Bioprospecting, Traditional Knowledge, and Benefit Sharing

Abstract: How do biotech patent systems affect indigenous peoples, particularly in relation to health products? This question raises two distinct issues. First, the question of biopiracy—to what extent do patent systems necessarily exploit traditional indigenous knowledge to produce valuable medicinal products? Second, the question of patenting gene-sequence and gene-product information taken from living organisms, especially human beings—how can we justify patenting naturally occurring substances? And how should we negotiate the myriad ethical issues that arise from doing so? This chapter argues that the core of the biopiracy problem is not the availability of patents based on traditional indigenous information but rather the unfair acquisition of knowledge and the inequitable sharing of profits derived from developing such information into a valuable product. Solving this problem requires ensuring that traditional information is fairly acquired and that fair compensation is paid to the group from which the information derives. In regards to patenting gene-sequence and gene-product information, this chapter concludes that such issues equally affect indigenous and nonindigenous populations and that the best way to address them is by making policy changes.

Abstract: The rules that govern the collection and use of biological matter have changed dramatically in the last 15 years. Arising out of the Convention on Biological Diversity (CBD), the Access and Benefit-Sharing (ABS) project applies to research carried out for either purely scientific or commercial reasons, for which organisms or parts thereof and/or related traditional knowledge are obtained from countries that are party to the CBD and their local and indigenous communities. Other agreements have added new ABS legislation to govern the acquisition and use of biological material and related information. Everyone—including tourists, nature conservationists, scientists, photographers, and journalists—is subject to these new regulations. But scientists and researchers who seek to access and use proprietary genetic resources, biological matter, and related information (such as traditional knowledge and farming know-how) are especially affected by the ABS project. It is essential for scientists and researchers to understand the fundamental principles of ABS. This includes knowing the relevant rules, regulations, laws, customs, and conditions for benefit sharing in the country where one intends to conduct research and/or collect samples. One must carefully plan ahead for any such activities by contacting key organizations and filing the proper documentation. Lack of planning may lead to unfortunate and undesired outcomes, including fines, imprisonment, deportation, and denied future access. Planning is critical.

Abstract: The Convention on Biological Diversity (CBD) contains rules that clarify the rights and responsibilities of parties accessing biological resources from member nations. One aspect of the convention addresses the system that governs access to genetic resources and how the benefits arising from their use are shared. This legislation is commonly called the Access and Benefit-Sharing (ABS) program. Anyone pursuing collection activities, whether of tangible materials or intangible information, may be subject to these new regulations. Especially targeted are scientists and researchers who make significant use of proprietary genetic resources, biological matter, and related information, such as traditional knowledge and farming know-how. Therefore, it is important for all potential collectors to be familiar with the fundamental principles of ABS law as well as the procedures that must be followed in order to be fully compliant with the rules and regulations of the countries where collecting occurs. Well in advance of any collection activities, researchers should review the ABS situation, determine who could best answer questions about ABS, find authorized partners in the country of interest, locate relevant information on the specific ABS regime, and, most importantly, execute the documents, letters and agreements necessary to proceed with collection activities.

Abstract: There is an upward trend in demand for intellectual property protection in agriculture. While international agreements exist to protect agricultural biodiversity, the specific rights, benefits, and responsibilities of parties entering into commercial agreements that involve the use of genetic resources still must be clarified. This chapter provides practical guidance for creating agreements around the use of biodiversity resources, as well as guidance that may provide valuable insights for creating similar agreements on the use of unique agricultural resources.

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Abstract: Traditional knowledge (TK) is the information that people in a given community, based on experience and adapted to local culture and environment, have developed over time and that continues to develop. This knowledge is used to sustain the community and its culture, as well as the biological resources necessary for the continued survival of the community. Since 1948, international human-rights standards have recognized the importance of protecting intellectual property. Yet, to date, intellectual property (IP) rights are not adequately extended to the holders of TK. The requirements for IP rights protections under current IP regimes remain largely inconsistent with the nature of TK. As a result, it is neglected and considered part of the public domain with no protections or benefits for the knowledge holders, or expropriated for the financial gains of others, often referred to as biopiracy. This chapter presents basic IP concepts in the context of TK with specific attention to identifying, classifying, and protecting elements of TK. The advantages and disadvantages of the various IP protection options are discussed, and a number of case studies are presented to facilitate a better understanding of each option or issue.

Abstract: In the years since the Convention on Biological Diversity was adopted, issues of traditional knowledge have come to affect the legitimacy of the multilateral trading system, in general, and its IP (intellectual property) aspects, in particular. In order to engage indigenous knowledge in furthering socio-economic development, policy-makers will need to reconsider the prevailing notion of a fundamental dichotomy between indigenous and scientific knowledge and begin to challenge both types of knowledge. This chapter concentrates on traditional knowledge—and how it relates to the ecology of agriculture, in all of its variants—and compares it to recent advances in scientific knowledge and the resulting applications of biotechnology in global agriculture.

The chapter argues that this dichotomy between traditional and scientific ways of knowing is not only artificial but problematic, in that it hinders exchange and communication between the two. The dichotomy between traditional knowledge and scientific knowledge is most apparent in, and lies at the root of, perceived differences between the approaches of today’s organic farming and technology-intensive farming systems. While indeed there are important differences, traditional knowledge and scientific knowledge share important similarities. Knowledge, in both cases, is based on human observation and experience and is tested, replicated, and transmitted within its respective community through social institutions and mechanisms put in place for that purpose. Moreover, deeper examination of the genetic integrity of plants used within organic and biotechnology-based agricultural systems shows that the respective crop varieties being used under each system are more similar than they are different. Increasingly, organic farming is building on scientific knowledge, and agricultural biotechnology is seeking to draw on traditional knowledge.

This chapter challenges policy-makers and scientists to examine and, ultimately, to move beyond those conceptual worldviews, or constructs, that maintain the current divide between traditional knowledge/organic agriculture and scientific knowledge/agricultural biotechnology.

By building the bridge between traditional knowledge and science and becoming free to draw upon the best existing ideas and practices from both, a larger palate is available to draw from. But, more importantly, by integrating the innovation systems of both traditional and scientific communities, a much larger range of new ideas and practices could be generated. The chapter calls such dynamic integration the “participatory approach” to agricultural innovation, building upon the “unifying power of sustainable development” and leading to balanced choices in agricultural production chains and rural land use.

Such an integration would require adaptations of Western social institutions and mechanisms of intellectual property in order to interface in a more nuanced fashion with quasi-public-domain knowledge that is external to the published records of Western science and IP systems. At the same time, indigenous communities will need to learn to adapt their social institutions and mechanisms that govern what is, in a sense, sovereign or communal property to coexist with and at times be translated into formal IP rights and practical uses that are external to their traditional systems.

Abstract: As multinational technology-development partnerships have become more common, so have disputes between the parties. Litigation, however, is not the only option for resolving such disputes. In fact, for partnerships between entities in developing and developed countries, litigation may be a complicated, time-consuming, expensive, and doubtful process. Arbitration and mediation may offer the promise of more effectively resolving disputes, and this chapter explains how these methods work, their advantages and disadvantages, and suggests which questions should be asked (especially for a developing country institution) to begin to establish a dispute prevention and resolution strategy. The chapter offers both strategic and practical insights about how to use these mechanisms to resolve disputes and preserve partnerships.

Abstract: The chapter discusses the meanings of data protection and data exclusivity in the context of the provisions of the Trade-Related Aspects of Intellectual Property Rights agreement. In addition, it outlines the relationship between data exclusivity and patent protection and briefly reviews the possible costs and benefits of introducing data exclusivity laws. Finally, the chapter explains that countries need to consider the costs and benefits when negotiating bilateral trade agreements that might require the introduction of these laws.

Abstract: Ethical concerns and controversies about patenting are playing an increasingly prominent role in the development and applications of the biosciences. Despite the growing importance of ethical issues, there is currently no consensus or clarity on the ethical principles that should guide patenting of human, animal, and plant genes and cells. The three major areas of contention are: (1) whether some or all patents on genes and cells are unethical per se, based on concerns such as commodification, dignity, and similar concepts; (2) how tissue samples are collected, particularly in reference to the principles of prior informed consent and benefit sharing; and (3) how patents are used to restrict access to medical and agricultural use of biotechnology innovations. Given the lack of any agreed guiding principles for navigating these issues, policy-makers, decision-makers, scientists, and users of biotechnology have no choice but to address these contested ethical concerns using a case-by-case approach.

Abstract: This chapter outlines the range of plant variety protection regimes that currently exist internationally, including the International Convention for the Protection of New Varieties of Plants, the Convention on Biological Diversity, the Agreement on Trade-Related Aspects of Intellectual Property Rights, and the International Treaty on Plant Genetic Resources for Food and Agriculture. The chapter commences with a history of intellectual property laws affecting plant breeding and the genetic modification of plants. It explores the trend toward the harmonization of international standards and concludes with an examination of the impact of these developments upon germplasm exchange, international agricultural research, and food security.

Abstract: In ever-increasing numbers, institutions are establishing technology transfer offices (TTOs). These offices serve a variety of functions, all of which must be integrated to cost effectively transfer technologies and to benefit the institutions. A critical function of the TTO is to proactively manage intellectual property (IP) issues pertinent to crops. Crops can be covered by more than one form of IP rights protection, often simultaneously. These rights protections include trademarks, trade secrets, plant and utility patents, and plant variety protection (PVP). Closely related is the importance of careful and organized gene-bank management, a critical component of an overall IP and tangible property management system. PVP provides one type of protection that allows TTOs to responsively serve clients and generate revenue. PVP is a form of IP rights protection for crops with potentially global applications, and either a PVP office, or a PVP subsection in the TTO, would be wisely established by an institution. In addition, this chapter provides important information to assist in establishing a national PVP office and in the selection and implementation of various types of IP rights protection for crops and germplasm.

Abstract: This chapter reviews the options for effective public sector management of intellectual property (IP) in the life sciences, focusing on the need for a judicious, pragmatic choice of options along two axes: (1) deployment of exclusive rights over technology and (2) use of market mechanisms to bring a new technology to the public. The essence of public sector IP management is finding the right settings along these two axes that will deliver tangible outcomes in line with defined public-interest objectives. Experience shows that ex ante assumptions about how to gain optimal leverage from exclusive rights, and the appropriate degree of reliance on market mechanisms, are unlikely to serve a public sector IP manager well. In clarifying objectives and the practical means of achieving them, pragmatic coordination between the practical and policy levels is essential. Public sector IP managers are more likely to be assessed against public interest expectations than their private sector colleagues. In IP management in the life sciences, policy and practice are ultimately two sides of the same coin; practitioners cannot hope, expect, or plan to operate outside the broader policy perspective. Policy-makers therefore need to consider the actual practice of IP management when assessing a policy framework for innovation in the life sciences. IP managers should be open to using legal mechanisms flexibly for inclusion, or exclusion, as required to achieve their goals. Finally, managers should seek mechanisms to pragmatically structure and promote partnerships with those who have the resources necessary to bring life-sciences innovation to the public. Such partnerships may be centered in the public, philanthropic, or private sectors, but more likely fall into a hybrid mix of these categories.

Abstract: This chapter sets out the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as related to intellectual property in health and agriculture and the policy work done in the World Trade Organization (WTO). The first part focuses on matters related to public health, including the protection of patents and undisclosed information. An overview is given of the three key instruments addressing the flexibilities available to Members of the WTO: the Doha Declaration on the TRIPS Agreement and Public Health, the Decision on the Implementation of Paragraph 6 of this Declaration, and the Protocol amending the TRIPS Agreement. The second part looks into TRIPS provisions relevant to agriculture and sets out the issues reviewed in the Council for TRIPS with respect to optional exclusions to patentability and the protection to be given to plant varieties. The second part also addresses work related to the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD), including the suggested introduction of a disclosure requirement into the patent system, as well as the protection of traditional knowledge. In addition, two issues relating to geographical indications are taken up, namely, the ongoing negotiations on the establishment of a multilateral register of geographical indications for wines and spirits, and the extension of the higher level of protection currently available for wines and spirits to other products. To complete the picture, the third part discusses WTO programs aimed at enhancing capacities in the developing world with respect to the TRIPS Agreement.

Abstract: In this chapter, the revenue consequences of varying collection fees and royalties with regard to germplasm prospecting contracts are demonstrated. Principal factors are the uncertainty of finding marketable products and the value of these products. Negotiation factors are finding a good balance between collection (initial) fees as opposed to royalty (delayed) payments. Emphasizing collection fees reduces total payments except when national interest rates are very high. Reducing the risk of failure through in-country screening, including the use of indigenous knowledge, is a potentially valuable activity. Issues for contract negotiators are outlined and the implications for biodiversity conservation discussed. Conceptually, the highest valuation approach, royalties, will most encourage conservation, but as the future is typically heavily discounted, collection payments may get more attention and be most effective. Policy considerations for national governments, nongovernmental organization (NGOs), and development agencies are reviewed and it is concluded that grants/loans and training/equipment for in-country screening should be given a high priority as a potentially viable activity in the long term.

It should be noted that the figures and calculations in this chapter are merely for illustration. The valuation of samples, and by extension a country’s biodiversity, is a negotiation and will depend on many factors, including alternative investment options by a company, alternative technologies that could be used for lead compounds, interest rates, and a range of risk factors, such as the political situation in a given country surrounding the national debate on bioprospecting. The latter point is a key factor: valuation is always a calculation that has important political consequences. Another complicating factor is the need for confidentiality with which a country and company will hold its overall business estimates. Neither a company nor a country will be likely to share their valuation basis purely for negotiation purposes and because neither want to tip off other entities about the opportunity. It is therefore concluded that, from a practical perspective, the proper valuation is the one that (1) provides the country with compensation and other benefits such that it does not feel taken advantage of and can withstand criticism from its constituents and (2) provides the licensee (typically a company) with a reasonable cost of obtaining the crucial raw or semifinished goods it requires as an input to its business.