Higher category: Property and Property law
Bioprospecting (also known as biodiversity prospecting) is the exploration of natural sources for small molecules, macromolecules and biochemical and genetic information that could be developed into commercially valuable products for the agricultural,aquaculture, bioremediation, cosmetics, nanotechnology, 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 products or compounds derived from natural products.
Terrestrial plants, fungi and actinobacteria have been the focus of many past bioprospecting programs,but interest is growing in less explored ecosystems (eg. seas and oceans) and organisms (eg. myxobacteria, archaea) 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, historical or genomic 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, and international treaties such as the UN Convention on Biological Diversity, the UN Convention on the Law of the Sea, and the UN Antarctic Treaty.
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 (also called Bt) and the annonins (obtained from seeds of the plant Annona squamosa ) are examples of biopesticides, and valnemulin and tiamulin (discovered and developed from the basidiomycete fungus Clitopilus passeckerianus ) are examples of veterinary antibiotics.
Examples of bioprospecting products used in bioremediation include Coriolopsis gallica - and Phanerochaete chrysosporium -derived laccase enzymes, used for treating beer factory wastewater and for dechlorinating and decolorizing paper mill effluent.
Cosmetics and personal care products obtained from bioprospecting include Porphyridium cruentum -derived oligosaccharide and oligoelement blends used to treat erythema (rosacea, flushing and dark circles),Xanthobacter autotrophicus -derived zeaxanthin used for skin hydration and UV protection, Clostridium histolyticum -derived collagenases used for skin regeneration, and Microsporum -derived keratinases used for hair removal.
Because microbial laccases have a broad substrate 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 lignins and phenols in wastewater.
Many of the antibacterial drugs in current clinical use were discovered through bioprospecting including the β-lactam antibiotics, aminoglycosides, tetracyclines, amphenicols, polymyxins, macrolides, pleuromutilins, glycopeptides, rifamycins, lincosamides, streptogramins 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 , and the pleuromutilin antibiotics (eg. lefamulin) were discovered and developed from the basidiomycete fungus Clitopilus passeckerianus.
Other examples of bioprospecting-derived anti-infective drugs include the antifungal drug griseofulvin (discovered from the soil fungus Penicillium griseofulvum ),the antifungal and antileishmanial drug amphotericin B (discovered from the soil bacterium Streptomyces nodosus ), the antimalarial drug artemisinin (discovered from the plant Artemisia annua ), 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 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 ), and the acetylcholinesterase inhibitor galantamine used to treat Alzheimer's disease (obtained from plants in the Galanthus genus).
The term biopiracy was coined by 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 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.
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's Disease and leukemia were discovered instead. The Hodgkin's lymphoma chemotherapeutic drug vinblastine is derivable from the rosy periwinkle.
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.
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.In 2000 the patent was successfully 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 Indian traditional medicine. WR Grace appealed and lost in 2005.
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 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, in 2005, the US-PTO ruled in favor of the farmers. In 2008, the patent was revoked.
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.
The following is a selection of further recent cases of biopiracy. Most of them do not relate to traditional medicines.
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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.[ 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 – 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) 2321–2582.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. §§
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 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.
The requirements for bioprospecting as set by CBD has created a new branch of international patent and trade law, bioprospecting contracts.Bioprospecting contracts lay down the rules of benefit sharing between researchers and countries, and can bring royalties to 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 and INBio of Costa Rica.
Due to previous cases of biopiracy and to prevent further cases, the Government of India has converted 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, 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 library has also signed agreements with leading international patent offices such as European Patent Office (EPO), 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.
The Convention on Biological Diversity (CBD), known informally as the Biodiversity Convention, is a multilateral treaty. The Convention has three main goals: the conservation of biological diversity ; the sustainable use of its components; and the fair and equitable sharing of benefits arising from genetic resources. Its objective is to develop national strategies for the conservation and sustainable use of biological diversity, and it is often seen as the key document regarding sustainable development.
Biodiversity is the variety and variability of life on Earth. Biodiversity is typically a measure of variation at the genetic, species, and ecosystem level. Terrestrial biodiversity is usually greater near the equator, which is the result of the warm climate and high primary productivity. Biodiversity is not distributed evenly on Earth, and is richest in the tropics. These tropical forest ecosystems cover less than 10 percent of earth's surface, and contain about 90 percent of the world's species. Marine biodiversity is usually highest along coasts in the Western Pacific, where sea surface temperature is highest, and in the mid-latitudinal band in all oceans. There are latitudinal gradients in species diversity. Biodiversity generally tends to cluster in hotspots, and has been increasing through time, but will be likely to slow in the future.
A medication is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.
Secondary metabolites, also called specialised metabolites, secondary products, or natural products, are organic compounds produced by bacteria, fungi, or plants which are not directly involved in the normal growth, development, or reproduction of the organism. Unlike primary metabolites, absence of secondary metabolites does not result in immediate death, but rather in a long-term impairment of the organism's survivability, fecundity, or aesthetics, or perhaps in no significant change at all. Specific secondary metabolites are often restricted to a narrow set of species within a phylogenetic group. Secondary metabolites often play an important role in plant defense against herbivory and other interspecies defenses. Humans use secondary metabolites as medicines, flavourings, pigments, and recreational drugs.
Hoodia is a genus of flowering plants in the family Apocynaceae, under the subfamily Asclepiadoideae, native to Southern Africa.
Medicinal plants, also called medicinal herbs, have been discovered and used in traditional medicine practices since prehistoric times. Plants synthesise hundreds of chemical compounds for functions including defence against insects, fungi, diseases, and herbivorous mammals. Numerous phytochemicals with potential or established biological activity have been identified. However, since a single plant contains widely diverse phytochemicals, the effects of using a whole plant as medicine are uncertain. Further, the phytochemical content and pharmacological actions, if any, of many plants having medicinal potential remain unassessed by rigorous scientific research to define efficacy and safety.
As with all utility patents in the United States, a biological patent provides the patent holder with the right to exclude others from making, using, selling, or importing the claimed invention or discovery in biology for a limited period of time - for patents filed after 1998, 20 years from the filing date.
Vincristine, also known as leurocristine and marketed under the brand name Oncovin among others, is a chemotherapy medication used to treat a number of types of cancer. This includes acute lymphocytic leukemia, acute myeloid leukemia, Hodgkin's disease, neuroblastoma, and small cell lung cancer among others. It is given intravenously.
A natural product is a chemical 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 synthesis and have played a central role in the development of the field of organic chemistry by providing challenging synthetic targets. The term natural product has also been extended for commercial purposes to refer to cosmetics, dietary supplements, and foods produced from natural sources without added artificial ingredients.
Cannabidiol (CBD) is a phytocannabinoid discovered in 1940. It is one of 113 identified cannabinoids in cannabis plants and accounts for up to 40% of the plant's extract. As of 2019, clinical research on CBD included studies of anxiety, cognition, movement disorders, and pain, but there is insufficient high-quality evidence that it is effective for these conditions.
Traditional knowledge, indigenous knowledge and local knowledge generally refer to knowledge systems embedded in the cultural traditions of regional, indigenous, or local communities. Traditional knowledge includes types of knowledge about traditional technologies of subsistence, midwifery, ethnobotany and ecological knowledge, traditional medicine, celestial navigation, craft skills, ethnoastronomy, climate, and others. These kinds of knowledge, crucial for subsistence and survival, are generally based on accumulations of empirical observation and on interaction with the environment.
The Traditional Knowledge Digital Library (TKDL) is an Indian digital knowledge repository of the traditional knowledge, especially about medicinal plants and formulations used in Indian systems of medicine. Set up in 2001, as a collaboration between the Council of Scientific and Industrial Research (CSIR) and the MINISTRY OF AYUSH the objective of the library is to protect the ancient and traditional knowledge of the country from exploitation through biopiracy and unethical patents, by documenting it electronically and classifying it as per international patent classification systems. Apart from that, the non-patent database serves to foster modern research based on traditional knowledge, as it simplifies access to this vast knowledge of remedies or practices.
The Council for Scientific and Industrial Research (CSIR) is South Africa's central and premier scientific research and development organisation. It was established by an act of parliament in 1945 and is situated on its own campus in the city of Pretoria. It is the largest research and development (R&D) organisation in Africa and accounts for about 10% of the entire African R&D budget. It has a staff of approximately 3,000 technical and scientific researchers, often working in multi-disciplinary teams.
International Cooperative Biodiversity Groups is a program under National Institutes of Health, National Science Foundation and USAID established in 1993 to promote collaborative research between American universities and research institutions in countries that harbor unique genetic resource in the form of biodiversity - the practice known as bioprospecting. The basic aim of the program is to benefit both the host community and the global scientific community by discovering and researching the possibilities for new solutions to human health problems based on previously unexplored genetic resources. It therefore seeks to conserve biodiversity, and to foment, encourage and support sustainable practices of usage of biological resources. Groups are headed by a principal investigator who coordinates the efforts of the research consortium which often has branches in the US and the host country as well as in the countries of other third party institutions. There are currently International Cooperative Biodiversity groups operating in Latin America, Africa, Asia and Papua-New Guinea. The Maya ICBG, a group dedicated to collecting the ethnobiological knowledge of the Maya population of Chiapas, Mexico led by Dr. Brent Berlin was closed in 2001 after two years of funding after accusations of having failed to obtain prior informed consent.
The Maya ICBG bioprospecting controversy took place in 1999–2000, when the International Cooperative Biodiversity Group led by ethnobiologist Dr. Brent Berlin was accused of engaging in unethical forms of bioprospecting (biopiracy) by several NGOs and indigenous organizations. The ICBG had as its aim to document the biodiversity of Chiapas, Mexico and the ethnobotanical knowledge of the indigenous Maya people – to ascertain whether there were possibilities of developing medical products based on any of the plants used by the indigenous groups.
In the field of drug discovery, classical pharmacology, also known as forward pharmacology, or phenotypic drug discovery (PDD), relies on phenotypic screening of chemical libraries of synthetic small molecules, natural products or extracts to identify substances that have a desirable therapeutic effect. Using the techniques of medicinal chemistry, the potency, selectivity, and other properties of these screening hits are optimized to produce candidate drugs.
The Biological Diversity Act, 2002 is an Act of the Parliament of India for preservation of biological diversity in India, and provides mechanism for equitable sharing of benefits arising out of the use of traditional biological resources and knowledge. The Act was enacted to meet the obligations under Convention on Biological Diversity (CBD), to which India is a party.
An Access and Benefit Sharing Agreement (ABSA) is an agreement that defines the fair and equitable sharing of benefits arising from the use of genetic resources. ABSAs typically arise in relation to bioprospecting where indigenous knowledge is used to focus screening efforts for commercially valuable genetic and biochemical resources. ABSAs recognise that bioprospecting frequently relies on indigenous or traditional knowledge, and that people or communities who hold such knowledge are entitled to a share of benefits arising from its commercial utilization.
Plant genetic resources are plant genetic materials of actual or potential value. They describe the variability within plants that comes from human and natural selection over millennia. Their intrinsic value mainly concerns agricultural crops.
At its essence, intellectual property rights are described as “a legal framework for contractual agreements concerning technologies, which encourage the institution of ‘markets for technology’, making easier the international transfer of technology and its diffusion at the local level.” The discussion that has taken place, concerning intellectual property rights and the following agreements, centers around spreading global knowledge and technologies. Intellectual property has been largely discussed and gone through a series of changes. At the globalized level, a global network for ideas led institutions to put policies in place and key players to form opposing viewpoints. Beyond intellectual property, alternative sources for innovation include forming partnerships and moving business activities abroad.
CBD stating that the benefits arising from the use of genetic resources should be shared in a fair and equitable way (Rau, 2010)