Generic Medicines and Patenting of Medicinal Biotechnology in India: An Assessment of Political and Economic Stakes

Srivastava, S. P.
September 2012
Effective Executive;Sep2012, Vol. 15 Issue 3, p36
In the pharmaceutical industry, firms normally invest hundreds of millions of dollars in R&D and clinical trials on their drugs before they are sold in the market, while their generic medicine rivals are exempted from those requirements and enter the market at low cost with nominal investments. Pharma companies from the developed countries argue as to why generic drugs manufacturers should be permitted to reap the fruits of patented medicine. However, generic drug manufacturers are of the opinion that big pharmaceutical houses indulge in unfair practices and are trying to get extra duration through evergreen patent. The basic formula of the compound is already known, and persons with ordinary skill and knowledge in the art can easily obtain the new crystalline form through general and routine operations. Hence, there is nothing novel to the development of a new crystalline form; instead, it should be manufactured as a 'discovery' of a natural substance, not as an 'invention' that can be protected under patent law. Considering the global importance and politicaleconomic stakes involved thereto, this paper is an attempt to find out ways for maintaining a balance between the Indian biotech industry, global economic players and government liability to the society.


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