CHINA Law and Practice Contributed by: Hans She, Muran Sun, Andy Zhu and Ray Cao, Fangda Partners
1.15 Defences and Exceptions to Patent Infringement In patent infringement litigation, besides the non-infringement defence, common defences include:
infringement or the defendant’s domicile, allow - ing forum shopping. Differences between courts primarily arise from judges’ experience and case trial durations, though the legal foundation for court rulings remains consistent, resulting in no significant overall deviation.
• prior use defence; • prior art defence;
2. Generic Market Entry 2.1 Infringing Acts
• patent exhaustion defence; • Bolar exception defence; • scientific research purpose defence; • temporary transit defence; • non-production and operation purpose defence; • abuse of patent right defence; and • legitimate source defence. The legitimate source defence does not assume liability for compensation. 1.16 Stays and Relevance of Parallel Proceedings Generally, patent infringement lawsuits will not be stayed due to patent invalidation procedures. However, the litigation period is generally longer than for administrative procedures. Therefore, administrative decisions can in fact also affect court rulings. For example, if an administrative decision declares a patent invalid, the court typi - cally rejects the lawsuit. 1.17 Patent Amendment Patents cannot be amended during litigation, though they can be amended during patent invalidation proceedings. 1.18 Court Arbiter In pharmaceutical and life sciences cases, judges, rather than juries, preside over civil pro - ceedings. Both preliminary injunctions and main actions in patent infringement disputes fall under the jurisdiction of the court in the location of
According to Article 11 of the PRC’s Patent Law, unless otherwise specified, exploiting a patent without the patentee’s permission for production or business purposes, or making, using, offering for sale, selling or importing patented products, is prohibited. This applies to small-molecule pharmaceutical products as well. In Chinese practices, a marketing authorisa - tion application or grant is typically considered exempt from patent infringement as a pre- launch activity. However, actions such as reim - bursement, pricing, listing applications or tender submissions (which in principle would not be available on the public record) may be deemed patent infringement. Article 18 of the 2020 Amendment to Several Provisions of the Supreme People’s Court on Issues Concerning the Application of Law in the Trial of Cases on Patent Disputes defines the offer to supply or sell as declaring the inten - tion to sell through advertising, shop displays or exhibitions. Offering for sale without authori - sation remains an independent act of patent infringement under the PRC’s Patent Law. Further, an administrative punishment decision by the Shanghai Intellectual Property Office (Case No [2019] 2) illustrated that a disclaimer stating “Products under patent are not offered
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