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Bioprospecting

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(Redirected fromEnola bean)
Not to be confused withBiomining.
Many important medications have been discovered by bioprospecting including the diabetes drugmetformin(developed from a natural product found inGalega officinalis).[1]
Intellectual property
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Bioprospecting(also known asbiodiversity prospecting) is the exploration of natural sources forsmall molecules,macromoleculesand biochemical and genetic information that could be developed intocommerciallyvaluable products for theagricultural,[2][3]aquaculture,[4][5]bioremediation,[4][6]cosmetics,[7][8]nanotechnology,[4][9]orpharmaceutical[2][10]industries. In the pharmaceutical industry, for example, almost one third of all small-molecule drugs approved by theU.S. Food and Drug Administration(FDA) between 1981 and 2014 were eithernatural productsor compounds derived from natural products.[11]

Terrestrialplants,fungiandactinobacteriahave been the focus of many past bioprospecting programs,[12]but interest is growing in less explored ecosystems (e.g. seas and oceans) and organisms (e.g.myxobacteria,archaea) as a means of identifying new compounds with novelbiological activities.[7][10][13][14]Species may be randomly screened for bioactivity or rationally selected and screened based onecological,ethnobiological,ethnomedical,historicalorgenomicinformation.[10][15][16]

When a region's biological resources orindigenous knowledgeare unethically appropriated or commerciallyexploitedwithout providing fair compensation, this is known asbiopiracy.[12][17]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 theUNConvention on Biological Diversityand theNagoya Protocol.[2][10]TheWIPOis currentlynegotiating more treatiesto bridge gaps in this field.

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 USMarine Mammal Protection Actand USEndangered Species Act,and international treaties such as the UN Convention on Biological Diversity, the UNConvention on the Law of the Sea,theBiodiversity Beyond National Jurisdictions Treaty,and theAntarctic Treaty.[10][18]

Bioprospecting-derived resources and products

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Agriculture

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Annonin-based biopesticides, used to protect crops from beetles and other pests, were developed from the plantAnnona squamosa.[19]

Bioprospecting-derived resources and products used in agriculture includebiofertilizers,biopesticidesandveterinary antibiotics.Rhizobiumis a genus of soil bacteria used as biofertilizers,[20]Bacillus thuringiensis(also called Bt) and theannonins(obtained from seeds of the plantAnnona squamosa) are examples of biopesticides,[21][22][19][23]andvalnemulinandtiamulin(discovered and developed from thebasidiomycetefungiOmphalina mutilaandClitopilus passeckerianus) are examples of veterinary antibiotics.[24][25]

Bioremediation

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Examples of bioprospecting products used in bioremediation includeCoriolopsis gallica- andPhanerochaete chrysosporium-derivedlaccaseenzymes, used for treatingbeer factorywastewaterand for dechlorinating and decolorizingpaper milleffluent.[9]

Cosmetics and personal care

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Cosmetics and personal care products obtained from bioprospecting includePorphyridium cruentum-derivedoligosaccharideand oligoelement blends used to treaterythema(rosacea,flushinganddark circles),[7]Xanthobacter autotrophicus-derivedzeaxanthinused forskin hydrationandUVprotection,[8]Clostridium histolyticum-derivedcollagenasesused forskinregeneration,[8]andMicrosporum-derivedkeratinasesused forhair removal.[8]

Nanotechnology and biosensors

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Becausemicrobiallaccaseshave a broadsubstraterange, they can be used inbiosensortechnology to detect a wide range oforganic compounds.For example, laccase-containingelectrodesare used to detectpolyphenolic compoundsinwine,andligninsandphenolsinwastewater.[9]

Pharmaceuticals

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Thetuberculosisdrugstreptomycinwas discovered from theactinomyceteStreptomyces griseus.[10]

Many of theantibacterial drugsin current clinical use were discovered through bioprospecting including theaminoglycosides,tetracyclines,amphenicols,polymyxins,cephalosporinsand otherβ-lactam antibiotics,macrolides,pleuromutilins,glycopeptides,rifamycins,lincosamides,streptogramins,andphosphonic acidantibiotics.[10][26]The aminoglycoside antibioticstreptomycin,for example, was discovered from the soil bacteriumStreptomyces griseus,the fusidane antibioticfusidic acidwas discovered from the soil fungusAcremonium fusidioides,and the pleuromutilin antibiotics (eg.lefamulin) were discovered and developed from the basidiomycete fungiOmphalina mutilaandClitopilus passeckerianus.[10][24]

Other examples of bioprospecting-derived anti-infective drugs include theantifungaldruggriseofulvin(discovered from the soil fungusPenicillium griseofulvum),[27]the antifungal andantileishmanialdrugamphotericin B(discovered from the soil bacteriumStreptomyces nodosus),[28]theantimalarialdrugartemisinin(discovered from the plantArtemisia annua),[1][29]and theantihelminthicdrugivermectin(developed from the soil bacteriumStreptomyces avermitilis).[30]

Bioprospecting-derived pharmaceuticals have been developed for the treatment ofnon-communicable diseasesand conditions too. These include theanticancer drugbleomycin(obtained from the soil bacteriumStreptomyces verticillus),[31]theimmunosuppressantdrugciclosporinused to treat autoimmune diseases such asrheumatoid arthritisandpsoriasis(obtained from the soil fungusTolypocladium inflatum),[32]the anti-inflammatory drugcolchicineused to treat and preventgoutflares (obtained from the plantColchicum autumnale),[1]theanalgesicdrugziconotide(developed from thecone snailConus magus),[13]and theacetylcholinesterase inhibitorgalantamineused to treatAlzheimer's disease(obtained from plants in theGalanthusgenus).[33]

Bioprospecting as a discovery strategy

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

Strengths

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Halichondrin B,an example of a structurally complex and medically important natural product[34]

Bioprospecting-derivedsmall molecules(also known asnatural products) are more structurally complex than synthetic chemicals, and therefore show greaterspecificitytowardsbiological targets.This is a big advantage indrug discoveryanddevelopment,especiallypharmacologicalaspects of drug discovery and development, where off-target effects can causeadverse drug reactions.[10]

Natural products are also more amenable tomembrane transportthan synthetic compounds. This is advantageous when developingantibacterialdrugs, which may need to traverse both anouter membraneandplasma membraneto reach their target.[10]

For somebiotechnologicalinnovations to work, it is important to haveenzymesthat function at unusually high or low temperatures. An example of this is thepolymerase chain reaction(PCR), which is dependent on aDNA polymerasethat can operate at 60°C and above.[14]In other situations, for exampledephosphorylation,it can be desirable to run the reaction at low temperature.[13]Extremophilebioprospecting is an important source of such enzymes, yielding thermostable enzymes such asTaqpolymerase(fromThermus aquaticus),[14]and cold-adapted enzymes such as shrimpalkaline phosphatase(fromPandalus borealis).[13]

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).[2][35]

For useful molecules identified throughmicrobialbioprospecting, scale up of production is feasible at reasonable cost because the producing microorganism can beculturedin abioreactor.[8][36]

Weaknesses

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Zingiber officinale,an example of a medicinal plant used in multiple cultures[37]

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.[38]This problem may be resolvable bygenetically manipulatingeasier-to-culture organisms such asEscherichia coliorStreptomyces coelicolorto express thegene clusterresponsible for the desired activity.[14][39]

Isolating and identifying thecompound(s)responsible for a biological extract's activity can be difficult.[39]Also, subsequent elucidation of themechanism of actionof the isolated compound can be time-consuming.[39]Technological advancements inliquid chromatography,mass spectrometryand other techniques are helping to overcome these challenges.[39]

Implementing and enforcing bioprospecting-related treaties and legislation is not always easy.[2][35]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.[2]Intellectual property rightsmay be difficult to award too. For example, legal rights to amedicinal plantmay be disputable if it has been discovered by different people in different parts of the world at different times.[2]

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 analogueeribulinnow approved and marketed as ananticancer drug.[40]

Bioprospecting pitfalls

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Errors and oversights can occur at different steps in the bioprospecting process including collection of source material, screening source material forbioactivity,testing isolated compounds fortoxicity,and identification ofmechanism of action.

Collection of source material

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Voucher deposition allows species identity to be re-evaluated if there are problems re-isolating an active constituent from a biological source.[10]

Prior to collectingbiologicalmaterial ortraditional knowledge,the correct permissions must be obtained from the source country, land owner etc. Failure to do so can result incriminal proceedingsand rejection of any subsequentpatentapplications. It is also important to collect biological material in adequate quantities, to have biological material formallyidentified,and to deposit a voucher specimen with arepositoryfor long-term preservation and storage. This helps ensure any important discoveries are reproducible.[10][13]

Bioactivity and toxicity testing

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When testing extracts and isolated compounds for bioactivity and toxicity, the use ofstandardprotocols (eg.CLSI,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 considersolventeffects on the cells orcell linesbeing tested, to include reference compounds (ie. purechemical compoundsfor 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 negativecontrols,and to be aware of assay limitations. These steps help ensure assay results are accurate, reproducible and interpreted correctly.[10][13]

Identification of mechanism of action

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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 singlein vitroassay, gives a very incomplete picture of an extract or compound's effect on the human body.[41][42]In the case ofValeriana officinalisroot extract, for example, thesleep-inducingeffects of this extract are due to multiple compounds and mechanisms including interaction withGABA receptorsandrelaxationofsmooth muscle.[41]The mechanism of action of an isolated compound can also be misidentified if a single assay is used because some compoundsinterferewith assays. For example, the sulfhydryl-scavenging assay used to detecthistone acetyltransferaseinhibition can give a false positive result if the test compound reacts covalently with cysteines.[42]

Biopiracy

[edit]
Look upbiopiracyin Wiktionary, the free dictionary.

The termbiopiracywas coined byPat Mooney,[43]to describe a practice in which indigenous knowledge of nature, originating withindigenous peoples,is used by others for profit, without authorization or compensation to the indigenous people themselves.[44]For example, when bioprospectors draw on indigenous knowledge of medicinal plants which is laterpatentedby 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.[45]Critics of this practice, such asGreenpeace,[46]claim these practices contribute to inequality between developing countries rich inbiodiversity,and developed countries hostingbiotechfirms.[45]

In the 1990s many large pharmaceutical and drug discovery companies responded to charges of biopiracy by ceasing work on natural products, turning tocombinatorial chemistryto develop novel compounds.[43]

Famous cases of biopiracy

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A white rosy periwinkle

The rosy periwinkle

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Therosy periwinklecase dates from the 1950s. The rosy periwinkle, while native toMadagascar,had been widely introduced into other tropical countries around the world well before the discovery ofvincristine.Different countries are reported as having acquired different beliefs about the medical properties of the plant.[47]This meant that researchers could obtain local knowledge from one country and plant samples from another. The use of the plant fordiabeteswas the original stimulus for research. Effectiveness in the treatment of bothHodgkin lymphomaandleukemiawere discovered instead.[48]The Hodgkin lymphoma chemotherapeutic drugvinblastineis derivable from the rosy periwinkle.[49]

The Maya ICBG controversy

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Main article:Maya ICBG bioprospecting controversy

TheMaya ICBG bioprospecting controversytook place in 1999–2000, when theInternational Cooperative Biodiversity Groupled byethnobiologistBrent Berlinwas accused of being engaged in unethical forms of bioprospecting by severalNGOsand indigenous organizations. The ICBG aimed to document the biodiversity ofChiapas,Mexico,and theethnobotanicalknowledge of the indigenousMaya people– in order to ascertain whether there were possibilities of developing medical products based on any of the plants used by the indigenous groups.[50][51]

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.[52]

The neem tree

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A neem tree

In 1994, theU.S. Department of AgricultureandW. R. Grace and Companyreceived a European patent on methods of controlling fungal infections in plants using a composition that included extracts from theneemtree (Azadirachta indica), which grows throughoutIndiaandNepal.[53][54][55]In 2000 the patent was successfullyopposedby several groups from the EU and India including the EU Green Party,Vandana Shiva,and theInternational Federation of Organic Agriculture Movements(IFOAM) on the basis that the fungicidal activity of neem extract had long been known inIndian traditional medicine.[55]WR Grace appealed and lost in 2005.[56]

Basmati rice

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Main article:RiceTec § Basmati patent controversy

In 1997, the US corporationRiceTec(a subsidiary of RiceTec AG of Liechtenstein) attempted to patent certain hybrids ofbasmatirice and semidwarf long-grain rice.[57]The Indian government challenged this patent and, in 2002, fifteen of the patent's twenty claims were invalidated.[58]

The Enola bean

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The Enola bean

The Enola bean is a variety of Mexicanyellow bean,so called after the wife of the man who patented it in 1999.[59]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."[60]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.[61]

Hoodia gordonii

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The succulentHoodia gordonii

Hoodia gordonii,asucculent plant,originates from theKalahari DesertofSouth Africa.For generations it has been known to the traditionally livingSan peopleas anappetite suppressant.In 1996 South Africa'sCouncil for Scientific and Industrial Researchbegan working with companies, includingUnilever,to develop dietary supplements based onHoodia.[62][63][64][65]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 ofHoodiaproducts.[66]

In 2008 after having invested €20 million in R&D onHoodiaas a potential ingredient indietary supplementsfor weight loss, Unilever terminated the project because their clinical studies did not show thatHoodiawas safe and effective enough to bring to market.[67]

Further cases

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The following is a selection of further recent cases of biopiracy. Most of them do not relate to traditional medicines.

[edit]

Patent law

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Further information:Societal views on patents

One common misunderstanding is that pharmaceutical companiespatentthe 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.[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 theUnited States,patent lawcan be used to protect "isolated and purified" compounds – even, in one instance, a new chemical element (see USP 3,156,523). In 1873,Louis Pasteurpatented a "yeast" which was "free from disease" (patent #141072). Patents covering biological inventions have been treated similarly. In the 1980 case ofDiamond v. Chakrabarty,theSupreme Courtupheld 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." TheUnited 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".[76]

Also possible under US law is patenting acultivar,a new variety of an existing organism. The patent on the Enola bean (now revoked)[77]was an example of this sort of patent. Theintellectual propertylaws of the US also recognizeplant breeders' rightsunder thePlant Variety Protection Act,7 U.S.C. §§ 2321–2582.[78]

Convention on Biological Diversity

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Parties to the CBD[79]
Signed, but not ratified[79]
Non-signatory[79]
Main article:Convention on Biological Diversity

The Convention on Biological Diversity (CBD) came into force in 1993. It secured rights to control access togenetic resourcesfor 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 obtaininformed consentto access such resources, and must share any benefits with the biodiversity-rich country.[80]However, some critics believe that the CBD has failed to establish appropriate regulations to prevent biopiracy.[81]Others claim that the main problem is the failure of national governments to pass appropriate laws implementing the provisions of the CBD.[82]TheNagoya Protocolto the CBD, which came into force in 2014, provides further regulations.[83]The CBD has been ratified, acceded or accepted by 196 countries and jurisdictions globally, with exceptions including theHoly SeeandUnited States.[79]

Bioprospecting contracts

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The requirements for bioprospecting as set by CBD has created a new branch of internationalpatentandtrade law,bioprospecting contracts.[2]Bioprospecting contracts lay down the rules of benefit sharing between researchers and countries, and can bring royalties tolesser-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,[84]as it would be difficult to ensure every individual is included.[85]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.[85]Unethical bioprospecting contracts (as distinct from ethical ones) can be viewed as a new form of biopiracy.[81]

An example of a bioprospecting contract is the agreement betweenMerckandINBioofCosta Rica.[86]

Traditional knowledge database

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Due to previous cases of biopiracy and to prevent further cases, the Government of India has convertedtraditional Indian medicinalinformation from ancient manuscripts and other resources into an electronic resource; this resulted in theTraditional Knowledge Digital Libraryin 2001.[87]The texts are being recorded fromTamil,Sanskrit,Urdu,PersianandArabic;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.[88]Hundreds ofyoga posesare also kept in the collection.[88]The library has also signed agreements with leading internationalpatent officessuch asEuropean Patent Office(EPO),United Kingdom Trademark & Patent Office(UKTPO) and theUnited States Patent and Trademark Officeto protecttraditional knowledgefrom biopiracy as it allowspatent examinersat International Patent Offices to access TKDL databases for patent search and examination purposes.[73][89][90]

See also

[edit]
Look upbioprospectingin Wiktionary, the free dictionary.

References

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Bibliography and resources

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