Commercialization of traditional medicines

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A white Rosy Periwinkle

Biopiracy has emerged as a term to describe the ways that corporations from the developed world allegedly claim ownership of or otherwise take unfair advantage of, the genetic resources and traditional knowledge and technologies of developing countries.

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

Many developing countries have drawn political and ethical analogies between perceived biopiracy and intellectual piracy, claiming that whilst the developing world is often guilty of disrespecting copyright, patents and other intellectual property, the developed world is often guilty of disrespecting the ownership of indigenous biological resources.

Bioprospecting is a more positive term more commonly used by supporters of commercialization of traditional medicines. While there is still no hard definition,[1] 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.

Contents

[edit] Famous cases

[edit] 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.[2] The Hodgkin's Lymphoma chemotherapeutic drug vinblastine is also derivable from the rosy periwinkle.[3]

[edit] The Neem Tree

A 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 in 2005.[4]

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".[5]

[edit] 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.[6] 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."[7] A lawsuit 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.[8] An appeal to the Court against the revocation was unsuccessful (Decided October 2009).

[edit] Basmati Rice

In September 1997, a Texas company called RiceTec won a patent (U.S. Patent No. 5,663,484) on "basmati rice lines and grains." The patent secures lines of basmati and basmati-like rice and ways of selecting that rice for breeding. RiceTec, owned by Prince Hans-Adam of Liechtenstein, faced international outrage over allegations of biopiracy. It had also caused a brief diplomatic crisis between India and United States with India threatening to take the matter to WTO as a violation of TRIPS which could have resulted in a major embarrassment for the United States.[9] Both voluntarily and due to review decisions by the United States Patent Office, RiceTec has lost most of the claims of the patent. This was a huge victory for Indian farmers who believed they faced enormous economic losses from the patent and that the right to call rice 'basmati' was being monopolised.

[edit] The Hoodia Cactus

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 to help obesity. The long-term benefits are controversial.

[edit] Further cases

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

[edit] Legal and political aspects

[edit] 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".[10]

Also possible under U.S. law is patenting a cultivar, a new variety of an existing organism. The patent on the Enola bean is 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.[11]

[edit] Convention on Biological Diversity (CBD)

Main article: Convention on Biological Diversity

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[12]. 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.

[edit] 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.[13]

[edit] Ownership

 This article may contain original research or unverified claims. Please improve the article by adding references. See the talk page for details. (September 2007)

The rights at issue in the biopiracy debates are primarily ownership rights. Who owns the earth's biodiversity?[14] 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.[citation needed]

[edit] 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.[citation needed]

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).[citation needed] 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.[citation needed] 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.[citation needed]

[edit] Ownership rights of local communities

Many groups 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]

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.[citation needed] 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).

[edit] 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.

[edit] Consequentialist arguments

Consequentialist arguments typically consider the maximisation of utility or other benefits.

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.[citation needed] In the case of the Enola bean, however, Consequentialist arguments favour the interests of Mexican bean farmers.[citation needed]

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, .[15]

[edit] Virtue-based arguments

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.[citation needed]

[edit] References

  1. ^ UNU-IAS Report Bioprospecting of Genetic Resources in the Deep Seabed: Scientific, Legal and Policy Aspects p.15
  2. ^ Smithsonian Centre for Education and Museum Studies, A traditional brew leads to cancer cure.
  3. ^ Karasov, C. (2001). "Who Reaps the Benefits of Biodiversity?". Environmental Health Perspectives 109 (12): A582–A587. doi:10.2307/3454734. http://links.jstor.org/sici?sici=0091-6765%28200112%29109%3A12%3CA582%3AWRTBOB%3E2.0.CO%3B2-1. 
  4. ^ Vandana Shiva, The neem tree - a case history of biopiracy
  5. ^ John Lancaster (2006), Age-old cures go online
  6. ^ L. Pallottinia, E. Garciab, J. Kamic, G. Barcacciaa and P. Gepts (01 May 2004). "The Genetic Anatomy of a Patented Yellow Bean". Crop Science 44 (3): 968–977. http://crop.scijournals.org/cgi/content/abstract/44/3/968. 
  7. ^ Danielle Goldberg (2003), Jack and the Enola Bean
  8. ^ http://www.ciat.cgiar.org/newsroom/enolabean2008.htm
  9. ^ Basmati Case Study
  10. ^ US Patent and Trademarks Office (2001), Utility Examination Guidelines
  11. ^ 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. 
  12. ^ International Chamber of Commerce: Access and benefit-sharing; protection of traditional knowledge [1]
  13. ^ John Eberlee (2000), Assessing the Benefits of Bioprospecting in Latin America
  14. ^ 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. 
  15. ^ 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. 

[edit] Bibliography and resources

[edit] See also

[edit] External links

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