151 Pages Posted: 17 Aug 2006 Last revised: 23 Mar 2013
India developed a world-class generic drug manufacturing industry by excluding pharmaceutical products from patent protection in 1972. In 2005, India reintroduced pharmaceutical patenting in order to comply with its obligations as a WTO member. For an emerging superpower still mired in poverty and public health crises, the change did not come quickly or without controversy. This Article provides the first major comparative analysis of India's new patents regime. Based on the author's data gathering and interviews in India, the Article evaluates the regime's first eighteen months. It critiques the new law and the capacity of India's administrative and judicial infrastructure to implement it. Multiple influences shape India's mosaic view of patents: a huge population, widespread poverty, lack of health insurance, wariness towards foreign influences, a developed but fragmented pharmaceutical sector, a fledgling entrepreneurial culture of innovation among indigenous pharmaceutical and biotechnology firms, a fragile coalition government, and a vocal citizenry remarkably aware of esoteric patent law developments. Concluding that the new patents regime is neither the fully-Westernized panacea hoped for by its pro-TRIPS advocates nor the unmitigated disaster for the Indian public predicted by its fiercest critics, the Article offers recommendations for the future of India's evolving patent system.
Keywords: patent, intellectual property, India, pharmaceutical, generic, innovation, health, developing country, WTO, TRIPS
Suggested Citation: Suggested Citation
Mueller, Janice M., The Tiger Awakens: The Tumultuous Transformation of India's Patent System and the Rise of Indian Pharmaceutical Innovation. University of Pittsburgh Law Review, Vol. 68, No. 3, 2007. Available at SSRN: https://ssrn.com/abstract=923538