Biotechnology Patenting in India: Will Bio-Generics Lead a 'Sunrise Industry' to Bio-Innovation?

Abstract:     
This article evaluates TRIPS-level patent protection as an incentive mechanism for biotechnology innovation in India. Recent enhancements to India's patent laws, a new acceptance of biotechnology patents by the Indian judiciary, and an expanding global demand for generic bio-pharmaceuticals all predict a surge in biotechnology process development and patenting in India.

Many Indian biotechnology companies have developed proprietary processes for manufacturing "bio-generics" or "bio-similars," i.e., copies or derivative forms of first-generation biologics such as recombinant human insulin and erythropoietin now coming off patent in the U.S. and elsewhere. Despite their success in process development, the Indian firms are not yet filing a significant number of patent applications in India. Data gathered for this article, limited to companies generating significant biotechnology revenues in India in 2005 and 2006, reveal that they filed only a handful of Indian patent applications during that period.

Are the Indian firms' efforts to meet the growing worldwide demand for generic biologics draining resources that might otherwise be put towards now-potentially patentable innovation? Rather than developing novel recombinant proteins or methods of manufacturing them, for example, the bulk of India's skilled biotechnologists might remain focused on merely copying off-patent biologics. The enhanced incentives provided by India's newly strengthened patents regime might take a back seat to supplying the demand for generic biologics.

This article rejects such a scenario. The TRIPS-mandated term extension of Indian chemical (including biotechnological) process patents from seven to twenty years from filing, coupled with a shifted burden of proof for alleged infringements of process patents, will work in concert with the Indian biotechnology industry's desire to lead the world in supplying generic biologics. As multiple Indian companies compete to sell the same biotechnology product, each firm's need to distinguish itself by process development increases. Stronger process patent protection will facilitate competitive advantage among Indian biotechnology companies.

Keywords: Patent, Intellectual Property, India, Biotechnology, Generic, Bio-Generic, Pharmaceutical, Process, Innovation, Health, Developing Country, TRIPS

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