Yuying ZHANG, Patent Attorney

I. Institutional Framework

The early resolution mechanism for pharmaceutical patent disputes (also known as the pharmaceutical patent linkage system) represents a significant institutional innovation in the field of pharmaceutical intellectual property protection in China. Its core purpose is to align the marketing approval procedure for generic drugs with the patent dispute resolution process, thereby resolving potential infringement risks before generic drugs are approved for marketing. Article 76, newly added in the Fourth Amendment of Chinese Patent Law in 2020, established this system at the legal level. In July 2021, the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued the Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes (Trial) (hereinafter referred to as the "Implementation Measures"), and the CNIPA also issued the Administrative Adjudication Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes (hereinafter referred to as the "Administrative Adjudication Measures"). Concurrently, the Supreme  Court    issued    a  judicial  interpretation, marking the official implementation of this system.

Article 76 of the Chinese Patent Law provides parties with two parallel dispute resolution avenues: filing a lawsuit with the court, or requesting administrative adjudication with the CNIPA. This “dual track” design not only reflects the distinctive features of China’s patent protection system, but also gives rise to ongoing discussions on how the two avenues should be coordinated in practice. This article aims to systematically introduce the early resolution mechanism for pharmaceutical patent disputes, with a particular focus on the institutional design and operational practice of the administrative adjudication pathway, and to conduct a comparative analysis of the similarities and differences between administrative adjudication and judicial proceedings.

II. Key Institutional Aspects of the Administrative Adjudication Pathway

(1) Legal Basis

On July 5, 2021, the CNIPA issued the Administrative Adjudication Measures, which set forth systematic provisions on the acceptance conditions, adjudication procedures, and legal effect of administrative adjudication.

According to the Administrative Adjudication Measures, the CNIPA is responsible for handling administrative adjudication as referred to in Article 76 of the Chinese Patent Law, and has specifically established     the Administrative Adjudication Committee for the Early Resolution Mechanism for Pharmaceutical Patent Disputes to organize and conduct the relevant adjudicative work. The establishment of this specialized body reflects the professional orientation of the administrative adjudication pathway.

(2) Acceptance Conditions and Qualification of Parties

Article 4 of the Administrative Adjudication Measures explicitly stipulates seven conditions that a request for administrative adjudication must satisfy. Among these, particular attention should be paid to subparagraph (6): where the applicant for drug marketing authorization files a request for administrative adjudication, it is required that within forty five days from the date when the Center for Drug Evaluation (CDE) under the NMPA publicly discloses the application for drug marketing authorization, neither the patentee nor any interested party has filed a lawsuit with the people’s court or filed a request for administrative adjudication concerning the pharmaceutical patent dispute. This provision establishes the “supplementary” status of the generic drug applicant in initiating administrative adjudication, meaning that the generic drug applicant may initiate administrative adjudication only on the condition that the patentee or interested party has not filed an administrative adjudication request or lawsuit within a 45-day period. 

With regard to the qualification of parties, where the patentee or an interested party requests a determination that the technical solution of the generic drug falls within the scope of patent protection, the applicant for drug marketing authorization shall be named as the respondent. Conversely, where the applicant for drug marketing authorization requests a determination that its technical solution does not fall within the scope of protection, the patentee shall be named as the respondent. Interested parties include licensees of the relevant patent or registered drug marketing authorization holders.

(3) Procedural Features and Rules of Evidence

The administrative adjudication procedure exhibits several notable features:

First, efficiency. Administrative adjudication does not follow the complex civil litigation procedures; it does not require the full suite of judicial steps such as filing a complaint, acceptance, hearing, examination and cross‑examination of evidence, and appeal, resulting in a relatively shorter adjudication cycle.

Second, professionalism. Administrative adjudication is conducted by patent examiners with technical backgrounds, who possess professional advantages when comparing complex technical solutions. The core of the adjudication lies in determining whether the technical solution of the generic drug falls within the scope of protection of the patent claims, which is essentially a question of technical fact‑finding.

Third, the specificity of the burden of proof. In the administrative adjudication procedure, the generic drug applicant bears the obligation to submit its technical solution. Failure to submit within the specified time limit will result in adverse legal consequences for failing to meet the burden of proof. The evidence submitted by the generic drug applicant should focus on whether all technical features of the patent in question are covered by the generic drug's technical solution.

Fourth, the confidentiality protection mechanism. The technical solution of the generic drug may involve trade secrets of the applicant. In the administrative adjudication procedure, the CNIPA imposes strict confidentiality measures on the submitted technical solutions, restricts the circle of case participants, and conducts separate exchanges of confidential evidence.

(4) Legal Effect of the Adjudication

Once an administrative adjudication is rendered, the determination of whether the generic drug falls within the scope of patent protection may serve as the basis for the drug regulatory authority in approving the generic drug for marketing. However, it should be noted that the administrative adjudication itself is not a final decision. Parties dissatisfied with the administrative adjudication may, in accordance with the law, initiate administrative litigation with the people’s court. Notably,   even   if   such administrative litigation is initiated, the nine‑month waiting period for the registration and approval of chemical generic drugs will not be extended accordingly. This institutional arrangement not only safeguards the parties’ right to judicial remedy, but also prevents the market entry of generic drugs from being indefinitely delayed due to prolonged litigation proceedings.

III. Comparison Between Administrative Adjudication and Judicial Approaches

(1) Institutional Positioning of the Two Approaches

Administrative adjudication and judicial approaches together constitute the “dual track” system of the early resolution mechanism for pharmaceutical patent disputes in China. Pursuant to the Implementation Measures, where a patentee or an interested party objects to a Type IV patent declaration, it may, within 45 days, elect either to initiate litigation with the people’s court or to request administrative adjudication from the CNIPA. The two approaches differ markedly in their institutional positioning: the judicial approach emphasizes final and authoritative adjudication, whereas administrative adjudication prioritizes the swift resolution of disputes.

(2) Comparison of Core Differences

First, the competent authorities and adjudicating bodies differ. In the judicial approach, first‑instance cases are under the centralized jurisdiction of the Beijing Intellectual Property Court.   In contrast,  administrative  adjudication is handled by the Administrative Adjudication Committee for the Early Resolution Mechanism for Pharmaceutical Patent Disputes, a specialized body established by the CNIPA.

Second, the adjudication cycles differ. Administrative adjudication has a clear efficiency advantage, with an average completion time of approximately six months. In the judicial approach, the first‑instance trial cycle is about six months, and the second‑instance trial cycle is about three months, with the total duration of both instances typically exceeding nine months. This difference directly affects whether a final and effective decision can be obtained within the nine‑month waiting period. Administrative adjudication can most likely be completed within the waiting period, whereas judicial judgments often cannot become final and effective within that timeframe.

Third, the finality of the adjudication/judgment differs. Civil judgments rendered by the people’s court have final and binding effect and, once effective, carry res judicata. Administrative adjudication, by contrast, does not have finality; parties dissatisfied with the adjudication may initiate administrative litigation.

(3) Coordination of the Two Approaches

While the “dual‑track” design offers parties a choice of forum, it also gives rise to challenges in procedural coordination. Under Article 4, subparagraph (5) of the Administrative Adjudication  Measures,  the  CNIPA  shall  accept  a request for administrative adjudication only if the people’s court has not previously docketed a civil case concerning the same pharmaceutical patent dispute. However, the Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Adjudication of Civil Cases Involving Patent Disputes Related to Pharmaceutical Applications for Registration explicitly stipulate that where a party argues that the people’s court should not accept the litigation on the ground that the CNIPA has already accepted a request for administrative adjudication, such argument shall not be sustained by the people’s court. This means that the administrative adjudication procedure does not constitute a pre‑condition or barrier to judicial proceedings, and the people’s court shall independently accept civil litigation related to pharmaceutical patent linkage in accordance with the law, without being affected by the parallel administrative adjudication.

IV. Conclusion

The early resolution mechanism for pharmaceutical patent disputes represents a significant milestone in China’s pharmaceutical intellectual property protection system. As one of the two tracks of this mechanism, the administrative adjudication pathway provides an important channel for the early resolution of pharmaceutical patent disputes, characterized by its efficiency and professionalism. According to statistics, as of 2025, the CNIPA has heard several hundred    cases   of   administrative    adjudication concerning pharmaceutical patents, playing an irreplaceable role in practice.

At the same time, the coordination between administrative adjudication and judicial approaches still requires further optimization. How to establish a smoother procedural linkage mechanism while preserving the respective advantages of both approaches, and how to avoid resource waste and conflicting outcomes, represent important directions for future institutional improvement. With the implementation of the Administrative Adjudication and Mediation Measures for Patent Disputes in February 2025, the administrative adjudication system under the early resolution mechanism for pharmaceutical patent disputes will be further standardized and systematized, providing stronger institutional safeguards for the innovative development of China's pharmaceutical industry.

Author

Ms. Yuying ZHANG

Ms. Zhang received her Bachelor of Engineering degree in Chemical Engineering and Technology from Qingdao University of Science and Technology in 2015, and her Master of Engineering degree in Chemical Engineering from Dalian University of Technology in 2018. She specializes in patent prosecution in the fields of chemical engineering, materials, organic chemistry, and pharmaceuticals, providing full‑cycle services covering patent mining, drafting, office action response, reexamination, and invalidation. She excels at constructing persuasive technical arguments based on unpredictable synergistic effects in chemical experiments, effectively safeguarding clients’ rights in reexamination proceedings. She is proficient in conducting novelty searches, invalidity searches, and infringement comparative analyses, and performing detailed dissection and comparison of key technical features of target products, thereby providing data‑driven strategic recommendations for corporate research & development directions and product market entry.