The dual barriers to biosimilar competition: A comparative analysis of US patent thickets and EU supplementary protection certificates

Abstract

The timely market entry of biosimilar medicines, crucial for healthcare cost reduction, is significantly impeded by distinct intellectual property (IP) strategies employed by originator pharmaceutical companies in the United States (US) and the European Union (EU). This article examines two primary IP mechanisms creating market exclusivity barriers: US patent thickets and the associated litigation/settlement manipulation under the Hatch-Waxman Act/Biologics Price Competition and Innovation Act (BPCIA), and EU Supplementary Protection Certificates (SPCs) combined with data exclusivity. In the US, complex webs of secondary patents (patent thickets) coupled with the potential for anticompetitive “reverse payment” settlements, often delay generic and biosimilar launches, utilizing distinctive regulatory advantages such as the 180-days exclusivity granted to initial challengers. Conversely, the EU system relies heavily on SPCs to compensate for regulatory delays, effectively prolonging market monopoly beyond the basic patent term. While EU courts have often found secondary patents surmountable for biologics, the strong safeguards created through SPC extensions and prolonged data exclusivity timelines (10-11 years) remains a powerful deterrent. The comparative analysis suggests that while both jurisdictions effectively delay affordable access, the EU’s SPC mechanism provides a clearer, albeit longer, period of guaranteed protection, whereas the US system introduces greater complexity and reliance on anti-trust litigation to dismantle artificial barriers to competition.