Patenting and regulatory requirements of natural products

Patenting and regulatory requirements of natural products

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  Patent A patent refersto an exclusive right which is granted to an inventor. The person who has been granted patent is called "Patentee” Patent is a legal document that gives patent holder exclusive right to implement described invention commercially. The word patent is a Latin term "PATERE" which means to lay open or open letter. A patent is a form of intellectual property, it gives its owner the right to exclude others from making, using, selling and importing an invention for a limited period of time usually 20 years. If an invention is patented, it implies that no other person can commercially benefit from making, using, selling or distributing it.
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  Patent it refersto the right approved to anyone who invents something new, useful and non-obvious. It is a grant of security for an invention. It is a form of intellectual property that gives its ossessor the legal right to prohibit others from making, using, selling, and importing an invention for a limited period of years in exchange for detailed public disclosure of patented invention. In order to get a patent, technical information about the invention must be disclosed to the public in a patent application.
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  INTELLECTUAL PROPERTY RIGHTS(IPR) IPR is defined as the exclusive rights of the inventor for the protection of his or her actual property, thus excluding others from making, copying, using or selling his proprietary subject matter. It is a legal characterization and treatment of trade related biotechnological processes and product. Intellectual property right are the rights given to persons who over the creations of their mind. They usually give the creator an exclusive right over the use of his or her creation for a certain period of time.
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  INTELLECTUAL PROPERTY RIGHTS(IPR) IPR includes the following things. • Processes, product and apparatus having industrial applications. Patent • Design, book, charts, films, advertisement. Copy right • Literary works, artistic work, software, photography, Trade secrets • Words, signs. Trade marks
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  6 Purpose of thepatent To motivate the inventor It gives legal monopoly to the patentee ensures that ultimately better products and processes are found to prove the quality of human life.
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  FARMERS RIGHT This isthe right given to farmers for the improvement, conservation and making available of plant genetic resources (PGR) so that farmers need not go to the breeder every time. The protection of plant variety and farmers right act 2001 (PPV& FR act) is an act of the parliament of India that was enacted to provide for the establishment of an effect system for protection of plant varieties. The rights of the farmers and plant breeders are to encourage the development and cultivation of new varieties of plants. The PPV & FR act 2001 was enacted to grant intellectual property rights to plant breeders researchers and farmers who have developed any new or extinct plant variety.
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  These rights include: 1 •Farmers' Right to register traditional varieties developed by a farmer 2 • Farmers' Right for reward and recognition if he is engaged in the conservation of genetic resources of land races and wild relatives of economically important plants 3 • Farmers' Right on seed i.e. have rights to save, use, sow, re-sow, exchange and share or sell his farm produce including seed of a variety 4 • Farmers' Right for benefit sharing of new varieties developed by farmers which may lead to huge profit to Plant Breeders' Right (PBR) holder 5 • Farmers' Right to get compensation for the losses caused by the registered variety
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  Breeder's Right It isalso known as plant breeder's right (PBR) and is a form of intellectual property which is specially designed to protect new plant varieties. It is a special right over the commercial production and marketing of the reproductive or vegetative propagating material of the protected variety. These rights are assigned to the breeder of a new variety of plant which gives him exclusive control over the propagating material Le. seed, cuttings, divisions, tissue culture and harvested material like cut flowers, fruit foliage etc.
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  According to thisright anyone who creates a novel plant variety can obtain exclusive rights to it. With the help of these rights, the breeder can become an exclusive marketer of the variety, or can license the variety to others. In order to meet the criteria for these exclusive rights, a variety must be new, distinct, uniform and stable in nature. Breeder's Right
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  Bioprospecting It is definedas the orderly search for and development of new sources of chemical compounds, genes, micro-organisms, macro-organisms, and other valuable products from the nature. It encourages the search for economically valuable genetic and biochemical resources from nature. It aims at looking for ways to have maximum benefit from the natural resources.
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  It also includesexploration and research on native knowledge related to the utilization and management of biological resources. It helps in conservation and sustainable use of biological resources and the rights of local and indigenous communities. Majority of the medicinal plants were discovered by the process of bioprospecting. Bioprospecting
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  Biopiracy The term Biopiracywas coined by "Patmooney" to describe a practice in which indigenous wledge of nature, originating with indigenous people is used by others for profit without authorization or compensation to the indigenous people themselves. For example, when indigenous knowledge of medicinal plant which is later patented by medicinal companies without recognizing the fact that the knowledge is not new or invented by petentee and depriving the indigenous community to the rights to commercial exploitation of the technology that they themselves had developed.
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  It is definedas the unethical commercial exploitation of biological materials like medicinal plant extracts that are indigenous to a particular country without providing fait financial compensation to the people or government of that country or territory, Biopiracy occurs when research organizations take biological resources without official sanction from poor countries or trivial people. Developed countries are exploiting developing countries genetic resources and indigenous communities traditional knowledge in the name of patent on invention derived from those genetic resources. Biopiracy
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  The act ofPiracy is an unauthorized reproduction of another person's work or material. When someone indulges in piracy, the accused is using someone else's work illegally or without taking any permission. Biopiracy is the appropriation of another's knowledge of use of biological resources. Of late, the major issue involving biopiracy is the exploitation of patent biological resources or knowledge of farmers and traditional communities and indigenous tribes by many organizations and multinational companies. The innovations and discovery of the pharmaceutical and agricultural researches are not new as to qualify as invention as they are based on centuries of knowledge of the traditional societies.
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  Example of Biopiracy Patentingof Neem (Azadirachta indica) Patenting of Basmati Rice Biopiracy
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  Patenting Aspects OfTraditional Knowledge And Natural Products The Traditional knowledge is the knowledge of practice and the skills which have been developed, sustained and passed from generation to generation within a population which forms a part of its cultural or spiritual identity. The innovations which are based on the traditional knowledge may be benefited by the trade mark, the patent or it is being protected rights of local people in the form of known traditional knowledge.
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  After the endorsementof new legislations in India regarding the traditional knowledge and protection of other indigenous products there are certain issues in documentation of indigenous products and the traditional knowledge of Indian products are being patented in other countries and this at last leads to biopiracy of Indian traditional knowledge. Traditional knowledge (TKO) is the knowledge which has been gathered by a population through years of experience, tried and tested over long period of time, well adapted to load culture and environment
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  Patenting Aspects OfNatural Products Patentable natural products The following are the list of natural products which can be patentable. 1.Novel isolation process of natural products from its surroundings. Example an Indian patent for process of isolation of azadirachtin from the seeds of neem plant. 2.Characterization of new product either by its structure or by other physical parameters. 3.A new application of isolated product provided unless such knowledge or invention do not exist anywhere. Example a Japanese patent for the use of turmeric as a stabilizer for an antifungal agent.
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  20 4.Invention and novelties.For example products like biopesticides. 5.Patenting in relation to biotechnology. 6.Patenting for biological matter. For example microorganisms like E coli in which human genes are introduced for the production human insulin, human growth hormone, human tissue, plaminogen activators are patented.
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  Methods for producingnew organisms. Reducing pathogenicity, Increasing biological activity. Invention of new organisms and their composition. 8.Transgenic plants can be altered genetically to obtain transgenic plants of desired characters Example herbicide resistant cotton plant, insecticidal resistant tobacco plant Such techniques are patentable. 9.Patenting of secondary metabolites by cell culture which includes sophisticated and specific methods can be patented. Example production of taxol by cell culturing of taxus species 7.Patentable microbial inventions include the following.
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  Non patentable naturalproducts Plants grown in wild. Plants adopted for cultivations Hybrids or other cultural varieties which have been tried for particular use.
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  Procedure For ObtainingPatent 1.FILLING AN PPLICATION 2.EXAMINATION OF APPLICATION 3.OPPOSITION/C LAIM FOR PATENT 4.GRANTING & PATENT SEALING
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  Case Study OfCurcuma Turmeric is a tropical herb grown in east India. Turmeric powder has a deep distinct colour and bitter taste. It is used as dye, cooking ingredient, litmus in chemical tests and for medicinal purposes. A United States patent on turmeric was awarded to the university of Mississippi Medical centre in May 1995, specifically for the use of turmeric in wound healing. Two years later, a complaint was filed by India’s council of scientific and industrial Research (CSIR). CSIR argued that turmeric has been used in India for thousands of years for healing wounds and rashes and therefore the patent on its medicinal use was not a novel invention.
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  The CSIR claimwas supported by documentary evidence of traditional knowledge including ancient Sanskrit text and paper published in 1953 in the journals of Indian medical association. United States patent and trade mark office (USPTO) investigated the validity of the patent. In 1997 despite an appeal made by the patent holders, the USPTO upheld the CSIR objection and cancelled the patent due to lack of novelty. 25
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  26 Case Study OfNeem The Neem tree Azadirachta indica is a tropical evergreen tree native to India and is also found n other south east countries. The seeds, bark and leaves contain compounds with proven antiseptic, antiviral, antipyretic, anti-inflammatory, anti ulcer and antifungal properties. In 1971, US timber importer "Robert Harson" observed that the trees usefulness in India and began importing neem seeds to his company head quarters. He conducted safety and performance test of neem. Three years later he sold his invention to the US Department of agricultural and multinational chemical corporation WR Grace and co.
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  27 In 1992 theWR Grace and co secured its right to the formula that used the emulsion from the neem trees, seeds to make a powerful fungicide. In applying for the patent, the company had argued that it had used an extract of the trees, seed to make a new fungicide but the Indians claim that its patent was not sufficiently novel as Indian farmers have used this fungicide for decades. The Indians and members of the green party in the European union opposed the patent because they believed that the rights of the poor farmers in developing countries will be harmed. The Neem patent became the first to challenge European and US patents on grounds of biopiracy.
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  28 The Indian scientistsargued that the Indians have known the medicinal properties of neem long back. The European patent office (EPO) accepted the arguments offered by Indian scientist and rejected the order of the US patent office to award the patent to WR Grace and The victory is a result of four yearlong effort by the research foundation for science, technology and environment.