China: An Intellectual Property: Non-litigation (PRC Firms) Overview

China’s Patent Term Extension (PTE) System for Pharmaceuticals: Opportunities, Challenges and Outlook

Driven by sustained growth in demand and the release of policy dividends, China's pharmaceutical market is undergoing a profound transformation from “generics-dominated” to “innovation-driven”. In this process, the length of patent protection significantly determines the commercial value and return on investment for new drug products. On 1 June 2021, with the formal introduction of the PTE system through the Fourth Amendment to the Patent Law, China's pharmaceutical intellectual property protection entered a new stage. This system, by extending the patent protection term for new drugs, effectively compensates for the time costs consumed by clinical trials and regulatory review/approval processes. It provides institutional safeguards for corporate research and development (R&D) investments and stands as a significant milestone in incentivising pharmaceutical innovation.

Overview of China's PTE system

Pharmaceutical patents grant innovative drug companies temporary market exclusivity, allowing them to recoup substantial R&D costs through post-marketing sales revenue. However, rigorous clinical trials and administrative approval procedures significantly compress the actual profitability period, and after patent expiry, companies face fierce competition from generic drugs. Therefore, to compensate for R&D time and incentivise continuous corporate investment in R&D, the pharmaceutical patent term extension system emerged. China implemented it comprehensively following the revision and implementation of the Implementing Regulations of the Patent Law on 20 January 2024.

According to the provisions of Article 42, Paragraph 3 of the Chinese Patent Law (2020 Amendment) and Articles 80 to 84 of the Implementing Regulations of the Chinese Patent Law (2023 Revision), for innovative drugs approved for marketing by the drug regulatory department under the State Council and improved new drugs meeting specified conditions, the patent administration department may grant patent term extension for eligible invention patents. The compensation term shall not exceed five years, and the total effective patent term after the new drug’s approval for marketing shall not exceed fourteen years.

The Patent Examination Guidelines further stipulate that a request for pharmaceutical patent term extension must meet the following requirements:

• The announcement date of the patent grant for which compensation is requested must be earlier than the date on which the drug marketing authorisation application is approved.
• At the time of submitting the compensation request, the patent right must be in a valid state.
• The patent must not have previously received a pharmaceutical patent term extension.
• The claims of the patent for which compensation is requested must include the technical solution related to the new drug that obtained marketing authorisation.
• If multiple patents exist for the same drug simultaneously, the patentee can only request patent term extension for one of those patents.
• If one patent relates to multiple drugs simultaneously, a patent term extension request for that patent can only be made for one drug. This means detailed regulations are provided regarding the timing of the compensation application, patent status, and technical relevance.

Changes and challenges in practice

Since 2024, the pharmaceutical patent term extension system has shown a significant development trend of year-on-year growth. Approved products cover various fields including chemical drugs, traditional Chinese medicines, and biological drugs. The patent claims of approved products primarily involve protection subjects such as compounds, sequences, compositions, and uses. Overall, the pharmaceutical patent term extension system has played a positive role in incentivising pharmaceutical innovation, promoting the research, development, and marketing of more innovative drugs, extending the market exclusivity period for innovative drugs, and providing strong support for the high-quality development of the pharmaceutical industry.

Although the PTE system has further improved pharmaceutical IP protection, in practice, a number of issues remain unclear.

Firstly, in determining whether to grant PTE, the definitions of what constitutes “containing the active pharmaceutical ingredient” and “the claims include the technical solution related to the marketing-authorised drug” lack clear standards, making it difficult to predict examination conclusions in complex cases. Taking pharmaceutical use claims as an example, the scope of protection for medical use claims is limited to the approved indications of the marketed new drug product. Generally, the protection scope covered by pharmaceutical patent claims may be more specific. In such cases, whether the patent claims “include” the technical solution related to the new drug is key to determining eligibility for compensation. If “include” is interpreted as requiring complete coverage, many substantially related use patents might be excluded. Here, interpreting the technical solution of the claims in conjunction with technical effects might be more appropriate. Given the complexity of pharmaceutical patents, maintaining information exchange with the national drug regulatory authorities during the review process and obtaining timely technical support would better help achieve the system’s original purpose of encouraging innovation.

Secondly, how to balance trade secrets and public interest in the approval process also requires consideration. Similar to substantive examination, during the PTE approval process, applicants can communicate with the China National Intellectual Property Administration (CNIPA) by submitting opinions. To prove the correspondence between the technical solution in the claims and the marketing-authorised drug, applicants may need to provide some technical materials containing trade secrets for argumentation. When publishing examination opinions, whether information involving trade secrets can be differentiated and processed, with trade secret portions published after anonymisation, or introducing a confidentiality review mechanism at this stage, it is important to balance commercial interests and procedural transparency, thereby harmonising the encouragement of innovation with public trust.

Finally, current laws do not provide clear stipulations on how to seek remedies against decisions denying approval. The Supreme People’s Court, in cases (2025) Supreme People’s Court Zhi Xing Zhong No 448 and 449, clarified that dissatisfaction with a rejection decision concerning the pharmaceutical patent term extension system falls within the scope of administrative litigation under the Administrative Procedure Law, and applicants may initiate administrative lawsuits according to the law. These cases provide clear guidance for relevant right-holders to safeguard their interests.

Future prospects

The implementation and promotion of the pharmaceutical patent term extension system is a significant milestone in China’s pharmaceutical intellectual property protection. Over the past year, the system has played a positive role in promoting pharmaceutical innovation and safeguarding public health. However, refining the system still requires time. Enterprises need to actively adapt to the new rules and rationally utilise intellectual property tools to achieve a balance between innovation and public interest. As the system continues to improve, the pharmaceutical patent term extension system is expected to further drive the innovative development of China’s pharmaceutical industry.

中国药品专利期限补偿制度：机遇、挑战与展望

中国医药市场在需求持续增长与政策红利释放的双重驱动下，正经历从“仿制为主”向“创新驱动”的深刻转型。在这一进程中，专利保护期的长短很大程度上决定了新药产品的商业价值与投资回报。2021年6月1日，随着专利法第四次修正案正式引入药品专利期限补偿制度（Patent Term Extension, PTE），中国药品知识产权保护迈入新阶段。该制度通过延长新药专利保护期，有效补偿临床试验与审评审批所耗损的时间成本，为企业研发投入提供制度性保障，成为激励医药创新的重要里程碑。

中国药品专利期限补偿制度概述

药品专利赋予创新药企暂时的市场独占权，使其得以通过上市后的销售收益回收巨额研发成本。然而，严格的临床试验与行政审批程序显著压缩了实际盈利周期，专利到期后更面临仿制药的激烈竞争。因此，为了补偿研发时间，激励企业持续投入研发，药品专利期限补偿制度应运而生。中国于2024年1月20日修订的中国专利法实施细则落地后全面实施药品专利期限补偿制度。

根据中国专利法（2020修正）第四十二条第三款和中国专利法实施细则（2023修订）第八十条至第八十四条的规定，对于国务院药品监督管理部门批准上市的创新药和符合规定的改良型新药，专利局可以对符合条件的发明专利给予药品专利权期限补偿。补偿期限不得超过五年，新药批准上市后总有效专利权期限不超过十四年。

专利审查指南进一步规定了请求药品专利权期限补偿应当满足以下六点：

• 请求补偿的专利授权公告日应当早于药品上市许可申请获得批准之日。
• 提出补偿请求时，该专利权处于有效状态。
• 该专利尚未获得过药品专利权期限补偿。
• 请求补偿专利的权利要求包括了获得上市许可的新药相关技术方案。
• 一个药品同时存在多项专利的，专利权人只能请求对其中一项专利给予药品专利权期限补偿。
• 一项专利同时涉及多个药品的，只能对一个药品就该专利提出药品专利权期限补偿请求。即对期限补偿申请的时间、专利状态以及技术关联等方面进行了详细规定。

实践中的变化、问题与挑战

自2024年以来，药品专利期限补偿制度呈现出逐年增长的显著发展态势，获批产品涵盖化药、中药和生物药等多个领域，获批产品的专利权利要求主要涉及化合物、序列、组合物和用途等保护主题。整体来看，药品专利期限补偿制度在激励医药创新方面发挥了积极作用，推动了更多创新药物的研发和上市，延长了创新药的市场独占期，为医药行业的高质量发展提供了有力支持。

尽管PTE制度进一步完善了药品知识产权保护，但实践中还存在一些困惑。

首先，在判断是否给予专利期限补偿（PTE）时，何谓“包含药品活性成分”以及“权利要求包括上市许可药品相关技术方案”等尚缺乏明确标准，导致在复杂案件中难以预判审查结论。以制药用途权利要求为例，医药用途权利要求的保护范围仅限于上市新药产品的经批准的适应症，通常来说，药品专利权利要求涵盖的保护范围可能更为具体，这种情况下，专利权利要求是否“包括”新药相关技术方案，是关系到能否给予补偿的关键。若将包括解释为全面覆盖，不少实质相关的用途专利可能被排除，此时，将权利要求技术方案结合技术效果解释，或许更为恰当。鉴于药品专利的复杂性，若能在审评过程中与国家药监部门保持信息交流，并获得及时的技术支持，将更有助于实现制度鼓励创新的本旨。

其次，如何在审批中兼顾商业秘密与公共利益，同样需要考量。与实质审查类似，PTE审批过程中，申请人能够以意见称述的方式与国家知识产权局沟通。为证明权利要求技术方案与上市许可药品的对应关系，申请人可能需要提供一些商业秘密技术资料进行论述。在公开审查意见时，能否对涉及商业秘密的信息做区分处理，涉及商业秘密的部分经脱敏处理后公布，或在这一环节引入保密审查机制，以实现商业利益和程序透明的平衡，使鼓励创新与公共信赖得以兼顾。

最后，对于不予批准的决定如何寻求救济，现行法律暂未给出明确规定。最高人民法院在（2025）最高法知行终448、449号案件中明确，对药品专利期限补偿制度的驳回决定不服，属于行政诉讼法的受案范围，申请人可依法提起行政诉讼。该案例为相关权利人维护自身利益提供了明确指引。

未来展望

药品专利期限补偿制度的落地与推行，是中国药品知识产权保护的重要里程碑。在过去一年中，该制度在促进药品创新和保障公共健康方面发挥了积极作用。然而，制度的完善仍需时间，企业需积极适应新规则，合理利用知识产权工具，以实现创新与公共利益的平衡。随着制度的不断完善，药品专利期限补偿制度有望进一步推动中国医药行业的创新发展。