Legal Issues Raised by Profitable Biotechnology Development Through Marine Scientific Research
In July 2003, the Secretary of State for Environment, Food and Rural Affairs of the United Kingdom invited proposals for a "Study into the Legal and Moral Framework for Marine Biotechnology Development in the UK." The study, when complete, should constitute a pioneering effort to deal with a growing and important field of international law that is poorly understood and researched but that is gaining considerable significance in practice, and poses complex legal, moral and environmental issues. [1]
The international law of the sea has not kept pace with the development of profitable application of biotechnology, [2] or with pharmaceutical and marine biomedical research relating to marine biota. As a result, there is a very limited understanding of the relationships between different legal instruments dealing with ownership of marine data, samples and results, and the principles regulating the allocation of legal title to products and processes deriving from such applications, or about the environmental and moral consequences of such uses. Studies on biotechnology applications focus on three main industries: agriculture, [3] pharmaceutical, [4] and shipping, [5] even though marine biotechnology is a growing field. Marine biotechnology has been applied to aquaculture and seafood supply enhancement, to the commercial and industrial production of marine substances and processes such as antibio-fouling agents and adhesives for the shipping and maritime industries, and for the navies of industrialized States; it has yielded marine pharmaceuticals, cosmetics and biomedical applications, and it has improved environmental monitoring and resource management. [6]
The potential market revenue for these industrial uses has conservatively been assessed at US$3 billion per year. [7] Another estimate puts world-wide sales of marine biotech related products at $100 billion in the year 2000. [8] These estimates indicate the potential royalty and other monetary returns that university researchers may receive as a result of patenting and licensing innovations to private industry. Current literature, however, fails to estimate the potential financial returns for coastal States of origin of the marine biogenetic resources used in tests and cell cultures driving the bonanza of commercialized marine resource-related inventions.
What is MSR?
Marine Scientific Research (MSR) is a term applied to a range of scientific disciplines (such as physics, biology, chemistry, geology, geophysics) concerned with the study of the ocean, its biota and its physical boundaries with the solid earth and the atmosphere. [9] The conduct of MSR activities is regulated in Part XIII, 1982 UNCLOS and other rules of international law. In essence, MSR is a freedom of the high seas beyond the limits of a coastal nations' jurisdiction (usually beyond the 200 nautical mile boundary measured from the low water mark). MSR activities conducted within the 200 nautical mile boundary of another nation are subject to the prior consent of that nation, and require the researching State to comply with a range of obligations toward the host nation, including a duty to share data, samples and results obtained, and to permit the participation of the host nation's observers or participants on board the foreign vessel. In practice, the extent of international law regulation over MSR activities can be described as cumbersome but successful.
However, the current international regime for MSR under UNCLOS does not deal with proprietary title over MSR data, samples and results. The vast majority of MSR projects do not directly bear on the exploration or exploitation of natural resources, but on fundamental oceanographic research. The results are openly disseminated through regional and international exchange systems. By contrast, a growing field of MSR activities, not directly bearing on the exploration or exploitation of natural resources, may yield data, samples and results leading to the potential commercialization of marine products or processes protected under Intellectual Property Rights regimes (IPRs). These property rights determine who owns the product of the human intellect that has commercial value and what rights the law is prepared to protect on the basis of such ownership. The extent of protection varies across national systems. International protection is dependent upon interested states' membership in international IPR treaties. International law has not dealt with these interrelated issues adequately.
Integrating MSR Regulation under UNCLOS with Other International Law Regimes
Access to MSR data and samples in foreign coastal areas is regulated under the 1982 UNCLOS and under coastal State domestic legislation. The export of certain samples from coastal State maritime areas may be regulated under the Convention on International Trade in Endangered Species of Flora and Fauna (CITES) and under coastal and researching State customs and import laws. The ownership of data and samples in the researching State may be regulated by private agreements between the research oceanographer and the university or institution where he or she is employed. Ownership over published results is regulated by private employment agreements and agreements with the publisher, stemming out of copyright laws in the researching State. If the results lead to innovations of a potentially commercial nature, their ownership is regulated by private employment agreements and other agreements with funding agencies, whether the latter are private industry, non-profit corporations or governments. These agreements specify the distribution of benefits arising from the commercialization of the products or services derived from Research & Development (R&D), including oceanographic research. Before a product or process is commercialized, it is subject to patent or other intellectual property protection under domestic statutes and international intellectual property treaties.
The rights that may accrue to coastal States of origin of the commercialized samples are regulated under the 1992 Convention on Biological Diversity (CBD) and other private or bilateral agreements between the coastal and the researching State. The protection across international boundaries of exclusive rights to use and sell certain information or commercialized products, such as pharmaceuticals derived from marine macro/micro-organisms, is the subject of regulation under the General Agreement on Tariffs and Trade (GATT), and may trigger the application of relevant Trade Related Aspects of Intellectual Property (TRIPS) Agreement provisions. These regulatory regimes may give rise to domestic disputes to be resolved by national judicial authorities, or may be subject to settlement of disputes mechanisms under UNCLOS, or may result in disputes of such a global nature as to trigger dispute settlement proceedings before the World Intellectual Property Organization (WIPO) as well as the World Trade Organization (WTO).
The following example illustrates how these regimes can affect MSR. Under the 1982 UNCLOS, an oceanographer seeking access into foreign coastal areas for the purpose of collecting samples of live organisms (i.e. marine flora and fauna) with potential medical properties must first obtain clearance through its Department of State or Foreign Affairs Ministry. The diplomatic organ in the foreign coastal State may grant clearance upon the condition that such samples not be used for commercial purposes. UNCLOS Arts. 241, 246.5, and 249.2 allow the coastal State to block such development or to place significant restrictions on the publication of results bearing on its natural resources (i.e. live organisms with potential economic value). But it can also use these legal provisions to negotiate. Domestic legislation and Art. 15 of the CBD may entitle a coastal State to require that access be on mutually beneficial terms. The coastal State is entitled to negotiate for a share in the benefits deriving from commercialized medical or pharmaceutical products that use innovations derived from coastal State marine organisms. Increasingly, the collection of such organisms takes place under "letter of collection" agreements, "material transfer" agreements, or cooperative agreements between the coastal State (or its qualified institution) and the oceanographer's institution, pursuant to standards set out by funding agencies in the State of the oceanographer (its university or federal funding source). These agreements aim to establish fair and equitable arrangements for the protection of IPRs, set criteria for the distribution of commercial benefits, and provide continuity of international collaboration, not least of which is continued access to raw materials (where these may be required for clinical tests leading to the commercial exploitation of a pharmaceutical or other product).
Samples are then re-imported into the oceanographer's country to be tested at the university laboratories. Samples showing active components can be cultured and the cultures may be deposited under the Budapest Treaty on the Deposit of Microorganisms for Patent Procedure, pending future application for patents concerning new discoveries. If a new product or process emerges as a result of the innovative effort of the oceanographer (or his/her professional colleagues), the oceanographer may proceed to patent it. A patent grants the oceanographer (or his or her institution) an exclusive right to exploit the invention by taking out an exploitation license. This may be achieved through a university's own biotech "start-up" companies, or through independent companies, including pharmaceutical and biotech companies.
The ability to protect a patent internationally is not automatic. It depends on the scope of membership in international patent treaties and also on bilateral or regional agreements. Membership in these treaties or agreements is not compulsory. States may choose not to become parties. However, TRIPS compels States members of the WTO to implement and abide by the system of international property rights law. In this way, the sample obtained in a foreign coastal State may make its way, albeit indirectly, into the global trade arena in the form of an anti-viral drug, or as an additive in an infant formula nutritional supplement, or in a cosmetic. [10] The oceanographer who collected the sample becomes therefore a pawn in the complex and fascinating chess-board of international trade.
Title Issues
Ownership of MSR data, samples and results is shared among foreign oceanographers, researching States, and coastal States of origin of the raw materials. Determining their ownership shares requires international lawyers and policy makers to reconcile different principles of international law relating to title. Central to this task is a thorough understanding of UNCLOS Art. 241, according to which MSR activities "shall not constitute the legal basis for any claim to any part [11] These articles have effects similar to those of Art. 15, 1992 CBD, as they entitle coastal States to negotiate the details over proprietary claims to MSR data, samples and results obtained by foreign oceanographers in coastal State waters. Articles 10 (compilations of data), 39 (confidential information/trade secrets) and 27 (patentable subject-matter) of the TRIPS Agreement may also have a considerable impact on certain MSR data, samples and results. of the marine environment or its resources" (emphasis added). Arguably, intellectual property claims would constitute a "claim" under Art. 241, and such claims would be subject to negotiation. State practice indicates an increase in such negotiations. Coastal States have also used UNCLOS Art. 249.2 to restrict the publication by foreign researchers of MSR data, samples and results directly bearing on coastal State natural resources and obtained in coastal State waters.
Just as oceanographers did not welcome MSR regulation under UNCLOS Part XIII, but generally have complied with it in a satisfactory manner, Intellectual Property Rights issues arising under the CBD and TRIPS may cause initial concern, but are likely to lead eventually to a mutually beneficial accommodation between coastal and researching States' economic, scientific, and intellectual property interests over MSR data, samples and results. The UK study, when published, should shed much needed light in this area of international law if it examines in depth the issues outlined above.
About the Author:
Montserrat Gorina-Ysern is an International Law & Ocean Policy Consultant with extensive publications in the field, including a book on maritime law contracts (Editorial Bosch, Barcelona, 1984) and her forthcoming book on An International Regime for Marine Scientific Research (Transnational Publishers, N.Y. 2003). Doctor Gorina-Ysern has served as an adviser to the US Department of State, the US Commission on Ocean Policy and is currently an adviser to Conservation International on the concept of a World Ocean Public Trust. She teaches International Law & Legal Order at the School of International Service, American University in Washington, D.C.
[1] This article reproduces excerpts from Montserrat Gorina-Ysern, AN INTERNATIONAL REGIME FOR MARINE SCIENTIFIC RESEARCH, Transnational Publishers (Forthcoming 2003) with the publisher's permission.
[2] Biotechnology refers to a range of techniques for identifying, developing and using the properties of "living things" to make products or services. It selects "natural strains of organisms that carry desirable traits, makes hybrids by fusing cells from different parental sources, uses chemicals and radiation to create mutant strains, or genetically engineers plants, animals, and microorganisms to produce specific phenotypic characteristics." See Sean D. Murphy, Biotechnology and International Law 42:1, 47-139 HARVARD INT'L. L.J. (2001) at 47; see also GENOMES TO LIFE. ACCELERATING BIOLOGICAL DISCOVERY (US Department of Energy, Apr. 2001).
[3] PERSPECTIVES ON INTELLECTUAL PROPERTY (Peter Drahos and Michael Blakeney eds.) 160 (2001).
[4] See Scripps Scientists Discover Rich Medical Drug Resource in Deep Ocean Sediments Promising cancer-fighting candidates emerge from tropical ocean 'mud' at http://scrippsnews.ucsd.edu/article_detail.cfm?article_num=561; see also Access to Drugs During Public Health Crises, 2002 ABA ANNUAL MEETING (Washington, D.C.) August 9, 2002.
[5] Opportunities for Environmental Applications of Marine Biotechnology, NATIONAL RESEARCH COUNCIL (Washington, D.C.) October 1999.
[6] Biliana Cicin-Sain, Robert W. Knecht, Lori Denno Bouman, and Gregory W. Fisk, Emerging Policy Issues in the Development of Marine Biotechnology, 12 OCEAN YEARBOOK 179 (1996).
[7] Lyne Glowka, The Deepest of Ironies: Genetic Resources, Marine Scientific Research, and the Area, 12 OCEAN YEARBOOK 96 (1996) at 160.
[8] Cicin-Sain et al at 180 and 188 respectively.
[9] Intergovernmental Oceanographic Commission (of Unesco). Ocean Science for the Year 2000. Twelfth Session of the Assembly, Paris, November 3-20 1982, reprinted in OCEAN YEARBOOK (1983).
[10] MARINE BIOTECHNOLOGY IN THE TWENTY-FIRST CENTURY: PROBLEMS, PROMISE, AND PRODUCTS (National Academy of Sciences, 2002). Table 1. Some Examples of Commercially Available Marine Bioproducts.
[11] UNCLOS Art. 249.2 says, "This article is without prejudice to the conditions established by the laws and regulations of the coastal State for the exercise of its discretion to grant or withhold consent pursuant to Article 246, paragraph 5, including requiring prior agreement for making internationally available the research results of a project of direct significance for the exploration and exploitation of natural resources."