Home > Topics > Bioprospecting, Traditional Knowledge, and Benefit Sharing > Biotechnology Patents and Indigenous Peoples > Editor's Summary, Implications and Best Practices

It has been argued that biotech patent systems have harmful effects on indigenous peoples, particularly in relation to health products. This chapter breaks these arguments down into two distinct questions. First, the question of “biopiracy”—to what extent do patent systems necessarily exploit traditional indigenous knowledge to produce valuable medicinal products? Second, how can we justify patenting gene-sequence and gene-product information taken from living organisms—especially human beings—when these are naturally occurring substances? And what about the host of ethical issues surrounding such patents?

The author argues that the core of the biopiracy problem is not patenting inventions derived from traditional indigenous information, but rather the sometimes unfair acquisition (misappropriation) of knowledge and then the inequitable sharing of profits derived from developing such information into a valuable commercial products. Pointing to the need for incentives for product development, the author cautions against exclusive information rights outside the patent and copyright regimes for indigenous people. Instead, provided that traditional information is acquired fairly and that fair compensation is paid to the group who “owns” the information, it is not the use of traditional knowledge in a patent that is inherently wrong. It is rather the inequitable misappropriation and subsequent profiteering that is the real problem. Therefore, the question becomes one of how to provide for fair and equitable compensation for traditional knowledge that finds its way into patent applications.

Policy makers should formulate methods for equitable access to the traditional knowledge held by indigenous societies. In this way, compensation can be provided to the “owners” of this information. However, there is a very delicate balance, in that access ought to be denied without permission, but, on the other hand, the price which is assessed for permission to bioprospect should not be so onerously high that it impedes companies and individuals from access. High permission costs effectively lock such information away, rendering its potential value inaccessible, both for the owners and for the potential developers.

In regard to patenting gene-sequence and gene product information, although historical analysis of the justification for such patents suggests that nothing in the language of the extant patent statutes or in the international IP or trade agreements requires that naturally occurring chemicals (DNA sequences and genes, and their natural products) be treated as patentable, isolated/purified genes or gene products can qualify as patentable subject matter provided that the utility and novelty requirements are met. Granting patents for naturally occurring substances per se is not permitted under U.S. patent law; however, patenting of gene sequences, which is permitted, appears to be an inconsistency that the courts have not yet settled. Patenting natural products, however, is not the unique concern of indigenous peoples; policymakers in developing and developed countries should resist pressure to adopt such changes. Patentabilty of natural products should not be determined solely on how it might impact indigenous peoples, but on how it impacts all. It is reasonable to argue that patents on upstream “inventions”, i.e., isolated genes, might in fact inhibit subsequent downstream research and development. This is because the upstream patenting of natural products, specifically isolated gene sequences alone, would effectively hamstring downstream incentives in inventive activity because it would lock-up the gene itself, removing it from the public domain. Also, such patents would inhibit information flow, promoting overinvestment in the search for genes and underinvestment in the utilization of genes for advanced applications. However, this is not an issue limited to concerns about the rights of indigenous peoples; it affects all, and should be dealt with accordingly.

The important ethical issues raised by gene-related patents include whether:

1. private control over genes or their products monopolizes the “common heritage of mankind,”
2. patents denigrate human life by reducing it to a commodity,
3. patents may be inconsistent with individual or collective privacy, and
4. patents promote distributive justice when they are concentrated in a few economically developed countries (a related concern is that patents on crop varieties might threaten biodiversity).

The chapter addresses these issues by observing that they equally affect both indigenous and non-indigenous populations, and that where there are differences in how costs or benefits are distributed, patenting is not the problem. In negotiating these and other issues concerning technology transfer and access, the author proposes that careful cost/benefit analyses should guide our decisions.

The “common heritage of mankind”, and what this logically might entail, if interpreted broadly, can include nearly everything. Therefore it might not represent an ideal legal strategy. A better way to deal with gene-related patents is through established patent law, wherein established rules and regulations better address this type of situation. This common heritage is not limited to indigenous peoples, as humankind (or mankind) includes all people, whether indigenous or not. Hence, traditional patent law is the best approach because the real question is not whether a gene or gene-product should be protected as the common heritage of humankind, but whether or not it is even an invention.

As for commoditization of genes and indigenous societies, it is difficult to see how this would impact most indigenous societies, who for the most part are far removed from the commodity markets of developed countries; it is simply not applicable. Furthermore, human genes most likely of value from indigenous population would inevitably pertain to those that confer some sort of positive advantage, and would therefore not implicate either privacy concerns or stigmatization. Once again, with a gene-related invention, patent law would likely most effectively address genes with value, i.e., conferring an advantage. Nevertheless, freely available information should not be protected by IP rights. If necessary, possibly other forms of legal theory will provide more suitable protection, such as breach of confidence or privacy rights. This might fit better into a more generalized argument for traditional knowledge as an ethical good.

One critical concern is whether patenting conflicts with indigenous knowledge and value systems. In a basic theoretical sense, patents can significantly add to costs to new inventions, and thereby act as barriers. However, when one balances the costs and benefits of patent law in developing counties, there might be no correlation between access and patent status in developing countries. Furthermore, assuming no redirection of patented biotechnology to more lucrative markets, the chapter points out that there would essentially be no financial loss to owners of such biotechnology if they were to sell at cost in such countries. However, prevention of product “leakage” would entail enforcement capacity. This sort of distribution is not feasible if market segmentation is not strictly maintained.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• There is potential value embedded in the traditional knowledge (TK) and/or bio-resources that indigenous populations hold stewardship over. In order to avoid biopiracy, yet also realize potential value, policies and laws that direct the management of these resources should be carefully balanced.
• Passage and enforcement of appropriate legislation, that coherently regulates access to and commercialization of indigenous TK resources, should foster equitable and sustainable sharing in product development. Although patent law can play an important part, other legal mechanisms, such as contract and unfair competition law can also be considered.
• Patent laws per se are not what drives biopiracy activities. Rather, misappropriation, unfair acquisition and subsequent inequitable sharing of benefits are the fundamental issues and problems.

For Senior Management (university president, R&D manager, etc)

• Management of traditional indigenous knowledge involves establishing policies, systems and protocols for implementing legislation aimed at balancing access for development and commercialization with equitable sharing of possible generated proceeds. This is implemented by an institution’s technology transfer office.

For Scientists

• Be aware, not only of the biological and sociological value of indigenous traditional knowledge and related genetic resources, but also of the potential commercial value. Hence, investigations and research ought to be conducted within guidelines set by the technology transfer office, for example, appropriate and timely disclosure of any potential inventions.
• Interactions with foreign colleagues and collaborators ought to be established according to institute and/or university policy guidelines, guidelines that are established to both preserve and reap the full value of these national natural resources.

For Technology Transfer Officers

• Your office can serve as a critical gateway for providing access to traditional indigenous knowledge and gene resources (a national natural resource) the value of which can be realized only via coherent and consistent management best practices. For intellectual property, including patents, your office ought to be able to recognize potential inventions, and likely commercial applications.
• When dealing with foreign bio-prospectors, your office will function as the gateway and regulator of their activities, for example, negotiating agreements for equitable sharing of rewards, defining access, discussing possible patentability, and protecting the rights of indigenous peoples, who are the stewards of these resources.