A Techno-Legal Study on Current IPR Scenario for Commercialization of Biosimilars in the USA

Abstract

Biologics are essential medical innovations, but they often come at high cost, limiting patient access. Biosimilars provide lower-cost alternatives. However, their entry into the U.S. market is complicated by Intellectual Property Rights (IPR). The Biologics Price Competition and Innovation Act (BPCIA) established an abbreviated pathway for biosimilars, allowing reliance on clinical data from Reference Product Sponsors (RPS). Before IPR reforms, challenging patents was difficult and costly, as granted patents were presumed valid and re-examination processes were often ineffective. The objective of this article is to present, in a nutshell, the IPR scenario related to biosimilars from the perspectives of the patient, the innovator, the regulator, and the biosimilar manufacturers. Biologics and biosimilars are introduced, BPCIA provisions for resolving patent disputes are discussed, some case studies on patent litigation are reviewed, mentioning the patent dance, and Inter Partes Reviews. The article highlights the need for stricter patentability standards to mitigate patent thickets and secondary patenting practices that delay biosimilar market entry, ultimately advocating improved access to affordable biologic therapies and also providing reasonable protection for Biological innovations.