CHINA Law and Practice Contributed by: Binxin Li, Guangzhen Shang, Yue He and Lesley Wang, LeanWill Law Firm
1.18 Court Arbiter Civil lawsuits are tried by a panel normally formed by three or five judges. One or two jurors may be invited to form the panel, and a technical investigation officer may be invited as supporting staff. As administrative action is available in China, the IP office may form a panel of three or five officers to adju ‑ dicate a case. A technical investigation officer could also be invited to provide support. Forum shopping is important for various reasons, including experience and practice. For a patent infringement case, an action can be filed to a com ‑ petent court where the defendant is located or where the infringement is committed. For civil actions, China has established a centralised judicial system for handling technical IP cases (phar ‑ ma/life sciences cases are mainly included within such scope), which improves the consistency and fairness of case adjudication. To be specific, China has cur ‑ rently established four specialised IP courts, in Beijing, Shanghai, Guangzhou and Haikou, and 31 specialised IP tribunals across the nation to handle invention pat ‑ ent infringement cases within their respective jurisdic ‑ tions. The Supreme People’s Court IP tribunal will hear the appeal accordingly. For administrative actions, the local IP office will try the case; the CNIPA only takes influential cases such as those that cross multiple provincial territories across the nation or that have a significant impact on public health. The decision is subject to judicial review by the corresponding IP courts or IP tribunals.
Bolar Exemption Chinese law exempts making, having made, using, importing, and having imported patented drugs, with ‑ out the patentee’s authorisation, solely for the pur ‑ pose of providing information required by the authori ‑ ties for market approval in China or overseas from infringement. However, selling and offering for sale is not covered by the Bolar exemption. Research Exemption A research exemption is also available in China, which permits the exploitation of a patent without the pat ‑ entee’s authorisation solely for research purposes. The research exemption is applied strictly in prac ‑ tice. The Supreme People’s Court has held that the research exemption applies to the manufacturing of a patented product in small volumes to understand the manufacturing process, but not to the use of a pat ‑ ented product even for scientific research purposes. The research exemption is limited to the party’s own activities, which means that manufacturing, selling, offering for sale and importing a patented product for others’ scientific research is not covered by the research exemption. Government-Centralised Procurement/Volume- Based Purchase (VBP) Filing an application to participate in government- centralised procurement and VBP was classified as infringement of offering for sale in the benchmark case of Sandoz v Hansoh . Offer to Supply After Patent Term Expiry A statement of offering to supply after a patent expires is not a valid defence, as concluded by the Shanghai IP Office in Bayer v Acebright . Second Medical Use Patents and Skinny Labelling China protects second medical use patents, and skin ‑ ny labelling (ie, carve-out of the patented indication) is a way to avoid infringement. Parallel Imports Article 75.1 of the PRC Patent Law legitimises the par ‑ allel importation of patented products. However, in practice, the parallel importation of patented drugs is
2. Generic Market Entry 2.1 Infringing Acts
Under the PRC Patent Law, anyone making, using, offering for sale, selling or importing an infringing product without the patentee’s authorisation commits patent infringement. Common issues relating to patent infringement in the pharmaceutical industry include the following.
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