Biotechnology and Patent Challenge
Biotechnology promises more efficacious drugs, medical treatment tailored to the individual patient’s biological make-up, new crops, new industrial processes and much more. As pointed out by Geoffery Carr, it has the potential to transform humanity provided humanity wishes to be transformed . Biotechnology companies invest hundreds of millions of dollars and sometimes decades to develop a product . Patents provide the needed assurance for investors to risk the capital necessary in the long development process, so that investment can not only be recouped but also generate a profit . In the absence of effective patent regime, investors would not be interested in investing millions on long term R and D because research output could be exploited by any person, which would jeopardize their returns and profits. In this context, biotechnology assumes very high importance when seen in the light of the patent regime because of its research and investment intensive nature and so the patent regime plays a very important role in encouraging the progress of biotechnology. However, the application of the patent system to biotechnology as a field is fraught with uncertainty and ambiguity because of its unique nature.One of the most unique features of biotechnology is its diversity. Biotechnology as a field is divided into number of sub fields under it. Though there is a common line running through all of them, each sub field has characteristics and features which are differentiable from the others so that a broad set of general rules cannot be framed for biotechnology as a whole. For example, genomics is different from tissue culture in characteristics, applications, processes and products and even in tissue culture; plant tissue culture has different characteristics when compared to animal tissue culture. Because of its diversity and the varying characteristics of its sub fields, it is difficult to frame common patent principles or rules for biotechnology as a whole. This makes the application of patent law to biotechnology very complex.
As biotechnology deals with life, it gives rise to moral, ethical and religious issues. Most issues in biotechnology, from patenting of genes or genetically modified crops to patenting life is confronted with moral, ethical and religious controversies. As a result, public consciousness has for long been intertwined with the progress of biotechnology and policy framers have had difficulty in creating a patent regime to promote a field that is believed to have the potential of disturbing ethics and values that have been built into the society.
Furthermore, there is fear among the public that biotech research might result in environment hazards. Fear of environmental hazards shape in the form of lot of controversies. One issue that raised moral, ethical and environmental controversies is the rDNA controversy, which lead to promulgation of safety guidelines for biotech research .
Another unique problem with applying the patent regime to biotechnology is the meaning of the term itself. The meaning of the term biotechnology has since long been very vague and ambiguous. It has been attributed different meanings based on context, place, etc. The World Intellectual Property Organization (WIPO) defines biotechnology as “any technology using living entities, in particular animals, plants, or microorganisms, or causing change in them” . The United States Office of Technology Assessment defines Biotechnology as “any technique that uses living organisms or substances from those organisms to make or modify a product, to improve plants or animals, or to develop microorganisms for specific uses .” The OECD defines biotechnology as: ‘The application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services . All three definitions have different meanings and scopes. The WIPO definition is very broad and covers any technology that uses living organisms. On the other hand definition of Office of Technology is narrower as it is limited to only techniques using living organisms to make or modify products and to improve plants or animals. The OECD definition has a different scope when compared to WIPO and US Office of Technology because it defines the scope of biotechnology to include techniques using living organisms for production of knowledge, goods or services, which is a commercial way of looking at the field. So, the meaning of the term biotechnology is different in different countries and contexts, which makes its scope very unclear leading to confusion and uncertainty in understanding it for purposes of applying patent principles.
The unique nature of biotechnology makes it challenging to apply traditional patent principles to the field. Considering the unique nature of the field, differential patent principles have been evolved and applied to biotechnology.
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