Biopiracy

Biopiracy is a negative term for the appropriation, generally by means of patents, of legal rights over indigenous knowledge - particularly indigenous biomedical knowledge - without compensation to the indigenous groups who originally developed such knowledge.^[1] A classic case is that of the Rosy Periwinkle (Madagascar Periwinkle).^[2] Research into the plant was prompted by the plant's traditional medicinal role and resulted in the discovery of a large number of biologically active chemicals, including vincristine, a lucrative agent useful during leukemia chemotherapy. A method for purifying vincristine was initially patented and marketed by Eli Lilly.^[3] It is widely reported that the country of origin did not receive any payment.^[4]

Biopiracy allegedly contributes to inequality between developing countries rich in biodiversity, and developed countries served by pharmaceutical industry exploiting those resources.

Bioprospecting is a more positive term more commonly used by supporters of commercialization of traditional medicines. While there is still no hard definition,^[5] media and academia use this less pejorative term when speaking about endeavors to capitalize on indigenous knowledge of natural resources. However, bioprospecting may also describe the search for previously unknown compounds in organisms that have never been used in traditional medicine.

Role in pharmaceutical research

In pharmaceutical research, thousands of dead-ends may be investigated before a positive result is found. The lobby group ETC (formerly Rural Advancement Foundation International) reports that random testing has a success rate of about 1:10000, but if testing is combined with local shamanic knowledge, the success rate can be improved to about 1:2.^[6] A less optimistic, but nevertheless significant success rate increase to 1:5000 is attributed to the NIH.^[7]

Since knowledge of and practice with these compounds has typically accumulated over centuries or millennia within an ethnic group, pharmaceutical researchers have found this to be a good place to look for "leads" to new drugs.

Famous cases

The Rosy Periwinkle

The Rosy Periwinkle case dates from the 1950s. The Rosy Periwinkle, while native to Madagascar, had been widely introduced into other tropical countries around the world well before the discovery of vincristine. This meant that researchers could obtain local knowledge from one country and plant samples from another. The locally known medical properties of the plant were not the same as the medical properties discovered and commercially used by Eli Lilly. The use of the plant as a cure for diabetes was the original stimulus for research, but cures for cancer were the most important results. Different countries are reported as having acquired different beliefs about the medical properties of the plant.^[8] The Hodgkin's Lymphoma chemotherapeutic drug vinblastine is also derivable from the rosy periwinkle.^[3]

The Neem Tree

In 1995 the U.S. Department of Agriculture and a pharmaceutical research firm received a patent on a technique to extract an anti-fungal agent from the Neem tree (Azadirachta indica), which grows throughout India; Indian villagers have long understood the tree's medicinal value. Although the patent had been granted on an extraction technique, the Indian press described it as a patent on the Neem tree itself; the result was widespread public outcry, which was echoed throughout the developing world. Legal action by the Indian government followed, with the patent eventually being overturned (2005).^[9]

Importantly, the pharmaceutical company involved in the Neem case argued that as traditional Indian knowledge of the properties of the Neem tree had never been published in an academic journal, such knowledge did not amount to "prior art" (prior art is the term used when previously existing knowledge bars a patent).

In response to biopiracy threats such as this, India has been translating and publishing ancient manuscripts containing old remedies in electronic form. The texts are being recorded from Sanskrit, Urdu, Persian and Arabic; they will be made available to patent offices in English, German, French, Japanese and Spanish in 2006. The aim is to protect India's heritage from being exploited by foreign companies. Hundreds of Yoga poses are also kept in the collection. The project has been criticized by a spokesman for the pharmaceutical industry as "a solution in search of a problem".^[10]

The Enola Bean

The Enola bean is a variety of Mexican yellow bean, so called after the wife of the man who patented it for the variety's distinct shade of yellow in 1999.^[11] The patent-holder subsequently sued a large number of importers of Mexican yellow beans with the following result: "...export sales immediately dropped over 90% among importers that had been selling these beans for years, causing economic damage to more than 22,000 farmers in northern Mexico who depended on sales of this bean."^[12] A law suit was filed on behalf of the farmers, and on April 14, 2005 the US-PTO ruled in favor of the farmers. An appeal was heard on 16 January 2008, and the patent was revoked in May 2008.^[13]

The Hoodia Cactus

The Hoodia Cactus originates from the Kalahari Desert of South Africa. For generations it has been known to the traditionally-living San people as an appetite suppressant. In recent years (2004 onwards) there has been sensationalist media coverage of the cactus. Derived products may be introduced into developed countries as a cure for obesity. The long-term benefits are controversial.

Further cases

The following is a selection of some of the more interesting cases in recent biopiracy studies.

Legal and political aspects

Patent law

One common misunderstanding is that pharmaceutical companies patent the plants they collect. While obtaining a patent on a naturally occurring organisms is not possible, patents may be taken out on specific chemicals isolated or developed from plants. Often these patents are obtained with a stated and researched use of those chemicals.^{citation needed} Generally the existence, structure and synthesis of those compounds is not a part of the indigenous medical knowledge that led researchers to analyze the plant in the first place. As a result, even if the indigenous medical knowledge is taken as prior art, that knowledge does not by itself make the active chemical compound "obvious," which is the standard applied under patent law.

In the United States, patent law can be used to protect "isolated and purified" compounds. In 1873, Louis Pasteur patented a "yeast" which was "free from disease" (patent #141072). Patents covering biological inventions have been treated similarly. In the 1980 case of Diamond v. Chakrabarty, the Supreme Court upheld a patent on a bacterium that had been genetically modified to consume petroleum, reasoning that U.S. law permits patents on "anything under the sun that is made by man." The United States Patent and Trademark Office (USPTO) has observed that "a patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature".^[14]

Convention on Biological Diversity (CBD)

The CBD came into force in 1993. It secured rights to control access to genetic resources for the countries in which those resources are located. One objective of the CBD is to enable lesser-developed countries to better benefit from their resources and traditional knowledge. Under the rules of the CBD, bioprospectors are required to obtain informed consent to access such resources, and must share any benefits with the biodiversity-rich country. However, some critics believe that the CBD has failed to establish appropriate regulations to prevent biopiracy. Others claim that the main problem is the failure of national governments to pass appropriate laws implementing the provisions of the CBD^[16]. The CBD has been ratified all countries in the world except for the United States, Somalia, Iraq, Andorra, and Brunei. The 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) and the 2001 International Treaty on Plant Genetic Resources for Food and Agriculture are further relevant international agreements.

Bioprospecting contracts

The ethical debate has sparked a new branch of international patent and trade law. Bioprospecting contracts lay down the rules, between researchers and countries, of benefit sharing and can bring royalties to lesser-developed countries. However, the fairness of these contracts has been a subject of debate. Unethical bioprospecting contracts (as distinct from ethical ones) can be viewed as a new form of biopiracy.

An extensively discussed example of a bioprospecting contract is the INBio agreement between Merck and Costa Rica.^[17]

Ownership

The rights at issue in the biopiracy debates are primarily ownership rights. Who owns the earth's biodiversity?^[18] Under what circumstances is it appropriate to talk of 'ownership' of biodiversity, or of particular elements of it?

Ownership rights of national governments

Under current international law, national governments exercise a degree of physical control over the biological resources within their country, just as they control mineral rights. However, it is less clear that governments have the right to control knowledge of the application of biological resources, nor are governments able in practice to control the extraction of biological resources in small amounts for research purposes. Moreover, regardless of the theoretical legal situation, the case for national governments having an ethical right to ownership of their biological resources must be argued separately.^{citation needed}

An advantage of national government ownership is that some national governments may be strong enough to defend those property rights (e.g. against pharmaceutical corporations). There is little point in assigning property rights to parties who are too weak to defend them.^{citation needed}

One problem with national government ownership is that there may be conflicts of interest in developing countries between national governments and local communities. High biodiversity tends to occur in the least developed regions. National governments tend to represent the more developed and urbanised populations of a country. Ethnic and historical gaps between governmentally well-represented groups and the populations of the least developed regions are not infrequent. The knowledge at issue in the biopiracy debates is the knowledge of these local communities, not the knowledge of their governments.^{citation needed}

Ownership rights of local communities

One might argue that it is the local communities who possess the traditional biomedical knowledge should benefit from the commercial use of such knowledge. Ownership rights should be attributed to these communities in order to safeguard their interests.^{citation needed}

An argument against this is that patent and copyright law have long been understood as merely temporary legal mechanisms for allowing inventors to recoup some profits - enough to motivate them to make their discoveries in the first place. The ethical basis of intellectual property thinking is that knowledge is a public good over which a monopoly is only temporarily granted to any specific possessor of that knowledge. Patents and copyrights expire, and rightly so, so that everyone can eventually benefit. If one applied this thinking to the ownership rights of local communities, their intellectual property rights would have long since expired in the interests of the benefit of the rest of humanity.^{citation needed}

All humankind as the owner of biodiversity

A more humanistic view of this debate is the claim that biodiversity is something that should be held in common by people in general. Such that any and all people who have a need for an advantage reaped by scientific exploration should be granted access to it.

Temporary patent rights imply that entrepreneurship is valued and investing in new research and experimentation can be profitable.

Consequentialist arguments

Consequentialist arguments typically look at issues such as the maximisation of utility or other benefits. In the case of the Rosy Periwinkle, the most important consequences are the numbers of children's lives saved (and those of various other types of cancer sufferer). An ownership right entails the right to refuse use to anyone - in other words, a deontological approach to the biopiracy problem would logically entail that the owner of the biological resource could impose (for example) export licences and then refuse to grant these or restrict them excessively. To the consequentialist mind, it is intuitively intolerable that large numbers of children should have to die out of respect for a government's property rights.^{citation needed}

The Rosy Periwinkle case is somewhat exceptional, however - the benefits arising from vincristine are unusual among pharmaceutical products. In the case of the Enola bean the consequentialist arguments clearly favour the interests of Mexican bean farmers. In the case of the Hoodia cactus the moral need for the drug is less obvious, while at the same time the payment of significant compensation to the San would probably have the consequence of finally destroying their fragile way of life.^{citation needed}

An alternative approach to the utilitarian argument assesses claims of biopiracy by examining the economic incentives underlying each step of the inventive transformation of genetic information into commercially valuable applications. Because most ethnobiological information already lies in the public domain, a utilitarian approach to intellectual property as a tool for persuading inventors to disclose their discoveries in exchange for a temporary patent undermines most claims to compensation for alleged biopiracy.^[19]

Virtue-based arguments

A virtue-based approach might argue that there is something fundamentally and intuitively offensive about taking shamanic knowledge from traditional communities and making millions out of this without paying anything back to the communities in question. A virtue-based approach can thus bypass the difficult rights issues while nevertheless appealing to fundamental concepts of virtue to encourage some kind of exchange between prospectors and indigenous peoples.^{citation needed}

References

^ An extended discussion of the definition of biopiracy: Graham Dutfield (2004). "What is Biopiracy?". International Expert Workshop on Access to Genetic Resources and Benefit Sharing.
^ Mitzi Perdue, The Rosy Periwinkle
^ ^a ^b Karasov, C. (2001). "Who Reaps the Benefits of Biodiversity?". Environmental Health Perspectives 109 (12): A582–A587. doi:10.2307/3454734.
^ Living Rainforest, Cancer cured by the rosy periwinkle
^ UNU-IAS Report Bioprospecting of Genetic Resources in the Deep Seabed: Scientific, Legal and Policy Aspects p.15
^ Rural Advancement Foundation International (1994), Bioprospecting/Biopiracy And Indigenous Peoples.
^ Global Exchange (2004), Biopiracy: A New Threat to Indigenous Rights and Culture in Mexico.
^ Smithsonian Centre for Education and Museum Studies, A traditional brew leads to cancer cure.
^ Vandana Shiva, The neem tree - a case history of biopiracy
^ John Lancaster (2006), Age-old cures go online
^ L. Pallottinia, E. Garciab, J. Kamic, G. Barcacciaa and P. Gepts (2004). "The Genetic Anatomy of a Patented Yellow Bean". Crop Science 44: 968–977.
^ Danielle Goldberg (2003), Jack and the Enola Bean
^ http://www.ciat.cgiar.org/newsroom/enolabean2008.htm
^ US Patent and Trademarks Office (2001), Utility Examination Guidelines
^ Jim Chen (2005). "The Parable of the Seeds: Interpreting the Plant Variety Protection Act in Furtherance of Innovation Policy". Notre Dame Law Review 81: 105–166.
^ International Chamber of Commerce: Access and benefit-sharing; protection of traditional knowledge [1]
^ John Eberlee (2000), Assessing the Benefits of Bioprospecting in Latin America
^ Paul Gepts (2004). "Who Owns Biodiversity, and How Should the Owners Be Compensated?". Plant Physiology 134: 1295–1307. doi:10.1104/pp.103.038885. PMID 15084724.
^ Jim Chen (2006). "There's No Such Thing as Biopiracy ... And It's a Good Thing Too". McGeorge Law Review 37.

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