On April 23rd, the Intellectual Property Court of the Supreme People’s Court held a simultaneous hearing, publicly hearing the appeal cases of standard patent infringement for “leech Chinese herbal medicine decoction pieces” and gene patent infringement for “cordyceps sinensis”. The two cases respectively touch on hot and difficult issues such as the relationship between traditional Chinese medicine standards and patent protection, and the scope of patent protection for gene sequences of traditional Chinese medicinal materials, which have important case demonstration significance.

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Two typical cases that directly address core legal disputes

Case 1: Chinese Medicine Standard Patent Infringement Appeal Case – Rice Leech Patent Infringement Dispute

1、 Basic facts of the case

The appeal case of standard patent infringement of “leech traditional Chinese medicine decoction pieces” in this court hearing is a typical standard essential patent dispute caused by the embedding of local Chinese medicine standards into patents.

DeMou Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “DeMou Company”) is the patentee of the invention patent for “a rice leech and its preparation method”. Previously, after an outsider applied to the Sichuan Provincial Drug Administration, 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 above standards, and their technical solutions fall within the scope of patent protection, constituting infringement.

The first instance court determined that infringement was established and ordered Shen Company to cease infringement, compensate De Company for economic losses of 100000 yuan and reasonable expenses for rights protection of 30000 yuan, and clarify that the FRAND (fair, reasonable, and non discriminatory) licensing principle should not be applied in this case. Shenmou Company is dissatisfied and has filed an appeal.

2、 Core dispute between both parties

In the second instance trial, both parties engaged in a heated debate regarding the patent disclosure obligations in standard setting and the legality of patent rights exercise.

Shenmou Company advocates:

The leech standard involved in the case is a mandatory local standard in Sichuan Province, and it was declared by a company led by De. During the standard setting process, a certain company deliberately concealed patent information and sued the production enterprise only after the standard was implemented and widely applicable in the industry. This behavior constitutes malicious “patent ambush” and violates the principle of good faith in the Civil Code. Therefore, the FRAND licensing principle should be applied in this case.

De Company’s defense:
The current laws and regulations do not impose patent information disclosure obligations on the formulation of standards for traditional Chinese medicine decoction pieces, and there is no legal responsibility to actively publicize or make FRAND commitments. The exercise of patent rights in accordance with the law has a legitimate legal basis.

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.

3、 Significance of the case
This case is a typical case of conflict between local standards and patent protection in the field of traditional Chinese medicine. According to Liu Xiaojun, the presiding judge of this case, the trial will revolve around the legal attributes and scope of effectiveness of provincial traditional Chinese medicine standards, aiming to clarify the legal responsibilities and behavioral boundaries of traditional Chinese medicine decoction piece production enterprises.

Through the trial of this case, the following rules can be clarified:

The legal responsibility boundary of traditional Chinese medicine decoction piece production enterprises based on local standards for production and operation

Judgment rules for standard implementation behavior and patent infringement determination

The scale of exercising the rights of patent holders when participating in the formulation of industry standards

The verdict of this case 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, providing important judicial guidance for the balance between the standardized development of traditional Chinese medicine and the legitimate protection of intellectual property rights.

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Case 2: Chinese Medicine Gene Patent Infringement Appeal Case – Cordyceps sinensis Gene Patent Infringement Dispute Case

On the same day, the Intellectual Property Court of the Supreme People’s Court held a public hearing in its Second Court to hear the dispute over the infringement of the “Cordyceps sinensis” gene patent rights between Zhongmou Pharmaceutical Co., Ltd. and Zhumou Cordyceps sinensis Pharmaceutical Co., Ltd., Zhumou Cordyceps sinensis Raw Material Co., Ltd.

1、 Basic facts of the case

This case is a typical patent infringement dispute involving the deep integration of traditional Chinese medicine knowledge and modern biotechnology.

The patent holder of the invention patent “Enzyme, Gene, and Application of Adenosine Acid Synthesis and Metabolism in Cordyceps sinensis Spore in China” is Zhongmou Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhongmou Company”), and 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 Cordyceps sinensis Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhumou Pharmaceutical Company”) produce “Bailing Tablets” mainly composed of fermented Cordyceps sinensis powder, and have been approved for market by the National Medical Products Administration.

A certain company in China has filed a lawsuit, claiming that Zhumou Cordyceps Raw Materials Co., Ltd. (hereinafter referred to as “Zhumou Raw Materials Company”) manufactures, uses, promises to sell, and sells mushroom powder, Zhumou Pharmaceutical Company uses mushroom powder to manufacture “Bailing Tablets”, and Wumou Pharmacy Co., Ltd. sells “Bailing Tablets”, infringing on its patent rights involved in the case. A certain company in China requests a judgment to order the defendant to cease infringement, and Zhu Raw Material Company and Zhu 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 protects gene sequences with specific functions, and that Zhumou Raw Material Company and Zhumou Pharmaceutical Company did not implement the technical solutions protected by the patent at the level of genetic engineering, which did not constitute infringement. Therefore, the court ruled to reject all of Zhongmou Company’s claims. 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.

2、 Core dispute between both parties

The collegiate bench believes that the main focus of the second instance dispute 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 patent protection is the core issue of dispute among all parties.

According to member Wang Zhao of the collegiate bench, there are two major difficulties in the trial of this case:

To understand the essence of the patent invention involved and the production process of the accused infringing technical solution, one needs to possess professional knowledge in multiple fields such as genetic engineering, strain selection, and microbial fermentation

How to determine the scope of patent protection limited by gene sequences is a complex issue intertwined with law and technology

The collegiate bench will combine the evidence of both parties, fully consider the opinions of the defense, and involve technical investigators to ensure the scientific, objective, and reliable investigation of technical facts. The collegiate bench announced that the verdict of this case will be announced at a later date.

3、 Significance of the case

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 are being 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.

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Based on the Supreme Court’s trial approach and recent intellectual property judicial policies, the trial of these two cases has released three clear judicial orientations, which will deeply affect the future intellectual property protection pattern in the field of traditional Chinese medicine.

Firstly, strengthen the comprehensive protection of innovative achievements in traditional Chinese medicine and broaden the scope of patent protection.

The judicial authorities have explicitly recognized the patent value of modern innovation achievements in traditional Chinese medicine, no longer limiting traditional formula and production processes to traditional Chinese medicine patents. They have also clarified new innovation achievements such as quality standards, testing methods, medicinal genes, breeding techniques, etc., which are equally protected by patent law. As long as it meets the requirements for patent authorization, possesses novelty, creativity, and practicality, regardless of the type of technology, it will be fully protected by law and fully stimulate the innovation drive of traditional Chinese medicine enterprises.

Secondly, distinguish the attributes of patents and delineate the boundaries for exercising differentiated rights.

Regarding the standard patents of traditional Chinese medicine, the judiciary will focus on balancing the relationship between private rights protection, public health, and industry regulation. For technical solutions included in mandatory drug standards, reasonable restrictions on patent abuse will be imposed to ensure that pharmaceutical companies operate in compliance with regulations; For independent research and development, non mandatory internal control standards, and high-end testing technologies of enterprises, strict protection shall be provided in accordance with the law, and malicious plagiarism and theft shall be prohibited. Regarding gene patents, distinguish between naturally occurring public genes and innovative genes that are artificially screened, modified, or specifically applied, eliminate the monopoly of public resources, and severely crack down on gene patent infringement in commercial scenarios.

Thirdly, adapt to the unique characteristics of the traditional Chinese medicine industry and establish specialized adjudication rules.

Traditional Chinese medicine combines both traditional inheritance and modern technology, and cannot completely copy the patent infringement recognition rules in the fields of chemical medicine and machinery. The Supreme People’s Court has gradually established a patent adjudication system that is suitable for the traditional Chinese medicine industry through typical cases. In terms of technology comparison, infringement judgment, and allocation of burden of proof, it fully considers the conventions of the traditional Chinese medicine industry, the current status of technological development, and the public nature of traditional knowledge, achieving an organic combination of legal principles and industry practice.

Conclusion

The trial of the two cases is not only a concrete practice of the people’s court’s precise response to the judicial needs of the traditional Chinese medicine industry, but also a powerful measure to safeguard the high-quality development of traditional Chinese medicine through unified judgment standards and clear legal boundaries.

As emphasized by the court, ensuring genuine innovation is protected and guaranteeing the high-quality development of the traditional Chinese medicine industry. The final verdict of the case deserves continuous attention from the industry.

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Note: This article is compiled based on the press release and relevant trial information released on the official website of the Supreme People’s Court on April 24, 2026. The company names mentioned in the article are all pseudonyms.

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