Publications, patents, and commercialization

Introduction

Currently, there is no notification obligation on information about publication, intellectual property or commercialization of a product utilizing marine genetic resources (MGRs) of areas beyond national jurisdiction (ABNJ) or the associated digital sequence information. The BBNJ Treaty addresses this gap in a unique way. This section provides some background information on the accessibility of information on publication, patents, and commercialization. 

Why are publications part of the notification obligation?

A publication of the result of research can provide useful information and data that can be used for other research, publications, patents, and commercialization purposes. There is currently no single place to find information on publications that utilized MGRs of ABNJ or the associated digital sequence information. The Treaty aims to address this gap by requiring notification of publication to the Clearing-House Mechanism.

One aspect that may need to be clarified by either the Conference of the Parties (COP) or at the national level is the meaining of "publication." For example, one question that may be asked is, "does the requirement only apply for certain publications, such as peer-reviewed journals?"

Why are patents part of the notification obligation?

A patents is a type of intangible property right (i.e., intellectual property). It is rare for patents to be awarded. The work to produce a patentable product takes significant time and resources. Further, obtaining patent requires technical and legal expertise. The developing countries felt strongly that patentss should be included in the benefit sharing requirements.

Two global organizations and their agreements set minimum international standards for different forms of intellectual property: World Intellectual Property Organization and the World Trade Organization. The Parties to those agreements are obliged to implement domestic laws that comply with at least the minimum standards. Further, there are bilateral and regional free trade agreements that impose certain obligations on intellectual properties. Some intellectual properties, such as patents, give the holder exclusive rights to use, make, sell and import the products or process of an invention. There are exceptions or exemptions under a range of intellectual property rights that give limited access to protected products or processes without the holder’s permission.

Why is the information on commercialization part of the notification obligation?

MGRs and the associated digital sequence information may have application not only in medicine but also in other applications, such as cosmeticsm food, and remediation of contamination. However, while genetic resources may hold great promise, development of commercial application have been rare and almost all have been accomplished utilizing MGRs within national jurisdiction. Further, significant monetary investment is required for research and development and for medical application, years, if not decades of development and clinical trials are required. For that reason, even if monetary benefits are generated, they are likely to be few and the timing of distributing any monetary benefits will be decades away. 

BBNJ Treaty's notification requirement on utlization of MGRs of ABNJ and the associated digital sequence information

The BBNJ Treaty defines utilization of marine genetic resources as:

…to conduct research and development on the genetic and/or biochemical composition of marine genetic resources, including through the application of biotechnology.

Further, biotechnology used in the above definition is defined as:

…any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.

In terms of “utilization of MGRs,” the BBNJ Treaty has notification obligations to the Clearing-House Mechanism as soon as such information becomes available. The notification requirement applies to MGRs of ABNJ, and where practicable, digital sequence information associated with MGRs of ABNJ. The notice must include the “BBNJ” standardized batch identifier for the relevant MGRs of ABNJ or the associated digital sequence information. Note that the BBNJ Treaty specifically states that “utilization of MGRs” includes commercialization. The notice requirement applies to those who are within the jurisdiction of a Party.

  • Where the results of the utilization, such as publications, patents granted, if available and to the extent possible, and products developed, can be found;
  • Where available, details of the post-collection notification to the Clearing-House Mechanism related to MGRs that were the subject of utilization;
  • Where the original sample that is the subject of utilization is held;
  • The modalities envisaged for access to MGRs and digital sequence information on MGRs being utilized, and a data management plan for the same;
  • Once marketed, information, if available, on sales of relevant products and any further development.

Will there be additional guidance associated with the notification requirements on publications, patents, and commercialization of products that include MGRs of ABNJ and associated digital sequence information? 

The access and benefit-sharing committee that was established by the BBNJ Treaty may provide guidance for consideration and adoption of a guidance by the Confernece of the Parties (COP). Also, at the national level, Party country will need to take into consideration existing national laws and obligations under other multilateral agreements to ensure compatibility with any new requirements pursuant to the BBNJ Treaty.

The objective of the access and benefit-sharing committee is to establish guidelines for benefit-sharing associated with MGRs of ABNJ and associated digital sequence information. The committee is tasked with providing transparency and ensuring a fair and equitable sharing of both monetary and non-monetary benefits. It will be composed of fifteen members with appropriate qualifications in the related fields. The Parties will nominate, and the COP will elect the members. The committee members will be elected with considerations for gender balance and equitable geographical distribution as well as representation from developing States, including from the least developed countries, from small island developing States and from landlocked developing countries.

The terms of reference and modalities for the operation of the access and benefit-sharing committee will be determined by the COP. However, the committee will make recommendations to the COP on the following:

  • Guidelines or a code of conduct for activities with respect to MGRs and digital sequence information on MGRs of ABNJ;
  • Measures to implement decisions taken in accordance with the requirements on MGRs of ABNJ and associated digital sequence information;
  • Rates or mechanisms for the sharing of monetary benefits;
  • Matters in relation to the Clearing-House Mechanism;
  • Matters in relation to the financial mechanism (Art. 52);
  • Any other matters that the COP may request.

Through the Clearing-House Mechanism, each Party is required to provide to the access and benefit-sharing committee the following information:

  • Legislative, administrative and policy measures on access and benefit-sharing;
  • Contact details and other relevant information on national focal points;
  • Other information required pursuant to the decisions taken by the COP.

The access and benefit-sharing committee may consult and facilitate the exchange of information with relevant legal instruments and frameworks and relevant global, regional, subregional and sectoral bodies on activities under its mandate, including benefit-sharing, the use of digital sequence information on marine genetic resources, best practices, tools and methodologies, data governance and lessons learned. The access and benefit-sharing committee may make recommendations to the COP in relation to such information.

At this point, it is unclear if the access and benefit-sharing committee has an obligation to or opportunities to consult with the Scientific and Technical Body. The STB functions discussed in the Treaty do not include matters on benefit-sharing associated with MGRs of ABNJ and associated digital sequence information. That said, it is possible for the COP to clarify the functions that the STB may perform and include cooperation with the ABS Committee on benefit-sharing. The same concept applies to other committees that the BBNJ Treaty established, such as the financial committee, compliance and implementation committee, and capacity-building and transfer of marine technology committee. Since the Treaty focuses on cooperation, the COP may look for positive synergies among the STB and the various relevant committees. For more information on the institutional arrangement, visit the page here.

Ref. BBNJ Treaty Art. 1.3, 1.14, 12.8, and 15.

For specific information on the outcome of the COP meetings, visit the page here. For specific information about a Party country, visit the page here.

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