Debated Heroes from the Deep Sea - Marine Genetic Resources
A "black smoker" in the Atlantic Ocean - home to an extraordinary range of biodiversity. (Photo P.Rona, National Oceanic & Atmospheric Administration (NOAA))
By Kirsten E. Zewers
This article is adapted from an excerpt by Kirsten E. Zewers from her paper, “Bright future for marine genetic resources, bleak future for settlement of ownership rights: reflections on the United Nations Law of the Sea consultative process on marine genetic resources, June, 2007.”1 Kirsten Zewers is a former WIPO intern, currently studying law at the University of St. Thomas in Minneapolis, Minnesota.
Many miles beneath the water’s surface, a range of unique organisms have adapted to withstand the extreme pressure, temperature and toxicity of their surroundings, giving these organisms extraordinary properties unlike any terrestrial life forms. Recent technological advances have created unprecedented scope for exploration of the deep sea bed, and for research into the genetic material derived from the organisms which inhabit it. New discoveries are revealing their invaluable potential for biotechnological and pharmaceutical applications. This in turn has sparked debate about the extent of ownership rights or sovereignty over these genetic resources and the patentability of inventions derived from them.. These issues were the focus of negotiations at the United Nations Informal Consultative Process on the Oceans and the Law of the Sea (UNICPOLOS) in June 2007.
Most of the organisms from which these new marine genetic resources derive are found near hydrothermal vents – or “black smokers” – on the deep sea bed. These areas are highly volatile, associated with tectonic and volcanic activity that constantly reform the sea floor. Extreme changes in temperature (up to 400° C), pressure and hydrothermal fluid create difficult environments for sustainable life. Yet many organisms have adapted to such demands by converting hydrothermal vent fluid into useful chemical energy; a characteristic that makes marine genetic resources of particular value, especially in combating human diseases.
A number of marine genetic resources already collected, examined, and cultured, show great promise for application in pharmaceuticals, bio-remediation (e.g. the use of organic matter to clean hazardous waste spills) and cosmetics. Proteins coded by DNA and RNA derivatives extracted from marine genetic resources have, for example, been found to have therapeutic uses, including antioxidant, antiviral, anti-inflammatory, anti-fungal, antibiotic properties, as well as specific activity against HIV, some forms of cancer, tuberculosis and malaria. However, the development of new pharmaceuticals is an uncertain, lengthy and expensive process, often spanning many years and costing millions. So far, less than 1 percent of marine genetic resource derivatives have succeeded in reaching the final stage of clinical trials.2 Yet the ratio of potentially useful natural compounds has been found to be significantly higher in marine organisms than in land organisms, and the success rate regarding the development of potential anti-cancer agents is reportedly twice as high as for any land-based samples.3
Patentability of genetic material
To date some 37 patents have been granted in the United States (US) for products derived from marine genetic resources. But many questions continue to surround the basic patentability of these organisms.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) administered by the World Trade Organization (WTO) requires patents to be available for inventions “in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.” But TRIPS does not stipulate patent protection for the mere discovery of a living organism as it exists in nature, and national laws generally distinguish between simply discovering existing organisms, on the one hand, and inventions that are either useful derivatives from organisms, or genetically modified organisms on the other. So it is clear that marine life forms themselves cannot be patented in the form they are collected. But what about the commercially valuable genetic material derived from these organisms?
Valuable genetic resources. Tube worms living in deep sea hydrothermal vents have adapted to survive in conditions of extreme pressure, heat and toxicity. (Photo OAR/National Undersea Research Program (NURP) and C. Van Dover, OAR/NURP
Much international debate surrounds the patentability of whole or partial strands of DNA and RNA and different countries have taken very different approaches to this matter. The US for example, has generally allowed for patentability of genetic sequences, provided a specific utility is disclosed (merely identifying the existence of a sequence is not enough, for instance). But recent US case law (e.g. the In re Fisher decision, which held that genetic markers, known as expressed sequence tags, lack substantial and specific utility unless the underlying gene function is identified) and legislative action, such as the bill presented in Congress in February 2007to prohibit the patenting of human genetic material, suggest a trend towards more restrictive patentability standards for whole or partial strands of DNA and RNA.
In Europe, the European Patent Convention (EPC) excludes patents on inventions the commercial exploitation of which is contrary to ordre public or morality. The European Union Directive on the Legal Protection of Biotechnological Inventions, adopted in 1998, clarified that biological material could be considered a patentable invention provided it is isolated from its natural environment or produced by a technical process – in short, when it is the subject of inventive human intervention.
While setting a common minimum standard for patentable subject matter, TRIPS allows latitude for cultural and moral differences. Thus WTO members can exclude inventions from patentability when it is necessary to prevent commercial exploitation of the invention “to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment.” It also allows them to exclude from patentability plants and animals other than micro-organisms, and “essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.” Thus, under TRIPS, WTO members retain sovereignty over the question of which inventions should be considered contrary to morality.
Another challenge to the patentability of marine genetic resources lies in basic taxonomy. To meet patentability requirements, the inventor must disclose the invention fully, so that others reading the patent document will have enough information to reproduce the invention. This may entail, for instance, giving the full botanical name of plants used in the claimed invention, or references to deposits of microorganisms in recognized international collections. However, because some recently discovered marine genetic resources have unique properties and their taxonomy has not been settled, establishing a sufficiently precise reference in a patent document can be problematic.
Novelty, inventive step, capable of industrial application
Under TRIPS, and in line with already accepted international practice, an invention must be new or novel and be non-obvious or include an inventive step to be patentable. There is a general debate internationally about whether inventions that are derived from naturally occurring genetic material should be considered new and inventive. For instance, as we have seen, the EU Biotech Directive clarified that in Europe biological material can be considered patentable even if it is identical to material found in nature, provided there is sufficient human input to develop an invention that serves a useful purpose. Debate continues over what degree of ‘isolation’ and technical transformation of genetic material is enough to make it truly new and inventive for patent purposes.
Another TRIPS requirement for patent protection is that the invention is useful or capable of industrial application. Despite jurisdictional differences, many countries require inventors to state a specific use; hypothetical uses often do not meet patent requirements. However, as marine genetic resources have vast and several unknown possibilities, specific use requirements may limit the capacity of applicants to obtain patents on broad-brush claims over newly isolated marine genetic materials.
The final requirement for patent protection under the TRIPS agreement is that the invention be disclosed in a publication so as to enable a person skilled in the relevant art to reproduce the invention. However, it is questionable exactly how much background disclosure is required. In addition, a number of countries have introduced specific disclosure requirements relating to inventions based on or derived from genetic resources and traditional knowledge – with a view to tracking compliance with prior informed consent and equitable benefit sharing obligations. There are on-going debates within WIPO’s Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC) and in WIPO’s Standing Committee on Patents (SCP), as well as in the WTO (where an amendment to TRIPS has been tabled), as to whether there should be an international requirement for inventors to disclose the original source or origin of traditional knowledge or genetic resources used in an invention, as well as demonstration of compliance with prior informed consent and equitable benefit sharing arrangements. This debate also addresses issues of equitable remuneration, transfer of technology and benefit sharing. At this point, discussions have not yielded any resolution at the international level. But the inclusion of such requirements already in national laws, may already impact the process of patenting inventions based on marine genetic resources, even in the absence of any international standard.
Who owns marine genetic resources?
Due to the massive potential of marine genetic resources, significant debate surrounds ownership rights and entitlements to benefit from these organisms when they are located in areas beyond national jurisdiction. At the June 2007 meeting, UNICPOLOS delegates sought to negotiate ownership rights of marine genetic resources found in international waters beyond areas of national jurisdictions. The 1982 United Nations Convention on the Law of the Sea does not specifically address or regulate this issue.
Derivatives from marine sponges are well known as a source of pharmaceutical products, e.g. in the treatment of leukemia. (Photo John Reed, HBOI, NOAA Office of Ocean Exploration)
The Convention does, however, address various acts beyond areas of national jurisdictions, such as commercial fishing and marine scientific research. For example, the Convention says that all states’ nationals have a right to fish for profit on the high seas, allowing commercial fishing on a “first come, first served” basis (subject to cooperation with the conservation and management of living resources within the high seas). The Convention has also, over time, established guidelines regarding marine scientific research. Although this term is not specifically enumerated in the Convention, marine scientific research is understood to encompass the study of the marine environment and its resources for peaceful purposes, and to be carried out for the benefit of the common heritage of mankind, including equitable benefit sharing.
In trying to develop a draft document to be submitted to the UN General Assembly for adoption, the UNICPOLOS debate broadly diverged between developing and developed countries. By analogy with the regulation of marine scientific research within the Convention, developing countries proposed that the Convention should regulate bio-prospecting of marine genetic resources through equitable benefit sharing regimes for the common heritage of mankind.
Developed countries, however, argue that because marine genetic resources are not specifically defined in the Convention, they fall outside the scope of the Convention’s regulation. Developed countries draw an analogy with the rights of commercial fishermen in international waters beyond national jurisdictions, proposing that only the bio-prospectors who take the initiative to collect these organisms should own them.
Ultimately delegates were unable to agree whether or not the 1982 Convention on the Law of the Sea set out the legal framework within which all activities in the ocean and seas must be carried out. On midnight of June 29, 2007, the negotiations remained at a stalemate. Since then, delegations have been holding informal consultations, the outcome of which is unpredictable.
While marine genetic resource discovery is expanding, little progress has been made regarding their ownership rights in areas beyond national jurisdiction. However, given the pressing need for new pharmaceuticals derived from marine genetic material, despite issues over patentability and ownership, their tremendous economic potential will ensure that marine genetic resources remain a hot topic in the international community for years to come.
Acknowledgements: Tony Taubman, WIPO Life Sciences Program