Historical Evolution of India’s Patent Regime and Its Impact on Innovation in the Indian Pharmaceutical Industry

Abstract

Article 21 of the Indian Constitution guarantees every person and citizen of India the right to life and the right to personal liberty. Further, Article 47 of the Indian Constitution declares that it is the duty and obligation of the Indian state to improve public health. In addition, Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) adopted by India asserts that nations have an obligation to facilitate the right to health. Thus, the Indian government operates under the premise that medicines critical to the important healthcare needs of India's population must be both available and affordable. Indeed, this paradigm is the foundational basis for India's vision for the right to health under the Article 21 of the Indian Constitution. Thus, the Indian policy makers strive to meet India's constitutional obligations for the right to health while promoting its innovation ecosystem and safeguarding the legitimate business interests of MNCs. Indeed, this powerful undercurrent has been shaping the evolution of the Indian patent regime since India's independence in 1947, through the 1970s, the economic liberalization era initiated in the 1990s, through the membership of WTO and TRIPs Agreement in 1995, post-TRIPS in 2005 and all the way up to today. In this context, this chapter analyzes how the Indian patent regime has been leveraging the flexibilities afforded under the TRIPS Agreement for the prevention of evergreening, award of compulsory licenses, retention of pre-grant opposition, and introduction of post-grant opposition and discusses how these dynamic changes are having a global impact.