Beyond primary patents: Strategic intellectual property frameworks for sustained pharmaceutical market dominance in US & EU

Pharmaceutical industry is experiencing unprecedented difficulties in market exclusivity and recovery of the massive research and development expenditures. This review crucially examines the numerous approaches taken by pharmaceutical companies in terms of patenting their products to extend product life-cycle, create competitive barriers and effectively ensure their dominance as market leaders. The article offers an organized critique of the modern patenting trends in pharmaceuticals, including more primitive methods of polymorph and formulation patents and advanced methods of patent clustering, product hopping and regulatory lagging. We examine the emerging management of pharmaceutical intellectual property, the business reasons supporting such practices and business regulation in response to the intersection of innovation and affordable access to medicine. This review presents critical case studies and demonstrates how such approaches have driven the modern pharmaceutical landscape.