On the morning of April 23rd, the Intellectual Property Court of the Supreme People's Court held simultaneous hearings in the First and Second Courts to publicly hear the patent infringement cases of "leech Chinese herbal medicine decoction pieces" and "cordyceps sinensis" gene patents. The two hearings focused on hot issues such as the relationship between Chinese medicine standards and patent protection, and the scope of patent protection for traditional Chinese medicine gene sequences. After the trial, the Intellectual Property Court of the Supreme People's Court organized a symposium on the theme of "Inheritance and Innovation of Traditional Chinese Medicine and Modern Intellectual Property Protection". The attendees conducted in-depth discussions on how to coordinate and handle the relationship between traditional Chinese medicine standards and patent protection based on two cases. The appeal case of "Leech Chinese Herbal Medicine Decoction Pieces" standard patent infringement, which is being heard in this court hearing, is a typical standard essential patent dispute caused by the embedding of local Chinese herbal medicine standards into patents. DeMou Pharmaceutical Technology Co., Ltd. (hereinafter referred to as DeMou Company) is the patentee of an invention patent named "A Rice Leech and Its Preparation Method". After the first instance judgment was submitted to the Sichuan Provincial Drug Administration by an outsider, the agency issued the Chinese medicine standard "Leech Standard" (SCYPBZ2021-006). DeMou Company filed a lawsuit claiming that the rice fried leech products manufactured and sold by ShenMou Pharmaceutical Co., Ltd. (hereinafter referred to as ShenMou Company) comply with the leech standards involved in the case, fall within the scope of protection of the patent in question, and constitute patent infringement. The first instance court made a judgment that the infringement was established, and ordered that the fair, reasonable, and non discriminatory (FRAND) licensing principle should not be applied in this case. Shenmou Company stopped the infringement and compensated Demou Company for economic losses of 100000 yuan and reasonable expenses for rights protection of 30000 yuan. Shenmou Company is dissatisfied and has filed an appeal, claiming that the accused infringing product complies with legal regulations and should not be held liable for infringement. During the trial, the litigation representative of Shen Company expressed opinions that the leech standard involved in the case is a mandatory local standard in Sichuan Province, and the declaration of the leech standard involved is an independent act of De Company, which should be subject to the principles of fair, reasonable, and non discriminatory licensing. A certain company in Germany did not disclose the patent information involved in the standard formulation process and sued the standard implementers after the implementation of the standard, which constitutes a "patent ambush" and violates the principle of good faith in the Civil Code. The relevant regulations do not require the development of standards for traditional Chinese medicine decoction pieces to coordinate the relationship with patents. De Company has no legal obligation to disclose patent applications and authorizations, nor is it required to make FRAND licensing commitments. ”The legal representative of a certain company argued against it. During the trial, the collegiate bench guided both parties to provide evidence and cross examine in an orderly manner around the focus of the dispute, and fully express their arguments and opinions. The collegiate bench announced that the verdict will be announced at a later date based on factual evidence and legal provisions. The presiding judge of this case, Liu Xiaojun, stated that this case involves the legal attributes and scope of effectiveness of provincial-level traditional Chinese medicine standards. It is necessary to clarify the legal responsibilities and behavioral boundaries of traditional Chinese medicine decoction piece production enterprises, which will to some extent promote the optimization and implementation of traditional Chinese medicine standards and the high-quality development of the traditional Chinese medicine industry. On the same day, the Intellectual Property Court of the Supreme People's Court held a public hearing in its second court to clarify the scope of protection of traditional Chinese medicine gene patents in the billion yuan target gene patent dispute. The case of Zhong Pharmaceutical Co., Ltd. (hereinafter referred to as Zhong Company) and Zhu Cordyceps sinensis Pharmaceutical Co., Ltd. (hereinafter referred to as Zhu Pharmaceutical Company), Zhu Cordyceps sinensis Raw Material Co., Ltd. (hereinafter referred to as Zhu Raw Material Company) infringing on the gene patent rights of "Cordyceps sinensis" was publicly heard. The patentee of the invention patent "Enzyme, Gene and Application of Adenosine Acid Synthesis and Metabolism by Cordyceps sinensis Spore in China" involved in this case is a certain company in China. Claim 1 of the patent limits the amino acid sequence of a certain enzyme from Cordyceps sinensis Spore in China. Both Zhongmou Company and Zhumou Pharmaceutical Company produce "Bailing Tablets" mainly composed of fermented Cordyceps sinensis powder, which have been approved for market by the National Medical Products Administration. A certain company in China has filed a lawsuit, claiming that the production, use, promise to sell, and sale of mushroom powder by Zhumou Raw Material Company, the use of mushroom powder by Zhumou Pharmaceutical Company to manufacture "Bailing Tablets", and the sale of "Bailing Tablets" by Wumou Pharmacy Co., Ltd. infringe on its patent rights involved in the case. The company requests that the defendant stop infringing and Zhumou Raw Material Company and Zhumou Pharmaceutical Company jointly compensate for economic losses and reasonable expenses totaling more than 110 million yuan. The first instance court determined that the patent in question mainly protected gene sequences with specific functions, and that Zhu's raw material company and Zhu's pharmaceutical company did not implement the technical solutions protected by the patent at the genetic engineering level, which did not constitute infringement. Therefore, the court ruled to reject all of the claims of Zhu's company. A certain company in China is dissatisfied and has filed an appeal, requesting a change of judgment to support all of its first instance litigation requests. The collegiate bench believes that the main focus of dispute in the second instance is whether the accused infringing technical solution falls within the scope of protection of the patent right in question, including the determination of the scope of protection of the patent right in question, and the comparison between the accused infringing technical solution and the patented technical solution in question. Among them, the determination of the scope of protection of the patent right involved is the core issue of dispute among the parties in this case. According to Wang Zhao, a member of the collegiate bench in this case, in order to understand the essence of the patent invention involved and the production process of the accused infringing technical solution, it is necessary to have knowledge of genetic engineering, strain selection, microbial fermentation, and other aspects, which is one of the difficulties in the trial of this case. Another challenge is how to determine the scope of patent protection limited by gene sequences. The collegiate bench will combine the evidence submitted by both parties, fully consider their defense opinions, and involve technical investigators to ensure that the investigation of technical facts is scientific, objective, and reliable. The collegiate bench announced that the verdict of this case will be announced at a later date. The presiding judge of this case, Cui Ning, stated that it is a typical case involving the deep integration of traditional Chinese medicine knowledge and modern biotechnology. With the rapid development of biotechnology, more and more technology solutions involving genes and proteins have been granted patent rights. How to reasonably define the protection boundary of such patents in infringement disputes, which not only fully protects innovative achievements but also maintains public interests and innovation space, has important case demonstration significance. After the trial of deepening the judicial protection of traditional Chinese medicine intellectual property and empowering the high-quality development of traditional Chinese medicine, the Intellectual Property Court of the Supreme People's Court organized a themed symposium on "Inheritance and Innovation of Traditional Chinese Medicine and Modern Intellectual Property Protection". The meeting mainly discussed how to reasonably determine the boundary between intellectual property protection of modern biotechnology and the rational utilization of traditional Chinese medicine knowledge, how to coordinate and handle the relationship between traditional Chinese medicine standards and patent protection, and how to better achieve the innovation, inheritance and development of traditional Chinese medicine. He Zhonglin, Deputy Secretary of the Party Group and Deputy Chief Judge of the Intellectual Property Court of the Supreme People's Court, introduced that in the more than 7 years since its establishment, the court has accepted a total of 25171 cases and concluded 23510 cases. The court actively practices the concept of "protecting intellectual property is protecting innovation", and has achieved significant results in stimulating and safeguarding technological innovation, maintaining fair competition in the market, serving high-level opening up to the outside world, and deepening judicial system reform. The court will uphold the judicial concept that is conducive to the acquisition and protection of rights, and combine the innovative laws and characteristics of traditional Chinese medicine to properly handle the relationship between inheritance, utilization, and innovative development, actively creating a rule of law business environment conducive to innovation. According to Zhu Li, a member of the Party Group and Vice President of the Intellectual Property Court of the Supreme People's Court, the court is based on the needs of the times for the inheritance and innovation of traditional Chinese medicine, follows the development laws of traditional Chinese medicine, accurately grasps the characteristics of traditional Chinese medicine innovation, effectively plays its judicial function, continuously improves the patent examination rules and infringement judgment standards in the field of traditional Chinese medicine, and uses refined and operable judgment rules to safeguard the innovation and development of traditional Chinese medicine, continuously meeting the needs of patent protection for traditional Chinese medicine. Traditional Chinese medicine culture has medical value and cultural attributes. How to clarify the boundaries of patent applications, strengthen patent protection, and handle the relationship between public standard inclusiveness and patent technology exclusivity on the basis of inheritance, sharing, and benefiting the public requires the people's courts and relevant departments to strengthen collaborative governance. ”Establishing a sound intellectual property protection system is conducive to creating an innovative environment. It is suggested that the people's courts strengthen the mechanism for identifying technical facts, increase the punishment for infringement, strengthen the guidance of typical cases, so that true innovation can be truly protected, and ensure the high-quality development of the traditional Chinese medicine industry. ”It is suggested that the people's courts balance the relationship between traditional Chinese medicine standards and patent protection, properly handle conflicts between public standards and private intellectual property rights of traditional Chinese medicine, continuously strengthen regular coordination and linkage with drug regulatory departments, improve information sharing mechanisms, form a joint force for protection, and help promote the inheritance and innovation of traditional Chinese medicine and the healthy development of industry norms. ”At the symposium, the attendees engaged in lively discussions. The public trial of two cases of patent infringement of traditional Chinese medicine and the holding of a symposium this time are not only specific practices of the people's court to accurately respond to the judicial needs of the traditional Chinese medicine industry, but also powerful measures to safeguard the high-quality development of traditional Chinese medicine through unified judgment standards and clear legal boundaries. Some National People's Congress deputies, representatives of administrative departments, relevant officials and researchers of the Chinese Academy of Social Sciences, experts and scholars, etc. attended the court hearing on site and participated in the symposium. (Outlook on the New Era) (The companies mentioned in the article are all pseudonyms)