ABSTRACT Patent infringement in the Indian pharmaceutical industry presents a complex interplay between encouraging innovation, ensuring access to affordable medicines and responding to evolving regulatory processes. Commonly referred to as a “global commodity”, India has a pharmaceutical industry that provides the world with affordable medicines. The country’s adoption of product patent protection under the TRIPS agreement in 2005 marked a significant change that created tensions between the multinational pharmaceutical companies seeking to protect their innovations and domestic manufacturers focusing on affordable medicines. While patent laws in India aim to protect innovation, they also emphasise the need to make essential medicines accessible to millions of citizens. A nuanced approach, encompassing legislative reforms, judicial clarity and stakeholder collaboration is essential to strike an equitable balance. This study aims to explore the fundamental issues of patent infringement in India, including the challenge of balancing intellectual property rights with the welfare of the public. It examines important cases such as Novartis v/s Union of India and Bayer Corporation v/s Natco Pharma ltd. which addresses patent errors, patentability procedures and legal approaches to infringement. The paper also examines how Section 3(d) of the Indian Patent Act,1970 can be an important tool in protecting the patent environment while encouraging innovation, interference, poor governance and India’s compliance with international obligations. It highlights the need for a legal framework that supports the local actors while ensuring the compliance with international intellectual property rights. The research concludes by suggesting policy measures that will foster a balanced approach that encourages innovation without hindering access and ensures that the Indian pharmaceutical industry remains a global leader in healthcare solutions. By addressing the legal complexities surrounding the patent infringement while prioritising public health, India can maintain its status as the “pharmacy of the world” while promoting innovation and accessibility.

Keywords: Indian pharmaceutical industry, patent infringement, TRIPS, pharmacy of the world.

INTRODUCTION

The Indian pharmaceutical industry is among the largest in the world, ranking third globally by volume and 14th by value. It plays a crucial role in supplying affordable, generic medicines, particularly to developing nations. However, the growth of the sector has not been devoid of controversy, particularly those surrounding patent infringement, and the balance between innovation and accessibility.^[1] This paper examines the historical evolution of India’s patent laws, landmark legal battles, and the challenges associated with enforcing patent rights while ensuring affordable access to medicines. It also provides a comparative perspective with other countries and suggests a way forward for balancing the competing interests of innovation and public health.^[2] The evolution of Patent Laws in India:

^[1]An International Guide to Patent Case Management for Judges. (n.d.).

^[2]Ibid.