1. Introduction

State Revenue Rights Over National Genome Assets refers to the legal authority of a sovereign state to regulate, protect, manage and obtain financial benefits from the commercial exploitation of genetic resources, biological materials, genomic databases and associated scientific information belonging to, originating from, or collected within its national territory.

National genome assets may include:

Human genetic and genomic datasets collected through national research programmes.

Plant genetic resources, indigenous crop varieties and traditional seeds.

Animal genetic resources and livestock germplasm.

Microorganisms, bacteria, viruses and other biological materials.

Indigenous biological resources and traditional medicinal knowledge.

Genetic sequences and biotechnology discoveries derived from national biological resources.

National biobanks, genomic research databases and biological specimen repositories.

The central legal question is whether a state can claim royalties, licence fees, taxes, access charges or a share of commercial profits when domestic genetic resources or genomic information are used by pharmaceutical companies, biotechnology corporations, research institutions or foreign governments.

An important distinction: State revenue rights do not automatically mean that the government owns every human genome, genetic sample or DNA sequence collected within its territory. Revenue claims must have a legal foundation, such as statutory ownership of particular resources, access-and-benefit-sharing legislation, contractual obligations, intellectual property rights or taxation laws.

2. Legal Nature of National Genome Assets

National genome assets involve different categories of legal interests.

A. Biological resources

Biological resources include plants, animals, microorganisms and genetic material obtained from them. Governments may regulate access to these resources and require benefit-sharing when commercial utilisation occurs.

B. Human genomic information

Human genomic information includes DNA sequences, genetic variations, inherited characteristics and genomic research datasets. Such information raises questions of privacy, informed consent, confidentiality, research ethics and data protection.

A government cannot automatically treat citizens' DNA as state-owned property merely because it has been collected through a public healthcare programme.

C. Traditional knowledge and indigenous genetic resources

Traditional medicinal knowledge, indigenous crop varieties and community-associated biological resources may generate commercial value. Legal frameworks can require benefits to be shared with the communities that conserve or provide those resources.

D. Commercially developed genetic inventions

Genetic inventions, diagnostic technologies, gene-editing methods and biotechnology products may generate patent royalties and licensing revenue. However, the state does not automatically acquire patent ownership merely because the underlying research used domestic biological material.

3. International Legal Framework

A. Convention on Biological Diversity, 1992 (CBD)

The Convention on Biological Diversity establishes the foundation for national control over genetic resources.

Its Article 15 recognises the sovereign rights of states over their natural resources and places authority over access to genetic resources within national governments, subject to domestic legislation.

Article 15(7) requires parties to take appropriate measures to share research results and benefits arising from the commercial utilisation of genetic resources fairly and equitably with the country providing those resources.

This creates an important legal basis for national benefit-sharing systems.

B. Nagoya Protocol, 2010

The Nagoya Protocol is particularly important for state revenue rights.

Its principal provisions include:

Article 5: Fair and equitable sharing of benefits arising from genetic-resource utilisation.

Article 6: Access to genetic resources subject to prior informed consent, where applicable.

Article 7: Protection of traditional knowledge associated with genetic resources.

Article 15: Compliance with domestic access and benefit-sharing legislation.

Article 17: Monitoring utilisation of genetic resources.

Article 18: Compliance with mutually agreed terms.

The Protocol's Annex recognises several monetary benefits, including access fees, upfront payments, milestone payments, royalties, licence fees and contributions to conservation funds.

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Example: Suppose a pharmaceutical company obtains a medicinal plant from India and develops a commercially successful medicine. If the applicable access-and-benefit-sharing requirements are triggered, the company may be required to share benefits with the relevant Indian authorities and eligible benefit claimers.

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

The International Treaty on Plant Genetic Resources for Food and Agriculture establishes a multilateral system for facilitating access to specified plant genetic resources for food and agriculture.

Its benefit-sharing arrangements include:

Sharing research and development results.

Exchange of information.

Technology transfer.

Capacity-building.

Sharing monetary benefits arising from commercialisation in circumstances specified by the Treaty.

This framework is important because agricultural genetic resources are valuable for food security, crop improvement and biotechnology research.

D. Convention on Biological Diversity and the limits of state sovereignty

State sovereignty over genetic resources is not unlimited ownership of all biological information.

The legal framework distinguishes between:

Biological resources over which states exercise sovereign rights.

Human genetic material and personal genomic information.

Digital sequence information (DSI).

Genetic resources held by indigenous and local communities.

Inventions developed through subsequent research.

This distinction prevents governments from claiming revenue merely because a commercial invention contains genetic information associated with their population.

4. Indian Legal Framework

India provides an important example of how state revenue rights can be implemented through biodiversity legislation.

A. Biological Diversity Act, 2002

The Biological Diversity Act, 2002 was enacted to achieve three principal objectives:

Conservation of biological diversity.

Sustainable utilisation of biological resources.

Fair and equitable sharing of benefits arising from their utilisation.

The Act establishes the National Biodiversity Authority (NBA), State Biodiversity Boards and Biodiversity Management Committees.

These institutions regulate access, commercial utilisation and benefit-sharing according to the applicable statutory requirements.

B. Section 3 – Regulation of access

Section 3 regulates access to biological resources and associated knowledge by specified foreign persons and entities.

The regulatory framework requires prior approval from the National Biodiversity Authority for covered activities.

C. Section 4 – Transfer of research results

Section 4 regulates the transfer of research results relating to Indian biological resources and associated traditional knowledge to specified foreign persons and entities.

This provision is important because transferring research results abroad can create commercial opportunities without physically exporting biological samples.

D. Section 6 – Intellectual property rights

Section 6 regulates intellectual property applications based on research or information concerning biological resources accessed from India.

It connects biodiversity regulation with the commercialisation of biotechnology inventions.

E. Section 7 – Indian entities

Section 7 regulates access to biological resources by persons covered by the provision, subject to its exceptions and statutory conditions.

This is important because benefit-sharing obligations are not necessarily restricted to foreign corporations.

F. Section 21 – Fair and equitable benefit-sharing

Section 21 is central to the revenue rights of biodiversity institutions.

It empowers the National Biodiversity Authority to determine benefit-sharing arrangements, including monetary and non-monetary benefits.

Potential arrangements include:

Royalty payments.

Advance payments.

Technology transfer.

Research funding.

Joint intellectual property arrangements.

Financial contributions to conservation.

Benefits for local communities and traditional knowledge holders.

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Important human-genome limitation: The Biological Diversity (Amendment) Act, 2023 expressly excludes human genetic material from the amended definition of biological resources. Consequently, the biodiversity benefit-sharing regime must not be confused with ownership or revenue rights over citizens' human genomes. Human genomic information raises separate privacy, consent, research and data-governance questions.

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5. Case Laws and Judicial Principles

The following cases are particularly relevant to understanding state revenue claims, biological-resource utilisation and the limits of commercial exploitation.

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

Directly relevant Indian precedent

Court: Uttarakhand High Court

Decision: 21 December 2018

Citation: 2018 SCC OnLine Utt 1035

Facts:

Divya Pharmacy manufactured Ayurvedic medicines and nutraceutical products using biological resources.

The Uttarakhand Biodiversity Board demanded fair and equitable benefit-sharing payments. Divya Pharmacy challenged the demand, arguing that an Indian company without foreign participation should not be required to make such payments.

Legal issue:

Whether an Indian commercial entity could be required to share benefits arising from the commercial utilisation of biological resources.

Judgment:

The High Court dismissed the petition and upheld the statutory authority to demand fair and equitable benefit-sharing.

The Court explained that benefit-sharing was not confined to foreign companies. Domestic commercial entities could also be subject to the applicable obligations.

It emphasised the importance of protecting indigenous and local communities and ensuring that the commercial value generated from biological resources was shared fairly.

Legal principle:

Commercial utilisation of biological resources may create enforceable benefit-sharing obligations even where the user is an Indian company.

Importance for national genome assets:

The judgment demonstrates that biological resources can have economic value beyond their initial market price. However, it does not establish state ownership of human genetic information.

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Case 2: Bayer Corporation v. Union of India (2014–2015)

Court: Delhi High Court

Proceedings: 2014 and 2015

Facts:

The litigation concerned Bayer's pharmaceutical patent and the export of an active pharmaceutical ingredient, Sorafenib, for development and clinical studies.

Legal issue:

The principal question concerned the scope of the experimental-use exception under Section 107A of the Patents Act, 1970.

Judicial significance:

The proceedings illustrate the distinction between patent-based commercial rights and other regulatory interests associated with pharmaceutical research and development.

Relevance:

A company developing a pharmaceutical product using biological resources may encounter several independent legal obligations:

Patent law compliance.

Biodiversity access requirements.

Benefit-sharing obligations.

Drug regulatory approvals.

Research and clinical-trial requirements.

A patent does not automatically eliminate an otherwise applicable biodiversity benefit-sharing obligation. Equally, biodiversity regulation does not automatically transfer patent ownership to the state.

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Case 3: Animal Welfare Board of India v. A. Nagaraja (2014)

Court: Supreme Court of India

Citation: (2014) 7 SCC 547

Facts:

The litigation concerned the treatment of bulls in Jallikattu and related traditional activities.

Judgment:

The Supreme Court examined animal welfare, statutory protection and constitutional duties.

It emphasised the importance of preventing unnecessary pain and suffering to animals.

Relevance:

Although this was not a biodiversity revenue case, it demonstrates that biological resources and animals cannot be treated exclusively as economic commodities.

Commercial exploitation must operate within applicable legal and welfare obligations.

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Case 4: Centre for Environmental Law, WWF-India v. Union of India (2013)

Court: Supreme Court of India

Citation: (2013) 8 SCC 234

Legal significance:

The litigation concerned wildlife conservation and the state's responsibilities in protecting endangered species.

Relevance to national genome assets:

Conservation law establishes that the state has responsibilities extending beyond revenue generation. Genetic resources connected with endangered species must be managed consistently with conservation requirements.

This means that revenue-generating activities cannot justify the destruction or unsustainable exploitation of biological resources.

Note: This case supports the conservation dimension of national biological-resource governance rather than establishing a direct royalty entitlement.

6. Comparative International Case Laws

Case 5: Moore v. Regents of the University of California (1990)

Court: Supreme Court of California

Citation: 51 Cal. 3d 120 (1990)

Facts:

John Moore's cells were used by researchers to develop a commercially valuable cell line without obtaining his informed consent regarding the financial interests involved.

Legal issue:

Whether a patient could claim property rights in cells removed from his body and obtain a share of profits generated through their commercial development.

Judgment:

The Court rejected Moore's conversion claim concerning the excised cells but allowed claims based on potential breaches of informed consent and fiduciary duties to proceed.

Legal principle:

The commercial value of biological material does not automatically create ownership or profit-sharing rights for the person from whom it originated.

Importance:

This case is highly relevant to national genome revenue debates. A government cannot assume that the collection of human biological material gives it unrestricted commercial ownership over that material.

Case 6: Greenberg v. Miami Children's Hospital Research Institute (2003)

Court: United States Court of Appeals for the Eleventh Circuit

Citation: 264 F.3d 1066 (11th Cir. 2003)

Facts:

Families and organisations contributed genetic information and research assistance towards identifying the gene associated with Canavan disease.

Researchers subsequently obtained patent protection relating to the discovery.

Legal issue:

Whether contributors could claim ownership interests in the resulting genetic discovery and its commercial benefits.

Judgment:

The Court rejected the plaintiffs' conversion claim over the genetic material and information contributed to the research.

However, the litigation addressed other potential claims concerning informed consent, fiduciary duties and unjust enrichment.

Legal principle:

Contributing biological samples and research information does not automatically establish ownership of resulting inventions.

Importance:

National governments should distinguish between:

The source of genetic material.

The research contribution.

The resulting scientific discovery.

The intellectual property created.

The contractual rights to commercial benefits.

Case 7: Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)

Court: Supreme Court of the United States

Citation: 569 U.S. 576 (2013)

Facts:

Myriad Genetics obtained patents relating to isolated BRCA1 and BRCA2 genes associated with breast and ovarian cancer risks.

Legal issue:

Whether naturally occurring human DNA could be patented merely because it had been isolated from the human body.

Judgment:

The Supreme Court held that naturally occurring DNA is not patent-eligible merely because it has been isolated.

However, synthetically created complementary DNA (cDNA) may be patent-eligible, subject to the relevant patent requirements.

Legal principle:

Naturally occurring genetic information and human-made inventions must be distinguished.

Importance:

This judgment is relevant to national genome assets because states must distinguish between natural genetic sequences and genuinely inventive biotechnology developments before making claims about royalties or commercial intellectual property.

Case 8: S. and Marper v. United Kingdom (2008)

Court: European Court of Human Rights

Citation: Applications Nos. 30562/04 and 30566/04

Facts:

The case concerned the indefinite retention of fingerprints, cellular samples and DNA profiles of individuals who had not been convicted of criminal offences.

Legal issue:

Whether the retention of such personal biological information violated the right to respect for private life under Article 8 of the European Convention on Human Rights.

Judgment:

The Court found a violation of Article 8.

Legal principle:

The state cannot retain and use personal genetic information without appropriate legal safeguards and regard for privacy rights.

Importance:

A national genomic database cannot be treated simply as a government revenue-generating asset. Privacy, lawful processing, proportionality and purpose limitation must be considered before commercial use.

7. Mechanisms Through Which States Can Generate Revenue

States can develop different legal and financial models to obtain benefits from national biological resources.

Illustration:

Suppose an Indian research institution discovers a medicinal compound from a plant traditionally used by an indigenous community.

A pharmaceutical corporation develops a medicine from that compound and earns substantial commercial revenue.

Depending on the applicable legislation and agreements, the benefit-sharing arrangement could provide:

Initial access payments.

Research funding for Indian institutions.

Royalties linked to commercial sales.

Technology transfer.

Financial contributions to conservation.

Direct benefits to the relevant traditional knowledge holders.

The government must ensure that payments reach the legally entitled beneficiaries rather than treating all revenue as unrestricted government income.

8. Rights of Indigenous and Local Communities

A major issue in national genome asset governance is whether the state can collect commercial benefits without adequately protecting the communities responsible for conserving biological resources.

The Nagoya Protocol recognises benefit-sharing rights relating to genetic resources and associated traditional knowledge held by indigenous and local communities, subject to applicable domestic law.

Important protections include:

A. Prior informed consent

Communities should be involved in decisions concerning access to resources or traditional knowledge where the applicable legal framework requires their consent.

B. Mutually agreed terms

Commercial users and relevant providers should establish clear terms governing access, permitted uses and benefit distribution.

C. Recognition of traditional knowledge

Traditional medicinal practices, agricultural knowledge and community innovations should not be treated as freely exploitable commercial information merely because they are publicly known.

D. Community-level financial benefits

Benefits can include royalties, development funds, healthcare facilities, research infrastructure, education and technology transfer.

E. Prevention of biopiracy

Biopiracy occurs when biological resources or associated traditional knowledge are commercially exploited without complying with applicable access, consent and benefit-sharing requirements.

9. State Revenue Rights and Human Genomic Databases

This is one of the most important emerging issues.

National genome sequencing programmes may generate enormous scientific and economic value. Their databases can support:

Pharmaceutical research.

Precision medicine.

Disease prediction.

Drug discovery.

Population genetics.

Diagnostic development.

Biotechnology innovation.

However, three different legal interests must be separated.

A government may establish fees for accessing public research infrastructure or enter into lawful research partnerships.

However, it cannot automatically claim royalties from every medicine developed using genomic information from its population.

For example, a national genome programme may permit researchers to use properly governed genomic datasets for non-commercial scientific research. A subsequent commercial application would require examination of the original consent, data-use agreements, applicable privacy laws and intellectual property arrangements.

The governing principle is that control over genomic infrastructure is not equivalent to ownership of every individual's genetic identity.

10. Constitutional and Human Rights Limitations

State revenue rights over national genome assets must remain consistent with constitutional protections.

In India, the following constitutional provisions are particularly relevant:

The Supreme Court's decision in Justice K.S. Puttaswamy (Retd.) v. Union of India (2017), (2017) 10 SCC 1 is particularly relevant.

The Court recognised privacy as a fundamental right under Article 21 and the Constitution.

Its principles are important for genomic databases because genetic information can reveal highly personal information about individuals and their biological relatives.

Therefore, state revenue policies must not override informed consent, privacy, bodily autonomy and lawful data protection requirements.

11. Major Legal Challenges

Several challenges arise when governments attempt to commercialise national genome assets.

1. Ownership disputes: Whether genetic material belongs to the state, the individual, the community or another lawful holder.

2. Unauthorised commercialisation: Foreign companies may use biological resources without complying with applicable domestic access requirements.

3. Cross-border benefit-sharing: Genetic materials and research data may pass through multiple jurisdictions, creating difficulties in enforcing royalty obligations.

4. Digital sequence information: Genetic information may be shared electronically without transferring the original biological sample.

5. Community compensation: Governments may collect payments without ensuring that local communities receive appropriate benefits.

6. Patent monopolisation: Commercial companies may obtain intellectual property rights over inventions developed from biological resources originating in another country.

7. Privacy violations: Commercial genomic databases may expose sensitive information about individuals and their relatives.

8. Regulatory uncertainty: Different countries may apply different rules concerning genetic resources, digital information, consent and benefit-sharing.

12. Emerging Legal Developments

The future of national genome revenue regulation is likely to involve several important developments.

Digital sequence information: International benefit-sharing mechanisms for the commercial use of digital genetic information.

National genomic sovereignty: Greater regulatory oversight of national genomic databases and biological research infrastructure.

Genomic commercialisation agreements: Contractual arrangements governing pharmaceutical and biotechnology research.

Artificial intelligence: Regulation of commercial AI systems trained on genomic datasets.

Community benefit-sharing funds: Financial mechanisms to distribute commercial benefits to resource-conserving communities.

International biotechnology taxation: Examination of cross-border taxation and revenue allocation for biotechnology-related commercial activity.

Public-private research partnerships: Agreements providing research funding, technology transfer and appropriately negotiated financial returns.

The CBD's multilateral mechanism on digital sequence information and its Cali Fund represent important developments in international benefit-sharing. These mechanisms should be distinguished from the traditional Nagoya Protocol framework for physical genetic resources.

13. Critical Legal Analysis

The most difficult legal question is whether a nation can convert its biological and genomic resources into an independent source of public revenue.

There are three competing interests.

First: National economic sovereignty.

Countries supplying valuable biological resources should have an appropriate opportunity to participate in the economic benefits arising from their utilisation.

Second: Individual and community rights.

Genetic resources may be connected with individual identity, community knowledge and traditional conservation practices. Government revenue policies must respect these interests.

Third: Scientific innovation.

Excessively restrictive access arrangements may discourage international research collaboration, pharmaceutical development and biotechnology investment.

An effective legal framework must balance these interests.

For India, the Biological Diversity Act and its benefit-sharing mechanisms provide a statutory foundation for revenue-related claims involving covered biological resources. However, human genomic information requires a separate legal analysis, particularly in light of the 2023 amendment's exclusion of human genetic material from the relevant definition.

14. Suggestions for Legal and Regulatory Reforms

The following reforms could strengthen national genome asset governance:

Establish a transparent national framework distinguishing human genomic information from non-human biological resources.

Create legally enforceable benefit-sharing agreements for covered commercial research.

Establish dedicated biodiversity and community benefit-sharing funds.

Require appropriate disclosure of biological-resource origins in relevant intellectual property applications.

Develop international mechanisms for tracking digital sequence information.

Strengthen informed-consent requirements for genomic research.

Establish independent oversight of public-private genomic research partnerships.

Introduce transparent royalty calculation and distribution procedures.

Protect indigenous and local communities against unauthorised commercial exploitation.

Establish effective judicial and administrative remedies for unlawful revenue demands.

15. Conclusion

State Revenue Rights Over National Genome Assets represents an important intersection of constitutional law, environmental law, biotechnology regulation, intellectual property law, international trade and human rights.

The Convention on Biological Diversity and Nagoya Protocol establish the international foundation for sovereign control over covered genetic resources and fair and equitable benefit-sharing.

In India, the Biological Diversity Act, 2002, particularly its access and benefit-sharing provisions, provides the statutory framework for collecting financial benefits from qualifying commercial utilisation.

The judgment in Divya Pharmacy v. Union of India (2018) demonstrates that even domestic commercial enterprises can be subject to applicable benefit-sharing obligations.

However, national revenue rights must not be confused with unrestricted government ownership of human DNA, individual genetic identity or all scientific discoveries derived from genomic research.

Ultimately, the legal objective should be to ensure that commercial exploitation of national biological resources produces fair economic benefits, promotes scientific development, protects individual rights and supports the communities responsible for conserving biodiversity.

16. Important Legal Authorities for Academic Research

Useful official legal resources:

Nagoya Protocol – Official text and benefit-sharing provisions

National Biodiversity Authority – Indian legal framework

Indian biodiversity regulations and notifications

Divya Pharmacy – Full High Court judgment

Academic note: The cases above do not all directly decide state royalty rights over national human genome databases. They establish related principles concerning biodiversity benefit-sharing, biological-material ownership, patents and genetic privacy. The distinction is important when developing an independent legal argument.