“Biopiracy” On The High Seas? Countries Launch Negotiation Towards A New International Legally Binding Instrument On Marine Genetic Resources In Areas Beyond National Jurisdiction

IP Watch is re-publishing with permission this slightly adapted version of an article that appeared in November 2018 on the website of the Intellectual Property Unit of the University of Cape Town, South Africa. It was written by Wend Wendland in his capacity as an honorary Adjunct Professor, Law Faculty, University of Cape Town, as part of his blog series “Multilateral Matters” addressed primarily to IP students and researchers. View the original publication here. Any views expressed are the author’s alone and not those of any institution or organization. He may be contacted at wend.wendland@uct.ac.za

Key points

Countries have begun to negotiate a new international legally binding instrument on marine genetic resources in the high seas.

The negotiation is an opportunity for countries to re-think existing frameworks which regulate access to and benefit-sharing in genetic resources.

Countries have divergent views on if and how IP issues should be addressed in the new instrument.

Developing countries have an interest in the establishment of mechanisms for the fair and equitable sharing of benefits from research into marine genetic resources and for the transfer of marine technologies. IP issues are relevant in both cases.

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What is the issue?

International law already regulates access to and fair and equitable benefit-sharing in genetic resources located within the territories of countries.

The Convention on Biological Diversity, 1992, its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, 2010, the Food and Agricultural Organization’s International Treaty on Plant Genetic Resources for Food and Agriculture, 2001, and, the World Health Organization’s Pandemic Influenza Preparedness Framework, 2011, are some of the main international instruments that currently regulate access to and benefit-sharing in genetic resources.

However, it’s not clear what legal regime applies to marine genetic resources (MGRs) in areas beyond national jurisdiction – such as in the high seas and the seabed beyond the limits of national jurisdictions.

Member countries of the United Nations (UN) have therefore begun to develop a new international legally binding instrument on MGRs beyond national jurisdiction.  This negotiation is taking place under the United Nations Convention on the Law of the Sea, 1982 (UNCLOS).

This negotiation touches on a panoply of issues – realization of the Sustainable Development Goals, poverty alleviation, the reduction of hunger, mitigating climate change, biodiversity conservation, the improvement of health, the “Blue Economy” and so on.

This blog post focusses on one aspect of this process:  the intellectual property (IP) dimension, and its relationship with two issues that are of particular interest to developing countries:  fair and equitable benefit-sharing and the transfer of marine technologies.

As the negotiation has only just started – there is not even a zero draft text of the instrument yet – this first post simply sketches the main issues and navigates the broad contours of the process so far.  It will be followed by updates as the process evolves.

Why is this process interesting?

Like any multilateral process, this process is complex and likely to last a number of years.

It’s deeply interesting for a number of reasons.

In general, there are two contrasting views on the legal principle that ought to apply to MGRs in areas beyond national jurisdiction:  the “common heritage of mankind” (the resources belong to all) or “freedom of the high seas” (the resources belong to those who first access and exploit them).  Predictably, the latter view is held predominantly by developed countries which have the technologies and resources needed to reach, study and exploit these resources.

These two different approaches will sound broadly familiar to students of the historical evolution of international policy regarding biodiversity, genetic resources for food and agriculture and intangible cultural heritage.

As the most recent initiative to address access to and the fair and equitable benefit-sharing in genetic resources, it has implications for other ongoing processes (such as the negotiations on IP and genetic resources taking place at the World Intellectual Property Organization (WIPO)).

The negotiation is significant too because it is launching just as doubts are surfacing about the existing access and benefit-sharing frameworks referred to above.  As Manuel Ruiz writes, new disruptive technologies, such as digital sequencing of genetic information and synthetic biology, strongly suggest that the principles underlying existing regimes, notably the principles of sovereignty, prior informed consent and mutually agreed terms, are no longer appropriate, and that a re-think of these regimes is long overdue.[1]

The UNCLOS negotiation may, therefore, be a kind of laboratory in which countries can experiment with new approaches to access and benefit-sharing, including to the related IP questions. While the existing regimes reflect somewhat different approaches, ultimately a single model might be more desirable. An eventual outcome in this process may be a bellwether for how the international community may in future forge a new approach to these questions in other forums.

Marine biology, marine bioprospecting and patents

As Marja Vierros and others have written, organisms from the deepest areas of the oceans, including slugs, sponges, vertebrates such as fish, worms, seaweed, algae and bacteria, are subject to extremes of pressure and temperature, and sometimes toxicity.  As a result, these “extremophiles”, many of which have not yet been properly researched, have unique molecular and metabolic characteristics that allow their survival in such conditions.[2]

These unique qualities mean that they are of actual and potential scientific, industrial and commercial value, especially for the pharmaceutical, food, cosmetics and alternative energy sectors.

In South Africa, for example, the SEAChange Programme, which was initiated in 2007, discovered several South African marine natural products of value.  Describing the results of this program after five years, Bolton, Davies-Coleman and Coyne, wrote: “It is clearly time South Africa makes marine biotechnology a priority research focus area in order to unlock the untapped wealth of scientific information and commercial applications that remain hidden in the South African marine environment”.[3]

Reaching these organisms, and then analyzing them, however, requires expensive technologies, and its little surprise then to learn that most of the research and subsequent patenting and commercialization are carried out by companies and research institutions in a limited number of wealthier countries.

By and large, developing countries do not presently engage in these research efforts.  As Elisa Morgera argues and discusses further, it’s therefore key, from a developing country perspective, that the outcome of the negotiation includes a mechanism for the sharing of both monetary and non-monetary benefits with developing countries in a fair and equitable manner.[4]

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A few words on patents and MGRs                                                                      

Like all genetic resources, MGRs as such are not patentable.  However, if they are modified through human intervention through the application of biotechnology for example – and the resulting invention is novel, inventive and industrially useful – the invention may be patentable. 

One of the benefits of the patent system is that information about which patents have been applied for and granted is publicly available and generally free of charge.  This “patent information” is enormously valuable for follow-on inventors because they can see exactly how a patented invention was made and then improve upon it.

By tracking publicly available patent information, as Paul Oldham and others have one, it can be seen that patenting activity in relation to marine genetic resources is a relatively new phenomenon but is increasing.[5] 

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What has occurred in the negotiation so far?

In 2015, the UN General Assembly decided that countries should develop an international legally binding instrument under UNCLOS

on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction. [6]

This instrument should address the topics identified in a package that had been agreed on in 2011, namely, (a) the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction, in particular, together and as a whole, MGRs, including questions on the sharing of benefits, (b) measures such as area-based management tools, including marine protected areas, (c) environmental impact assessments, and (d) capacity-building and the transfer of marine technology.

To that end, a Preparatory Committee met four times in 2016 and 2017.

In its final report, there is a tentative and open-ended reference to if and how IP could be addressed in a future text: “The text could set out the relationship between the instrument and intellectual property rights.”[7]

Interestingly, the Chair of the Preparatory Committee at that time (Mr. Carlos Sergio Sobral Duarte, Brazil) had made available a “streamlined non-paper”[8] in advance of the fourth preparatory meeting.  In a section on “Access and benefit-sharing”, it sets out five options regarding IP rights, summarized as:

Option 1: IP rights, including disclosure of origin requirements in patent applications, would not be within the scope of the instrument, as this issue would need to be dealt with within WIPO and the World Trade Organization (WTO)).

Option 2: A mandatory disclosure of origin of the marine genetic resource in patent applications or other IP right would be established.

Option 3: The instrument would prohibit private appropriation and the exercise of IP rights where this would limit access to MGRs for further research and other aims.  If IP rights were claimed in respect of products developed from MGRs, the approach taken in the FAO’s International Treaty could be considered.

Option 4: The matter of IP rights would have to be addressed in a manner that ensures consistency with the work being conducted under WIPO.

Option 5: A sui generis system would be developed.

In the earlier corresponding non-paper that had been prepared for the third Preparatory Committee, the different country positions on these approaches are identified.[9]

A few words on a proposed mandatory disclosure requirement

The reference in the “streamlined non-paper” to work being conducted under WIPO refers mainly to the negotiations underway in the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore.  A mandatory disclosure of origin requirement in international patent law or, more generally, IP law, is one of the issues under negotiation in this WIPO Committee.  In brief, such a requirement would oblige the disclosure of certain information in applications where the subject matter/claimed invention uses or is based on genetic resources (GRs) and associated traditional knowledge (TK).  The information that would need to be disclosed would include information about the country of origin or source of the GRs and associated TK and evidence that that country’s access and benefit-sharing regime has been complied with.[10]

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The next step was that the UN General Assembly decided, in September 2017, to authorize the convening of an Intergovernmental Committee to elaborate the text of an international legally binding instrument under UNCLOS.[11]  This Intergovernmental Committee will meet four times in total in 2018, 2019 and 2020.

The first session of the Intergovernmental Committee took place in September 2018, under the Presidency of Rena Lee (Singapore).

Four informal working groups were set up at the first session, one each on the four topics that make up the 2011 package of issues.  The informal group on capacity-building and the transfer of marine technology recognized the need for the instrument to address the IP aspects associated with the transfer of marine technology.  The informal group on marine genetic resources, including questions on the sharing of benefits, noted divergent views on whether the instrument should cover IP rights.

The ongoing negotiation in the WIPO Intergovernmental Committee was mentioned several times, with some delegations arguing that IP issues should be left to WIPO and/or WTO to handle.  In one of the informal meetings, the African Group requested more information on the state of the negotiation at WIPO, specifically whether it covers MGRs beyond national jurisdiction, and the WIPO Secretariat provided the necessary information.

Ahead of the first session, the Committee’s President had published a “President’s Aid to discussions”.[12]  Regarding IP, and in the context of access and benefit-sharing, the document simply asked “Would the relationship between the instrument and intellectual property rights be set out in the instrument? If so, how?”[13]

Next steps

So, this is where the process is now.

References to IP are tentative and non-committal, reflecting divergent country positions on if and how IP should be addressed in the new instrument.  The most useful elaboration of possible IP options so far is in the Chair’s non-paper submitted in advance of the July 2017 Preparatory Committee meeting.

The second and third sessions of the Intergovernmental Committee will take place in March 2019 and August 2019, respectively.[14]

The President of the Intergovernmental Committee will prepare, for the Committee’s second session in March 2019, a document aimed at facilitating focused discussions and text-based negotiations, containing treaty language and reflecting options concerning the four elements of the package.

Future blogs will provide updates on the process as it unfolds.

[1] Ruiz Muller, M (2018) Access to Genetic Resources and Benefit-sharing 25 Years on: Progress and Challenges. Geneva: International Centre for Trade and Sustainable Development (ICTSD).

[2] Vierros, M., Salpin, C., Chiarolla, C., and Arico, S., “Emerging and Unresolved Issues: The Example of Seabed and Open Ocean Genetic Resources in Areas Beyond National Jurisdiction”, in Arico S. (Ed.), Ocean Sustainability in the 21^st Century, (Cambridge University Press, 2015), p. 2.

[3] Bolton, JJ, Davies-Coleman, MT and Coyne, VE (2013) Innovative processes and products involving marine organisms in South Africa, African Journal of Marine Science, 35:3, 449-464. The SEAChange programme ended in 2011/2012, and will be replaced as from 2019 by a new Marine and Coast Programme launched by the National Research Foundation (personal communication with Professor Vernon Coyne, November 15, 2018).

[4] Morgera, E, Equity and benefit sharing from marine genetic resources in areas beyond national jurisdiction, IIED Briefing Paper (April 2018).

[5] WIPO, “The Scientific and Patent Landscape for Marine Genetic Resources in Southeast Asia”, (title tbc, forthcoming, 2018).  See also Blasiak, R., Jouffray, J-B, Wabnitz, C, Sundstron, E and Osterblom, H, “Corporate control and global governance of marine genetic resources”, Sci. Adv. 4, eaar5237 (2018), and Murphy, H., “What 13,000 Patents Involving the DNA of Sea Life Tells Us About the Future”, New York Times, September 17, 2018, https://www.nytimes.com/2018/09/17/science/patents-marine-dna.html (accessed November 16, 2018).

[6] UN GA, Resolution 62/292, June 19 2015.

[7] Report of Preparatory Committee, UN document A/AC.287/2017/PC.4/2, July 31, 2017.

[8] Chair’s streamlined non-paper on elements of a draft text of an international legally-binding instrument 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, undated.

[9] Chair’s non-paper on elements of a draft text of an international legally-binding instrument 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, February 28, 2017.

[10] WIPO, Key Questions on Patent Disclosure Requirements for Genetic Resources and Traditional Knowledge (WIPO, 2017).

[11] UN GA, Resolution 72/249, December 24, 2017.

[12] UN document A/CONF.232/2018/3.

[13] Ibid. page 6, para. 3.2.3.

[14] 25 March to 5 April and 19 to 30 August 2019.

 

Image Credits: University of Cape Town Intellectual Property Unit