As a new round of scientific and technological revolution and industrial transformation deepens, emerging fields such as artificial intelligence and biomedicine place higher demands on intellectual property protection. Patent reexamination, invalidation and administrative adjudication procedures, as important links in IP protection, play an important role in clarifying rights boundaries and resolving infringement disputes. Recently, the 15th China Intellectual Property Annual Conference successfully held a thematic sub-forum on “Optimising Reexamination, Invalidation and Administrative Adjudication Hearing Mechanisms, and Strengthening IP Protection in Emerging Fields.” CNIPA Deputy Commissioner Hu Wenhui attended the forum and delivered remarks.

In his remarks, Hu Wenhui noted that since the 18th CPC National Congress, the CPC Central Committee with Comrade Xi Jinping at its core has placed IP work in a more prominent position, leading China’s IP cause to historic achievements and a path of IP development with Chinese characteristics. CNIPA has earnestly implemented General Secretary Xi Jinping’s important instructions, continuously advancing reforms of reexamination, invalidation and administrative adjudication systems, optimising hearing mechanisms for administrative adjudication cases, establishing the CNIPA Administrative Adjudication Committee, strengthening the adjudication team, and handling in accordance with law a batch of industry-representative and influential cases fairly and efficiently. Next, CNIPA will continue to optimise institutional rules, deepen hearing-mechanism reform, strengthen coordination between entitlement and enforcement procedures, and enhance linkage between administrative and judicial authorities, providing strong support for accelerating building China into an IP power and promoting high-quality economic development.

The forum was divided into morning and afternoon sessions, chaired respectively by Gao Shenghua, Director of the Patent Reexamination and Invalidation Department of the CNIPA Patent Office, and Deputy Director Li Yue. Representatives from government departments, courts, universities, industry associations, IP service agencies and enterprises gathered to discuss institutional practice and difficult issues in depth, escorting development in emerging fields.

Guo Wen, Director of the CNIPA IP Protection Department, spoke on “Improving the Administrative Adjudication System and Strengthening IP Protection.” She said CNIPA has earnestly implemented decisions of the CPC Central Committee and the State Council, strengthened top-level design, optimised work systems, and continuously deepened IP administrative adjudication. Since the 14th Five-Year Plan period, CNIPA has worked with relevant departments focusing on mechanism building, case handling and coordinated linkage; work has advanced in an orderly way and institutional efficacy has continued to be released. Going forward, CNIPA will further improve institutional norms, raise case quality and efficiency, strengthen enforcement of decisions, and work with all parties to continuously unleash the institutional advantages of administrative adjudication, strive to build a preferred venue for global IP dispute resolution, and contribute IP strength to Chinese modernisation.

Tai Zhonglin, Deputy Chief Judge (presiding over day-to-day work) of the Intellectual Property Court of the Supreme People’s Court, reviewed China’s patent judicial protection history around “Escorting the Development of New Quality Productive Forces with High-Quality IP Adjudication,” and introduced adjudication of various cases and basic achievements in the seven years since the Court’s establishment. He said the Court will continue to strengthen protection and raise adjudication quality and efficiency, more vigorously incentivise scientific and technological innovation, take more solid measures to maintain fair competition, participate more actively in international IP governance, deepen reform of IP adjudication with greater confidence, strengthen professional adjudication teams with a longer-term vision, and more closely cooperate to safeguard innovation and creation.

Gao Shenghua spoke on “Improving the Quality and Efficiency of Reexamination, Invalidation and Administrative Adjudication Cases to Support Innovative Development in the 15th Five-Year Plan Period.” He said under the correct leadership of the CNIPA Party Group, the Reexamination and Invalidation Department considers reexamination, invalidation and administrative adjudication as a whole, continuously advancing institutional building and process optimisation to steadily raise hearing quality and efficiency. Focus areas include advancing quality and efficiency together; procedural linkage toward integrated entitlement-and-enforcement hearing; strengthening rule supply and diversified hearing models for emerging fields; and deepening administrative-judicial coordination and international exchange. The Department will continue to optimise systems and mechanisms to provide solid guarantees for building an IP power and serving high-level sci-tech self-reliance.

Feng Xiaobing, first-level inspector of the Department, shared practice and outlook on the typical-case guidance system for patent reexamination and invalidation. She explained that reexamination and invalidation work is conducted strictly under the normative system of the Patent Law, Implementing Regulations and Guidelines for Patent Examination, with the typical-case guidance system enriching and supplementing that system—through compiling books to settle examination views and convey standards, and through selecting and publishing annual top-ten cases, case decision commentaries and key points of typical decisions, systematically advancing “explaining the law through cases.” She said the system is vivid practice of people-centred service to innovative development, and the Department will continue to improve it to escort high-level innovation with high-quality examination.

What practical progress has the administrative adjudication system for early resolution of drug patent disputes (drug adjudication) made in five years of implementation? Deputy Director Feng Xianping introduced that drug adjudication is a key institutional arrangement linking drug review and approval with IP protection. Over five years, CNIPA has accepted 400 drug adjudication cases and concluded 279, with hearing quality and efficiency continuously improving. The Department has built a working model adapted to the pharmaceutical industry, formed a specialised hearing team, and fully played the institutional function of rapidly resolving disputes through administrative adjudication. Next, it will continue to improve rules and standards, optimise hearing mechanisms, strengthen capacity building and collaborative exchange, and turn the institutional advantages of administrative adjudication into practical measures serving innovators, ensuring every decision withstands legal and practical tests and jointly escorting innovative development of the pharmaceutical industry.

“Examination standards for supplementary experimental data” remain a focus of industry attention. Hou Yao, second-level inspector of Chemical Appeal Division I, interpreted examination rules for supplementary experimental data in the chemical-pharmaceutical field by reference to the closely watched crizotinib invalidation request case, covering problem framing, basic examination thinking, and overall assessment of supplementary experimental data, and proposed that overall assessment should adhere to “one perspective, two principles and four standards.” The case analysed necessity, choice of comparison methods, experimental process and results across multiple dimensions, recognised the technical effects proved by the supplementary data, and provided highly referential practical thinking for industry review of supplementary experimental data.

How should “commercial success” be scientifically and rigorously considered in inventiveness assessment? Wei Cong, deputy division chief of Pharma-Bio Appeal Division II, shared consideration points and thinking, and the link between commercial success and the technical solution of the invention, around the nusinersen sodium invalidation request case. He said claiming inventiveness based on commercial success requires fully addressing two aspects: proving that the corresponding product achieved commercial success; and proving that the success stems from technological innovation embodied in the invention’s technical solution. The case provides examination thinking for practitioners on considering “commercial success.”

In drug adjudication procedures, delimiting the scope of hearing and grasping the standard of proof directly affect fairness and efficiency of the system’s operation. Tian Tian, deputy division chief of Pharma-Bio Appeal Division I, introduced handling of multiple defence grounds including objections to patent-registration accuracy in the edoxaban tosylate tablets drug adjudication case. She said administrative adjudication at the early patent-dispute resolution stage is “confirmation adjudication,” aimed at the core dispute whether a generic’s technical solution falls within the patent’s protection scope, and does not hear patent invalidity disputes; current laws and regulations also do not empower “confirmation adjudication” to hear prior-art defences. For objections to patent-registration accuracy, conditional hearing is adopted, both preventing generics from abusing procedure and protecting originator rights, and curbing false patent registration while safeguarding legitimate market-entry paths for generics.

How should numerical features’ limiting effect on claim scope be understood in drug adjudication? Wang Dong, deputy division chief of Materials Engineering Appeal Division II, used the sitagliptin metformin tablets (II) drug adjudication case to explain rules for applying the doctrine of equivalents to numerical or numerical-range features in drug patents. He said numerical features have inherent definiteness and the doctrine of equivalents should be applied strictly; if values outside the range were later brought into the claim scope, the definiteness value of numerical features would be harmed and claim scope blurred. Determination of numerical-range features is the result of the patentee’s autonomous and prudent choice; allowing expansion via equivalents would undermine the public notice function of claims and harm the public interest.

Source：China National Intellectual Property Administration (CNIPA)；2026-10-16；https://www.cnipa.gov.cn/art/2026/10/16/art_2633_208612.html