Policy ForumGLOBAL GENETIC RESOURCES

Marine Biodiversity and Gene Patents

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Science  25 Mar 2011:
Vol. 331, Issue 6024, pp. 1521-1522
DOI: 10.1126/science.1200783

The October 2010 Nagoya conference of the United Nations (UN) Convention on Biological Diversity (CBD) saw establishment of the protocol for improved access to genetic resources and fair and equitable sharing of benefits arising from their utilization (1). This allows effective implementation of provisions in Article 15 of CBD regulating access to genetic resources through mutual agreements between countries of origin of resources and those acquiring them. Yet the principle of sovereign rights of states underlying the CBD does not apply to Marine Genetic Resources (MGRs) in Areas Beyond National Jurisdiction (ABNJs), international waters encompassing 65% of the ocean; thus, no consensus could be reached to include them in this new protocol.

Although recent CBD efforts tackled terrestrial genetic resources and those distributed in Exclusive Economic Zones (EEZs), where states holds rights over marine resources, the increasing industrial use of MGRs, particularly those extracted from ABNJs, occurs in a legal void because of the lack of an internationally accepted framework to ensure ethical and equitable access, and sharing of benefits (26). We describe imbalances in ownership of patent claims on MGRs and propose steps toward addressing gaps in governance.

Ownership of Patent Claims

Marine biodiversity contains most phylogenetic and genomic diversity on Earth (e.g., 34 of 36 animal phyla hitherto described versus 17 on land). Progress in marine and molecular technologies has facilitated “bioprospecting,” with the number of patent claims associated with genes of marine organisms growing at 12% per year (2). Although patenting does not always result in effective exploitation, the existence or lack of patent claims and their relative distribution offer a reasonable ranking of countries' accessing of resources.

We screened records in the patent division of GenBank (7) to extract international claims valid in all countries subscribing to the World Trade Organization (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and deposited in the World International Property Organization (WIPO). Among 677 international claims of marine gene patents deposited between 1991 and 2009, 8648 sequences from 520 species were found. Gene patent claims from marine organisms make up only 2% of the WIPO gene patents (table S1), whereas claims associated with human genes dominated (35%), closely followed by the most frequently raised cultivars (wheat, rice, maize, and barley).

Claims associated with marine genes originate from only 31 of the 194 countries in the world. Ten countries own 90% of the patents deposited with marine genes, with 70% belonging to the top three (see the table). These 10 nations represent only about 20% of the world's coastline, but they benefit from access to advanced technologies required to explore the vast genetic reservoir of the oceans. The power law describing the distribution of “ownership” of MGRs across countries (see the figure) (table S1), fits the Pareto principle describing the “rich get richer” distribution of wealth in society (810). Benefits derived from application of MGR patents may fuel further investment in marine bioprospecting (11, 12), broadening the gap in oceanographic and biotechnological capacities among countries. A similar distribution for patent claims associated with human genes or key plant crops (table S1 and fig. S1) suggests differential access to molecular technologies as the main advantage. This inequality calls for policies targeting capacity-building in countries that lag behind and stresses the need for an internationally recognized framework governing MGRs.

Patent claims associated with genes of marine origin.

Cumulative distribution of patent claims showing the proportion of countries (y axis) at the origin of x or more patent claims. See SOM.

The Legal Gap

With 95% of claims filed after 2000, the growth of marine gene patents is a recent phenomenon, but it has matured well beyond “proof of concept.” The global market for marine biotechnology was estimated at U.S. $2.4 billion in 2004, with estimated average growth of 5.9% per year from 1999 to 2007 (13). Marine molecules include cancer- and HIV-fighting agents representing $1 billion and $125 million, respectively, annual markets in 2005 (5). Most MGRs are derived from organisms sampled in territorial waters. However, source organisms can be shared by several different EEZs and/or may disperse across international waters during their life cycles. Exploration of extreme ecosystems, such as hydrothermal vents and polar oceans, mostly located in ABNJs, has disclosed a broad spectrum of molecules of biotechnological interest (2, 6). Examples include thermostable enzymes for molecular biology or the food industry (2, 5) and amylase isolated from a black smoker hydrothermal vent used for biofuel production with an annual market value of about $150 million (5).

The scope for bioprospecting of MGRs surpasses national jurisdictions, a situation that does not apply to terrestrial resources. Frameworks in place for regulating the use of genetic resources (e.g., the UN Food and Agriculture Organization and CBD) were agreed on in the context of sovereign rights of states and therefore apply only to land areas and EEZs. The International Seabed Authority, a body within the UN Convention on the Law of the Sea (UNCLOS), manages activities linked to mineral resources in the seabed and subsoil in ABNJs. It is not clear why parties' agreement on mineral resource governance under UNCLOS was not extended to a similar framework for governance of genetic resources. Thus, lacking regulation, MGRs in ABJNs are accessed on a “first-come, first-served” basis (2, 5, 14).

The applications that MGRs offer to benefit humankind (2, 5, 15, 16) emphasize the need for an equitable solution. The issues of conservation and fair exploitation of oceans are increasingly present on the UN agenda to progress toward a governance framework for biodiversity in ABNJs (4). Although nations recognize the urgency of facilitating protection, the process is stalled by the lack of agreement regarding the status and governance of MGRs (4). One group of nations, including developing countries, proposes that MGRs in international waters should be considered common heritage of humankind, whereas another wishes to maintain the status quo of “freedom” of exploitation. These positions emerged in Nagoya where some states' proposal to include ABNJs was not retained in the final protocol.

Prospects

The governance framework for MGRs in ABNJs will require a multifaceted approach to improve coordination of the protection of biodiversity and of intellectual property (IP) regimes to promote equity. Of the genes associated with WIPO patents, 17% are of unknown taxonomic origin, and almost none of the patent claims examined disclosed the geographic origin of material. Although states compromised in promoting establishment of sharing agreements under CBD, this is not a legally binding agreement and so does not imply that companies will necessarily comply. A sustainable CBD regime of access and benefit-sharing of genetic resources, terrestrial or marine, would profit from complementary efforts from the WTO to require geographic and taxonomic origin of resources associated with a patent under TRIPS, allowing identification of the country (or countries) or geographical areas of origin of the genes involved. This would support application of Article 15 of CBD and the associated Nagoya Protocol for sharing between countries at the origin of resources and those exploiting them. This may also help ease constraints on bioprospecting for academic and environmental research that stem from national laws (e.g., Brazil) (17) protecting against “biopiracy” of resources.

Addressing inequality in exploitation of MGRs requires an international consensus over MGR status. The UN Universal Declaration on the Human Genome and Human Rights recognized that the human genome is a common heritage of humankind. Yet this has not prevented the patenting of human genes or given special status for sharing of benefits from those patents (18). But within the UNCLOS, there is specific meaning and significance of common heritage applied to mineral resources of the seabed. If this meaning could be applied to MGRs, they, too, could be managed by the International Seabed Authority. Alternatively, a new authority could be established that would benefit from the joint expertise of the CBD regarding conservation measures and access and benefit-sharing protocols and from the International Seabed Authority large-scale management of resources in vast areas beyond national jurisdictions, as well as the promotion of knowledge transfer.

MGRs should be regulated by an internationally negotiated regime that includes payment of fees to a common fund when exploiting resources, or any option promoting access and benefit-sharing. Such a regime may encompass other genetic resources, as inequality in the appropriation of biological resources through gene patents is not unique to MGRs but applies also to human genes and cultivars as well. Recent court cases in North America and the UK (19) involving human genes have challenged the legal basis for patenting genes that exist in nature. Also, patenting has been claimed to discourage rather than promote scientific progress (16, 20). Solutions are emerging, involving patent pools (2123) to facilitate access to new technologies and more equitable use and benefits from IP rights. The idea of licensing all patents in a pool collectively, and sharing risks and royalties, such as was recently applied in HIV research (23), may save time and money for both claimers and users, and facilitate access to the information.

A patent pool for genetic resources managed by a UN authority could ensure fair reward of research efforts and equitable sharing of benefits derived from resources that we believe should be considered a common good. In turn, coordination of instruments required to address governance of MGRs may inspire solutions for IP and access and benefit-sharing around other gene patenting, including human ones. We must pursue a framework in which exploration of marine life, and the biotechnological potentials it contains, serve to improve the lives of all humans rather than generate wealth for a few.

References and Notes

  1. Materials and methods are available as supporting material on Science Online.
  2. This is a contribution to the Malaspina 2010 project, funded by the CONSOLIDER-Ingenio 2010 program of the Spanish Ministry of Science and Technology, the DIVERSITAS program, and the European Union Framework Programme 7 Hermione project. We thank S. Teixeira, E. Jarmache, P. Boudry, B. Guilloux, K. Gjerde, J. Rochette, and Institut du développement durable et des relations internationals (IDDRI).

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