Lawsuits in Monoclonal Antibody Biosimilars as a Corporate Strategy to Safeguard Intellectual Property Rights and Prevent Market Competition

Approving biosimilars for monoclonal antibodies has become a critical tactic for enhancing patient access and addressing healthcare problems in both developed and developing nations. However, it has proven challenging to implement this regulatory strategy in clinical settings due to the aggressive patent litigation tactics employed by originator companies to boost their market exclusivity and suppress competition from biosimilars. This analysis looks closely at the patent litigation dynamics surrounding mAb biosimilars in four jurisdictions (the United States, EU, Canada, and India) between 2010 and 2025. The study emphasizes the tactics employed by original pharmaceutical companies, such as patent thicketing and evergreening, to prevent biosimilars from entering the market, safeguard revenue streams, and maintain monopolistic dominance. The study shows that patent claims related to biosimilars are more common in the United States and it also identifies significant variations in court rulings and patent litigation practices across other jurisdictions. Though legal frameworks have improved to encourage competition for biosimilars, originator companies still employ complex intellectual property strategies to maintain barriers to competition. The study looks at the implications for fair competition, global policy alignment, and patient access to reasonably priced biologic medications in light of recent regulatory changes and important court rulings.