Intellectual Property Rights and Patent Strategies in Nanotechnology-Based Pharmaceutics

Abstract

The convergence of nanotechnology and pharmaceutical sciences has established nanotechnology-based drug delivery systems as a transformative therapeutic paradigm, while simultaneously generating unprecedented challenges for intellectual property (IP) frameworks. This chapter examines intellectual property rights (IPR) and patent strategies in nanopharmaceutics, encompassing foundational patentability criteria, nanomedicine-specific IP challenges, lifecycle management strategies, and a comparative regulatory analysis across the United States, European Union, and India. Recent advances between 2022 and 2025 in CRISPR-based nanomedicine patents, Artificial Intelligence (AI)-Al-assisted drug delivery design, personalized mRNA cancer vaccines, and next-generation lipid nanoparticle (LNP) technologies are critically evaluated. The role of Al patent tools, including PatSnap, Derwent Innovation, and Lens.org, is assessed with respect to its capabilities, limitations, and ethical concerns. Case studies encompassing Doxil, Abraxane, ONPATTRO, and mRNA-4157/V940 illustrate applied IP strategy. Ethical dimensions, including equitable access, evergreening, and technology transfer obligations, are also discussed.