China’s “Hatch-Waxman” System: A Comparative Overview

Introduction

China’s 2020 Amended Patent Law (“2020 Amendment”) introduces a “Hatch-Waxman” like patent linkage system, which took effect on June 1, 2021. Article 76 of the 2020 Amendment outlines a general framework, allowing early patent dispute resolution before generic drug approval.

In the past, generic drugs could be approved and enter the market in China even though they may be infringing certain patents. A patent owner had no cause of action to bring a patent infringement suit until a generic drug had actually entered the market, because filing a generic application per se was not an infringement act in China.

Under the new framework, a patent owner/new drug application (NDA) holder can initiate a civil judicial proceeding or an administrative adjudication proceeding (collectively “an Article 76 action”) prior to marketing approval of an allegedly infringing generic drug product.

Article 76 of the 2020 Amendment is extremely brief, which states in its entirety the following:

During the drug marketing authorization review period, if disputes arise around the drug-related patents, the applicant and the patent holder or other interested party may file suit before a court to seek legal judgment on whether the drug falls within the patent protection scope.

The National Medical Products Administration may decide to stay the drug marketing authorization based on an effective court ruling. Alternatively, the parties may petition for an administrative ruling at the China National Intellectual Property Administration.

Three Chinese government agencies, the National Medical Products Administration (NMPA), the China National Intellectual Property Administration (CNIPA), and the Supreme People’s Court were tasked to implement Article 76 of the 2020 Amendment. After about a month of delay from the anticipated release date, three sets of implementing measures were issued in early July this year. They are

1. “Measures on the Early Resolution Mechanism for Drug-Related Patent Disputes” (referred to as “the Early Dispute Resolution Measures” herein) jointly by NMPA and CNIPA, issued and effective on July 4, 2021, accompanied with a policy interpretation presented in a form of questions and answers (“Policy Interpretation”);
2. “Legal Provisions on Several Issues Concerning the Application of Laws in the Trial of Disputes over Drug Patent Linkage” (“Legal Provisions”) by the Supreme People’s Court, issued and effective on July 5, 2021, and
3. “Measures on Administrative Adjudication in the Early Resolution Mechanism for Drug-Related Patent Disputes” (“Administrative Adjudication Measures”) by the CNIPA, issued and effective on July 5, 2021.

This Article provides a preliminary overview of the Chinese patent linkage system and a comparison with the United States Hatch-Waxman framework.

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