CHINA Law and Practice Contributed by: Hans She, Muran Sun, Andy Zhu and Ray Cao, Fangda Partners
1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action Who Can Be the Plaintiff for Bringing a Patent Infringement Lawsuit? The patentee and relevant interested parties are entitled to initiate a patent infringement lawsuit. These interested parties encompass the patent licensee and the heir of the original patent holder. Under PRC law, both the patentee and the exclusive licensee possess the independent right to file patent infringement lawsuits in court. The sole licensee is empowered to file a lawsuit jointly with the patentee or independently, pro - vided it can furnish evidence that the patentee has expressly waived legal action or refrained from filing a lawsuit due to awareness of the infringement. Furthermore, a non-exclusive licensee is author - ised to file patent infringement lawsuits in its own name after obtaining explicit authorisation from the patentee. Notably, there is no manda - tory requirement for the registration or recording of a licensee to bring legal action. The licensee can substantiate its rights towards the patent by providing the contract with the patentee. In situations where the licensee can indepen - dently file the lawsuit, if the patentee does not consent to being a plaintiff, it shall not be joined as a defendant either. Who Can File a Nullity/Revocation Action? Any party or individual who contends that the granting of the patent right does not align with the applicable provisions may petition to the China National Intellectual Property Administra - tion (CNIPA) to declare the patent right invalid.
If any party is unsatisfied with the decision of patent invalidation or adjudication of patent infringement made by the relevant administrative authority, such party is entitled to file administra - tive litigation against such decision/adjudication. 1.2 Defendants/Other Parties to an Action Defendants Involved in Life Sciences/Pharma Patent Infringement Cases According to the PRC’s Patent Law, unauthor - ised entities or individuals are prohibited from manufacturing, using, selling, offering to sell or importing patented products or employing pat - ented methods without the patentee’s permis - sion for business purposes. This implies that suppliers, manufacturers, local distributors/ wholesalers, pharmacists, doctors and hospitals could potentially face patent lawsuits as defend - ants. However, in practice, few pharmaceutical patentees sue doctors, hospitals or other health providers in China. Notably, healthcare regulatory authorities (HRAs) and intellectual property offices (IPOs) also do not form part of infringement proceedings. How - ever, if dissatisfied with an IPO’s decision on pat - ent application or invalidation, a party can file an administrative lawsuit against such IPO, with the IPO listed as the defendant. 1.3 Preliminary Injunction Proceedings Preliminary Injunction Proceedings Under PRC law, if a patentee or interested party possesses evidence demonstrating that another individual is currently infringing or is expected to infringe upon a patent, or is engaging or expect - ed to engage in actions hindering the realisa - tion of rights by the patentee or interested party, and such infringement could result in irreparable harm to the lawful rights and interests of the pat - entee or interested party if not promptly halted,
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