Abstract
This paper investigates India’s balancing act of fostering pharmaceutical innovation while ensuring affordability for the public within its intellectual property and competition law structure. It outlines the history of patent law in India from the process – patent centric view of the Patents Act 1970 to the comprehensive changes made in compliance with the TRIPS Agreement. A key focus in this legal saga is Section 3(d) which aims to prevent “evergreening”, a practice where non-therapeutic, trivial modifications are made to existing drugs to extend patent life and prolong market exclusivity. The paper discusses key judicial decisions such as Novartis AG v. Union of India, where India’s policy of granting patents predominantly for significant therapeutic advances is reinforced. It analyses competition law and its role, especially through the actions of the Competition Commission of India, in mitigating the abuse of dominant position in relation to generic drug market access. They emphasize on the COVID-19 pandemic as a watershed in the conversation of intellectual rights and public health during a pandemic, looking at the vaccine race as a combination of competition and novel collaboration licensing as well as contentious development mechanism. Finally, the paper provides recommendations for strengthening standards for patent examination, clarifying the roles of regulatory authorities, increasing transparency, and improving the governance structure. Such measures are necessary to maintain a healthy legal environment that fosters innovation and offers adequate access to medicines.
Keywords: IPR, competition law, pharmaceutical industry, evergreening, COVID 19, patent law affordable medicine, innovation
- Hypothesis:
India’s enforcement of Section 3(d) of the Patents Act and proactive competition law enforcement successfully restrict evergreening in the pharmaceutical industry, favouring both legitimate innovation and low-cost access to medicines.
- Research Questions:
- Is Section 3(d) of the Indian Patents Act successful in curbing evergreening and promoting real pharmaceutical development?
- How does evergreening affect the Indian pharma industry?
- How has the COVID 19 pandemic exposed the symbiotic relationship vis-à-vis IPR and Competition law with regard to the pharma sector?
- Scope of Research:
This study examines the domain of the IPR regime, competition law and public health in Indian pharmaceutical industry. It discusses the historic development of India’s patent law, especially after the TRIPS amendments, the impact and success of Section 3(d) as a check against evergreening, the utility of the Competition Commission of India (CCI) in controlling anti-competitive practices centred around pharma. Landmark court rulings that balanced innovation and access. The impact of global developments (e.g., COVID-19) on India’s IPRs and affordability of life saving drugs). The paper’s focus is on India, but it touches several global frameworks and debates, particularly those concerning the access to life saving drugs in the developing world.
- Research Methodology:
This paper makes use of doctrinal research methodology that was employed since according to the questions posed and when examining the legitimacy of statutory laws as well as their consequences of society it is necessary to refer to court cases, statutory laws, annotations, and other materials from the library. Since the subject of the research did not introduce the need for an inquiry based on empirical data in a great extent. We choose this method as the most appropriate method.
- Introduction
Issues involving the inter relation between international trade law, the theory of IPRs, pharmaceutical innovation and public health concerns have come under legal and policy scrutiny lately, particularly in the developing world including India. With the dynamic growth of the pharmaceutical industry, its laws have to deal with new problems of affordability, accessibility, and competition for market share. One such problem is “evergreening,” a practice whereby pharmaceutical companies extend patent protection for existing drugs by modifying them in trivial ways to block the entry of generic substitutes.
India’s legal framework concerning this matter stands out due to the country’s approach by balancing innovation and public welfare policy. India can be regarded as a case study for tackling the global intellectual property system challenges with built in protections for affordable healthcare. In this regard, this paper analyses innovations and access in India’s pharmaceutical sector by investigating the impacts of patent, competition, and judicial activism focusing on evergreening practices on public health.