Anti-Monopoly Regulation and Improvement of Reverse Payment Agreements in Drug Patent Rights

Yutong Xie

2025

Abstract

Following the implementation of China’s drug patent linkage system, reverse payment agreements have proliferated in the pharmaceutical sector. While streamlining patent dispute resolutions, these agreements risk suppressing market competition and undermining public health. Analysis identifies structural deficiencies in China’s legal framework, including ambiguous re-view criteria, fragmented regulatory systems. The system fails to reconcile patent protection with antitrust objectives, as evidenced by the 2021 landmark case revealing imbalances in bur-den of proof and legal interpretation. To address these challenges, three reforms are proposed: a tiered review framework to categorize agreements based on risk, mandatory patent registration coupled with dynamic quantitative evaluation mechanisms, and enhanced scrutiny of non-monetary compensation and robust public interest litigation. The study emphasizes dismantling the “zero-sum game” between patent monopolies and public health through adaptive legislation, risk early-warning systems, and multi-stakeholder governance. These measures aim to incentivize pharmaceutical innovation while safeguarding public welfare, ensuring sustainable industry development.

Paper Citation

in Harvard Style

Xie Y. (2025). Anti-Monopoly Regulation and Improvement of Reverse Payment Agreements in Drug Patent Rights. In Proceedings of the 1st International Conference on Politics, Law, and Social Science - Volume 1: ICPLSS; ISBN 978-989-758-785-6, SciTePress, pages 358-363. DOI: 10.5220/0014380800004859

in Bibtex Style

@conference{icplss25,
author={Yutong Xie},
title={Anti-Monopoly Regulation and Improvement of Reverse Payment Agreements in Drug Patent Rights},
booktitle={Proceedings of the 1st International Conference on Politics, Law, and Social Science - Volume 1: ICPLSS},
year={2025},
pages={358-363},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0014380800004859},
isbn={978-989-758-785-6},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 1st International Conference on Politics, Law, and Social Science - Volume 1: ICPLSS
TI - Anti-Monopoly Regulation and Improvement of Reverse Payment Agreements in Drug Patent Rights
SN - 978-989-758-785-6
AU - Xie Y.
PY - 2025
SP - 358
EP - 363
DO - 10.5220/0014380800004859
PB - SciTePress