeguards and consideration of the communities that have conserved it.

14. Important Legal Authorities for Examination and Research

Legal authorityMain principle
CBD, 1992 – Articles 3 and 15National sovereignty and access to genetic resources
Nagoya Protocol, 2010Access and benefit-sharing
ITPGRFA, 2001Plant genetic-resource governance
UNCLOS, 1982Marine resource jurisdiction
Biological Diversity Act, 2002Indian biodiversity governance
Divya Pharmacy v. Union of India (2018)Benefit-sharing obligations
Intellectuals Forum v. State of Andhra Pradesh (2006)Public trust doctrine
T.N. Godavarman v. Union of India (1997)Forest conservation
Vellore Citizens' Welfare Forum v. Union of India (1996)Precautionary principle
Turmeric Patent Dispute (1997)Traditional knowledge protection
Neem Patent Dispute (2000)Prevention of biopiracy
RiceTec Basmati Dispute (2001)Agricultural heritage and patent protection
Pulp Mills (2010)Environmental impact assessment
Costa Rica v. Nicaragua (2015)Territorial sovereignty and environmental responsibility

Primary research resources:

Convention on Biological Diversity

National Biodiversity Authority, India

FAO Plant Treaty

International Court of Justice

BBNJ Agreement

Academic note: The cases involving turmeric, neem and Basmati are patent-administration proceedings rather than judicial judgments. They are useful comparative authorities but should not be described as court precedents. Similarly, the environmental cases discussed above support related principles rather than directly deciding ownership of genetic resources.

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