Intellectual Property and Genetic Resources; the Regulatory Challenge
World Intellectual Property Organization
20 – 22 January 2021
Seminar on Intellectual Property and Genetic Resources
As the coronavirus and its implications continue to hinder and plague the global community, rapid advances are constantly being made in the field of genomics. This is also causing new complexities to emerge around the legal control of genetic resources.
The past year included many new challenges for the World Intellectual Property Organization (WIPO). Genetic developments occurred at a rapid pace, demanding the WIPO to reschedule previously planned meetings, and work around the disruptions caused by the coronavirus pandemic. This also affected the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) meeting. In light of these challenges, the WIPO set up a seminar on Intellectual Property and Genetic Resources, which took place between 20 and 22 January 2021. Despite the seminar not being an official part of the IGC process, the empirical nature of this seminar provided an invaluable platform for the parties committed to the IGC and its mandate to exchange information and share ideas based on recent developments .
The development of biofuels in the search for alternatives to fossilized-carbon energy has led to rapid advances being made in the fields of synthetic and molecular biology. Information technology also help seed up the release of numerous new products, such as the new vaccines in the ongoing attempts to combat the coronavirus. Control of genetic resources are inevitably playing a more dominant role in global developments.
These examples, highlighted by the Director General of WIPO Daren Tang at the start of the three-day seminar, are indicative of the extent that genetic resources are present in our everyday life. Inevitably, the WIPO will play a more vital role in the drive to provide for international legal stability on these matters. The main challenge will be to create an IP system which can at national, regional, and international levels foster innovation and protect the interests of the people committed to such innovations. However, such an IP system would also have to recognize and safeguard the biodiversity of countries and Indigenous Peoples and communities, all with their own rights and interests in genetic resources and associated traditional knowledge. With these issues in mind, the exploration of possible future IP-ecosystems for genetic resources was an underlying objective throughout the three-day seminar.
The seminar was conducted under three main themes, each assigned to a particular day. The opening day focused on the Disclosure Requirements relating to genetic resources and associated traditional knowledge. When it comes to applying for intellectual property patents regarding genetic resources and associated traditional knowledge, applicants are required to disclose information such as the source of origin of the genetic resource and any prior informed consent obtained. Surveys and information were presented by experts in the field based on experiences and recent studies on the implementation of such regional and national disclosure requirements. The diverse background of these experts provided for a unique exchange of insights.
The Nagoya Protocol (2010) and its effects on disclosure and Access Benefit Sharing (ABS) was presented by Pierre du Plessis, who played a leading technical role in the African negotiations throughout the Protocol’s development. The lack of progress on Article 10 of the Nagoya Protocol, aimed at providing a global multilateral benefit sharing mechanism, faced some difficulty in obtaining bilateral solutions on disclosure and transparency for related patents. This came across in striking contrast to the urgent challenges which biodiverse countries and communities are facing due to the rapid developments in the scientific field. International treaties, such as the UN Declaration on the Rights of Indigenous Peoples (2007) and the Nagoya Protocol itself, are indicative of efforts to tackle these increasing challenges.
In contrast to these international developments, progress on national level in legal dealings with genetic resources and patent applications provided some reason for optimism. The case of Switzerland serves as a promising example with its adoption of a Patent Disclosure Requirement (PDR) and was presented by Marco d’Alessandro of the Swiss Federal Institute of Intellectual Property. In Switzerland, patent applications are required to provide the primary source of the genetic resource, namely the country of origin. In cases where the primary source is unknown, the secondary source, the place where the source was collected by the applicant, must be provided. A clear differentiation is made between primary and secondary sources. This allows for a flexible PDR system, which in turn provides for easier applicant compliance whilst also allowing for effective legal regulation. Besides the Swiss example, other presentations during the day illustrated different national approaches to the issue, from New Zealand to Colombia. In light of these first-day presentations, it became clear that examples such as the Swiss PDR could provide a basis from which global transparency measures, regarding genetic resources and patents can help shape a global IP system capable of addressing genetic resources.
The second day of the seminars focused on the theme of Information systems and Due Diligence mechanisms relating to genetic resources and associated traditional knowledge. Information systems play a crucial role in assisting patent examiners with relevant past information to help prevent the granting of false patents to applicants. Due diligence mechanisms on the other hand play a key role in allowing access to genetic resources according to national and regional ABS systems. The day provided the opportunity for various presentations to relay different national approaches. It became clear that more than one approach to the matter is possible.
The United States Patent and Trademark Office (USPTO) and its approach to both information systems and due diligence mechanisms was presented by Dominic Keating, Director of the IP Attaché Program of the USPTO. This presentation provided an example of a highly technical and developed national approach. The minimum documentation periodical requirements for PCT patent applications adopted in this approach, relevant to genetic resources and traditional knowledge, act as a guide to support this high standard[1]. Alongside this minimum information requirement, the USPTO provide patent examiners access to other databases, such as the Northern Ontario Database and the Indian Traditional Knowledge Digital Library. This access enabling a better due diligence and a more thorough examining of patent applications.
In contrast to the technical and developed example of the USPTO, an interesting perspective was provided by Larisa Simonova of the Federal Institute of Industrial Property and the Federal Service of Intellectual Property of the Russian Federation. In Russia, specific treaties or standards dedicated to patent applications and genetic information and traditional knowledge have not been developed. Instead, the Russian Constitution, and Russian federal law and its principles, serve to protect against erroneous patents and to safeguard the interests of communities and peoples in associated traditional knowledge.
Alongside the presentations of various national approaches to information systems and due diligence mechanisms, Sue Noe, senior staff attorney of the Native American Rights Fund, provided another interesting insight into the native American experiences with regards to intellectual property rights on genetic resources and associated traditional knowledge. There appears to be a difference in requirements between human rights standard, evident through declarations such as the 2007 UN Declaration on the Rights of Indigenous Peoples[2], and intellectual property law and national approaches to information systems and due diligence mechanisms. The key concern here remains to ensure that any future intellectual property law and mechanisms will not undermine human rights law, which already sets a high standard of protection for communities and people associated with genetic resources and traditional knowledge. An interesting differentiation was made between two types of protections that intellectual property law may offer to communities and affected groups—Defensive and Positive Protection. Defensive protection assists in the avoidance of erroneous patents, while Positive Protection prevents the misuse of genetic resources and associated traditional knowledge. Ideally, a balance between the two would allow for better protection of the interests of all the involved parties.
The final day of the seminars covered the topic of Intellectual Property and Genetic resources: New and Emerging Technologies. Presentations were delivered by speakers with suitable technical and legal expertise reflected on emerging technologies, their impact on genetic resources and associated traditional knowledge, and how this affected the WIPO IGC negotiations. The rapid pace at which these new technologies keep on developing present a formidable task for future regulations. This prevailing concern set the tone for the third day of the seminar.
Clearly, synthetic biology and its impact upon the world appear central to topics on genetic resources and emerging technologies today. Synthetic biology in short provides for the application of engineering principles to redesign organisms with new abilities to benefit humanity. Professor Marcel Jaspars of the University of Aberdeen provided a fascinating presentation on this topic and the science behind Digital Sequencing Information” (DSI) and synthetic molecular biological engineering.
Using genetic sequencing, transcriptomics, proteomics and metabolomics, the genetic information (DNA, RNA, protein and metabolite information) of ecosystems, species, biodiversity and microbial communities and their environments can now be artificially modified. Access to genetic sequencing also allows for new and better understanding of how all these life forms exist, interact and function. Both technology and bioscience have advanced to such a degree that the duration of the sequencing process and the cost of DSI have now decreased significantly[3]. As a result, a persistent flow of DSI, bioengineered proteins, enzyme and DNA sequence data are now emerging. This creating the potential of many new therapeutics and essential medicines to enter the market in an effort to combat disease. As one example amongst many, using synthetic biology, quality-assured artemisinin-based combination therapies can now provide significant advances in new antimalarial drug production, this helping to sustain escalating global demands. From vaccines and industrial enzymes to food safety and conservation, DSI presents us with vast new possibilities and benefits. However, these new opportunities also cautions with the potential danger of undermining the economic and environmental stability of biodiverse countries and communities, and of the benefits of these technological advancements not being justly shared and distributed. Many new ethical issues are also inevitable as this new technology advances.
Undeniably the science of these new emerging technologies is developing at such a rapid pace, that policy and regulatory options in this field constantly have to confront new demands in what has become a challenging task indeed. Manuel Ruiz Muller, senior advisor and researcher of the Peruvian Society for Environmental Law, addressed this issue in his presentation. This is also emphasized in current discussions regarding regulations on DSI in the Nagoya Protocol, Food and Agricultural Organization (FAO) International Treaty on Plant Genetic Resources for Food and Agriculture, World Health Organization (WHO) Pandemic Influenza Preparedness (PIP) Framework and in various national processes. The question of whether DSI should enter the material scope of the ABS frameworks appears to be a contentious issue, with different interests providing different perspectives. The critical role of DSI in biodiversity research and development, combined with its potential economic value, remain a complex and sensitive issue. Various possible approaches to the regulatory frameworks and modalities regarding DSI were also presented at the seminar.
Bilateral transactional models, regulated and governed under existing benefit sharing obligations and principles of the Nagoya Protocol, represents one of these options. Open access bilateral models, involving a form of adhesion agreement between user and database of DSI, provides for terms and conditions that could help regulate the benefits sharing of DSI, and protect the country of origin. Other models presented included open access with multilateral benefit sharing, open access with subscription fees, (with terms and conditions upon subscription), and open access with levies. The main issue in all these regulatory models appear to be the differentiation between the economics of tangibles and the diametrically opposite economics of intangibles— both arguable within the scope of DSI and both falling under different regulatory reasonings. In conclusion, any regulatory model must consider, amongst a number of things, the importance of information flow in research, fairness and equity in benefit sharing, and take into consideration case study-based approaches while allowing for some flexibility.
Throughout the three days of the seminar, the complexity of the science of genetic resources was apparent. Its rapid development and its seemingly infinite potential emphasized the structuring of its IP regulatory in the future as a challenging task. The presentations and discussions during the three-day seminar served as a platform for many different perspectives to be delivered, from legal to scientific perspectives, to human rights and economic views. Aptly highlighted in the presentation by Sue Noe of the Native American Rights Fund, was the fact that due to the rapid paced development of the science involving genetic resources, intellectual property regulatory framework run the danger of possibly being outdated by the time it comes into practice. This is a flaw of all regulations and frameworks attempting to be too specific and can severely limit its scope.
What became clear is that the law and its regulations should attempt to steer away from mirroring emerging science. The essential advantage of law is found in its nature and principles, allowing for comprehensively addressing issues and taking into consideration numerous factors. It appears that the task of catching up to science through intellectual property instruments, standards or guidance, in order to regulate and safeguard communities and the people affected by, or involved in genetic resources, will always find itself one step behind.
Legal statutes, deriving from international treaties and declarations and then nationally adapted, may provide for a realistic grasp on the matter. The answers to the concerns of the future may in fact lie in principles that we already know.
Alexander Carl Dinopoulos 5 February 2021
CS Consulting
[1] E.g. Planta Medica, Korean Journal of Traditional Knowledge, Journal of Ethnopharmacology.
[2] E.g. Article 11(2): Affirms Indigenous Peoples’ right to redress for the unauthorized use of their TK, TCEs and GRs and associated TK.
[3] DNA Sequencing Costs: Data, National Human Genome Research Institute, https://www.genome.gov/about-genomics/fact-sheets/DNA-Sequencing-Costs-Data, (accessed 3 February 2021).