# Patent Term Extension for Innovative Drugs in China: A Cohort Study from 2021 to 2024

## TL;DR

This study examines how China's new patent term extension system affects the patent life and accessibility of innovative drugs from 2021 to 2024.

## Contribution

The study provides the first analysis of China's PTE system's outcomes and compares them to those in the U.S. and EU.

## Key findings

- 61% of innovative drugs were eligible for a patent term extension with a median duration of 5 years.
- The median effective patent life increased by 55.6% after adding PTE, reaching 14 years.
- Variations in PTE and EPLL were observed across drug types and therapeutic areas.

## Abstract

In January 2024, China officially implemented the patent term extension (PTE) system, that is, began to implement PTE for innovative drugs approved after June 1, 2021. This study analyzed the PTE system’s outcomes in China and its potential impact on drug accessibility.

We conducted a simulation analysis of the PTE duration and effective patent life after listing (EPLL) of innovative drugs approved by Chinese regulatory authorities from June 2021 to December 2024, using data collected from public databases such as China’s marketed drug patent registration platform.

A total of 148 innovative drugs were included in the study. Among them, 61% were able to obtain PTE, with a median PTE duration of 5 years (IQR: 2.3–5). The median EPLL before adding PTE was 9 years (IQR: 6.1–11.7), and the median EPLL after adding PTE was 14 years (IQR: 11.1–14), an increase of 55.6%. Furthermore, the study reveals variations across drug types and therapeutic areas.

Compared to findings from prior studies on the U.S. and the European Union, the median PTE duration for innovative drugs in China is longer, while the median EPLL is only marginally extended. Both Chinese domestic stakeholders and foreign enterprises should evaluate the potential impact by considering both the incremental PTE periods and the overall EPLL levels.

The online version contains supplementary material available at 10.1007/s43441-025-00903-x.