Commercialization of traditional medicines
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Biopiracy and bioprospecting
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Bioprospecting is an umbrella term describing the discovery of new and useful biological samples and mechanisms, typically in less-developed countries, either with or without the help of indigenous knowledge, and with or without compensation. In this way, bioprospecting includes biopiracy and also includes the search for previously unknown compounds in organisms that have never been used in traditional medicine.
Biopiracy is a situation where indigenous knowledge of nature, originating with indigenous people, is exploited for commercial gain without permission from and with no compensation to the indigenous people themselves. Detractors of utilization of natural knowledge such as Greenpeace claim these practices contribute to inequality between developing countries rich in biodiversity, and developed countries hosting companies which engage in 'biopiracy'.
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. The Hodgkin's Lymphoma chemotherapeutic drug vinblastine is also derivable from the rosy periwinkle.
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 and Nepal; 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, echoed throughout the developing world. Legal action by the Indian government followed, with the patent eventually being overturned in 2005.
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). Public knowledge and public disclosure (including oral or written descriptions) is considered prior art in most countries.
The Enola Bean
The Enola bean is a variety of Mexican yellow bean, so called after the wife of the man who patented it in 1999.. The allegedly distinguishing feature of the variety is seeds of a specific shade of yellow. 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." A lawsuit was filed on behalf of the farmers, and on April 14, 2005 the USPTO ruled in favor of the farmers. An appeal was heard on 16 January 2008, and the patent was revoked in May 2008. An appeal to the court against the revocation was unsuccessful (Decided October 2009).
In 2000, the US corporation RiceTec (a subsidiary of RiceTec AG of Liechtenstein) attempted to patent certain hybrids of basmati rice and semi-dwarf long-grain rice (see U.S. Patent No. 5,663,484). The Indian government intervened and several claims of the patent were invalidated. Meanwhile, the European Commission has agreed to protect basmati rice under its regulations pertaining to geographical indications.
Hoodia, a succulent plant, 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 plant. Derived products may be introduced into developed countries to help obesity. The long-term benefits are controversial.
The following is a selection of some of the further cases in recent biopiracy studies. Most of them do not relate to traditional medicines.
- A large selection of African biopiracy cases are discussed at GhanaWeb's Public Agenda (March 31, 2006)
- The case of the Maya people's pozol drink is discussed in The New England Journal of International and Comparative Law and at Global Exchange
- The case of the Maya and other people's use of Mimosa tenuifolia, including many other such cases in general are discussed at GRAIN
- The case of the Andean maca radish is discussed in the American University's Trade Environment Database
- The United Kingdom Select Committee on Environmental Audit 1999; Appendices to the Minutes of Evidence, Appendix 7: Trade Related Intellectual Property Rights (TRIPs) and Farmers' Rights interestingly lists and describes the cases of turmeric (India), karela (India), quinoa (Bolivia), brazzein berries (Gabon), and others.
Legal and political aspects
One common misunderstanding is that pharmaceutical companies patent the plants they collect. While obtaining a patent on a naturally occurring organism as previously known or used 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. 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 - even, in one instance, a new chemical element (see USP 3,156,523). 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".
Also possible under US law is patenting a cultivar, a new variety of an existing organism. The patent on the enola bean (now revoked) was an example of this sort of patent. The intellectual property laws of the US also recognize plant breeders' rights under the Plant Variety Protection Act, 7 U.S.C. §§ 2321-2582.
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. The CBD has been ratified by all countries in the world except for Andorra, Holy See and United States. 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.
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.
On June 14, 2011, Colombia approved a policy for the sustainable commercial use of its biodiversity resources, primarily through the development of biotechnology research. It includes plans to set up a national company for bioprospecting to link up with the commercial sector and will be backed with US$14 million in government funds over the next four years.
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The rights at issue in the biopiracy debates are primarily ownership rights. Who (if anyone) owns the Earth's biodiversity? Under what circumstances is it appropriate to talk of 'ownership' of biodiversity, or of particular examples of it? Various and sometimes inconsistent regional and international laws and regulations assign ownership rights to many entities. Moreover, regardless of the legal situation, the case for any party having an ethical right to ownership of biological resources is a separate issue.
Ownership rights of national governments
Under current international law, national governments may exercise 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 (or even the power) to control resources that have left the country legally. It is equally unclear how public knowledge relating to the application of biological resources is to be controlled.
An advantage of national government ownership is that some national governments may be strong enough to defend property rights (e.g. against pharmaceutical corporations or other nations). Among objections to national government ownership is the fact 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, historical, and cultural 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 often the knowledge of local communities, not the knowledge of their governments.
Ownership rights of local communities
Many groups argue that it is the local communities who possess the traditional biomedical knowledge who should benefit from the commercial use of such knowledge. Ownership rights should be attributed to these communities in order to safeguard their interests.
One argument against this is that patent and copyright law are widely implemented as temporary legal mechanisms. Under most intellectual property laws, patents and copyrights expire. In many cases where local communities have been using traditional medicines for generations, these kinds of intellectual property rights would have expired. Many such indigenous groups maintain that their knowledge of the medicines should be protected on an international scale according to each group's internal intellectual property laws (see Indigenous intellectual property).
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. Under this view, any and all people who have a need for an advantage reaped by scientific exploration should be granted access to it. This view may be difficult to reconcile with intellectual property law and with the Convention on Biological Diversity.
In the case of the Rosy Periwinkle, the most noticeable consequence of the plant's widespread medicinal use is the numbers of cancer patients whose lives it saved. Most ownership rights entail the right to refuse certain uses, and a Consequentialist might conclude that the benefit of saving people's lives should outweigh and supersede property rights. In the case of the Enola bean, however, Consequentialist arguments favour the interests of Mexican bean farmers.
An alternative approach to the utilitarian Consequentialist argument assesses claims of biopiracy by examining the economic incentives underlying each step of the inventive transformation of genetic information into commercially valuable applications. In this reasoning, the benefit of awarding a temporary patent as an incentive for parties that use this information to develop a medicine that can be widely distributed outweighs claims to compensation for alleged biopiracy, especially given the premise that most ethnobiological information already lies in the public domain.
Many virtue-based arguments hold that there is something fundamentally and intuitively offensive or wrong about outsiders using traditional knowledge from indigenous communities to make a profit without compensating the communities in question. Virtue-based debates underlie many of this controversy's ethical issues. Many virtue-based approaches recognize the importance of human knowledge of biodiversity while encouraging some kind of exchange between bioprospectors and indigenous peoples.
Traditional knowledge database
In response to biopiracy threats faced in cases of turmeric, neem and basmati rice, Government of India has been translating and publishing ancient manuscripts containing old remedies in electronic form, and in 2001 the Traditional Knowledge Digital Library was set up as repository of 1200 formulations of various systems of Indian medicine, such as Ayurveda, Unani and Siddha. The texts are being recorded from Sanskrit, Urdu, Persian and Arabic; made available to patent offices in English, German, French, Japanese and Spanish. 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". The library has also signed agreements with leading international patent offices such as European Patent Office (EPO), United Kingdom Trademark & Patent Office (UKPTO) and the United States Patent and Trademark Office to protect traditional knowledge from biopiracy as it allows patent examiners at International Patent Offices to access TKDL databases for patent search and examinations purposes.
- Intellectual capital
- List of environment topics
- Natural capital
- Biological patent
- Traditional knowledge
- Intellectual property
- Plant breeders' rights
- ^ http://www.oha.org/pdf/bioprospecting/20071130/definition.doc
- ^ http://www.scq.ubc.ca/bioprospecting-a-new-western-blockbuster-after-the-gold-rush-the-gene-rush/
- ^ http://www.thefreedictionary.com/biopiracy
- ^ http://www.greenpeace.org/australia/issues/GE/overview/causes/corporate/patents-and-biopiracy
- ^ Smithsonian Centre for Education and Museum Studies, A traditional brew leads to cancer cure.
- ^ Karasov, C. (2001). "Who Reaps the Benefits of Biodiversity?". Environmental Health Perspectives (Environmental Health Perspectives, Vol. 109, No. 12) 109 (12): A582–A587. doi:10.2307/3454734. JSTOR 3454734. PMC 1240518. PMID 11748021.
- ^ Vandana Shiva, The neem tree - a case history of biopiracy
- ^ a b c d "Know Instances of Patenting on the UES of Medicinal Plants in India". PIB, Ministry of Environment and Forests. May 6, 2010. http://pib.nic.in/release/release.asp?relid=61511. Retrieved 21 May 2010.
- ^ 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. http://papers.ssrn.com/abstract=784189.
- ^ International Chamber of Commerce: Access and benefit-sharing; protection of traditional knowledge 
- ^ John Eberlee (2000), Assessing the Benefits of Bioprospecting in Latin America
- ^ Fog, Lisbeth (July 6, 2011). "Colombia to commercialise its biodiversity". SciDev.net. http://www.scidev.net/en/news/colombia-to-commercialise-its-biodiversity.html. Retrieved July 11, 2011.
- ^ http://www.dnp.gov.co/portalweb/LinkClick.aspx?fileticket=8Ybn45Qx_sE%3D&tabid=1260 "Documento Conpes: Consejo Nacional de Política Económica y Social República de Colombia Departamento Nacional de Planeación," Official Colombian government policy document, June 14, 2011, accessed July 11, 2011
- ^ Paul Gepts (2004). "Who Owns Biodiversity, and How Should the Owners Be Compensated?". Plant Physiology 134 (4): 1295–1307. doi:10.1104/pp.103.038885. PMC 419806. PMID 15084724.
- ^ Jim Chen (2006). "There's No Such Thing as Biopiracy ... And It's a Good Thing Too". McGeorge Law Review 37. http://papers.ssrn.com/abstract=781824.
- ^ Traditional Knowledge Digital Library website.
- ^ John Lancaster (2006), Age-old cures go online
- ^ "CSIR wing objects to Avesthagen patent claim". Live Mint. Apr 28 2010. http://www.livemint.com/2010/04/28214947/CSIR-wing-objects-to-Avesthage.html.
- ^ "India Partners with US and UK to Protect Its Traditional Knowledge and Prevent Bio-Piracy". Press Information Bureau, Ministry of Health and Family Welfare. April 28, 2010. http://pib.nic.in/release/release.asp?relid=61122. Retrieved 25 May 2010.
Bibliography and resources
- The Secretariat of the Convention on Biological Diversity (United Nations Environment Programme) maintains an information centre which as of April 2006 lists some 3000 "monographs, reports and serials".
- Secretariat of the Convention on Biological Diversity (United Nations Environment Programme), Bibliography of Journal Articles on the Convention on Biological Diversity (March 2006). Contains references to almost 200 articles. Some of these are available in full text from the CBD information centre.
- Shiva, Vandana (1997). Biopiracy : The Plunder of Nature and Knowledge. South End Press.
- Jim Chen (2005). "Biodiversity and Biotechnology: A Misunderstood Relation". Michigan State Law Review 2005: 51–102. http://papers.ssrn.com/abstract=782184.
- Out of Africa: Mysteries of Access and Benefit-Sharing - a 2006 report on biopiracy in Africa by The Edmonds Institute
- Cape Town Declaration - Biowatch South Africa
- Genetic Resources Action International (GRAIN)
- Third World Network (TWN)
- Indian scientist denies accusation of biopiracy - SciDev.Net
- African 'biopiracy' debate heats up - SciDev.Net
- Bioprospecting: legitimate research or 'biopiracy'? - SciDev.Net
- ETC Group papers on Biopiracy : Topics include: Monsanto’s species-wide patent on all genetically modified soybeans (EP0301749); Synthetic Biology Patents (artificial, unique life forms); Terminator Seed Technology; etc...
- Coalition Against Biopiracy: Captain Hook Awards and Cog Awards http://www.captainhookawards.org/
- Richard Stallman on Biopiracy
- Biopirates in the Americas - By Carmelo Ruiz-Marrero, AlterNet (June 3, 2003).
- The US Patent System Legalizes Theft and Biopiracy - By Vandana Shiva.
- Who Owns Biodiversity, and How Should the Owners Be Compensated?, Plant Physiology, April 2004, Vol. 134, pp. 1295–1307
- Review article on bioprospecting from The Science Creative Quarterly
- Heald, Paul J. (2001), "'Your Friend in the Rain Forest': An Essay on the Rhetoric of Biopiracy" . Available at SSRN: http://ssrn.com/abstract=285177 or DOI: 10.2139/ssrn.285177
- Traditional Ecological Knowledge Prior Art Database
- An extensive master thesis on biopiracy by Johan Ragnar, Sweden