Compulsory Licenses for Pharmaceutical Patents in China in Light of the Trips Agreement

50 Pages Posted: 7 Apr 2023

See all articles by Qian YIN

Qian YIN

The Chinese University of Hong Kong, Law School

Date Written: March 31, 2023

Abstract

The recurrence of public health emergencies has made the issue of access to drugs a pertinent problem for developing countries. As a public health safeguard, the compulsory license system for patented pharmaceuticals is embodied in the international intellectual property (hereinafter “IP”) norms related to public health. The Agreement on Trade-Related Aspects of Intellectual Property Rights (hereinafter “TRIPS Agreement”) flexibility is a double-edged sword for the pharmaceutical patent system in developing countries. On the one hand, the exception clauses to IP protection under the TRIPS Agreement, especially the compulsory licensing system, give member states the possibility of exempting their treaty obligations in the event of a public health crisis. On the other hand, the different interpretations deriving from the ambiguity of TRIPS ‘‘flexibility’’ defer members from implementing compulsory licensing in response to a public health crisis. China has established a systematic set of rules, including legislation and policies on compulsory licensing and integrated the TRIPS flexibility into Free Trade Agreements (FTAs). However, it still lacks clear procedural provisions regarding the compulsory licensing of pharmaceutical patents in the context of the public health crisis, which affects China’s ability to use TRIPS flexibility of Compulsory licenses effectively.

Furthermore, China’s compulsory license law is never implemented despite the increasing need to ensure drug access and effectively respond to public health emergencies. This article aims to assess China’s compulsory license system in light of the TRIPS Agreement. The article analyses how and why China’s domestic compulsory license system fails to take advantage of TRIPS flexibility in substance and implementation. It suggests points for reform to enhance China’s compulsory license system for pharmaceutical patents, which can effectively be utilized in public health emergencies, as well as heading towards better integration and implementation of the TRIPS flexibility, referring to the interest-balanced guiding principle.

Keywords: compulsory license, pharmaceutical patents, TRIPS flexibility, the balance of interests, China

Suggested Citation

YIN, Qian, Compulsory Licenses for Pharmaceutical Patents in China in Light of the Trips Agreement (March 31, 2023). Asian Journal of WTO & International Health Law and Policy, Vol. 18, No. 1, pp. 131-180, March 2023 , Available at SSRN: https://ssrn.com/abstract=4410986

Qian YIN (Contact Author)

The Chinese University of Hong Kong, Law School ( email )

Hong Kong

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