Original ResearchVol. 19, Issue 4 • pp. 245-260DOI: 10.1007/s12345-024-00001-2
Patent Term Extension for Pharmaceutical Products: A Comparative Analysis of the United States, Japan, and Europe
Authors: John A. Smith, Emily R. Johnson, Michael T. Brown
This paper examines the legal frameworks for patent term extension (PTE) for pharmaceutical products in the United States, Japan, and Europe. It analyzes the regulatory provisions, eligibility criteria, and procedural requirements in each jurisdiction, and compares their effectiveness in compensating for regulatory delays. The study finds significant differences in the scope and duration of extensions, with the US system being more generous but complex, while Japan and Europe offer more streamlined processes. The paper concludes with recommendations for harmonization and policy improvements.
Graphical Abstract