Biotechnology law is a rapidly growing, highly specialized field of law, closely associated with pharmaceutical law and stemming from the field of science and technology. Despite its specialized nature, this area of law does overlap with a few other main practice areas: intellectual property law; patent law (and specifically, patent prosecution); licensing law; litigation; business law; and venture capital law.
Biotechnology is generally defined as the manipulation of microorganisms to perform certain processes and is largely identified with genetic engineering. The procedure usually involves the transfer of genes from one living entity into another, or into a synthetic compound, using advanced recombinant DNA technology. It covers any technological application that uses biological systems, living organisms, or their derivatives, to create, manufacture, modify or adapt plants, products, goods, animals or processes for specific use.
Its applications are useful in the medical field (red biotechnology), the aquatic field (blue biotechnology), the agricultural field (green biotechnology), and the industrial field (white biotechnology). It is involved in the development of new medicines and therapies; new research tools; increasing crop yields; creating hardier crops and plants; increasing the taste, texture and nutritional value of food; decontamination; removal of manmade pollutants and waste; and much more.
With biotechnology, the development time between working theory and a tangible product is far longer than that of other companies, generally seven to ten years. And these are very costly endeavors, ranging from $250 million to $300 million to create, develop, test and prepare a drug/product for market. The nature of these types of innovations and the rapidly evolving laws and regulations regarding biotechnology make this legal practice area both difficult and challenging. Lawyers, companies and scientists must struggle with complex issues involving necessary and applicable financial backing and how best to develop and create business agreements; intellectual property rights; convoluted, drawn-out regulatory proceedings; and many other challenges and obstacles spread over a lengthy time period.
The Coordinated Framework for Regulation of Biotechnology is the U.S. government’s formal policy for dealing with biotechnology and its applications. It was enacted by the Office of Science and Technology Policy (OSTP) Agency and is implemented by the Department of Agriculture (DOA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). The federal Biotechnology Patent Protection Act allows the patenting of biotechnological processes and/or the resulting products or materials, provided they are novel and non obvious. The FDA largely regulates how drugs and other pharmaceutical products may be brought to market.
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