Intellectual property rights in marine derived compounds

Introduction

Marine-derived compounds are biologically active substances obtained from marine organisms such as sponges, algae, bacteria, fungi, corals and other aquatic species. These compounds are increasingly used in pharmaceuticals, cosmetics, biotechnology, agriculture and industrial research. Examples include marine-derived antibiotics, anticancer compounds, enzymes, pigments and bioactive peptides.

The development of marine biotechnology raises important intellectual property (IP) questions concerning ownership, patentability, access to marine genetic resources and the sharing of benefits arising from their commercial use. The legal challenge is to balance scientific innovation with biodiversity conservation and the rights of countries and communities associated with biological resources.

Patent protection for marine-derived compounds

Patents are the most important form of IP protection for commercially valuable marine-derived compounds. In India, the Patents Act, 1970 governs the patentability of inventions involving such compounds.

Under Section 2(1)(j), an invention must be new, involve an inventive step and be capable of industrial application. A marine-derived compound may qualify for patent protection if it has been sufficiently characterised and demonstrates a patentable technical contribution.

For example, a researcher who develops a novel process to isolate and purify a marine microorganism's bioactive compound may seek patent protection for the process. A chemically modified compound or a new formulation may also qualify if it satisfies the statutory requirements.

However, merely discovering a naturally occurring substance is not sufficient. Section 3(c) excludes the mere discovery of a scientific principle or something occurring in nature. Section 3(d) may also restrict patents for new forms of known substances unless the required enhancement in efficacy is established. Section 10 requires adequate disclosure of the invention in the patent specification.

Biological Diversity Act and access to marine resources

Marine-derived compounds frequently originate from biological resources found in Indian territorial waters and other areas under national jurisdiction. Their collection, research and commercial utilisation must comply with applicable biodiversity legislation.

The Biological Diversity Act, 2002, as amended in 2023, regulates access to biological resources and associated traditional knowledge. The National Biodiversity Authority (NBA) plays an important role in regulating access and determining benefit-sharing requirements under the Act.

Relevant legal considerations include:

Access to biological resources for research and commercial utilisation.

Compliance with applicable approval, registration or intimation requirements.

Benefit-sharing obligations where applicable.

Protection of associated traditional knowledge.

Regulation of intellectual property applications involving biological resources.

The 2023 amendment changed certain compliance requirements and exemptions. Therefore, the applicable provisions must be examined according to the applicant's identity, the nature of the resource and the purpose of utilisation.

Internationally, the Convention on Biological Diversity (CBD), 1992 recognises national sovereignty over biological resources and promotes fair and equitable benefit-sharing. The Nagoya Protocol, 2010 provides a framework for access and benefit-sharing concerning genetic resources within its scope.

Marine genetic resources beyond national jurisdiction

Marine organisms collected from areas beyond national jurisdiction raise additional legal questions. The United Nations Convention on the Law of the Sea (UNCLOS), 1982 establishes the international legal framework governing marine areas. Its provisions distinguish between resources within national jurisdiction and resources found in areas beyond national jurisdiction.

The Agreement on Biodiversity Beyond National Jurisdiction (BBNJ Agreement), adopted in 2023 and entering into force in January 2026, addresses marine genetic resources and benefit-sharing in areas beyond national jurisdiction. It introduces mechanisms concerning notification, information-sharing and benefit-sharing from activities involving these resources.

The relationship between international access rules and private patent rights remains important. A patent may protect a qualifying invention, but it does not automatically establish ownership over the marine organism or biological resource from which the compound was obtained.

Other forms of intellectual property protection

Apart from patents, other IP mechanisms may protect different aspects of marine biotechnology.

Trade secrets: Confidential extraction methods, purification techniques, laboratory procedures and commercial production data may be protected through confidentiality agreements and contractual arrangements.

Copyright: Scientific publications, databases, research reports, software and technical illustrations may receive protection under the Copyright Act, 1957. Copyright does not protect the underlying biological compound itself.

Trademarks: Brand names and product identities associated with marine-derived medicines, cosmetics and industrial products may be protected under the Trade Marks Act, 1999.

Plant variety protection: Where marine biotechnology is used in developing qualifying plant varieties, the Protection of Plant Varieties and Farmers' Rights Act, 2001 may become relevant, subject to its statutory requirements.

Important case laws

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

The Uttarakhand High Court examined benefit-sharing obligations under the Biological Diversity Act, 2002. The judgment recognised the importance of ensuring that commercial utilisation of biological resources is accompanied by appropriate benefit-sharing where the law requires it. Its reasoning is relevant to companies developing commercial products from marine biological resources.

2. Novartis AG v. Union of India (2013)

The Supreme Court interpreted Section 3(d) of the Patents Act and emphasised that modifications of known substances must satisfy the statutory efficacy requirement. This principle is relevant when pharmaceutical companies seek patents for modified marine-derived compounds or new formulations of known substances.

3. Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries (1979)

The Supreme Court explained that patent protection requires a genuine inventive step and that a mere obvious improvement cannot qualify as an invention. This principle is relevant to evaluating whether a new extraction or purification method for marine compounds involves sufficient technical advancement.

4. Dimminaco A.G. v. Controller of Patents and Designs (2002)

The Calcutta High Court held that a process involving living organisms was not automatically excluded from patentability merely because the resulting product contained living material. The decision is relevant to biotechnology inventions involving marine microorganisms, although it did not directly concern marine-derived compounds.

Challenges in protecting marine-derived compounds

Several difficulties arise in protecting marine biotechnology inventions:

Determining whether a compound is naturally occurring or sufficiently modified through human intervention.

Establishing novelty when similar compounds have already been reported in scientific literature.

Identifying the country or jurisdiction responsible for regulating access to the biological resource.

Ensuring compliance with benefit-sharing obligations.

Preventing unauthorised commercial exploitation of marine genetic resources.

Balancing patent exclusivity with scientific research and conservation objectives.

Conclusion

Intellectual property rights in marine-derived compounds are essential for encouraging research, pharmaceutical development and biotechnology innovation. The Patents Act, 1970 provides protection for qualifying inventions, while the Biological Diversity Act, 2002 and international biodiversity agreements regulate access and benefit-sharing. Effective protection requires a balance between commercial interests, scientific progress, biodiversity conservation and equitable distribution of benefits.

Legal clarification: The cases discussed above establish general principles concerning patentability and biological-resource benefit-sharing. They are relevant by analogy; they are not direct judgments specifically deciding ownership or patent rights over marine-derived compounds.