Patent Rights In Marine Genetic Resources - Balancing Innovation And Conservation

Author: LawSphereX

Category: Intellectual Property

Published: 2026-08-23T20:43:29.735462+00:00

Updated: 2026-08-26T17:10:12.017+00:00

PATENT RIGHTS IN MARINE GENETIC RESOURCES:

BALANCING INNOVATION AND CONSERVATION

Ronak Sharma, SVKM’s NMIMS, The Kirit P. Mehta School of Law, Indore

ABSTRACT

The biological and ecological assets found in coastal areas and in seas offer extensive possibilities for emerging technologies, they are capable of transforming the biotechnology, pharmacy and many other industries, however, their commercialization brings significant challenges concerning their intellectual property forms, particularly with regard to the possibility of obtaining a patent. International governing treaties such as the UN Convention on the Law of the Sea, The Agreement on Trade-Related Aspects of Intellectual Property Rights, and The Nagoya Protocol do not all have the MGRs in the Areas Beyond National Jurisdiction ABNJ as their primary focus and therefore these areas are gaps that are not well governed within existing treaties.

It is these gaps that can create interrelations and disputes on what kind of patent protection ought to be provided to marine organisms that have undergone some form of human changes. As it stands, some existing patent laws seek to provide frameworks for all, which may unintentionally create situations where access to vital genetic information is restricted, undermining as a whole further research and development that is aimed at building sustainable development. The Biodiversity Beyond National Jurisdiction BBNJ is set to fill in the gaps by clearly defining the governance of access, benefit sharing, the protection of intellectual property, and other relevant areas of marine genetic resources. It is expected that this new legal framework will lead to changes in the intellectual property policies of other bodies like WIPO and WTO.

These changes would seek to make the balance of exercising IP laws, enforcement of innovation, and marine life protection more effective. Altering these legal tools is necessary for ensuring that the advantages resulting from MGRs are both protected and properly divided. The development of the legal framework for MGRs will not only promote science but will also enable sustainable governance of the oceans. This calls for cooperation between legal and scientific disciplines and economists to create an integrated system that encourages innovation while conservatively managing the world’s marine resources.

Introduction The untapped diversity of life within the deep sea has the capability of transforming biotechnology, pharmaceuticals, and materials science. However, the scientific quest for unlocking these treasures poses dire legal and ethical challenges concerning the ownership and use of marine genetic resources (MGRs). Who possesses the rights to the ocean’s genetic code? Who takes advantage of it’s exploitation? Marine genetic resources (MGRs), which include range from deep sea microbes to coral reef sponges, comprise a great concern beyond the scientific frontier. They play an important part in sustaining life on the globe and are important for developing industries in the twenty-first century. The advancement of marine biotechnology since the 1970s has unlocked their potential, tendering MGRs as catalysts towards profound medical, environmental, and economic value.

Disturbingly, resources are located beyond national waters, or Areas Beyond National Jurisdiction (ABNJ). This fuels gaps in governance, which creates a legal void1. Not unlike their possibilities, the investigation and patenting of MGRs in ABNJ operate without supervision. Unlike its terrestrial counterpart, there is no supra-claim under the responsibility to disclose the origin of MGRs or share the profits derived from their commercialization. The lack of this kind of openness poses a danger of biopiracy, where companies patent marinebased innovations without fair acknowledgement or remuneration recognizing the regions of the sources. While overarching documents to govern biodiversity within the waters of a state: UNCLOS and the Nagoya Protocol, mark its limits with ABNJ as the frontier still being fought over, stand international frameworks.

2 The BBNJ Agreement initiated in 2023 tried to integrate the assessment of environmental impact with benefit sharing obligations, marking a change in governance of areas beyond national jurisdiction. It started discussions back in 2004 and followed up on them every year until 20233. Although the agreement attempts to address some of the major issues in marine

1 Timothy A Bouley, Catherine Machalaba, Jake Keast, William H Gerwick and Lora E Fleming,

'Chapter 6 – Marine biotechnology: A One Health approach to linking life on land to life underwater' in Oceans and Human Health (2nd edn) (Academic Press 2023) 149–180, doi:10.1016/B978-0-323-95227- 9.00024-5 https://doi.org/10.1016/B978-0-323-95227-9.00024-5 accessed 15 March 2025. 2 World Economic Forum, Governing Marine Biodiversity Beyond National Jurisdiction: Roles and Opportunities for the Private Sector (White Paper, September 2024)

3 Pascale Ricard, 'The Advent of the 2023 “BBNJ” Agreement: A Preliminary Legal Analysis' (2024) 53

Environmental Policy and Law 1–11, doi:10.3233/EPL-239014 https://doi.org/10.3233/EPL-239014 accessed 15 March 2025

governance, it does almost nothing—again—about the impacts of marine genetic resource (MGR) exploitation. The absence of widely accepted definitions of MGRs poses enforcement challenges and creates potential avenues for exploitation. In the end, making it effective depends on transforming the vague sweeping provisions into unambiguous delineations of exclusionary patents, controlled commercialization, and proportional equitable profit sharing. This article critiques the BBNJ Agreement concerning the reconciliation of patent law and marine genetic resources (MGRs) and claims that the contemporary regimes do not adequately balance innovation and ecological ethics.

It stresses the need for the BBNJ framework to shift from a patent-centric paradigm—where MGRs are privatized and access freely granted to extractive monopolies—towards a model emphasizing collective stewardship and guardianship. The article proposes reforms for gaps in governance, including the creation of bioprospecting norms with effective MGRs, their sustained utilization within a robust benefit sharing framework, and declaring MGRs a common heritage. In general, the Agreement is positioned as an opportunity to foster change within the MGR intellectual property framework toward conserving ecosystems, equitable resource use, and sustainable governance of marine resources. Background & Legal Framework MGRs, as specified in BBNJ Agreement under A.

1(8) 4 , refers to it as “any material of marine plant, animal, microbial, or other origin containing functional units of heredity of actual or potential value. ” They remain critical in the domain of biotechnology, innovations, pharmaceuticals, and climate adaptation strategies, yet international law systems fail to define MGRs universally. The U. N. Convention on the Law of the Sea (UNCLOS), also known as, constitution for the oceans, stubbornly avoids incorporating this phrase, resulting in a vacuum of governance systems. It is increasingly common for lawyers and policymakers to turn to Article 2, Convention on Biological Diversity (CBD) 5 , that identifies genetic resources as “genetic material of actual or potential value,” hoping it serves as a guiding base. This tendency is visible in ongoing BBNJ negotiations as various delegations align in principle that

4 Agreement on the Conservation and Sustainable Use of Marine Biodiversity of Areas Beyond National

Jurisdiction (adopted 19 June 2023, not yet in force) UNGA Res 77/248 (19 June 2023) 5 Convention on Biological Diversity (adopted 5 June 1992, entered into force 29 December 1993) 1760 UNTS

future governance of MGRs needs to address the balance between the CBD agenda and the specificities of marine biodiversity. The definition of BBNJ relies on three disputable aspects: materiality, functional units of heredity, and value6. “Material” suggests to be means a sample with a tangible form, with genome’s generative assets in genetic form (e. g. DNA or RNA), and brings up the issue of whether assets that are informational in nature like digital sequence information (DSI)— genomic data contained in a computer—also fit as MGRs. Genetic material is under the jurisdiction of the Nagoya Protocol alongside Convention on Biological Diversity, but the debate in regards to DSI’s status as “material of other origin” because of its commercial value is still contentious.

These uncertainties have considerable consequences: the exclusion of DSI would enable biotechnology companies to consider genomic data collected from areas that are not within the authority of any state (ABNJ) as property with no responsibility to share the benefits. The COP 15 of the CBD accepted a policy in 2022 to establish a system of multilateral nature for sharing benefits arising from the DSI, underlining ethical and economic implications7. On the other hand, “functional units of heredity” scientifically applies to genes, DNA or RNA, but are flexible diplomatically in practice allowing states to use the term for their own purposes—generously or narrowly—to advance national objectives. Even if byproducts like proteins or enzymes not contain any such units as defined in Nagoya Protocol, they are still MGRs so long as they possess genetic parts.

The expression “actual or potential value” makes governance more complex than it already is. Value in the form of utility, such as enzymes in biotechnology, denotes actual value, while potential value specifies future applications contingent on technological growth. This distinction is problematic: if all genetic material is classified as “potentially” useful, the regulatory boundaries are likely to be infringed upon, yet restricting “value” to only usable terms overlook the progressive character of science. 8 The need for more skilful definitional boundaries is illustrated by marine microbes thought to possess therapeutic properties, which only now some decades after collection are beginning to reveal their true potential.

The 6 Peter Johan Schei and Morten Walløe Tvedt, ‘Genetic Resources’ in The CBD: The Wording, the Past, the Present and the Future (Fridtjof Nansen Institute Report 4/2010) https://www. files. ethz. ch/isn/114249/FNI- R0410. pdf accessed 15 March 2025

7 Convention on Biological Diversity (Decision adopted by the Conference of the Parties) UN Doc

CBD/COP/DEC/15/9 (19 December 2022) 8 Jakub Ciesielczuk, 'Defining Marine Genetic Resources: Navigating through the Sea of Uncertainties' in The Environmental Rule of Law for Oceans (February 2023) 178–190, doi:10.1017/9781009253741.018 https://doi.org/10.1017/9781009253741.018 accessed 15 March 2025.

difficulty stems from the distinction between genetic resources and commodities: passive governance of commercial fishing and seafood MGRs falls outside the scope of MGR governance, but synthesizing marine DNA for drug development activates the notification requirements of the BBNJ Agreement. The geographical area of focus adds a layer of complexity. Even though UNCLOS defines “marine” in a broad sense to include oceans and seas, there are gaps for certain species moving across ecosystems. The migration of certain fishes, like the salmon and eel, which move between fresh and saltwater, is problematic for delineating jurisdiction boundaries. Extreme subsoil organisms in hydrothermal vents or sea birds unlock ecological boundaries and legal boundaries.

Collectively, organisms collected within marine zones are treated as MGRs, but their interconnectedness with terrestrial ecosystems necessitates cross-regime coordination. The BBNJ Agreement’s notification requirements for MGR’s use (Article 1(14)), which they define as “research and development on the genetic and/or biochemical composition of MGRs” and under Article 12, “Where marine genetic resources of areas beyond national jurisdiction, and where practicable, the digital sequence information on such resources are subject to utilization, including commercialization” try to fill these gaps. For example, companies extracting ABNJ enzymes for commercial use are essential to provide information to the Clearing-House Mechanism, but enforcement has been made difficult because of differing views on the definition of “marine” and the absence of a DSI framework.

Their applications are widespread. Furthermore, the gene engineering of coral reefs to create resilient crops demonstrates their significance in climate adaptation and mitigation9. On the other hand, the absence of systemized definitions and regulatory frameworks undermines the fair distribution of benefits. While the BBNJ Agreement makes a constructive step towards transparency on utilization, it will not succeed without clarification on materiality, DSI, and geographical boundaries. In the absence of more defined parameters, the potential MGRs hold may be eclipsed by controversy over biopiracy, proprietary claims, ownership, ecological preservation, all pointing to the need for international collaboration to devise sustainable innovation and equitable frameworks. Oliver Selmoni, Line

K

Bay, Moises Exposito-Alonso and Phillip

A

Cleves, 'Finding Genes and Pathways that Underlie Coral Adaptation' (2024) 40(3) Trends in Genetics 213, doi:10.1016/j.tig.2024.01.003 https://doi.org/10.1016/j.tig.2024.01.003 accessed 15 March 2025.

International Framework Governing Marine Genetic Resources MGRs located regions beyond a country's jurisdiction are subject to a complex legal framework internationally that seeks to balance sustainable use and conservation alongside equitable sharing. The U. N. Convention on the Law of the Sea (UNCLOS), the foremost legal framework that controls ocean areas, incorporating concepts of autonomy of the high seas and common inheritance to humanity for deep seabed resources, although it does not specifically regulate MGRs. To fill this void the CBD COP 10 in 2010 adopted the Convention on Biological Diversity. It’s supplementing Nagoya Protocol on the access as well as benefit-sharing (ABS) of genetic resources; these instruments were initially designed to land and coastal resources, thus poorly deal with the intricacies of MGRs in ABNJ.

Subsequently, there was an escalation in the attempts of the international community towards formulating a new legally binding document referred to as the Biodiversity Beyond National Jurisdiction (BBNJ) Agreement focusing on preservation and maintainable utilization of marine biological sphere including MGRs in high seas. 10 The goal in regards to the new convention will be to reinforce the existing legal framework by establishing more clear and stringent criteria for benefit sharing, more transparency, and monitoring to trace the origin and use of MGRs. Furthermore, the BBNJ Agreement highlights the need to foster developing states' skills and to transfer marine technology, so that the advantages obtained from bioprospecting and other forms of MGR utilization benefit the global public and do not deepen pre-existing inequalities.

More specifically, the new instrument seeks to address overlapping intellectual property issues concerning genetic resource claims, including the tracking and tracing of genetic materials, so that innovation can be harnessed in a more legally certain and responsible context for ocean resources stewardship. These instruments, when combined, form a more advanced and coherent system of ocean 10 Fran Humphries, Hiroko Muraki Gottlieb, Sarah Laird, Rachel Wynberg, Charles Lawson, Michelle Rourke, Morten Walløe Tvedt, Maria Julia Oliva and Marcel Jaspars, 'A Tiered Approach to the Marine Genetic Resource Governance Framework under the Proposed UNCLOS Agreement for Biodiversity Beyond National Jurisdiction

(BBNJ)'

(2020) Marine Policy 103910, doi:10.1016/j.marpol.2020.103910 https://doi.org/10.1016/j.marpol.2020.103910 accessed 15 March 2025.

governance, embodying an interdisciplinary unification of UNCLOS, the CBD, Nagoya Protocol, lastly BBNJ, demonstrating the international community's growing commitment to conserving marine biodiversity while allowing scientific exploration and sustainable socioeconomic activities in ABNJ. IP Rights in Marine Genetic Resources The scientific research in marine sphere frequently results in the innovations of new biomolecules or genetic sequences associated with marine organisms. These discoveries further spearhead economic development by attracting investments in R&D and enabling the formation of patents. Such patents not only assist in safeguarding these innovations, but they also encourage the transfer of technology and its commercialization, thus establishing a bridge between fundamental research and its practical uses.

This part focuses on the point of issue of how managing and protecting IP rights over marine genetic resources fosters innovation and sustainable growth. Regardless of the perks, multiple overlapping patent claims pose striking concerns in regard to the legal outline of the materials in the issue at hand. In practice, the existence of numerous patent applications over marine organisms, as well as their discrete parts and components, can lead to a complex and fragmented patent landscape. These potentially overlapping claims may ex post facto create barriers for further innovation because potential inventors may be deterred from engaging with the technological possibilities encompassed by these patents owing to the potential of infringing existing Intellectual Property rights.

Such situation creates a void of innovation while raising concerns about the fairness in the use and access to the value created from the MGRs. The U. N. Convention on the Law of the Sea (UNCLOS) deepens these difficulties by defining and governing ABNJ. These include "the Area", which is usually acknowledged as the domain of humankind, and "the high seas", which are places not held or claimed by any one State. 11 The rich marine biodiversity found in these vast oceanic spaces is often unprotected, which places important resources at risk of suffering from overexploitation and other human-induced 11 United Nations Convention on the Law of the Sea (adopted 10 December 1982, entered into force 16 November

1994) 1833 UNTS 3, arts 86, 87 (High Seas), arts 1(1), 136–137 (The Area).

environmental harm. Because of the innate isolation and absence of a single governing body, these areas are difficult to regulate IP management and benefit-sharing systems. One of the activities which were not foreknown at the instance of drafting the UNCLOS is marine bioprospecting. The legal aspects of the UNCLOS still seem to focus on “freedom of scientific research” as found in A. 87. This law opens wide access to exploration. However, no responsibility is defined to share gains and profits from the use of MGRs, thus creating a void where extraction driven “first-come, first-served” policy prevails. Those who engage early with marine bioprospecting gain ownership of MGRs without frameworks for sharing benefits. This absence of norms not only violates fairness and equity but also fails to support countries that have limited capabilities to research the sea.

12 This approach has been commonly criticized as inequitable, particularly with regards to the standards set forth in the CBD and the Nagoya Protocol’s ABS frameworks. These documents highlight the relevance of “access and benefit sharing” (ABS) as key mechanisms for the protection alongside sustainable usage of biodiversity. The predominant practice of freely taking MGRs within regions beyond national jurisdiction (ABNJ) sits in violation of ABS principles and generates inequitable value with strong regard to perceived fairness, especially from developing countries or nations lacking sophisticated oceanographic research infrastructure. Such stresses the need for reform, especially in the context of deep-seated inequities emerging from unchecked technological and commercial exploitation masked under rapid advancement.

There is increasing global advocacy towards the creation of a distinct legal instrument under UNCLOS to solve these urgent problems. This new instrument would provide comprehensive guidelines for the efficient protection as well as the maintainable and replenishable usage of marine biodiversity in ABNJ. As core of the framework, there would be special clauses regarding the sharing of benefits which stipulate that the gains accruing out of exploitation of MGRs are dispersed in a way that accounts for the participation of all relevant parties, including those from historically underrepresented nations in marine research. This kind of an international instrument could provide unilateral policies for the recording the origins of 12 Abhaya Ganashree, 'Who Owns Ocean Biodiversity? : The Legal Status and Role of Patents as a Means to Achieve Equitable Distribution of Benefits' (2021) Case

W

Res

J

Int'l

L

https://scholarlycommons.law.case.edu/jil/vol53/iss1/9 accessed 15 March 2025.

MGRs, unify the patent systems so as to reduce multiple claim submissions, and set up pathways to allow the transfer of technology and skill development in less developed areas. In addition, the international environmental governance aspects of transparency and accountability could be incorporated into the proposed framework to strengthen it. For instance, creating a global MGR patent registry with accompanying disclosure instructions for the source of the marine genetic material and collection method would help alleviate some legal difficulties. Such a registry would not only improve transparency, but enable better policy and other decisions to be made by the commercial, academic, and policy circles.

Moreover, the proposed framework could incorporate self-regulation mechanisms to make sure that the benefit sharing clauses are fulfilled, which would help improve the overall equity in marine resource management. 13 Patentability In MGR Marine genetic resources (MGRs) provide unprecedented opportunities for industrial and scientific growth. For example, some biomolecules, DNA structures, and marine microorganisms are abundant in nature. They can also be created, reproduced, and altered within a laboratory environment. With the aid of modern science, these natural substances can be transformed into new life forms with unimaginable qualities, giving rise to remarkable biotechnological advancements.

Such transformations make the inventions eligible for patent protection if they exhibit an inventive step, industrial applicability, and encourages innovation and investment toward the industry. With TRIPS14, a patent gives its holder the sole authority to stop anyone from manufacturing, utilizing, offering, retailing, or in the importation of the specified item for a duration no shorter than 20 years. In the case of process patents, these exclusive rights apply to the products obtained through the patented process as well, guaranteeing absolute security for the innovation arising from the patented method. 13Fran Humphries, Todd Berry and Hiroko Muraki Gottlieb, 'Bridging Divides: The Evolution of Marine Genetic Resource Governance Beyond National Jurisdiction' in Decoding Marine Genetic Resource Governance Under the BBNJ Agreement (pp 1–25) doi:10. 1007/978-3- 031-72100-7_1.

https://doi. org/10. 1007/978-3-031-72100-7_1 accessed 15 March 2025 14 Agreement on Trade-Related Aspects of Intellectual Property Rights (adopted 15 April 1994, entered into force

1 January 1995) 1867 UNTS 3.

TRIPS A. 27. 1 further states that the patents must be awarded and that the rights are conferred indiscriminately regardless of the site of invention, the area of technology, or whether the objects in question are brought in from another country or made domestically. The primary goal of this article is to safeguard patent holders from the arbitrary law of the land, which may infringe on their rights. For example, states are prohibited from enacting regulations that are detrimental to an innovation for purely technological reasons, such as marine biotechnology, even if that invention is the result of MGRs.

It is fascinating to focus on the fact that whether a World Trade Organization (WTO) Member State could be allowed to adopt policies that do not allow the awarding of patents or the exercise of patent rights on inventions derived from MGRs from ABNJ has not arisen in any formal disputes. In agreement with TRIPs’ A. 27. 3(b), the nations are free to outline subject matter exclusions that are wide enough. Even so, there is no explicit reason why those restrictions should not exist under TRIPS as Article 27. 1 talks about the place of invention rather than the place where the materials used to create it are sourced from. Examining the legal status of biological materials' patentability exposes a wide range of possibilities.

WTO Member States appear to have more or less discretionary authority to deny patents on plants, animals, and, more specifically, the biological processes of production in dispute. Organisms and microorganisms, as well as microbiological and non-biological processes, must be protected under international intellectual property law. Some jurisdictions have chosen to exclude a wide range of subject matter from patentability, including plants, animals, findings of naturally occurring materials, and any inventions deemed necessary to limit commercial exploitation in order to protect public order, morality, or health. Despite these exclusions, patent departments in countries having developed biotechnological capabilities have traditionally issued patents for gene-based inventions, demonstrating a dynamic trend of patent law toward accommodating the advancement of innovative technologies.

As an example, the general rule in the EU is that biological substance which is isolated from the natural environment and, or fashioned by technical processes can be regarded as an invention even if that material is to be found in nature. This principle reflects the EU’s acknowledgement that through human intervention, a natural resource can be changed through

processes into a patentable invention by the inclusion of different properties or functions. 15 Alternatively, the United States adheres to the "Product of Nature Doctrine," which divides non-patentable subject matter into three categories: natural laws, natural events, and abstract concepts. This doctrine's boundaries are constantly challenged in legal battles regarding the patenting of DNA and gene-based inventions, arguing whether these patents stifle or aid further advancements in biological science16. Next to the U. S. A. , Australia, Canada, Indonesia, Japan, Singapore, and African Regional Intellectual Property Organization Member States are noted for having robust patent laws that issue complete and unlimited patents on animals, plants, and biological processes. There are discrepancies in methods to the implementation of subject matter exclusions between jurisdictions.

China, India, Malaysia, the Philippines, the Russian Federation, Tunisia, the Member States of the Organisation Africaine de la Propriété Intellecte (OAPI), and the Member States of the European Patent Organisation (EPO) have all adopted some limited exceptions that include plant varieties and/or animal breeds as well as essential biological processes. On the other hand, Brazil, members of the Andean Community of Nations, and Thailand have taken a more extreme position by excluding, wholly or in part, plants, animals, and essentially biological processes from patent protection17. These various approaches demonstrate ongoing sociopolitical tensions around the issue of striking a balance between aiding innovation with patents and fulfilling public interest requirements.

Newer inventions based on Marine Genetic Resources (MGRs) require more advanced legal oversight, especially in areas such as biotechnology patents. Developments in international law regarding intellectual property will increasingly focus on lowering the bar for patent eligibility and addressing the inconsistency in national policies to ensure that access to 15 Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (Biotechnology Directive) [1998] OJ L213/13, art 3(2). European Patent Convention (signed 5 October 1973, revised 29 November 2000) (EPC 2000), r 23b(1). 16 John M Conley and R Makowski, 'Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents in the United States—and Perhaps Europe as Well' (2004) 13(1) Information & Communications Technology Law 3, doi:10.

1080/1360083042000190625 https://doi. org/10. 1080/1360083042000190625 accessed

15 March 2025

17 Claudio Chiarolla, 'Intellectual Property Rights and Benefit Sharing from Marine Genetic Resources in Areas Beyond National Jurisdiction: Current Discussions and Regulatory Options' [2014] Queen Mary Journal of Intellectual Property 4(3) 171, http://dx.doi.org/10.4337/qmjip.2014.03.01 https://doi.org/10.4337/qmjip.2014.03.01 accessed 15 March 2025

innovations is efficiently controlled and distributed within society. MGR Based Patents Even though the scope of activities around the patenting of marine genetic resources (MGRs) could be larger than the current estimations, one of the challenges is the determining the precise territorial provenance which is, whether it falls within the national jurisdiction or an area beyond national jurisdiction (ABNJ). In numerous instances, the law on patents does not stipulate the identification of either the species of origin or the geographic coordinates of the genetic material incorporated into a biotechnological invention. This absence of mandatory disclosure makes it very difficult to make reasonable estimates regarding the scope of patenting work in relation to MGRs obtained from beyond jurisdictional boundaries.

Also, progress achieved in meta-genomic research makes it possible to determine the function of a gene from a sample of DNA from a number of organisms as long as that sample is not tied to a specific organism. This novel approach in molecular biology and bioinformatics has created new avenues in which MGRs can be transformed into a field that has useful and valuable information. The information that is captured in the DNA sequences, along with the description of the functions of the genes, makes it possible to bypass the patenting scrutiny which, if not challenged, could lead to the issuing of patents that would lock their inventors out from profit18. The mere attempt to assert claims over natural molecules or DNA constructs because one seeks to replicate natural processes may limit further research activities by other scientists on the claimed MGRs.

The advancement of research in science, including marine scientific research, requires unrestricted or at the very least free access to basic information, discoveries, and research outputs pertaining to MGRs. Moreover, the patenting of outcomes of basic research, especially those involving the extraction of DNA and biomolecules which are fundamentally the same as what exists in nature, may impede or restrict access to fundamental materials and research tools critical to innovation. 18 Marjo Vierros, Charlotte Salpin, Claudio Chiarolla and Salvatore Aricò, 'Emerging and unresolved issues: The example of marine genetic resources of areas beyond national jurisdiction' in Ocean Sustainability in the 21st Century (Cambridge University Press 2015) 198–231, doi:10. 1017/CBO9781316164624. 012 https://doi. org/10. 1017/CBO9781316164624. 012 accessed 15 March 2025

In response to these obstacles, patent legislations normally encompass some type of research exemption. While the TRIPs Agreement allows such exemptions, they are optional and there is no global obligation for domestic legislation to incorporate them. This lack of standardization results in differing interpretations from one country to another. Under TRIPs A. 30, any exception to patent rights there must be a fulfilment of three stipulative requirements: (1) it must not hinder the patent's usual exploitation, (2) it must not significantly harm the patent owner's authentic interests, and (3) it must take into account the genuine interests of other parties. The Importance of Transparent Sourcing and Geo-Referencing In marine scientific research, best practices involve providing an access point of disclosure for marine genetic resources (MGRs) and implementing geo-referencing biodiversity.

It is common practice among scientists collecting marine samples, including deep sea microbes, corals, and sponges, to note the geographic coordinates of the location. This is critical for tracing sample provenance and adhering to legal structures like the UNCLOS and the Nagoya Protocol on ABS. While geo-referencing has shown to be useful in theory, practice shows that the data pertaining to the sample’s location is often sparse or basic, resulting in incomplete or fractured metadata. Collection sites do not always contain reliable, trustworthy, or adequate documentation concerning the MGRs. This lack of clarity especially when the appropriate governance is reliant on the jurisdiction of the sample location becomes problematic from a legal standpoint. If an MGR is collected in full national jurisdiction, the country can claim sovereign benefit-sharing rights.

In contrast, if the sample is collected in areas beyond national jurisdiction (ABNJ), common pool resources governance, which poses complications for claiming benefits, applies19. Meeting these challenges requires the origin of MGRs and their geographical coordinates and related sequence information to be documented alongside the collected materials throughout the entire research and development (R&D) process. This also applies to specimens held in exsitu culture collections.

By having all relevant information available at every level of research, development, pre-commercialization, and commercialization, stakeholders will allow greater 19 Arianna Broggiato, 'Exchange of Information on Research Programs Regarding Marine Biodiversity in Areas beyond National Jurisdiction' in IUCN (eds), IUCN Information Papers for the Intersessional Workshop on Marine Genetic Resources 2–3 May 2013 (IUCN Environmental Law Centre

2013) 55–62

https://www.researchgate.net/publication/260553919_Exchange_of_Information_on_Research_Programs_Rega rding_Marine_Biodiversity_in_Areas_beyond_National_Jurisdiction accessed 15 March 2025

transparency and better verification of sample origins. This would also help in cooperating with the Nagoya Protocol on ABS (2010), especially with the responsibility to supervise and improve resource utilization openness as stated in Article 17. 20 Practically, the implementation of claim disclosure and verification systems for marine organisms’ origins would greatly improve compliance with legal frameworks for equitable benefit-sharing. Such systems would not only safeguard the interests of states in relation to the marine resources under their jurisdiction, but also assist in the sustainable conservation goals of marine biodiversity. Balancing Innovation, Access, and Control It is generally not allowed to maintain patents on inventions related to Marine Genetic Resources (MGRs) protected under UNCLOS Article 244. this is due to the need of keeping confidentiality prior to patenting.

Conversely, once a patent is applied for, all the technical details bound in the patent become public domain, therefore promoting the meant intellectual property. The interplay of concepts showcases the fragile line lying between the safekeeping of innovation and development of science. In some territories, where the patents are unavailable for genetic discoveries due to subject matter omissions, it is assumed that commercial developers would depend more heavily on secrecy and confidentiality to safeguard their breakthroughs. Furthermore, more effort is required to highlight the benefits that the copyright system offers in aiding the development of innovative distribution models for information and creative works. This is particularly important for closing the digital gap, especially in relation to Marine Scientific Research (MSR).

The availability of scientific literature on a no-fee basis alongside the development of free and open-source software contributes significantly to the advancement of marine biology and the sharing of outcomes of marine scientific research. Controlled unrestricted access to the relevant scientific literature, data, and appropriate analytical software should be regarded as an integral part of sharing benefits without monetary compensation, to 20 C Chiarolla, 'Intellectual property rights and benefit sharing from marine genetic resources in areas beyond national jurisdiction: current discussions and regulatory options' (2014) 4(3) Queen Mary Journal of Intellectual Property 171, doi:10. 4337/qmjip. 2014. 03. 01 https://doi. org/10. 4337/qmjip. 2014. 03. 01 accessed 15 March 2025

the extent that the knowledge resulting from marine genetic resources is made accessible to all. 21 For example, in the United Kingdom, a large segment of research funding available in the country comes with the requirement that research outputs be published online at no cost and be freely accessible. The Wellcome Trust in the UK has adopted an open access policy mandating that electronic versions of peer-reviewed research papers be available within six months of publication by the journal. 22 New open-source and common-pool licensing systems has arisen, providing more incentives based on the use of and sharing of info & data obtained via scientific research in a marine sphere and marine bioprospecting.

These models contrast with traditional copyright methods that are comparatively less stimulating to economically invest in sophisticated interdisciplinary fields like marine scientific research. An open-source framework is more favourable when an inventor or developer holds automatic IP rights, or when the author remains vulnerable to claims of technology ownership upon publication of a manuscript. Another favourable situation is when the terms of use stipulate that all improvements must be made freely accessible and shared under identical terms to the core technology. However, there are difficulties associated with applying Licenses for open-source technologies that are not software. Marine biotechnology is a notably more diverse field with a complicated, expensive, and timeconsuming reliance on patents.

In the case of implementing institutional policies on data sharing, striking a balance between a third party’s IP limitations is a critical concern of management. Such limitations can pertain not only to the data, but also its format and arrangement within the databases. It has been observed for databases that if originality and creativity is manifested in the organization of its data, copyright may be applied. Also, in cases where there is more than one contributor, there may be joint copyright ownership. However, legal protection customarily applies to the creation and control of data rather than to the individual data points themselves. Therefore, it 21 Montserrat Gorina-Ysern, 'Marine scientific research activities as the legal basis for intellectual property claims? ' (1998) 22(4–5) Marine Policy 337, doi:10. 1016/S0308-597X(97)00042-0 https://doi. org/10.

1016/S0308- 597X(97)00042-0 accessed 15 March 2025 22 Elena Stoica, The Implications of the New UK Open Access Policies on the Ownership of Copyright in Academic Publishing (The University of Edinburgh 2015) https://era. ed. ac. uk/bitstream/handle/1842/11682/4385100_INTELLECTUAL%20PROPERTY. pdf? sequence=1 accessed 15 March 2025

is possible that the data, once extracted, can be freely used; however, commercial databases may have the ability to restrict access electronically through license agreements containing proprietary clauses. 23 The European Union's legal protection for databases is unique, dating back to the EU Database Directive of 1996. The directive grants database creators the exclusive right to restrict the extraction or reuse of substantial content that has been obtained, verified, or presented with considerable investment. Unlike standard copyright protection, this legal protection does not require originality and is granted for a 15-year period, extendable with significant updates.

This mixed approach emphasizes a wider divide in the policy of intellectual property: stronger support for open access and open-source licensing to facilitate the proliferation of knowledge in marine research, and a strong inclination toward proprietary control over data. Achieving a balance among these contradicting approaches is predominantly tricky in the framework of international negotiations under UNCLOS concerning biodiversity in ABNJ. To recapitulate, the dealings between IPR and the preservation and usage of these resources creates a complex system to govern on a worldwide scale. Each mechanism of the rights has a specific function in fostering new ideas, safeguarding the investment, and providing access to scientific information.

Advancements in marine biotechnology will require the development of an exclusive approach that provides unrestricted access alongside the balanced control of proprietary claims, fostering progress in sustainable and fair deep sea scientific exploration. Conclusion The BBNJ Agreement demonstrates a key milestone for marine genetic resources law (MGRs) and for the sustainable advancement of biotechnology, medicine, and conservation. Fragmented governance (ABNJ) is an area of existing concern which is addressed through UNCLOS’ basic principles, however it fails to resolve distinct obstacles of MGRs pertaining to biopiracy and inadequate benefit sharing frameworks. The Nagoya Protocol and TRIPS further deepen existing gaps with an exploitation constraining equity model due to an imbalance of focus stemming from proprietary interests and terrestrial bias.

23 Albert I Ugochukwu and Peter W B Phillips, 'Open data ownership and sharing: Challenges and opportunities for application of FAIR principles and a checklist for data managers' (2024) 16 Journal of Agriculture and Food Research 101157, doi:10. 1016/j. jafr. 2024. 101157 https://doi. org/10. 1016/j. jafr. 2024. 101157 accessed 15 March

Amending such gaps with BBNJ regulations for the ABS distribution frameworks along with environmental management stipulations for ABNJ marks an innovative step. The mandate of disclosure along with profit sharing sets agreements that will necessitate rework in WIPO and WTO policies on patents seeking balance with marine biodiversity, thereby enhancing MGRs governance. Gaps regarding the status of digital sequence information, relocation of experts for encumbered migratory species, overlap jurisdiction, and ambiguity need to be navigated for effective agreement implementation succeeding the forefront changes in MGRs legislation. The interdisciplinary collaboration of MGR governance sustainability is essential.

The proprietary economic innovation and research open-access severity is maintained by equally sophisticated proprietary legal culture, scientific openness, and economic neutrality. Georeferencing protocols and their enhancement, patent eligibility unification, and open-source data sharing models implementation criticism leads to the conclusion that preventing monopolization and promoting global stewardship is a must. In the end, the MGRs future is tackling the gap between technological and ecological morals. The ocean genetic resources can be responsibly used for the fathomless wonder by the international community through advanced governance adaptation coupled with multilateral diplomacy preserving it as a shared heritage for the future generations.