Beijing Intellectual Property Court Report on Judicial Work During the First Five Years of the pharmaceutical Patent Linkage System

Friends from the media, ladies and gentlemen: 

Good morning. As China’s pharmaceutical patent linkage system reaches its fifth anniversary, we are here to report on the Beijing Intellectual Property Court’s adjudication of drug patent linkage cases. 

China’s drug patent linkage system took effect on June 1, 2021. It represents an important improvement to the country’s pharmaceutical intellectual property protection framework. It is also a key measure in China ’ s participation in international 
pharmaceutical intellectual property governance and its efforts to foster an international, law-based business environment. Over the past five years, as the court with centralized first-instance jurisdiction over these cases, the Beijing Intellectual Property Court has resolved numerous disputes involving Chinese and foreign pharmaceutical companies through specialized 
adjudication. The system takes account of the legitimate interests of both innovative-drug and generic-drug companies. It 
provides an institutional foundation for balancing protection of pharmaceutical innovation with access to medicines, and 
supports China’s development from a major pharmaceutical market into a leader in the field, more closely connected to the 
global pharmaceutical innovation chain. 

Over these five years, the Court has carried out its responsibilities in light of President Xi Jinping’s statement that “the health of the people is an important indicator of national prosperity and strength. ” We have strictly implemented the relevant judicial interpretations of the Supreme People’s Court and worked to safeguard the system’s operation. Focusing on adjudication quality and efficiency and on developing clear rules, we have established a specialized process covering every stage of a case and strengthened coordination between the Court and government agencies. These efforts respond to the needs of the pharmaceutical industry in China and abroad. They have helped translate legal provisions into sound market practice and provided judicial support for the high-quality development of China’s pharmaceutical industry under the rule of law and in an 
international setting. 

I. Institutional Background and the Court ’ s Role: Serving Broader Development Goals Through Judicial Responsibility 

The pharmaceutical industry is technology-intensive. Research and development require substantial investment, take a long time and involve considerable risk. Progress depends both on sustained research and breakthroughs by original drug companies and on timely follow-on development by generic drug companies. The latter improves access to medicines and 
lowers costs so that patients can benefit sooner from affordable, effective drugs. 

In recent years, as China ’ s pharmaceutical market has become more important globally, domestic research and development capabilities have grown, and supporting policies have taken effect, China has increasingly become a key market for patent planning and competition among Chinese and foreign pharmaceutical companies. The central value of drug patent linkage lies in connecting review and approval of generic drug applications with protection of original drug patents. By addressing potential patent infringement disputes before a generic drug reaches the market, the system seeks to ensure that innovators receive returns, generic developers have clear rules to follow, and patients have greater hope. Its implementation also creates an important opportunity for global original drug companies to pursue localized strategies in China and for China’ s pharmaceutical industry to align more closely with international practice. 

Article 76 of the Patent Law, effective June 1, 2021, formally established China ’ s drug patent linkage system in legislation. On July 4, 2021, the Supreme People’s Court issued the Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Patent Disputes Related to Drugs Applied for Registration. On the same day, the National Medical Products Administration and the China National Intellectual Property Administration issued and brought into effect the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial). On July 5, 2021, the China National Intellectual Property Administration issued and brought into effect the Measures for Administrative Adjudication under the Early Resolution Mechanism for Drug Patent Disputes. Together, these measures marked the system’s full implementation. 

Under the Supreme People ’ s Court ’ s provisions, the Beijing Intellectual Property Court has centralized first-instance jurisdiction over drug patent linkage cases nationwide. Recognizing that these cases often have an international dimension, involve novel issues and specialized subject matter, and attract substantial public attention, the Court has built a comprehensive, specialized and efficient adjudication model. 

From June 2021 to June 2026, the Court accepted 382 drug patent linkage cases: 358 civil cases and 24 administrative cases. It concluded 369 cases: 348 civil cases and 21 administrative cases. More than 90% of the cases accepted involved a foreign element. The parties included major international pharmaceutical companies such as AbbVie, Merck, Roche and AstraZeneca. 

The Court protects the lawful rights and interests of Chinese and foreign parties equally. It has concluded a number of representative cases that have attracted international attention and provided guidance on legal rules, including the first eldecalcitol capsules case and cases concerning baloxavir tablets and nilotinib capsules. Through these cases, it has developed rules that can be applied and drawn upon more broadly. This work has provided practical support for refining the relevant legal framework, helped move the system from statutory text into market practice, and created a constructive interaction among adjudication, legislation and market operations. It also offers a reference for international governance in this field. 

II. Procedural Innovation and Adjudication: Putting the System into Practice by Solving Difficult Problems 

Over the past five years, the Beijing Intellectual Property Court has sought to resolve the challenges presented by drug patent linkage cases and improve adjudication quality and efficiency. It has strengthened its teams, improved procedures, developed rules and deepened coordination to realize the system’ s benefits.

Building specialized trial teams and strengthening adjudication capacity. When the system first took effect, the Court established a dedicated trial team to hear drug patent linkage cases. Through relatively stable collegial panels, focused training, courtroom observation and case-based teaching, experienced judges have helped develop specialist expertise. In 2024, the Court introduced a regular forum called the “Pharmaceutical IP Classroom. ” More than 30 group discussions have addressed issues ranging from procedure and substantive determinations to coordination between mechanisms. The aim is to build a trial team with expertise in both law and pharmaceuticals, providing a strong professional foundation for case decisions and the development of precise adjudication rules.

Shortening case duration and improving efficiency. The Court has introduced measures covering identification at filing, case-flow management and monitoring of key procedural stages. In 2025, the average duration of a first-instance drug patent linkage case fell to 101 days, or approximately 3.4 months. The Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial) provide for a nine-month waiting period in the regulatory approval process for chemical generic drugs. With that period in mind, and seeking to align judicial proceedings with administrative processes by completing both court instances within nine months, the Court concluded more than 80% of its drug patent linkage cases within five months at first instance. This pace protects the parties ’ lawful rights while meeting the time-sensitive needs of drug 
approval. 

Improving technical fact-finding. Establishing pharmaceutical technical facts is central to these cases and often their most difficult aspect. The Court uses a “ four-part mechanism plus expert consultation, ” bringing together specialized people’s assessors, technical investigation officers, forensic appraisers and expert assistants, with additional support from an expert advisory pool. In the technically complex Bisoprolol and Amlodipine Tablets Case, a technical investigation officer participated throughout the fact-finding process. Drawing also on expert advice, the Court reached a fair decision in accordance with the law. 

Developing a process that covers the full life of a case. The Court has established procedures spanning filing, hearing, judgment, post-judgment work and the wider application of case outcomes. At the filing stage, it provides guidance so that 
relevant cases are accurately identified. During adjudication, it coordinates the resolution of difficulties concerning service of 
process, hearings and technical fact-finding. After judgment, a direct liaison mechanism with the Intellectual Property Court ofthe Supreme People’s Court facilitates prompt transfer of appeal materials, supported by the Court’s electronic case-management system and case files generated in parallel with proceedings. Finally, the Court promptly summarizes adjudication rules and publishes representative cases to make outcomes more predictable. This end-to-end approach supports both adjudication quality and the effective operation of the system. 

Deepening coordination between the Court and government agencies. In keeping with President Xi Jinping’s call to promote coordinated development and governance of medical services, medical insurance and pharmaceuticals, and with the requirement in the *Opinions of the CPC Central Committee on Strengthening Adjudication in the New Era* to improve coordination between courts, government departments and other social actors, the Court has established channels for 
cooperation with the China National Intellectual Property Administration, the National Medical Products Administration and the National Healthcare Security Administration. These channels support information-sharing, operational coordination and joint discussion of difficult issues. In 2025, the Court led a dedicated seminar on drug patent linkage cases to advance the substantive resolution of recurring problems. Cross-agency cooperation has brought judicial adjudication, administrative regulation and industry guidance together in a more effective approach to dispute resolution. 

III. Developing Rules and Improving the System: Drawing on Judicial Experience 

Five years of adjudication have involved not only applying existing law, but also clarifying and refining its rules. Through individual cases, the Court has addressed difficult questions arising in the operation of drug patent linkage, identified the legal relationships behind complex technical facts, and helped bridge the gap between legal provisions and their application. This work provides practical examples for future judicial interpretations and legislative improvements. 

Publishing representative cases and promoting consistent judicial standards. The Court has concluded the first drug patent linkage case, concerning eldecalcitol capsules, as well as important cases concerning baloxavir tablets, nilotinib capsules, palbociclib tablets, baricitinib tablets and lusutrombopag tablets. The eldecalcitol case was selected as one of *China Trial*’s Top Ten Representative Cases of 2022 and as a nominee among the Top Ten Cases Advancing the Rule of Law in the New Era in 2022. The baloxavir tablets case was named one of the 50 Representative Intellectual Property Cases of Chinese Courts in 2023. 

These cases did more than resolve individual disputes: they established rules that guide the industry. In the EdoxabanTosylate Tablets Case, for example, the Court clarified that the technical solution of a generic drug is ordinarily determined by the application materials used during regulatory review. That rule reflects the system’s purpose of resolving disputes early and provides a practical model for its operation. 

The Court has also published, in Chinese and English, Parts I and II of its *Guidelines for Filing Civil Cases Involving Patent Disputes Related to Drugs Applied for Registration (Trial)*. The guidelines clarify filing conditions, documentation requirements and procedural rules, helping protect parties ’ litigation rights. An internal training manual on these civil cases 
provides systematic guidance on filing review, pretrial 
preparation, adjudication and post-judgment work. 

Defining the boundaries of the drug patent linkage system. A system works effectively only when its scope is clear. Through a series of cases, the Court has clarified procedural issues including acceptance requirements, who may bring an action and filing deadlines, helping ensure that the system operates as intended. 

In the Lurasidone Hydrochloride Tablets Case, the Court held that an action under the drug patent linkage system may be 
dismissed where the patent has been declared invalid, avoiding proceedings that would serve no practical purpose. In the 
Palbociclib Tablets Case, it held that a drug not registered and marketed in China does not meet the relevant acceptance 
requirements, even if a related patent has been granted. In the Oseltamivir Phosphate Granules Case, it held that where the 
plaintiff’s drug is not the reference product, the patent at issue is not a “ patent related to the drug being copied. ” In the 
Baricitinib Tablets Case, it held that a generic drug already approved for marketing before the action is filed is no longer a 
“ drug applied for registration, ” so the action should be dismissed. Approval granted during litigation is treated differently. 

Refining substantive rules and encouraging honest, compliant conduct. Drug patent linkage is an early dispute resolution mechanism. The allegedly infringing technical solution is generally found in the generic-drug company ’ s regulatory application materials, rather than in a marketed product. The Court has tailored its rules to that feature and encouraged companies to act in good faith from the application stage onward. 

In the Edoxaban Tosylate Tablets Case, the Court held that the generic drug’s technical solution is ordinarily determined by 
its application materials, but where the Center for Drug Evaluation completes its review on the basis of an amended solution, that amended solution governs. In the Upadacitinib Extended-Release Tablets Case,Regarding the review, in 20circumstances where a generic drug company has made an improper declaration, of whether the acceptance condition concerning the type of declaration is met. It held that the company’s fault, if any, when making the original declaration must be considered, underscoring the need for careful and honest declarations. 

In the Vonoprazan Fumarate Tablets Case, the Court clarified the generic applicant ’ s initial burden to provide evidence where it controls the application materials. If the applicant fails to discharge that burden and the technical solution cannot otherwise be established, the generic drug may be presumed to fall within the patent’s scope of protection. This rule discourages withholding of information and helps proceedings move forward. 

IV. Looking Ahead: Providing Judicial Support for High-Quality Pharmaceutical Development

Five years of practice demonstrate that the drug patent linkage system has achieved significant results. Through sustained effort and innovation, the Beijing Intellectual Property Court has helped guide pharmaceutical companies toward sound innovation and business strategies, made judicial outcomes more predictable and improved the business environment for the 
pharmaceutical and healthcare sector. Rules established in representative cases have become important references for compliant operation by both original and generic drug companies. They also support better patent quality and healthy industry development. 

The fifth anniversary in 2026 is an important milestone. The Court will continue to improve its adjudication mechanisms and promote coordinated intellectual property protection across the pharmaceutical and healthcare sector. It will further develop 
adjudication rules, anticipate legal questions raised by advances involving new targets, structures and indications, and provide 
guidance through representative cases. It will continue to improve adjudication quality and efficiency, strengthen technical fact-finding and protect the lawful rights and interests of Chinese and foreign parties equally. 

The Beijing Intellectual Property Court will maintain a professional and careful judicial approach. We will work to ensure that more high-quality pharmaceutical innovations benefit the public, that the pharmaceutical and healthcare industry develops steadily in a law-based and international business environment, and that innovation and fair competition are supported by strong legal protections.