Life Sciences and Pharma IP 2026

CHINA Law and Practice Contributed by: Binxin Li, Guangzhen Shang, Yue He and Lesley Wang, LeanWill Law Firm

ant, although there are some exemptions. In practice, generics, API manufacturers, exporters and pharma ‑ cies are routine targets. Online pharmacies are allowed in China, and thus, e-commerce platforms could be actionable as well, in certain scenarios. Regulatory authorities, government tender offices and hospitals are not usually listed as defendants for various rea‑ sons, but they could also be listed as defendants if they exploit a patent for commercial purpose. If there are multiple infringers, the plaintiff has the right to choose any of them as a defendant. Having said that, upon the defendant’s request, or at the court’s discretion, a party of interest to the lawsuit could be added as a co-defendant or third party in the infringe ‑ ment proceedings. In a trade mark or trade dress infringement dispute, any participant in the chain of commerce can be listed as the defendant, such as manufacturers, distributors and e-commerce platforms. Regulatory authorities could be listed as defendants in certain IP disputes. For example, the CNIPA may be listed as the defendant in administrative proceedings relating to patent term extension (PTE), patent term adjustment (PTA) and invalidation. IP offices could be listed as defendants for their decisions in adminis ‑ trative patent infringement actions in the follow-up administrative proceedings. 1.3 Preliminary Injunction Proceedings Preliminary injunctions (PIs) are only available in civil actions in China. A party may apply before filing a law ‑ suit (ie, pre-suit PI) or after the action is docketed (ie, intra-suit PI). If the situation is urgent, the court must rule within 48 hours after the PI motion is docketed. The PI order is immediately effective once issued by a court. For a PI, the applicant must demonstrate: • a likelihood of success on the merits for infringe ‑ ment and patent stability; • a balance of hardships favouring the applicant; • irreparable harm; • impacts on public interest; and

• urgency, which is required only for intra-suit PI requiring urgent handling and for pre-suit PI. The irreparable harm and likelihood of success are the most challenging factors to be established in patent infringement cases. No statutory time limit exists for filing a motion for PI; however, the urgency standard may not be satisfied if the applicant causes an unreasonable delay (eg, if it files a pre-suit PI after knowing of the infringement for a significant time period). After a pre-suit PI is granted, the applicant must file a lawsuit within 30 days; otherwise, the PI order will be lifted by the court. PI against imminent infringement (ie, quia timet relief) is also available in China. Typical scenarios include trade secrets about to be illegally disclosed, infringe ‑ ment about to occur at a trade fair or a peak sales season, and the disputed IP about to be assigned or disposed of illegally. Generally, before granting a PI, the court shall ques ‑ tion both the applicant and the respondent. However, if the situation is urgent or if any such inquiry may frus ‑ trate the enforcement of the PI, the court may proceed without questioning the respondent. 1.4 Structure of Main Proceedings on Infringement/Validity In a patent infringement dispute, a civil action could be filed with a competent court, or an administrative action could be initiated before a competent IP office. Parallel enforcement is also available. The civil action could comprise two instances, and the first instance judgment would be pending and not enforceable if an appeal is filed. The administrative action is only one instance, and the decision takes effect once issued, albeit subject to judicial review. An enforcement action would usually prompt the defendant to file an invalidation action against the patent at issue. An invalidation action can only be filed before the CNIPA after the patent is granted. A patent enforcement action and a patent invalidation action are two separate proceedings, heard by courts/

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