A robust intellectual property rights (IPR) framework, with suitable enforcement systems, is critical to support India’s efforts to be a global leader in innovation and competitiveness. A world-class intellectual property (IP) system is fundamental to innovation and necessary to develop new products and technologies. This is especially true for the life sciences to upgrade the quality of health care. Currently, India’s share of global Patent Cooperation Treaty (PCT) patent applications in the life sciences stands at 1.5%. Without the cushion of a reliable IP system, biopharmaceutical researchers may not have much incentive to explore new areas of medical innovation and uncover insights that will lead to better medical treatments.
The scholars, Bhaven Sampat and Kenneth Shadlen, write in a 2015 paper: “it is possible that Section 3(d) of the Indian Patents Act is having an indirect effect. Explicit prohibitions on some forms of secondary patents in Section 3(d) may deter some applications that would potentially be rejected on 3(d) grounds from being filed in the first place.” This calls for a holistic empirical assessment of this unique legal provision. The efficacy threshold has also been studied by other scholars. Since several mechanisms already exist in the law, which help weed out frivolous patent applications, a re-look of Section 3(d) in the context of the concerns that have been raised would be beneficial. Strong IP standards can fuel the growth of domestic innovative industries, help attract greater foreign investment, and bolster India’s economic prosperity and global competitiveness. Innovators must be able to secure patents, protect regulatory test data and effectively enforce rights. Additionally, a world-class drug regulatory framework implemented by effective drug regulatory authorities will not only ensure that patients have greater access to safe, high-quality and efficacious medicines but also encourage scientific research and drug discovery.
India invests just 0.9% of its Gross Domestic Product (GDP) in overall research and development; it is 1.6% in the U.K., 1.9% in China, 2.8% in the U.S., and 3.3% and 4% in Japan and South Korea, respectively. India’s expenditure on pharmaceutical R&D, at 0.08% of GDP, is just one-eighth of the U.S.’s spend (0.62% of GDP), and a fourth of the expenditure of the U.K.’s 0.3% of GDP). To be able to bridge this gap, India must recognise the potential of science and innovation to improve the health of Indian patients and advance economic growth in the country through a healthy and skilled workforce and the expansion of manufacturing and research capacities. Today, cutting-edge medical science is transforming lives and Indian patients deserve to leverage the progress made globally to be able to reap benefits that medical innovations offer. India has an opportunity to collaborate and build on its strengths and move up the value chain by enabling innovation and new drug discovery.
Developing a robust, innovative ecosystem can improve the health of patients in India and around the world, while also generatinge economic benefits by making India an attractive destination for investment in R&D. This will create more jobs that can add greater value and drive a higher research output of global significance. According to a PWC report, India has the potential to attract $300-400 million worth of foreign direct investment (FDI) in R&D in the next five years. Industry, the government and other stakeholders must work together to build, sustain and grow a scientific, economic and policy ecosystem.
Innovators of new and effective medicines have contributed to India’s economic growth and development, through technical collaboration, awareness programmes, patient access initiatives and drug safety efforts. The bright promise of an innovative biopharmaceutical industry in India will only be fulfilled if we work together to build, sustain and grow a scientific, economic and policy ecosystem that promotes and rewards medical innovation.
Dr. Ashish Bharadwaj is Associate Professor at the Jindal Global Law School, and Director, Jindal Initiative for Research in IP and Competition (JIRICO). Punkhuri Chawla is Research Analyst, JIRICO, at the O.P. Jindal Global University