• The US PTE system provides up to 5 years of extension, but its complex eligibility criteria and multiple patents per product can lead to inequities.
• Japan's PTE system is more straightforward, with a single extension per product, but its duration is capped at 5 years and may not fully compensate for all regulatory delays.
• Europe's supplementary protection certificate (SPC) system offers up to 5 years of extension, but its scope is limited to the first authorization and does not cover subsequent approvals.
• Harmonization of PTE rules could reduce disparities and improve predictability for pharmaceutical innovators, while balancing public health concerns.