BIOPROSPECTING PATENTS AND THEIR IMPLICATIONS FOR MARINE ECOSYSTEMS

VOLUME 3 ISSUE 2

Abstract

Marine bioprospecting involves the investigation and utilisation of marine biological and genetic resources for potential applications in pharmaceuticals, biotechnology, cosmetics, nutraceuticals and biomaterials. Advances in molecular biology, genomic sequencing and marine biotechnology have increased commercial interest in these resources, raising concerns regarding patent protection, biodiversity conservation, access and benefit-sharing, and the equitable distribution of technological benefits. This article examines the legal and ecological implications of marine bioprospecting patents through a doctrinal analysis of international legal instruments, Indian legislation, identifiable patent records and relevant scientific literature. It distinguishes patent rights over qualifying inventions from rights to access, collect or utilise marine biological resources and argues that patent protection does not, by itself, authorise extraction or necessarily cause ecological degradation. Ecological risks principally arise from collection and exploitation practices, whereas patent exclusivity may indirectly influence commercial incentives, licensing, research access and the distribution of benefits. The article analyses the Convention on Biological Diversity, 1992, the Nagoya Protocol, 2010, and the Agreement on Marine Biological Diversity of Areas Beyond National Jurisdiction, which entered into force in 2026. It further examines the Patents Act, 1970, and the Biological Diversity Act, 2002, as amended, alongside the applicable Indian rules and access-and-benefit-sharing regulations. Three identifiable United States patent records concerning marine-derived compounds and peptides are examined to illustrate the relationship between invention claims, commercial utilisation and resource governance. Scientific studies on seabed disturbance provide evidence for proportionate environmental safeguards, although they do not establish that the patents examined caused ecological damage. The article concludes that effective governance requires coordination between intellectual property protection, lawful resource access, environmental regulation and equitable benefit-sharing.

Keywords: Marine bioprospecting, marine genetic resources, patent protection, biodiversity conservation, access and benefit-sharing, intellectual property rights.

Introduction

Marine ecosystems contain diverse organisms, including microorganisms, algae, sponges, tunicates and marine invertebrates, that have developed distinctive biochemical and physiological characteristics. These characteristics have attracted scientific interest because marine organisms may produce enzymes, peptides, metabolites and other substances with potential applications in medicine, biotechnology, food science, cosmetics and sustainable materials. Marine bioprospecting, understood as the systematic investigation of biological resources for their potential scientific or commercial value, has consequently become an important field of marine biotechnology.¹

Advances in genomic sequencing, computational screening, laboratory cultivation and synthetic biology have expanded the ways in which researchers investigate marine genetic resources. Research may begin with the collection of a small biological sample, followed by laboratory analysis and the identification of a potentially useful compound. Other projects may involve repeated sampling, cultivation at scale or commercial harvesting. These activities have different ecological consequences and should not be treated as a single category of resource exploitation.²

Patent protection occupies an important position in the commercial development of marine-derived inventions. A patent may provide its owner with the right to prevent specified unauthorised acts involving a qualifying invention within the relevant jurisdiction, subject to applicable exceptions and limitations. Such protection can encourage investment in research, development and commercialisation. Nevertheless, patent ownership may also affect licensing arrangements, access to protected technologies and the distribution of commercial returns.

The relationship between patents and marine conservation requires conceptual precision. A patent does not ordinarily confer ownership over an entire marine species, automatically authorise the collection of biological material or displace applicable environmental and access-and-benefit-sharing requirements. Patentability, control of a physical sample, permission to access genetic resources and environmental authorisation are legally distinct matters.³ Their relationship must be established through the relevant legislation, agreements and evidence rather than presumed.

Ecological impacts depend on the organism involved, the quantity collected, the sensitivity of its habitat, the frequency and method of sampling, and the production method subsequently adopted. Patent exclusivity may contribute indirectly to environmental pressure where commercial incentives increase demand for a compound that continues to be obtained through wild collection. Conversely, patent-supported cultivation, fermentation or synthesis may reduce the need for repeated extraction. The environmental consequences of these pathways require separate assessment.

The international legal framework adds further complexity. The Convention on Biological Diversity, 1992 (CBD), and the Nagoya Protocol, 2010, establish principles and mechanisms concerning biodiversity conservation, access to genetic resources and benefit-sharing within their respective scopes. The Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas Beyond National Jurisdiction (BBNJ Agreement) establishes a distinct framework for marine genetic resources in areas beyond national jurisdiction. It entered into force on 17 January 2026.⁴ These instruments operate alongside national patent legislation, biodiversity legislation and applicable environmental rules.

India offers a relevant domestic context because its legal framework combines patentability requirements, disclosure of biological-resource provenance, biodiversity governance and benefit-sharing arrangements. The interaction between the Patents Act, 1970, and the Biological Diversity Act, 2002, as amended, illustrates the need to coordinate intellectual property administration with biodiversity regulation. The applicable Biological Diversity Rules, 2024, as amended in 2025, and the Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulations, 2025, must also be considered.⁵

This article examines marine bioprospecting patents as part of a broader system of scientific innovation, resource access, commercialisation and environmental governance. Its central argument is that patents are neither inherently destructive nor sufficient to ensure sustainable use. Effective governance requires a clear distinction between intellectual property rights, lawful resource acquisition, ecological safeguards and the equitable distribution of benefits.

Research questions

The article addresses the following questions:

What is the legal distinction between patent protection, access to marine genetic resources, physical collection and environmental authorisation?
How do the CBD, Nagoya Protocol and BBNJ Agreement regulate access, utilisation and benefit-sharing within their respective scopes?
How do Indian patent and biodiversity laws address patentability, biological-resource provenance, and commercial utilisation? What do identifiable patent records and available ecological evidence reveal about the relationship between marine bioprospecting, commercial incentives and environmental sustainability?
What legal and institutional reforms could improve conservation, research access and equitable benefit-sharing?

Objectives and scope

The principal objective is to evaluate the legal and ecological implications of marine bioprospecting patents without presuming a direct or universal causal relationship between patent protection and environmental harm.

The article adopts a comparative international perspective with particular attention to India. It examines three United States patent records involving marine-derived compounds or peptides and analyses their relevance to the distinction between patent claims and resource access. It does not claim to provide an exhaustive global patent survey or to establish that any selected patent caused a measurable ecological impact.

Literature Review and Conceptual Framework

Marine bioprospecting and scientific innovation

Research on marine bioprospecting demonstrates the potential of marine organisms as sources of biologically active compounds and industrially useful substances. Santos et al., for example, examine the pharmaceutical applications of metabolites from marine bacteria.⁶ Such research establishes the scientific significance of marine biodiversity but does not demonstrate that every discovery leads to a patent or commercially successful product.

The development of a marine-derived product generally involves several stages: identification of a biological resource, collection or acquisition of material, laboratory investigation, identification of a useful property, development of a qualifying invention and eventual commercialisation. Patent protection may arise at one or more stages, provided that the relevant legal requirements are satisfied.

Intellectual property and biological resources

Scholarship concerning intellectual property and biodiversity identifies a recurring tension between incentives for innovation and equitable access to biological resources. Patent protection may encourage investment in research that is technically demanding and commercially uncertain. At the same time, exclusivity may influence licensing costs, market entry and access to protected technologies.

Tvedt’s analysis of patent law and bioprospecting in Antarctica and Bird’s examination of benefit-sharing from marine genetic resources beyond national jurisdiction illustrate the importance of separating invention rights from the governance of the underlying resource.⁷

Biopiracy concerns the unauthorised or inequitable appropriation of biological resources or associated knowledge where applicable legal rights, consent requirements or benefit-sharing obligations have been disregarded. The term should not automatically be applied to every patent involving a naturally occurring substance. The relevant questions include whether the claimed invention is patentable, how the biological material was acquired, whether associated knowledge was used and which access-and-benefit-sharing rules apply.

Ecological evidence and proportionality

Scientific literature documents the adverse effects of certain forms of physical disturbance on marine ecosystems. Pusceddu et al. found significant reductions in benthic abundance and biodiversity in chronically trawled deep-sea sediments compared with untrawled areas. Hiddink et al.’s global analysis estimated that the depletion and recovery of seabed biota following bottom trawling varied substantially according to fishing gear and environmental conditions.⁸

These studies are relevant to the broader principle that physical disturbance can affect marine biodiversity. They do not, however, establish that low-volume bioprospecting, laboratory sampling or any particular patent has caused comparable damage. Ecological claims must be linked to the actual organism, collection method and intensity of the activity under investigation.

International legal scholarship and research gap

Research on marine genetic resources beyond national jurisdiction identifies challenges involving jurisdiction, scientific research, commercial exploitation and benefit-sharing. Bonney and Bird discuss the legal and distributive concerns associated with deep-sea resources and marine genetic resources in areas beyond national jurisdiction.⁹

The present article addresses a gap in the way these issues are often discussed by bringing together four distinct questions: whether an invention is patentable; whether the underlying resource was accessed lawfully; whether collection and utilisation comply with environmental rules; and whether benefits are shared according to the applicable legal framework.

Research Methodology

This article adopts a doctrinal legal research methodology supported by a qualitative review of patent records and scientific literature.

Sources and research strategy

The primary legal materials comprise the CBD, Nagoya Protocol, BBNJ Agreement, Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Patents Act, 1970, Biological Diversity Act, 2002, and relevant Indian rules and regulations. Official treaty texts, legislation and government materials were used to verify the legal framework.

Patent searches were directed to identifiable marine-derived natural products and peptides. Patent-record pages were examined for publication numbers, titles, applicants or assignees, dates, claims and reported legal status. The selected records were:

United States Patent No. 5,089,273, concerning ecteinascidins.
United States Patent No. 7,348,400, concerning α-conotoxin peptides with analgesic properties.
United States Patent No. 11,814,416, concerning a polypeptide capable of passing through the blood-brain barrier.

The records were selected purposively to illustrate different types of claims and stages of technological development. They were not selected through a systematic global search, and the study does not claim that they are representative of all marine bioprospecting patents. Reported legal status is identified with the qualification that official registers should be consulted for definitive legal-status verification.

Scientific literature was selected for its relevance to marine-derived compounds, physical disturbance of marine habitats and the ecological consequences of seabed exploitation. The literature review was qualitative rather than bibliometric.

Analytical framework

Each issue was examined against four criteria:

Patentability: whether the claimed subject matter constitutes a qualifying invention under applicable patent law.
Resource governance: whether access, collection and utilisation comply with the rules applicable to the resource and its location.
Benefit distribution: whether monetary and non-monetary benefits are allocated in accordance with applicable legal obligations and agreements.
Ecological proportionality: whether sampling and subsequent production are consistent with the conservation requirements relevant to the organism and habitat.

Limitations

The study is limited by the absence of a systematic global patent-family census and by the limited availability of studies directly linking individual patents to measured ecological outcomes. Patent records establish the existence and scope of claims but do not ordinarily establish the quantity of biological material collected or the environmental effects of production.

The article consequently distinguishes findings grounded in primary legal materials from observations derived from secondary scientific literature. The three patent examples illustrate legal and technological distinctions; they are not treated as evidence that patent ownership itself caused ecological damage.

Marine Bioprospecting Patents: Patentability and Legal Boundaries

Patentability of marine-derived inventions

Marine bioprospecting may involve the discovery of a naturally occurring compound, isolation and characterisation of a substance, identification of a genetic sequence, development of an engineered microorganism or creation of a novel production process. These activities raise different patentability questions.

TRIPS Article 27 establishes the general framework for patentable inventions, subject to the agreement’s provisions. Article 29 addresses disclosure requirements. National law determines the precise application of these requirements, including exclusions relating to discoveries, biological material and traditional knowledge.¹⁰

A naturally occurring organism or substance is not automatically patentable merely because it has been discovered in the ocean. A claimed process, formulation, engineered organism or modified peptide may raise a different question, depending on the actual claims and the applicable law.

A patent must therefore be interpreted according to its claims. A patent directed to a particular extraction process or engineered peptide does not necessarily confer exclusive rights over every use of the source organism or every compound obtainable from it.

Patent rights, physical samples and access permissions

Four legal categories must be distinguished.

First, patent protection concerns a qualifying invention and permits the patent holder to prevent specified unauthorised acts within the relevant jurisdiction, subject to applicable exceptions.

Second, control of physical material concerns the acquisition, custody, transfer and use of the biological sample. It may depend on collection permits, ownership rules, contracts and the legal status of the area from which the sample was obtained.

Third, access-and-benefit-sharing obligations concern whether the researcher or commercial user may access or utilise the resource and whether benefits must be shared with a provider State or other eligible beneficiaries.

Fourth, environmental authorisation concerns compliance with applicable conservation, protected-area, fisheries, scientific research and environmental assessment requirements.

These categories may overlap, but they are not interchangeable. A patent does not retrospectively legalise unauthorised collection. Equally, lawful possession of a sample does not guarantee that every subsequent invention will be patentable.

Causal pathways between patent protection and ecological outcomes

Patent protection can affect marine ecosystems only through identifiable and context-dependent pathways.

Resource-demand effects. Exclusive rights may increase the commercial attractiveness of a product. If demand grows while production continues to depend on wild collection, extraction pressure may increase.

Production effects. Patents may encourage investment in laboratory synthesis, fermentation or controlled cultivation, potentially reducing reliance on wild populations.

Licensing effects. Restrictive licensing or overlapping patent claims may increase the cost of follow-on research or affect the development of alternative production methods. These effects depend on the claims, licensing practices and availability of alternatives.

Benefit-distribution effects. Where commercial returns are concentrated among patent holders without appropriate benefit-sharing, provider States or eligible communities may receive inadequate returns from resource utilisation. This may raise questions of equity and incentives for conservation.

None of these pathways is inevitable. Establishing causation requires evidence concerning the patent, the commercial activity, collection practices and environmental outcomes.

Verified Patent Case Studies

The following cases are traceable patent records involving marine-derived compounds or peptides. They are used to examine patent scope and commercialisation, not to infer ecological harm from patent ownership.

Ecteinascidins 729, 743, 745, 759A, 759B and 770

Patent record: U.S. Patent No. 5,089,273, Ecteinascidins 729, 743, 745, 759A, 759B and 770,

issued 18 February 1992.

Inventors: Kenneth L. Rinehart and Tom G. Holt.

Original assignee: Board of Trustees of the University of Illinois.

Reported status: Expired—lifetime, according to the patent-record page.¹¹

The patent concerns ecteinascidins, a group of marine-derived compounds associated with the tunicate Ecteinascidia turbinata. The patent record identifies the chemical compounds and associated analytical and preparation information. Ecteinascidin 743 is associated with trabectedin, a compound subsequently developed for pharmaceutical use.

The legal significance of this patent lies in the distinction between protection of identified compounds and ownership of the organism from which they were discovered. The patent does not establish ownership of all Ecteinascidia turbinata organisms, nor does it itself authorise collection from a particular habitat.

The ecological implications depend on how the compound is obtained and produced. If obtaining a useful quantity requires repeated wild collection, the scale and location of collection may raise conservation concerns. If laboratory production or synthesis reduces the need for extraction, the environmental effects may be different. The patent record alone does not establish which pathway produced a particular ecological outcome.

This case therefore demonstrates the importance of examining the claims and production methods separately from the source organism. It also illustrates why patent records should be linked to collection data and environmental evidence before conclusions about ecological harm are drawn.

α-Conotoxin peptides with analgesic properties

Patent record: U.S. Patent No. 7,348,400, α-Conotoxin Peptides with Analgesic Properties, issued 25 March 2008.

Inventors: Bruce Grayson Livett, Zeinab Khalil, Kenwyn Ronald Gayler, John Geoffrey Down, David Anthony Keays and David William Sandall.

Reported status: Expired—fee related, according to the patent-record page.¹²

Conotoxins are peptides associated with the venom of marine cone snails. Research into these peptides has identified potential therapeutic applications, including analgesic activity. The patent concerns particular α-conotoxin peptides and their analgesic properties.

The claims are directed to peptide subject matter rather than to ownership of the entire marine snail or its habitat. The example demonstrates how scientific research may transform a biological observation into a defined molecular invention. The patent does not itself grant permission to collect cone snails or authorise extraction in a protected area.

The ecological consequences depend on the methods used to obtain and develop the peptides. Repeated collection of wild organisms could raise questions where populations are vulnerable or geographically restricted. However, the use of chemically synthesised peptides may reduce the need for continued extraction once the relevant sequence and structure are known. The available patent record does not establish that this patent caused a decline in cone-snail populations.

This case illustrates the need to distinguish the biological origin of an invention from the source of material used in its subsequent production. It also highlights the importance of considering whether commercialisation can be achieved without continued pressure on wild populations.

Polypeptide capable of passing through the blood-brain barrier

Patent record: U.S. Patent No. 11,814,416, Polypeptide Capable of Passing Through Blood-Brain Barrier, issued 14 November 2023.

Inventors: Shupeng Li and Qiang Zhou.

Original assignee: Shenzhen Ruijian Bioscience Technology Limited Company.

Reported status: Active, according to the patent-record page.¹³

The patent concerns a polypeptide involving ziconotide and a cell-penetrating peptide, with claims directed to a fusion polypeptide capable of crossing the blood-brain barrier. Ziconotide is a synthetic peptide based on a marine cone-snail venom peptide.

The patent is relevant because it illustrates the development of a later engineered invention based on a marine-derived peptide. The claims concern a defined modified polypeptide and associated pharmaceutical or preparation subject matter, rather than a claim to the entire cone-snail species.

The case also demonstrates that a marine-derived invention may proceed through several technological stages. An initial discovery of a biologically active peptide may lead to synthetic production, modification of the molecule and development of new delivery methods. Each stage raises a distinct question of patentability and resource governance.

The reported active status should be verified against the official patent register before legal reliance. The existence of an active patent does not establish that its holder collected biological material unlawfully, that the source population was harmed or that commercial production depends on further wild extraction.

Comparative findings from the patent records

The three patent records demonstrate that marine bioprospecting patents can concern different forms of subject matter: natural-product compounds, defined peptides and engineered peptide constructs.

They also demonstrate that the patent status of a record may change over time. A patent may expire, lapse or remain active, but none of these outcomes determines whether the underlying resource was lawfully obtained or whether collection was ecologically sustainable.

The records do not establish that the inventions caused population decline, habitat damage or unequal benefit-sharing. Such conclusions would require additional evidence concerning sample provenance, collection permits, production methods, commercial scale and applicable benefit-sharing agreements.

The principal finding is therefore methodological: patent-level evidence must be connected to resource-access records and ecological data before it can support a causal conclusion about environmental outcomes.

International Legal Framework

Convention on Biological Diversity, 1992

The CBD establishes a framework for biodiversity conservation, sustainable use and the fair and equitable sharing of benefits arising from genetic resources. Article 1 identifies its objectives; Article 4 addresses its jurisdictional scope; and Articles 8, 10 and 14 address in-situ conservation, sustainable use and environmental impact assessment. Article 15 recognises State sovereignty over natural resources and establishes principles governing access to genetic resources within the Convention’s scope.¹⁴

Under Article 15, the authority to determine access to genetic resources rests with national governments and is subject to national legislation. Where applicable, access is based on prior informed consent and mutually agreed terms. The CBD should not, however, be interpreted as establishing a universal permit system for every marine genetic resource in every maritime area.

The CBD’s principal contribution is to establish conservation and benefit-sharing objectives while recognising national authority over access within its applicable scope. Its operation must be considered alongside UNCLOS, national jurisdictional rules and the distinct framework for areas beyond national jurisdiction.

Nagoya Protocol, 2010

The Nagoya Protocol supplements the CBD by providing more detailed rules concerning access to genetic resources and the fair and equitable sharing of benefits arising from their utilisation. Article 3 defines its scope, while Article 4 addresses its relationship with other international instruments. Articles 5 and 6 address benefit-sharing and access to genetic resources. Article 7 concerns traditional knowledge associated with genetic resources held by indigenous and local communities, subject to applicable domestic law. Articles 15–18 address compliance and related measures.¹⁵

The Protocol does not establish identical community-consent requirements in every case. The legal position depends on the applicable domestic framework, the nature of the resource and the rights recognised for indigenous and local communities.

The distinction between provider States and communities is important. Benefit-sharing may involve States providing genetic resources and, where domestic law recognises relevant rights, indigenous or local communities holding associated knowledge or resources. Benefits may be monetary or non-monetary and may include research collaboration, training and technology transfer.

The Protocol is particularly relevant where genetic resources are accessed under the jurisdiction of a State with applicable access-and-benefit-sharing legislation. It should not automatically be treated as the governing access regime for all resources collected in areas beyond national jurisdiction.

BBNJ Agreement and areas beyond national jurisdiction

The BBNJ Agreement was adopted on 19 June 2023 and entered into force on 17 January 2026. It establishes a dedicated international framework for the conservation and sustainable use of marine biological diversity in areas beyond national jurisdiction. Part II addresses marine genetic resources, including benefit-sharing, notification and information-sharing. Other parts address area-based management tools, environmental impact assessments, capacity-building and the transfer of marine technology.¹⁶

The Agreement is distinct from the CBD and Nagoya Protocol because it establishes a multilateral framework for marine genetic resources in areas beyond national jurisdiction rather than relying exclusively on the access permission of a single provider State.

Its provisions must be applied according to their defined scope and implementation mechanisms. The Agreement addresses marine genetic resources and associated digital sequence information, recognising that scientific and commercial utilisation may continue after physical collection.

The BBNJ Agreement does not eliminate the relevance of patent law. An invention developed from a marine genetic resource may still be assessed under the patent law of the jurisdiction in which protection is sought. Patentability and compliance with applicable BBNJ obligations are separate questions.

For activities in areas beyond national jurisdiction, researchers and commercial users must therefore consider the relevant notification, information-sharing, benefit-sharing and other obligations under the Agreement, together with other applicable rules of international law.

Interaction between the instruments

The CBD establishes broad conservation and benefit-sharing objectives and recognises national authority over access within its scope. The Nagoya Protocol develops more detailed access-and-benefit-sharing mechanisms. The BBNJ Agreement establishes a dedicated multilateral framework for marine genetic resources in areas beyond national jurisdiction.

Their interaction depends on geography, the nature of the resource, the activity being conducted, the relevant State’s obligations and applicable domestic law. No single instrument automatically resolves every issue arising from a marine bioprospecting project.

A researcher may consequently need to determine whether collection is lawful, whether access-and-benefit-sharing obligations apply, whether environmental assessment is required, whether the resulting invention satisfies patentability requirements and whether commercialisation complies with relevant agreements.

Indian Legal Framework

Patents Act, 1970

The Patents Act, 1970, provides the domestic framework for assessing inventions derived from marine biological resources.

Section 2(1)(j) defines an invention by reference to a new product or process involving an inventive step and capable of industrial application. Section 3 identifies subject matter excluded from patentability. Section 3(c) excludes the mere discovery of a scientific principle or the discovery of a living thing or non-living substance occurring in nature. Section 3(j) addresses plants and animals in whole or in part, other than microorganisms, subject to the statutory wording. Section 3(p) excludes inventions that, in effect, constitute traditional knowledge or merely aggregate or duplicate known properties of traditionally known components.¹⁷

These provisions distinguish the discovery of a naturally occurring marine organism from a qualifying invention involving that organism. The patentability of a compound, engineered microorganism, formulation or production process depends on the actual claims and applicable statutory requirements.

Section 10(4)(d) requires disclosure of the source and geographical origin of biological material used in an invention in the circumstances specified by the Act. Sections 25 and 64 provide relevant grounds for opposition and revocation, including provisions concerning non-disclosure or wrongful disclosure of source and geographical origin.¹⁸

Disclosure requirements make provenance information available within the patent system, but disclosure alone does not prove that access was lawful or that benefit-sharing obligations have been fulfilled.

Biological Diversity Act, 2002, as amended

The Biological Diversity Act, 2002, establishes India’s statutory framework for biodiversity conservation, sustainable use and fair and equitable benefit-sharing. Its application depends on the resource, the identity and legal category of the person accessing it, and the applicable statutory provisions.

Section 3 regulates access by specified categories of persons. Section 4 addresses the transfer of research results in the circumstances covered by the provision. Section 6 concerns applications for intellectual property rights based on biological resources accessed from India or associated traditional knowledge. Section 7 addresses prior intimation for specified access by persons covered by that section.¹⁹

The Biological Diversity (Amendment) Act, 2023, modified aspects of this framework. The amended section 6 distinguishes between persons covered by section 3(2) and persons covered by section 7. Under section 6(1), persons covered by section 3(2) must obtain prior approval of the National Biodiversity Authority before the grant of an intellectual property right in the circumstances specified by the Act. Section 6(1A) provides for registration with the Authority before grant for persons covered by section 7, while section 6(1B) addresses prior approval at commercialisation for persons covered by section 7 who have already obtained the relevant intellectual property right.²⁰

These provisions should not be simplified into a claim that every person seeking any patent involving any marine organism must follow an identical approval process. The relevant statutory category, source of the biological resource, activity and timing of the intellectual property application or commercialisation must be identified.

Rules and access-and-benefit-sharing regulations

The Biological Diversity Rules, 2024, superseded the earlier 2004 Rules and came into force in December 2024. They were subsequently amended by the Biological Diversity (Amendment) Rules, 2025. The National Biodiversity Authority also notified the Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulations, 2025, superseding the 2014 regulations.²¹

These instruments provide procedural and administrative mechanisms for implementing the amended Act, including applications, access and benefit-sharing arrangements, intellectual property applications and related compliance requirements.

The National Biodiversity Authority, State Biodiversity Boards and Biodiversity Management Committees perform distinct statutory functions. Their responsibilities should be assessed in relation to the relevant provision and activity rather than assumed to be interchangeable.

For marine bioprospecting, the legal inquiry should determine whether the resource falls within the Act’s scope, whether the person is subject to section 3 or section 7, whether section 6 applies and whether benefit-sharing or other statutory conditions are triggered.

Where a resource is obtained from an area beyond national jurisdiction, the Indian statute should not automatically be assumed to operate in the same manner as it would for a resource accessed from India. The geographical origin, applicable international framework and domestic implementing measures must be considered separately.

Institutional coordination

India’s statutory framework demonstrates that patent examination and biodiversity governance perform complementary functions. Patent law determines whether an invention qualifies for protection and whether relevant disclosure requirements have been met. Biodiversity legislation regulates access and benefit-sharing within its scope. Other applicable marine and environmental laws may regulate collection and habitat impacts.

Improved coordination could involve clear procedures for identifying patent applications involving biological resources accessed from India, specifying the documentation required and determining when competent authorities must verify compliance. Such procedures should protect legitimate confidentiality while ensuring that confidentiality does not prevent legally required reporting or regulatory oversight.

Ecological and Social Implications

Physical collection and ecological risk

The ecological effects of marine bioprospecting depend principally on collection methods, scale, frequency, location and the characteristics of the organism. Risks may arise from repeated removal of organisms from small or isolated populations, disturbance of benthic habitats, damage to coral structures or unintended collection of non-target organisms.

Scientific evidence demonstrates that certain forms of physical disturbance can have substantial ecological consequences. Pusceddu et al. found reductions in meiofaunal abundance, biodiversity and nematode species richness in chronically trawled deep-sea sediments. Hiddink et al. estimated that bottom-trawl gear removed between 6% and 41% of seabed faunal biomass per pass, depending on gear and conditions, with recovery times varying by context.²²

These findings establish that physical disturbance can harm marine ecosystems. They do not demonstrate that all bioprospecting activities produce similar effects. Low-volume sampling, laboratory cultivation and synthetic production may have very different ecological footprints from repeated large-scale collection.

Environmental assessments should therefore consider the organism’s abundance, reproductive rate, distribution, ecological role, vulnerability and habitat sensitivity. The scale and method of collection should be proportionate to the risks identified.

Patent incentives and environmental outcomes

Patent protection may influence environmental outcomes indirectly through demand, investment, production and licensing. Where a patent-supported product depends on continued wild collection, increased commercial demand may intensify extraction pressure. Where a protected process enables synthesis or controlled cultivation, it may reduce reliance on wild populations.

Neither pathway should be assumed without evidence. A patent document ordinarily does not establish collection volumes, ecological conditions or the environmental consequences of commercial production.

The appropriate regulatory response is to focus on measurable risks associated with collection and production while ensuring that patent-related incentives do not undermine applicable conservation obligations.

Community rights and traditional knowledge

Coastal and indigenous communities may depend on marine ecosystems for food, livelihoods, cultural practices and local knowledge. Bioprospecting may create opportunities for research partnerships and recognition of community knowledge, but it may also create conflicts where access, knowledge use or commercial returns are distributed inequitably.

The legal position of communities depends on the applicable domestic framework, recognised rights and the nature of the knowledge involved. The CBD and Nagoya Protocol do not establish identical consent requirements for every resource and maritime area.

Where traditional knowledge is associated with a genetic resource, researchers and commercial users should identify the relevant rights holders and determine which consent, consultation and benefit-sharing obligations apply. Agreements should specify permitted uses, the treatment of confidential information, the distribution of benefits and mechanisms for resolving disputes.

Proportionate environmental governance

A precautionary approach is relevant where information about a vulnerable species or deep-sea habitat is limited. Depending on the applicable legal framework, safeguards may include collection limits, non-destructive sampling, habitat restrictions, environmental assessment, monitoring and reporting.

Laboratory cultivation, fermentation and synthesis should be considered as possible alternatives to repeated wild collection, while assessing their actual environmental footprint. The objective is not to prohibit marine bioprospecting as a category but to ensure that research and commercial utilisation remain consistent with conservation requirements.

Economic Implications

Innovation and investment

Marine bioprospecting may contribute to innovation in pharmaceuticals, industrial biotechnology, cosmetics and biomaterials. Patent protection can support investment by enabling inventors and research institutions to seek commercial returns from qualifying inventions.

However, a patent application does not establish that a product has been commercialised, generated revenue or created employment. Economic contribution should be assessed through evidence of research expenditure, licensing activity, product development, market adoption and employment rather than inferred from patent counts alone.

Competition and research access

Patent protection may restrict specified commercial uses of a protected invention by parties that have not obtained permission from the patent holder. Depending on the claims, licensing practices and availability of alternatives, this may affect smaller enterprises and research institutions.

Nevertheless, the existence of a patent does not automatically establish market monopolisation. Competition depends on the relevant market, substitute technologies, licensing conditions and enforceability of the patent.

Research exceptions, where available under national law, and appropriate licensing arrangements may preserve opportunities for scientific investigation and follow-on innovation. Public research institutions can also support collaborative agreements and responsible data-sharing within the limits of applicable law.

Equitable benefit distribution

Countries with extensive marine biodiversity may lack the financial and technological infrastructure needed to commercialise discoveries independently. Institutions with stronger research capabilities may consequently capture a greater share of commercial returns.

This possibility does not establish that every marine biotechnology patent disadvantages developing countries. Joint research, licensing, technology transfer and benefit-sharing arrangements may support more equitable participation.

The relevant policy question is whether the governance framework provides practical opportunities for biodiversity-rich countries and eligible communities to participate in research, receive benefits and develop scientific capacity.

Economic sustainability

Long-term economic opportunities depend on the continued availability and ecological integrity of marine resources. Unsustainable collection may undermine the resource base on which future research depends, whereas carefully managed research and alternative production methods may reduce certain forms of extraction pressure.

The present study does not independently establish market-growth rates, employment effects, multinational patent concentration or the magnitude of licensing barriers. These claims require empirical investigation. Regulatory policy should therefore be guided by verified economic data and the specific characteristics of the industry concerned.

Results and Discussion

The doctrinal analysis produces five principal findings.

First, patent protection and environmental authorisation perform different legal functions. The existence of a patent does not establish that a marine organism has been overexploited or that a habitat has been damaged. The relationship depends on how patent exclusivity affects commercial demand, production choices and extraction practices.

Second, the CBD, Nagoya Protocol and BBNJ Agreement operate through distinct legal mechanisms. Their applicability depends on geography, resource characteristics, activity and relevant domestic law. They cannot be treated as interchangeable instruments.

Third, Indian patent and biodiversity legislation provide mechanisms concerning patentability, provenance disclosure, access and benefit-sharing. The central challenge is to coordinate these mechanisms so that patent examination, biodiversity administration and environmental regulation can operate effectively without being treated as substitutes for one another.

Fourth, the three patent records demonstrate the diversity of inventions derived from marine organisms, ranging from natural-product compounds to defined peptides and engineered peptide constructs. They do not establish that the inventions caused ecological harm. Patent records must be linked to resource-access documentation, collection data and environmental evidence before causal conclusions can be justified.

Fifth, innovation and conservation require coordinated governance. Patent protection may support research and commercialisation while raising questions concerning licensing, access and distribution of benefits. The appropriate response is to improve transparency, lawful access, environmental safeguards and benefit-sharing rather than to presume that patents are inherently incompatible with marine conservation.

Taken together, the findings support a governance framework in which patentability, lawful access, ecological sustainability and equitable benefit-sharing are assessed separately but connected through transparent administrative processes.

Recommendations for Legal and Policy Reform

Improve coordination between patent and biodiversity authorities

Patent offices and biodiversity authorities should establish clear procedures for identifying applications involving biological material obtained from the relevant jurisdiction. Procedures should specify the information required, the responsible authority and the circumstances in which evidence of approval, registration or benefit-sharing compliance must be provided.

Strengthen provenance disclosure

Disclosure requirements should identify the biological material used in the invention and, where reasonably ascertainable, its source and geographical origin. Relevant information may include scientific identification, collection location, collection date, repository details and the applicable access-permission reference.

In India, the Patents Act already contains provisions concerning disclosure of source and geographical origin. Further reform should clarify implementation and coordination rather than assume that every jurisdiction has identical requirements.

Internationally, States could consider a harmonised procedural obligation requiring applicants to disclose provenance information and identify relevant access-and-benefit-sharing documentation where applicable. Whether this should constitute a patentability condition or a separate compliance obligation requires explicit legislative or treaty-level decisions.

The framework should provide proportionate procedures for correcting errors, protecting legitimate confidential information and referring suspected access violations to the competent authority. Disclosure should not be treated as conclusive proof of lawful access.

Apply risk-proportionate environmental safeguards

Environmental assessment and collection restrictions should reflect the ecological sensitivity of the organism and habitat, the quantity and frequency of sampling, collection methods and cumulative impacts.

For activities with potentially significant adverse effects, applicable environmental assessment and authorisation requirements should be followed before collection or exploitation begins. Conditions may include collection limits, non-destructive sampling, monitoring, reporting and restoration obligations.

Strengthen benefit-sharing and community participation

Access-and-benefit-sharing arrangements should identify the applicable legal instrument, authorised provider, eligible beneficiaries, permitted uses and monitoring mechanisms.

Where domestic law recognises rights of indigenous or local communities over associated resources or traditional knowledge, those rights should be respected. Consent and consultation procedures should follow the requirements applicable to the relevant resource and jurisdiction.

Where appropriate, benefit-sharing may include royalties, joint research, training, scientific infrastructure, technology transfer and access to research results, subject to applicable intellectual property and confidentiality rules.

Improve patent and resource-use traceability

Authorities, research institutions and commercial users should maintain records that allow biological materials to be traced from collection through laboratory investigation, transfer, licensing and commercial utilisation.

Patent studies should identify publication numbers, applicants, jurisdictions, relevant claims and legal status. These records should be compared with available access permits, benefit-sharing documentation and environmental evidence before conclusions are drawn about ecological or distributional effects.

Promote research capacity and technology transfer

Biodiversity-rich developing countries should have opportunities to participate in marine biotechnology through research partnerships, technical training, scientific infrastructure and technology transfer.

Universities and public research institutions can support these objectives through collaborative agreements, appropriate licensing and responsible data-sharing. International cooperation should be implemented according to the distinct obligations and mechanisms of the CBD, Nagoya Protocol and BBNJ Agreement.

Establish an empirical research agenda

Future research should conduct a systematic review of marine-related patent families across jurisdictions. Each record should identify the patent number, title, applicant, priority date, jurisdiction, legal status, claimed invention and disclosed biological source.

Patent data should then be compared with environmental assessments, collection permits, benefit-sharing agreements and ecological studies. Such an approach would help establish whether particular commercialisation pathways are associated with extraction pressure, reduced wild collection or changes in access to research technologies. Economic claims should likewise be tested using evidence concerning licensing activity, research investment, product development, market concentration and technology transfer.

Conclusion

Marine bioprospecting offers important opportunities for scientific discovery and the development of pharmaceuticals, biotechnological products, cosmetics and sustainable materials. Patent protection can contribute to these developments by encouraging investment in qualifying inventions and supporting commercialisation. Nevertheless, its legal and ecological implications must be assessed within the broader framework governing resource access, environmental protection and benefit-sharing.

The central conclusion is that patent protection does not itself authorise the collection of marine organisms, establish ownership over an entire species or displace applicable biodiversity and environmental requirements. Ecological risks arise principally from the scale, method and location of collection and exploitation, although patent exclusivity may influence these activities indirectly through commercial incentives, licensing and production choices.

The analysis of the CBD, Nagoya Protocol and BBNJ Agreement demonstrates that international access-and-benefit-sharing rules differ according to their respective scope and mechanisms. India’s statutory framework further illustrates the importance of coordinating patent examination with biodiversity governance and applicable environmental regulation.

The three patent case studies demonstrate how marine-derived compounds and peptides may form the basis of different types of inventions. They do not, however, establish that patent ownership caused biodiversity loss or habitat damage. Such conclusions require additional evidence concerning provenance, collection practices, production methods, commercial scale and environmental outcomes.

Ultimately, intellectual property protection and marine conservation should not be treated as inherently incompatible. Effective governance requires a coherent system in which innovation incentives operate alongside lawful resource access, proportionate environmental safeguards, transparent disclosure and equitable benefit-sharing. This approach can support scientific progress and responsible commercialisation while protecting marine biodiversity for present and future generations.

REFERENCES

Primary Sources

International Treaties and Agreements

Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299.
Agreement Under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas Beyond National Jurisdiction, June 19, 2023, U.N. Doc. A/CONF.232/2023/4.
Convention on Biological Diversity, June 5, 1992, 1760 U.N.T.S. 79.
Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity, Oct. 29, 2010, 3008 U.N.T.S. 3.
United Nations Convention on the Law of the Sea, Dec. 10, 1982, 1833 U.N.T.S. 3.

Indian Legislation and Regulations

The Patents Act, 1970, No. 39, Acts of Parliament, 1970 (India), as amended.

The Biological Diversity Act, 2002, No. 18, Acts of Parliament, 2003 (India), as amended by The Biological Diversity (Amendment) Act, 2023, No. 10, Acts of Parliament, 2023.
Biological Diversity Rules, 2024, Gazette of India, pt. II, sec. 3(i) (India), as amended by Ministry of Environment, Forest and Climate Change Notification (2025).
Biological Diversity (Amendment) Rules, 2025, Gazette of India, pt. II, sec. 3(i) (India).
National Biodiversity Authority (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulations, 2025, Gazette of India (India).

Patent Records

Kenneth L. Rinehart & Tom G. Holt, Ecteinascidins 729, 743, 745, 759A, 759B and 770, U.S. Patent No. 5,089,273 (issued Feb. 18, 1992).
Bruce Grayson Livett et al., α-Conotoxin Peptides with Analgesic Properties, U.S. Patent No. 7,348,400 (issued Mar. 25, 2008).
Shupeng Li & Qiang Zhou, Polypeptide Capable of Passing Through Blood-Brain Barrier, U.S. Patent No. 11,814,416 (issued Nov. 14, 2023).

Official Legal Databases and Resources

Intellectual Property India, Patent Office, The Patents Act, 1970, https://ipindia.gov.in/ (last visited Oct. 22, 2026).
India Code, The Biological Diversity Act, 2002, indiacode.gov.in (last visited Oct. 22, 2026).
National Biodiversity Authority, Government of India, Access and Benefit-Sharing Regulations and Guidelines, https://nbaindia.nic.in/ (last visited Oct. 22, 2026).
United Nations, Agreement on Marine Biological Diversity of Areas Beyond National Jurisdiction: Official Text, https://www.un.org/bbnjagreement/en/bbnj-agreement/text-bbnj-agreement (last visited Oct. 22, 2026).
World Intellectual Property Organization, PATENTSCOPE, https://patentscope.wipo.int/ (last visited Oct. 22, 2026).
European Patent Office, Espacenet, https://worldwide.espacenet.com/ (last visited Oct. 22, 2026).

Secondary Sources

Journal Articles

J.S. Bird, Bio-Piracy on the High Seas? Benefit Sharing from Marine Genetic Resource Exploitation in Areas Beyond National Jurisdiction, 9 Nat. Resources 413 (2018).
S.A. Bonney, Bioprospecting, Scientific Research and Deep Sea Resources in Areas Beyond National Jurisdiction: A Critical Legal Analysis, 10 N.Z. J. Envtl. L. 41 (2006).
S.K. Chaudhuri, Marine Bioprospecting and Intellectual Property, in Life Below Water 575 (W. Leal Filho et al. eds., 2022).
K. Das, The Global Quest for Green Gold: Implications of Bioprospecting and Patenting for Indigenous Bioresources and Knowledge, 6 Soc’y & Culture S. Asia 74 (2020).
T. Efferth et al., Biopiracy of Natural Products and Good Bioprospecting Practice, 23 Phytomedicine 166 (2016).
N.E. Elkaliny et al., Macroalgae Bioplastics: A Sustainable Shift to Mitigate the Ecological Impact of Petroleum-Based Plastics, 16 Polymers 1246 (2024).
B.J. Hiddink et al., Global Analysis of Depletion and Recovery of Seabed Biota After Bottom Trawling Disturbance, 114 Proc. Nat’l Acad. Sci. 15,858 (2017).
Antonio Pusceddu et al., Chronic and Intensive Bottom Trawling Impairs Deep-Sea Biodiversity and Ecosystem Functioning, 111 Proc. Nat’l Acad. Sci. 8861 (2014).
J. Duarte Santos et al., From Ocean to Medicine: Pharmaceutical Applications of Metabolites from Marine Bacteria, 9 Antibiotics 455 (2020).
M.W. Tvedt, Patent Law and Bioprospecting in Antarctica, 47 Polar Rec. 46 (2011).
S. Mustafa, A. Estim & S.R.M. Shaleh, A Call for Open Access for Marine Bioprospecting, 49 Envtl. Pol’y & L. 232 (2020).
A.-I. Guyomard, Ethics and Bioprospecting in Antarctica, 10 Ethics Sci. & Envtl. Pol. 31 (2010).

Books and Research Papers

Graham Dutfield, Intellectual Property Rights, Trade and Biodiversity: The Case of Seeds and Plant Varieties (Background Paper, IUCN Intersessional Meeting on the Operations of the Convention, 1999).
P.G. Pan, Bioprospecting: Issues and Policy Considerations (Legislative Reference Bureau, 2006).
Victor Kuete, African Medicinal Spices of Genus Piper (Elsevier 2017).

FOOTNOTES

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