Due to the growing concerns arising from Genetically Modified Organisms (GMOs) throughout the globe the WHO has built an informal working group on biosafety in 1991. This group prepared the ‘voluntary code for the release of organisms into the environment’. ICGEB (International Centre for Genetic Engineering and Biotechnology) has played a significant role in issues related to biosafety and the environmentally sustainable use of biotechnology. The main ‘topic of concern’ related to the release of GMO’s are risks for human health, environment, and agriculture which is found on the website of ICGEB.
In India, DBT has evolved ‘rDNA safety guidelines’ to exercise powers conferred through the Environmental Protection Act 1986 for the manufacture, use, import, export and storage of hazardous micro organisms and genetically engineered organisms, cells etc., These guidelines are implemented and monitored by the Institutional Biosafety Committees (IBSCs), the Review Committee on Genetic Manipulation (RCGM) and the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forest.
The physical objects like household goods or land or properties of a person and the ownership and rights on these properties is protected by certain laws operating in the country. This type of physical property is tangible; but the transformed microorganisms, plants, animals and technologies for the production of commercial products are exclusively the property of the intellectuals. The discoverer or inventor has complete rights on his property or invention. The rights of intellectuals are protected by laws framed by a country. The intellectual property is an intangible asset. Legal rights or patents provide an inventor only a temporary monopoly on the use of an invention, in return for disclosing the knowledge to the others who may use the knowledge to develop further inventions and innovations.
The laws are formulated from time to time at national and international levels. Development of new crop varieties is also an intellectual property right. It is protected by ‘plant breeders rights’ (PBRs). PBRs recognize the fact that farmers and rural communities have contributed to the creation, conservation, exchange and knowledge of genetic and species utilization of genetic diversity. IPR and IPP are granted by the Government to plant breeders for producing a specific plant variety that is new and never existed before.
IPR is protected by different ways like patents, copyrights and trade marks.
The science of biotechnology involves the production of enormous number of commercial products of economic importance.
The inventions include biotechnology products and processes. The products include living entities like micro organisms, animals, plants, cell lines, cell organelles, plasmids and genes and naturally occurring products like primary and secondary metabolites produced by living systems e.g. alcohol, antibiotics.
The biotechnological processes involve isolation, purification, cultivation, bioconversion of novel, innovative, simple and cost effective processes, and creation of biotechnological products.
A patent is a Government issued document that allows the person for an exclusive right to manufacture, use or sell an invention for a defined period (usually 20 years). It is a legal document safeguarding the rights and privileges of an inventor / invention. The purpose of patenting in biotechnology ensures fair financial returns for those who have invested finances, ideas, time and hard work for an invention.
· The invention must be novel and useful;
· The product must be inventive and reproducible;
· The patent application should provide the full description of the invention and the invention must be patentable.
GATT was framed in 1948 by developed countries to settle dispute, among the countries regarding share of world trade. The benefits of GATT was enjoyed only by developed countries. In 1988 US congress enacted a law ‘the omnibus trade and competitiveness act’ (OTCA) which gave powers to US to investigate the laws related to trade.
A geographical indication is a name or sign used on products which correspond to a specific geographical origin and possess qualities or a reputation that are due to that origin. Geographical indications are typically used for agricultural products, food products,handicrafts and industrial products. Darjeeling tea was the first GI tagged product in India in 2004-05. In Tamilnadu, Kancheepuram silk, Coimbatore wetgrinder, Thanjavur paintings, Madurai Malli and Temple jewellery of Nagercoil are GI tagged.
The protection of authorships of published work comes under copyrights of IPRs. Copyright protection is given for form of expressions of ideas. For example the authors, editors, publishers or both the publisher/ editor of a book have copyrights. The content of the book cannot be reproduced or reprinted without written permission from copyright holders. Patents and trade secrets provide protection for the basic knowhow but copyright protects the expressed materials in printed, video recorded or taped forms. In the field of biotechnology the data base of DNA sequences or any published forms, photomicrographs, etc., are subject to copyright.
Any specific symbol or words to identify a particular product or process of a company constitute trademark. This enables the public to distinguish between a trader’s goods from similar goods of other traders
Biotechnology as an independent discipline has drawn world wide attention from the Governments and the corporate world because of its limitless applications. It is looked upon as a panacea for treating diseases and genetic disorders. The global demand of the biotechnological products is on the increase. It is the science for the future with solutions to many of the problems related to health, agriculture, environment and industries.