Commercialization of indigenous knowledge
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Bioprospecting (also known as biodiversity prospecting) is the exploration of natural sources for small molecules,
macromolecule A macromolecule is a very large molecule important to biophysical processes, such as a protein or nucleic acid. It is composed of thousands of covalently bonded atoms. Many macromolecules are polymers of smaller molecules called monomers. The ...
s and biochemical and genetic information that could be developed into
commercially Commerce is the large-scale organized system of activities, functions, procedures and institutions directly and indirectly related to the exchange (buying and selling) of goods and services among two or more parties within local, regional, nation ...
valuable products for the
agricultural Agriculture or farming is the practice of cultivating Plant, plants and livestock. Agriculture was the key development in the rise of Sedentism, sedentary human civilization, whereby farming of Domestication, domesticated species created food ...
,
aquaculture Aquaculture (less commonly spelled aquiculture), also known as aquafarming, is the controlled cultivation ("farming") of aquatic organisms such as fish, crustaceans, mollusks, algae and other organisms of value such as aquatic plants (e.g. lot ...
, bioremediation, cosmetics,
nanotechnology Nanotechnology, also shortened to nanotech, is the use of matter on an atomic, molecular, and supramolecular scale for industrial purposes. The earliest, widespread description of nanotechnology referred to the particular technological goal o ...
, or pharmaceutical industries. In the pharmaceutical industry, for example, almost one third of all small-molecule drugs approved by the U.S. Food and Drug Administration (FDA) between 1981 and 2014 were either
natural product A natural product is a natural compound or substance produced by a living organism—that is, found in nature. In the broadest sense, natural products include any substance produced by life. Natural products can also be prepared by chemical syn ...
s or compounds derived from natural products. Terrestrial plants, fungi and
actinobacteria The ''Actinomycetota'' (or ''Actinobacteria'') are a phylum of all gram-positive bacteria. They can be terrestrial or aquatic. They are of great economic importance to humans because agriculture and forests depend on their contributions to so ...
have been the focus of many past bioprospecting programs, but interest is growing in less explored ecosystems (e.g. seas and oceans) and organisms (e.g. myxobacteria,
archaea Archaea ( ; singular archaeon ) is a domain of single-celled organisms. These microorganisms lack cell nuclei and are therefore prokaryotes. Archaea were initially classified as bacteria, receiving the name archaebacteria (in the Archaebac ...
) as a means of identifying new compounds with novel biological activities. Species may be randomly screened for bioactivity or rationally selected and screened based on ecological, ethnobiological,
ethnomedical Ethnomedicine is a study or comparison of the traditional medicine based on bioactive compounds in plants and animals and practiced by various ethnic groups, especially those with little access to western medicines, e.g., indigenous peoples. Th ...
,
historical History (derived ) is the systematic study and the documentation of the human activity. The time period of event before the invention of writing systems is considered prehistory. "History" is an umbrella term comprising past events as well ...
or
genomic Genomics is an interdisciplinary field of biology focusing on the structure, function, evolution, mapping, and editing of genomes. A genome is an organism's complete set of DNA, including all of its genes as well as its hierarchical, three-dim ...
information. When a region's biological resources or indigenous knowledge are unethically appropriated or commercially exploited without providing fair compensation, this is known as biopiracy. Various international treaties have been negotiated to provide countries legal recourse in the event of biopiracy and to offer commercial actors legal certainty for investment. These include the UN Convention on Biological Diversity and the Nagoya Protocol. Other risks associated with bioprospecting are the overharvesting of individual species and environmental damage, but legislation has been developed to combat these also. Examples include national laws such as the US Marine Mammal Protection Act and US
Endangered Species Act The Endangered Species Act of 1973 (ESA or "The Act"; 16 U.S.C. § 1531 et seq.) is the primary law in the United States for protecting imperiled species. Designed to protect critically imperiled species from extinction as a "consequence of ec ...
, and international treaties such as the UN Convention on Biological Diversity, the UN Convention on the Law of the Sea, and the Antarctic Treaty.


Bioprospecting-derived resources and products


Agriculture

Bioprospecting-derived resources and products used in agriculture include biofertilizers, biopesticides and veterinary antibiotics. '' Rhizobium'' is a genus of soil bacteria used as biofertilizers, ''
Bacillus thuringiensis ''Bacillus thuringiensis'' (or Bt) is a gram-positive, soil-dwelling bacterium, the most commonly used biological pesticide worldwide. ''B. thuringiensis'' also occurs naturally in the gut of caterpillars of various types of moths and butterflie ...
'' (also called Bt) and the annonins (obtained from seeds of the plant '' Annona squamosa'') are examples of biopesticides, and
valnemulin Valnemulin (trade name Econor or Biotilina) is a pleuromutilin antibiotic used to treat swine dysentery, ileitis, colitis and pneumonia. It is also used for the prevention of intestinal The gastrointestinal tract (GI tract, digestive tract, a ...
and
tiamulin Tiamulin (previously thiamutilin) is a pleuromutilin antibiotic drug that is used in veterinary medicine particularly for pigs and poultry. Tiamulin is a diterpene Diterpenes are a class of chemical compounds composed of four isoprene units, o ...
(discovered and developed from the basidiomycete fungi ''Omphalina mutila'' and '' Clitopilus passeckerianus'') are examples of veterinary antibiotics.


Bioremediation

Examples of bioprospecting products used in bioremediation include ''
Coriolopsis gallica ''Coriolopsis gallica'' is a fungus found growing on decaying wood. It is not associated with any plant disease, therefore it is not considered pathogenic. For various ''Coriolopsis gallica'' strains isolated, it has been found, as a common featu ...
''- and ''
Phanerochaete chrysosporium ''Phanerochaete'' is a genus of crust fungi in the family Phanerochaetaceae. Taxonomy The genus was circumscribed by Finnish mycologist Petter Karsten in 1889. Marinus Anton Donk redefined the limits of the genus in two publications in 1957 ...
''-derived
laccase Laccases () are multicopper oxidases found in plants, fungi, and bacteria. Laccases oxidize a variety of phenolic substrates, performing one-electron oxidations, leading to crosslinking. For example, laccases play a role in the formation of lign ...
enzymes, used for treating beer factory wastewater and for dechlorinating and decolorizing
paper mill A paper mill is a factory devoted to making paper from vegetable fibres such as wood pulp, old rags, and other ingredients. Prior to the invention and adoption of the Fourdrinier machine and other types of paper machine that use an endless belt, ...
effluent Effluent is wastewater from sewers or industrial outfalls that flows directly into surface waters either untreated or after being treated at a facility. The term has slightly different meanings in certain contexts, and may contain various pollut ...
.


Cosmetics and personal care

Cosmetics and personal care products obtained from bioprospecting include ''
Porphyridium cruentum ''Porphyridium cruentum'' is a species of red algae in the family Porphyridiophyceae. The microalga ''Porphyridium sp''. is a potential source for several products like fatty acids, lipids, cell-wall polysaccharides and pigments . The polysacchar ...
''-derived oligosaccharide and oligoelement blends used to treat erythema ( rosacea, flushing and
dark circles Periorbital dark circles are dark blemishes around the eyes. There are many causes of this symptom, including heredity and bruising. Causes Anatomical factors Bony structure and prominence of the orbicularis oculi muscle can contribute to infra ...
), ''
Xanthobacter autotrophicus ''Xanthobacter autotrophicus'' is a Gram-negative, aerobic, pleomorphic and nitrogen-fixing bacteria from the family of Xanthobacteraceae which has been isolated from black pool sludge in Germany.Deutsche Sammlung von Mikroorganismen und Zellku ...
''-derived zeaxanthin used for skin hydration and UV protection, ''
Clostridium histolyticum ''Hathewaya histolytica'' (formerly ''Clostridium histolyticum'') is a species of bacteria found in feces and the soil. It is a motile, gram-positive, aerotolerant anaerobe. ''H. histolytica'' is pathogenic in many species, including guinea pigs ...
''-derived collagenases used for skin regeneration, and '' Microsporum''-derived
keratinase Keratinases are Protease, proteolytic enzymes that digest keratin. History They were initially classified as 'proteinases of unknown mechanism' by the Nomenculture Committee on the International Union of Biochemistry in 1978 with Enzyme Commissio ...
s used for hair removal.


Nanotechnology and biosensors

Because
microbial A microorganism, or microbe,, ''mikros'', "small") and ''organism'' from the el, ὀργανισμός, ''organismós'', "organism"). It is usually written as a single word but is sometimes hyphenated (''micro-organism''), especially in olde ...
laccase Laccases () are multicopper oxidases found in plants, fungi, and bacteria. Laccases oxidize a variety of phenolic substrates, performing one-electron oxidations, leading to crosslinking. For example, laccases play a role in the formation of lign ...
s have a broad
substrate Substrate may refer to: Physical layers *Substrate (biology), the natural environment in which an organism lives, or the surface or medium on which an organism grows or is attached ** Substrate (locomotion), the surface over which an organism lo ...
range, they can be used in biosensor technology to detect a wide range of organic compounds. For example, laccase-containing electrodes are used to detect polyphenolic compounds in wine, and
lignin Lignin is a class of complex organic polymers that form key structural materials in the support tissues of most plants. Lignins are particularly important in the formation of cell walls, especially in wood and bark, because they lend rigidity ...
s and phenols in wastewater.


Pharmaceuticals

Many of the antibacterial drugs in current clinical use were discovered through bioprospecting including the aminoglycosides, tetracyclines, amphenicols, polymyxins,
cephalosporin The cephalosporins (sg. ) are a class of β-lactam antibiotics originally derived from the fungus ''Acremonium'', which was previously known as ''Cephalosporium''. Together with cephamycins, they constitute a subgroup of β-lactam antibiotics ...
s and other β-lactam antibiotics, macrolides,
pleuromutilin Pleuromutilin and its derivatives are antibacterial drugs that inhibit protein synthesis in bacteria by binding to the peptidyl transferase component of the 50S subunit of ribosomes. This class of antibiotics includes the licensed drugs lefamu ...
s, glycopeptides,
rifamycin The rifamycins are a group of antibiotics that are synthesized either naturally by the bacterium ''Amycolatopsis rifamycinica'' or artificially. They are a subclass of the larger family of ansamycins. Rifamycins are particularly effective again ...
s, lincosamides,
streptogramin Streptogramins are a class of antibiotics. Streptogramins are effective in the treatment of vancomycin-resistant ''Staphylococcus aureus'' (VRSA) and vancomycin-resistant ''Enterococcus'' (VRE), two of the most rapidly growing strains of multidru ...
s, and phosphonic acid antibiotics. The aminoglycoside antibiotic streptomycin, for example, was discovered from the soil bacterium '' Streptomyces griseus'', the fusidane antibiotic fusidic acid was discovered from the soil fungus ''
Acremonium fusidioides ''Acremonium'' is a genus of fungi in the family Hypocreaceae. It used to be known as ''Cephalosporium''. Description ''Acremonium'' species are usually slow-growing and are initially compact and moist. Their hyphae are fine and hyaline, and pro ...
'', and the pleuromutilin antibiotics (eg.
lefamulin Lefamulin, sold under the brand name Xenleta, is an antibiotic medication used it to treat adults with community-acquired bacterial pneumonia. It is taken by mouth or by injection into a vein. Relatively common side effects include diarrhea, ...
) were discovered and developed from the basidiomycete fungi ''Omphalina mutila'' and ''Clitopilus passeckerianus''. Other examples of bioprospecting-derived anti-infective drugs include the
antifungal An antifungal medication, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis (thrush), serious systemic infections such as crypto ...
drug griseofulvin (discovered from the soil fungus '' Penicillium griseofulvum''), the antifungal and
antileishmanial Leishmaniasis is a wide array of clinical manifestations caused by parasites of the trypanosome genus '' Leishmania''. It is generally spread through the bite of phlebotomine sandflies, ''Phlebotomus'' and ''Lutzomyia'', and occurs most fre ...
drug amphotericin B (discovered from the soil bacterium ''
Streptomyces nodosus ''Streptomyces nodosus'' is a bacterial species in the genus ''Streptomyces''. Uses ''Streptomyces nodosus'' is used to produce amphotericin B. Saquayamycins ( saquayamycins A, B, C and D) are antibiotics of the aquayamycin Aquayamycin ...
''), the antimalarial drug artemisinin (discovered from the plant ''
Artemisia annua ''Artemisia annua'', also known as sweet wormwood, sweet annie, sweet sagewort, annual mugwort or annual wormwood (), is a common type of wormwood native to temperate Asia, but naturalized in many countries including scattered parts of North Am ...
''), and the antihelminthic drug ivermectin (developed from the soil bacterium '' Streptomyces avermitilis''). Bioprospecting-derived pharmaceuticals have been developed for the treatment of non-communicable diseases and conditions too. These include the anticancer drug bleomycin (obtained from the soil bacterium '' Streptomyces verticillus''), the immunosuppressant drug ciclosporin used to treat autoimmune diseases such as rheumatoid arthritis and psoriasis (obtained from the soil fungus '' Tolypocladium inflatum''), the anti-inflammatory drug colchicine used to treat and prevent gout flares (obtained from the plant '' Colchicum autumnale''), the
analgesic An analgesic drug, also called simply an analgesic (American English), analgaesic (British English), pain reliever, or painkiller, is any member of the group of drugs used to achieve relief from pain (that is, analgesia or pain management). It ...
drug ziconotide (developed from the cone snail '' Conus magus''), and the acetylcholinesterase inhibitor galantamine used to treat
Alzheimer's disease Alzheimer's disease (AD) is a neurodegeneration, neurodegenerative disease that usually starts slowly and progressively worsens. It is the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in short-term me ...
(obtained from plants in the ''
Galanthus ''Galanthus'' (from Ancient Greek , (, "milk") + (, "flower")), or snowdrop, is a small genus of approximately 20 species of bulbous perennial herbaceous plants in the family Amaryllidaceae. The plants have two linear leaves and a single ...
'' genus).


Bioprospecting as a discovery strategy

Bioprospecting has both strengths and weaknesses as a strategy for discovering new genes, molecules, and organisms suitable for development and commercialization.


Strengths

Bioprospecting-derived small molecules (also known as
natural product A natural product is a natural compound or substance produced by a living organism—that is, found in nature. In the broadest sense, natural products include any substance produced by life. Natural products can also be prepared by chemical syn ...
s) are more structurally complex than synthetic chemicals, and therefore show greater specificity towards biological targets. This is a big advantage in
drug discovery In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by ...
and development, especially pharmacological aspects of drug discovery and development, where off-target effects can cause adverse drug reactions. Natural products are also more amenable to
membrane transport In cellular biology, membrane transport refers to the collection of mechanisms that regulate the passage of solutes such as ions and small molecules through biological membranes, which are lipid bilayers that contain proteins embedded in them. Th ...
than synthetic compounds. This is advantageous when developing antibacterial drugs, which may need to traverse both an outer membrane and
plasma membrane The cell membrane (also known as the plasma membrane (PM) or cytoplasmic membrane, and historically referred to as the plasmalemma) is a biological membrane that separates and protects the interior of all cells from the outside environment (t ...
to reach their target. For some biotechnological innovations to work, it is important to have enzymes that function at unusually high or low temperatures. An example of this is the polymerase chain reaction (PCR), which is dependent on a DNA polymerase that can operate at 60°C and above. In other situations, for example dephosphorylation, it can be desirable to run the reaction at low temperature. Extremophile bioprospecting is an important source of such enzymes, yielding thermostable enzymes such as ''Taq'' polymerase (from '' Thermus aquaticus''), and cold-adapted enzymes such as shrimp
alkaline phosphatase The enzyme alkaline phosphatase (EC 3.1.3.1, alkaline phosphomonoesterase; phosphomonoesterase; glycerophosphatase; alkaline phosphohydrolase; alkaline phenyl phosphatase; orthophosphoric-monoester phosphohydrolase (alkaline optimum), systematic ...
(from ''
Pandalus borealis ''Pandalus borealis'' is a species of caridean shrimp found in cold parts of the northern Atlantic and northern Pacific Oceans, although the latter population now often is regarded as a separate species, ''P. eous''. The Food and Agriculture Orga ...
''). With the Convention on Biological Diversity (CBD) now ratified by most countries, bioprospecting has the potential to bring biodiversity-rich and technologically advanced nations together, and benefit them both educationally and economically (eg. information sharing, technology transfer, new product development, royalty payment). For useful molecules identified through
microbial A microorganism, or microbe,, ''mikros'', "small") and ''organism'' from the el, ὀργανισμός, ''organismós'', "organism"). It is usually written as a single word but is sometimes hyphenated (''micro-organism''), especially in olde ...
bioprospecting, scale up of production is feasible at reasonable cost because the producing microorganism can be
cultured Culture () is an umbrella term which encompasses the social behavior, institutions, and norms found in human societies, as well as the knowledge, beliefs, arts, laws, customs, capabilities, and habits of the individuals in these groups.Tylor ...
in a
bioreactor A bioreactor refers to any manufactured device or system that supports a biologically active environment. In one case, a bioreactor is a vessel in which a chemical reaction, chemical process is carried out which involves organisms or biochemistry, ...
.


Weaknesses

Although some potentially very useful microorganisms are known to exist in nature (eg. lignocellulose-metabolizing microbes), difficulties have been encountered cultivating these in a laboratory setting. This problem may be resolvable by genetically manipulating easier-to-culture organisms such as '' Escherichia coli'' or '' Streptomyces coelicolor'' to express the gene cluster responsible for the desired activity. Isolating and identifying the compound(s) responsible for a biological extract's activity can be difficult. Also, subsequent elucidation of the mechanism of action of the isolated compound can be time-consuming. Technological advancements in liquid chromatography,
mass spectrometry Mass spectrometry (MS) is an analytical technique that is used to measure the mass-to-charge ratio of ions. The results are presented as a ''mass spectrum'', a plot of intensity as a function of the mass-to-charge ratio. Mass spectrometry is use ...
and other techniques are helping to overcome these challenges. Implementing and enforcing bioprospecting-related treaties and legislation is not always easy. Drug development is an inherently expensive and time-consuming process with low success rates, and this makes it difficult to quantify the value of potential products when drafting bioprospecting agreements. Intellectual property rights may be difficult to award too. For example, legal rights to a medicinal plant may be disputable if it has been discovered by different people in different parts of the world at different times. Whilst the structural complexity of natural products is generally advantageous in drug discovery, it can make the subsequent manufacture of drug candidates difficult. This problem is sometimes resolvable by identifying the part of the natural product structure responsible for activity and developing a simplified synthetic analogue. This was necessary with the natural product halichondrin B, its simplified analogue eribulin now approved and marketed as an anticancer drug.


Bioprospecting pitfalls

Errors and oversights can occur at different steps in the bioprospecting process including collection of source material, screening source material for bioactivity, testing isolated compounds for toxicity, and identification of mechanism of action.


Collection of source material

Prior to collecting
biological Biology is the scientific study of life. It is a natural science with a broad scope but has several unifying themes that tie it together as a single, coherent field. For instance, all organisms are made up of cells that process hereditary in ...
material or traditional knowledge, the correct permissions must be obtained from the source country, land owner etc. Failure to do so can result in criminal proceedings and rejection of any subsequent patent applications. It is also important to collect biological material in adequate quantities, to have biological material formally
identified ''Identified'' is the second studio album by Vanessa Hudgens, released on July 1, 2008 in the U.S. June 24, 2008 in Japan, February 13, 2009 in most European countries and February 16, 2009 in the United Kingdom. The album re ...
, and to deposit a voucher specimen with a
repository Repository may refer to: Archives and online databases * Content repository, a database with an associated set of data management tools, allowing application-independent access to the content * Disciplinary repository (or subject repository), an ...
for long-term preservation and storage. This helps ensure any important discoveries are reproducible.


Bioactivity and toxicity testing

When testing extracts and isolated compounds for bioactivity and toxicity, the use of standard protocols (eg.
CLSI The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelin ...
, ISO, NIH, EURL ECVAM, OECD) is desirable because this improves test result accuracy and reproducibility. Also, if the source material is likely to contain known (previously discovered) active compounds (eg. streptomycin in the case of actinomycetes), then dereplication is necessary to exclude these extracts and compounds from the discovery pipeline as early as possible. In addition, it is important to consider solvent effects on the cells or cell lines being tested, to include reference compounds (ie. pure chemical compounds for which accurate bioactivity and toxicity data are available), to set limits on cell line passage number (eg. 10–20 passages), to include all the necessary positive and negative Scientific control, controls, and to be aware of assay limitations. These steps help ensure assay results are accurate, reproducible and interpreted correctly.


Identification of mechanism of action

When attempting to elucidate the mechanism of action of an extract or isolated compound, it is important to use multiple orthogonal assays. Using just a single assay, especially a single ''in vitro'' assay, gives a very incomplete picture of an extract or compound's effect on the human body. In the case of ''Valeriana officinalis'' root extract, for example, the Sleep induction, sleep-inducing effects of this extract are due to multiple compounds and mechanisms including interaction with GABA receptors and Smooth muscle#Relaxation, relaxation of smooth muscle. The mechanism of action of an isolated compound can also be misidentified if a single assay is used because some compounds Pan-assay interference compounds, interfere with assays. For example, the sulfhydryl-scavenging assay used to detect histone acetyltransferase inhibition can give a false positive result if the test compound reacts covalently with cysteines.


Biopiracy

The term biopiracy was coined by Pat Roy Mooney, Pat Mooney, to describe a practice in which indigenous knowledge of nature, originating with indigenous peoples, is used by others for profit, without authorization or compensation to the indigenous people themselves. For example, when bioprospectors draw on indigenous knowledge of medicinal plants which is later patented by medical companies without recognizing the fact that the knowledge is not new or invented by the patenter, this deprives the indigenous community of their potential rights to the commercial product derived from the technology that they themselves had developed. Critics of this practice, such as Greenpeace, claim these practices contribute to inequality between developing countries rich in biodiversity, and developed countries hosting Biotechnology, biotech firms. In the 1990s many large pharmaceutical and drug discovery companies responded to charges of biopiracy by ceasing work on natural products, turning to combinatorial chemistry to develop novel compounds.


Famous cases of 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. Different countries are reported as having acquired different beliefs about the medical properties of the plant. This meant that researchers could obtain local knowledge from one country and plant samples from another. The use of the plant for diabetes was the original stimulus for research. Effectiveness in the treatment of both Hodgkin lymphoma and leukemia were discovered instead. The Hodgkin lymphoma chemotherapeutic drug vinblastine is derivable from the rosy periwinkle.


The Maya ICBG controversy

The Maya ICBG bioprospecting controversy took place in 1999–2000, when the International Cooperative Biodiversity Group led by ethnobiologist Brent Berlin was accused of being engaged in unethical forms of bioprospecting by several NGOs and indigenous organizations. The ICBG aimed to document the biodiversity of Chiapas, Mexico, and the ethnobotanical knowledge of the indigenous Maya people – in order to ascertain whether there were possibilities of developing medical products based on any of the plants used by the indigenous groups. The Maya ICBG case was among the first to draw attention to the problems of distinguishing between benign forms of bioprospecting and unethical biopiracy, and to the difficulties of securing community participation and prior informed consent for would-be bioprospectors.


The neem tree

In 1994, the U.S. Department of Agriculture and W. R. Grace and Company received a European patent on methods of controlling fungal infections in plants using a composition that included extracts from the neem tree (''Azadirachta indica''), which grows throughout India and Nepal.Karen Hoggan for the BBC. May 11, 200
Neem tree patent revoked
In 2000 the patent was successfully Opposition proceeding, opposed by several groups from the EU and India including the EU Green Party, Vandana Shiva, and the International Federation of Organic Agriculture Movements (IFOAM) on the basis that the fungicidal activity of neem extract had long been known in Ayurveda, Indian traditional medicine. WR Grace appealed and lost in 2005.BBC News, March 9, 200
India wins landmark patent battle


Basmati rice

In 1997, the US corporation RiceTec (a subsidiary of RiceTec AG of Liechtenstein) attempted to patent certain hybrids of basmati rice and semidwarf long-grain rice. The Indian government challenged this patent and, in 2002, fifteen of the patent's twenty claims were invalidated.


The Enola bean

The Enola bean is a variety of Mexican Phaseolus vulgaris#Cultivars and varieties, 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, in 2005, the US-PTO ruled in favor of the farmers. In 2008, the patent was revoked.


''Hoodia gordonii''

''Hoodia#Uses and horticulture, Hoodia gordonii'', 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 1996 South Africa's Council for Scientific and Industrial Research began working with companies, including Unilever, to develop dietary supplements based on ''Hoodia''. Originally the San people were not scheduled to receive any benefits from the commercialization of their traditional knowledge, but in 2003 the South African San Council made an agreement with CSIR in which they would receive from 6 to 8% of the revenue from the sale of ''Hoodia'' products. In 2008 after having invested €20 million in R&D on ''Hoodia'' as a potential ingredient in dietary supplements for weight loss, Unilever terminated the project because their clinical studies did not show that ''Hoodia'' was safe and effective enough to bring to market.


Further cases

The following is a selection of further recent cases of biopiracy. Most of them do not relate to traditional medicines. * Thirty-six cases of biopiracy in Africa. * The case of the Maya people's ''pozol'' drink. * The case of the Maya and other people's use of ''Mimosa tenuiflora'' and many other cases. * The case of the Andean ''Lepidium meyenii, maca'' radish. * The cases of ''turmeric'' (India), ''karela'' (India), ''quinoa'' (Bolivia), ''Pentadiplandra brazzeana, oubli'' berries (Gabon), and others. * The case of captopril (developed from a Brazilian tribe's Arrow poison, arrowhead poison).


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 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 of the United States, 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

The Convention on Biological Diversity (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 Nagoya Protocol to the CBD, which came into force in 2014, provides further regulations. The CBD has been ratified, acceded or accepted by 196 countries and jurisdictions globally, with exceptions including the Holy See and United States.


Bioprospecting contracts

The requirements for bioprospecting as set by CBD has created a new branch of international patent law, patent and international trade, trade law, bioprospecting contracts. Bioprospecting contracts lay down the rules of benefit sharing between researchers and countries, and can bring royalties to Developing countries, lesser-developed countries. However, although these contracts are based on prior informed consent and compensation (unlike biopiracy), every owner or carrier of an indigenous knowledge and resources are not always consulted or compensated, as it would be difficult to ensure every individual is included. Because of this, some have proposed that the indigenous or other communities form a type of representative micro-government that would negotiate with researchers to form contracts in such a way that the community benefits from the arrangements. Unethical bioprospecting contracts (as distinct from ethical ones) can be viewed as a new form of biopiracy. An example of a bioprospecting contract is the agreement between Merck & Co., Merck and INBio of Costa Rica.


Traditional knowledge database

Due to previous cases of biopiracy and to prevent further cases, the Government of India has converted Ayurveda, traditional Indian medicinal information from ancient manuscripts and other resources into an electronic resource; this resulted in the Traditional Knowledge Digital Library in 2001. The texts are being recorded from Tamil language, Tamil, Sanskrit, Urdu, Persian language, 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 asana, yoga poses are also kept in the collection. The library has also signed agreements with leading international patent offices such as European Patent Office (EPO), United Kingdom Patent Office, United Kingdom Trademark & Patent Office (UKTPO) 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 examination purposes.


See also

* Intellectual capital/Intellectual property * Natural capital * Biological patent * Traditional knowledge/Indigenous knowledge * Pharmacognosy * Plant breeders' rights * Bioethics * Maya ICBG bioprospecting controversy * International Cooperative Biodiversity Group * Biological Diversity Act, 2002 * Agreement on Trade-Related Aspects of Intellectual Property Rights, Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (1994) * International Treaty on Plant Genetic Resources for Food and Agriculture (2001)


References


Bibliography and resources

* The Secretariat of the Convention on Biological Diversity (United Nations Environment Programme) maintains a
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 th
CBD information centre
* *


External links


Out of Africa: Mysteries of Access and Benefit-Sharing
– a 2006 report on biopiracy in Africa b
The Edmonds Institute

Cape Town Declaration
– Biowatch South Africa
Genetic Resources Action International (GRAIN)

Indian scientist denies accusation of biopiracy
– scidev, SciDev.Net
African 'biopiracy' debate heats up
– scidev, SciDev.Net
Bioprospecting: legitimate research or 'biopiracy'?
– scidev, 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...

Who Owns Biodiversity, and How Should the Owners Be Compensated?
''Plant Physiology'', April 2004, Vol. 134, pp. 1295–1307 * {{Property navbox Bioethics Botany Plant genetics Plant breeding Biodiversity Food security Plant conservation Seeds Sustainable agriculture Commercialization of traditional medicines