Abstract

The connection, between property (IP) rights and the advancement of biopharmaceuticals is crucial in influencing the healthcare environment. This research delves into how IP regulations affect both innovation and the availability of medications. This study shows that while IP protections are meant to motivate research and development (R&D) by providing rights to creators they also present obstacles, to public health by restricting the affordability of critical treatments. This article thoroughly examines the impact of patent regulations and data exclusivity, on the progress of innovation and the worldwide availability of medications. After studying intellectual property frameworks and real life examples in the field this research delves into crucial aspects of intellectual property such, as patent safeguards, data exclusivity provisions and regulatory exclusivity. The investigation tackles topics like patent extensions, strategies, like "evergreening" that aim to extend market monopolies and patent thickets that may impede innovations. Through scrutinizing these mechanisms we uncover how intellectual property rights can incentivize risk research and development investments while also imposing hurdles to the market entry of cost generic drugs and biosimilars. The difficulties posed by exorbitant drug costs, delays in generic competition, and restricted access to necessary treatments are the main topics of this paper's investigation into the effects of intellectual property on public health access. A critical analysis of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and compulsory licensing is presented, emphasising the ways in which both international laws aim to strike a balance between IP rights and the demands of global health. Real-world applications and disputes in IP law are demonstrated through case studies, such as the recent TRIPS waiver discussion for COVID-19 vaccines and the use of compulsory licensing in India to address HIV/AIDS treatment costs. In order to achieve a balanced approach to intellectual property in the biopharmaceutical industry, this study ends with policy recommendations. To guarantee fair access to medications while maintaining innovation, they include recommendations for adaptable patent terms, open pricing structures, and international collaboration frameworks. The results highlight the need for changes that can be made to accommodate changing healthcare issues so that IP systems can serve the public health requirement of easily accessible therapy while also promoting biopharmaceutical breakthroughs.

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