CHINA: An Introduction to Intellectual Property: Non-litigation (PRC Firms)

Current Status and Prospects of Intellectual Property Protection in China's Pharmaceutical Industry

Overall Development of China's Pharmaceutical Industry

With the aging population, rising health awareness, and the gradual improvement of the medical insurance system, the demand for the Chinese pharmaceutical market continues to grow. In recent years, China's pharmaceutical industry has been showing vigorous development.

In terms of research and development (R&D) and innovation, many companies are actively building innovative drug pipelines, with continual breakthroughs in fields like biopharmaceuticals and targeted therapies. The collaboration between pharmaceutical companies, research institutions, and capital is becoming increasingly close, accelerating the transformation of scientific achievements and the rapid development of innovative drugs. Innovative projects are increasingly going global, with domestic innovative drugs starting to make their mark in international markets.

Despite facing pressures from global economic fluctuations, rising R&D and manufacturing costs, the pharmaceutical industry's essential demand ensures strong resilience. National policies have a profound impact on the development of the industry. For instance, dynamic adjustments to the medical insurance catalog encourage companies to develop more cost-effective and clinically valuable drugs. The centralised procurement policy, while lowering drug prices, also pushes companies to optimise production processes, reduce costs, and increase industry concentration.

Looking ahead, China's pharmaceutical industry is expected to continue its steady development, gradually transitioning from a focus on generics to innovation-driven growth. Meanwhile, international expansion and competition will become key directions for the development of Chinese pharmaceutical enterprises.

Overview of Intellectual Property Protection and Legislative Developments

Innovation-driven growth in China's pharmaceutical industry is a widely accepted consensus. China is continuously improving its intellectual property (IP) legal system and exploring the establishment of a diversified dispute resolution mechanism to strengthen IP protection and safeguard innovation. Key measures include:

• Amending the Patent Law: A new IP protection system for pharmaceuticals has been introduced to meet the current needs of the pharmaceutical industry and align with international trends. New provisions on punitive damages have been added to strengthen the fight against infringement.
• In recent years, the Supreme People's Court has issued several judicial opinions on strengthening intellectual property protection, such as the "Opinions of the Supreme People's Court on Comprehensively Strengthening Intellectual Property Judicial Protection" and the "Opinions of the Supreme People's Court on Legally Increasing the Punishment for Intellectual Property Infringement." Meanwhile, the Supreme People's Court and China National Intellectual Property Administration (CNIPA) have jointly issued the "Opinions on Strengthening the Collaborative Protection of Intellectual Property Rights" and the "Opinions on Strengthening Patent Infringement Dispute Administrative Adjudication Work in the New Era" by CNIPA and the Ministry of Justice.
• Actively exploring a convenient, efficient, and win-win diversified dispute resolution mechanism for intellectual property disputes: Fully utilising and playing the advantages of various procedures such as mediation, arbitration, administrative adjudication, and judicial litigation, combining the characteristics of industry disputes to quickly resolve intellectual property disputes, and strengthening the connection and collaboration between different dispute resolution institutions.

Regarding legislation, the establishment of the following legal systems is crucial for the future development of China's pharmaceutical industry:

• Firstly, the introduction of a drug patent term extension (PTE) system, which compensates for the time consumed during the drug approval process for new drug listings. In China, patentees can submit requests for compensation for the term of patent right from 1 June 2021; CNIPA will apply the revised patent law implementation rules to review the above requests from 20 January 2024, and make decisions on whether to grant term compensation. Currently, CNIPA has announced several decisions on compensation for the term of patent right, allowing the execution standards of this newly implemented rule to be presented through specific cases in practical application and gradually become clearer and more explicit.
• Secondly, China officially implemented the Chinese Early Resolution Mechanism for Drug Patent Disputes (drug patent linkage system) from 4 July 2021. This system allows patentees or interested parties to apply for a court or CNIPA confirmation of whether the generic drug falls within the scope of protection of the relevant drug patent before the generic drug is approved for marketing, with the expectation of resolving potential patent infringement disputes between the innovator drug and generic drug manufacturers before the generic drug is launched.

The biggest feature of China's drug patent linkage system is the "dual-track parallel system," where patentees or interested parties can initiate a civil lawsuit for "whether it falls within the scope of patent protection" or an administrative adjudication with CNIPA; if dissatisfied with the administrative adjudication result, they can further appeal to the court. In addition, civil lawsuits or administrative adjudication cases under the drug patent linkage system are only used to determine whether the generic drug technical solution falls within the scope of patent protection and do not judge the validity of the patent itself. If the generic drug applicant wants to challenge the validity of the patent, they still need to initiate an invalidation request procedure with CNIPA.

To date, the drug patent linkage system has been implemented in China for more than three years. With the continuous accumulation of practical experience and the continuous exploration of judicial and administrative practices, preliminary issues such as case acceptance conditions, types of patents allowed for litigation, the burden of proof and responsibility allocation between the parties, litigation/adjudication procedure setup and operation, and exclusive term grant conditions have been clarified, and areas for improvement in early system rules have become increasingly clear. Both the innovator and generic drug companies, as participants in the legal activities of this system, are looking forward to the future development direction of the system and how to effectively achieve the original intention of "encouraging innovation, promoting high-level imitation, and balancing the interests of all parties."

In addition, Regulations for Implementation of the Drug Administration Law of the People's Republic of China and the data protection rules within it are in the public consultation stage, and the exploration and final implementation of this legislation will also have a profound impact on the pharmaceutical industry.

Opportunities and Challenges in IP Legal Services in the Pharmaceutical Sector

With the continuous development of China's pharmaceutical industry and the introduction of new laws and policies, there are increasing opportunities for legal service providers specialising in intellectual property (IP) in the pharmaceutical sector. For example, the growing number of innovative project transactions among Chinese pharmaceutical companies will significantly boost the demand for due diligence services. Whether for generic and innovator drug companies, there is a need to engage in patent linkage and related patent invalidation procedures under the new legal framework. These emerging demands offer IP legal professionals a broader range of services and business growth opportunities.

At the same time, because the pharmaceutical sector often involves cutting-edge legal issues and a high degree of integration between technology and law, it places higher demands on the professional competence of IP legal practitioners. Specialisation, professionalism, and internationalisation are becoming increasingly important as the industry evolves. With the intensifying competition between companies, IP legal services are focusing more on precision and efficiency, presenting a challenge that every relevant practitioner must seriously address.

中国医药行业知识产权保护的发展现状与展望

中国医药行业整体发展情况

随着人口老龄化加剧、居民健康意识提升以及医疗保障体系的逐步完善，中国医药市场的需求正持续增长。近年来，中国医药行业整体呈现出蓬勃发展的态势。

在研发创新方面，众多企业积极布局创新药研发管线，生物制药、靶向药物等领域的创新成果不断涌现。医药企业与科研机构、资本的合作愈发紧密，加速了科技成果转化，快速推进创新药物的研发进程，越来越多的创新项目走出国门，国产创新药开始在海外市场崭露头角。

尽管在当前经济形势下，会面临全球经济波动、研发和制造成本上涨等压力，但医药行业的刚性需求决定了产业发展具有较强韧性。中国国家政策对医药行业的发展影响深远。例如，医保目录的动态调整，促使企业研发更具性价比和临床价值的药物；带量采购政策在降低药品价格的同时，也推动企业优化生产流程、降低成本，加速提升行业集中度。

展望未来，中国医药行业将持续稳步发展，逐步实现以仿为主到创新驱动的转变。同时，国际化拓展和竞争将成为中国医药企业发展的重要方向。

知识产权保护的整体概况和立法新进展

创新驱动中国医药产业发展是普遍共识，中国正不断完善知识产权法律体系和探索建立知识产权纠纷多元化解决机制，以进一步加强医药知识产权保护力度，为创新保驾护航，具体举措主要包括：

1. 修订中国专利法：引入全新的医药知识产权保护制度以适应当前制药行业的发展需求和国际趋势；新增关于惩罚性赔偿的规定以进一步强化对侵权行为的打击。
2. 司法与行政联动，加强知识产权保护：近年来，最高人民法院陆续发布了多个关于加强知识保护的司法意见，例如，《最高人民法院关于全面加强知识产权司法保护的意见》、《最高人民法院关于依法加大知识产权侵权行为惩治力度的意见》等。同时，最高人民法院和国家知识产权局联合发布《关于强化知识产权协同保护的意见》、国家知识产权局和司法部联合发布《关于加强新时代专利侵权纠纷行政裁决工作的意见》等。
3. 积极探索便捷高效、畅通共赢的知识产权纠纷多元化解决机制：充分利用和发挥调解、仲裁、行政裁决、司法诉讼等程序各自的优势，结合产业纠纷特点来快速化解知识产权争议，并加强不同争议解决机构间的对接和协同合作。

在立法方面，以下法律制度的建立对未来中国医药产业的发展起到至关重要的影响：

首先，新增专门就新药上市审评审批所占用时间而给予的药品专利权期限补偿制度（PTE）。

在中国，专利权人自2021年6月1日起可以提出专利权期限补偿请求；而国家知识产权局则自2024年1月20日起适用修改后的专利法实施细则对上述申请进行审查，并做出是否同意给予期限补偿的决定。

目前，国家知识产权局已经陆续公布了一些关于专利权期限补偿的决定，使得这一新落地的规则在具体实践中的执行标准得以通过具体案例呈现，并逐渐变得更加清晰和明确。

其次，中国自2021年7月4日起开始正式实施中国的药品专利纠纷早期解决机制（药品专利链接制度）。这一制度允许专利权人或利害关系人在仿制药被批准上市前申请法院或国家知识产权局确认所述仿制药是否落入相关药品专利的保护范围，以期望在仿制药上市之前提前解决原研药与仿制药生产企业之间的潜在专利侵权纠纷。

中国药品专利链接制度最大的特点在于采取“双轨并行制”，即专利权人或者利害关系人可以向法院提起“是否落入专利权保护范围”的民事诉讼，也可以向国家知识产权局提起行政裁决；而如果对行政裁决的结果不服，则可以进一步上诉到法院。此外，药品专利链接制度下的民事诉讼或行政裁决案件仅用于确定仿制药技术方案是否落入专利权的保护范围，而不对专利本身的有效性进行判断。如果仿制药申请人想要挑战专利有效性，则仍然需要向国家知识产权局提起无效宣告请求程序。

截至目前，药品专利链接制度在中国已经实施了3年有余。随着实践经验的不断积累和司法与行政实线的不断探索，关于案件的受理条件，允许诉讼的专利类型，双方当事人的举证责任及举证责任分配，诉讼/裁决程序设置和运行，独占期授予条件等初步问题已经得到明确，而早期制度规则有待完善之处也日渐清晰。无论是原研药公司还是仿制药公司，该制度法律活动的参与者都对未来制度的发展方向，以及如何切实发挥“鼓励创新，促进高水平仿制，平衡各方利益”的初衷充满期待。

此外，中国药品管理法实施条例及其中关于数据保护规则的修订正在征求意见阶段，该立法探索及最终实施情况同样将对医药产业带来深远影响。

医药领域知识产权法律服务面临的机遇和挑战

随

着中国医药行为的持续发展以及新法律规定和政策的出台，能够为医药领域知识产权相关的法律服务提供者提供更多的机遇。例如中国医药企业日渐活跃的创新项目交易，将大大激发尽职调查服务的需求，无论是仿制药还是创新药公司，都有依据新法律制度参与药品专利链接及相关专利无效程序的需求，这些新的需求均为知识产权法律从业者提供了更加丰富的业务类型和业务增长点。

同时，由于医药领域通常涉及法律前沿问题，且技术与法律的结合度高，因而对知识产权法律从业者的业务水平等提出更高的要求。行业化，专业化，国际化是伴随行业发展而对法律服务人员提出的更高要求，随着企业间竞争的加剧，知识产权法律服务更加强调精准和高效，这是每个相关从业者都需要认真面对的挑战。