——(2021) Supreme People’s Court Final Administrative Judgment No.158

Recently, the Supreme People's Court concluded the case of dispute over invention patent application rejection review administrative between the appellant Luo and the appellee CNIPA, determined the patent application involved does not have inventive step, judged the appeal of Luo was rejected, and withheld the first instance judgment of Beijing Intellectual Property Court.

The patent application in this case belongs to the invention-creation in the field of traditional Chinese medicine, and the claim 1 of the application involved requests the protection of the preparation method of the drug magnet used for the treatment of tumors. After substantive examination, CNIPA believed that the application involved does not have inventive step and rejected the application. Luo filed a request for reexamination and revised the claims, and CNIPA upheld the original rejection decision after reexamination. Luo refused to accept the decision and sued to the Beijing Intellectual Property Court, requesting to revoke the sued decision, and ordered CNIPA to make a new decision. The Beijing Intellectual Property Court deemed that the application does not involve inventive step, and ruled to reject Luo's claim.

Luo refused to accept the decision and appealed to the Supreme People's Court, requesting for revocation of the first-instance judgment and the sued decision, and ordering CNIPA to make a new decision on reexamination. The main reasons are: (1) there are more than 10 different drug components in the traditional Chinese medicinal materials with therapeutic effect in the technical solution of the application involved and the reference document, and the reference document should not be deemed as the closest prior art; (2) there are many differences between the application involved and the reference document, such as the compatibility of medicinal flavors and the structure of medicinal magnetic stickers, and the application involved involves inventive step.

For Luo's grounds for appeal that CNIPA made a mistake in choosing the closest prior art, the Supreme People's Court held that for inventions in the field of traditional Chinese medicine, especially when the active ingredients of drugs involving multiple ingredients of traditional Chinese medicines, it is improper to pay too much attention to the number of technical features of the invention disclosed in prior the art, for example, the contact ratio of medicinal tastes. Instead, it should be based on the technical characteristics of the traditional Chinese medicine field, especially the rules of compatibility and composition, changes in prescriptions, and substitution of medicinal tastes and effects, comprehensively considering whether the adaptation of the technical solution of the invention is identical or sufficiently similar to the existing technical solution’s symptoms and related treatment principles, treatment methods, and medication ideas.

In this case, the reference document discloses a nanomedicine magnet for reducing swelling and analgesia of tumors and a preparation method thereof, it adopts the principles of promoting the circulation of qi and blood, regulating the meridians and removing stagnations, reducing swelling and relieving pain, and the effective ingredients of the medicine are mainly prepared from 23 kinds of Chinese medicinal materials in parts by weight. It is applied to acupoints along the meridians according to the tumor type. The technical solution of the application involved takes the methods of promoting digestion and dispelling stagnation such as regulating the meridians and dissipating blood stasis, eliminating phlegm and removing dampness, drawing out poison and reliving pain, the effective ingredients of the medicine that plays a role of treatment are mainly prepared from 22 types of Chinese medicinal materials in parts by weight. It is applied to the meridian of tumor lesions or relative acupoints. The purpose of the invention, the technical field and the technical problem to be solved in the comparative document is highly similar to that in the reference document. Even though there are more than 10 medicinal ingredients different between the two technical solutions, based on the regulations on the compatibility of traditional Chinese medicine, the medicinal taste and the efficacy, they have similar treatment principles and medication ideas, so it is not inappropriate for the decision to regard the reference document as the closet prior art.

In terms of Luo's appeal claim that the application involves inventive step, the Supreme People's Court held that, with regard to inventions in the traditional Chinese medicine area, when judging whether an invention is obvious to those skilled in the art, it is necessary to take the traditional theory of traditional Chinese medicine as guidance, and combine the basic principles of diagnosis and treatment in traditional Chinese medicine, comprehensively analyze and compare the technical solutions of the invention and the prior art in terms of treatment principles, treatment methods, compatibility, prescriptions, effects, etc., thereby determining whether the prior art provides certain technical enlightenment overall for those skilled in the art to solve the technical problems actually solved by the present invention. If there is, then the invention has obviousness.

In this case, compared with the reference document, there are two distinguishing technical features in claim 1 of the application involved: (1) some of the traditional Chinese medicinal materials in the formula of the reference document is deducted from the traditional Chinese medicine formula of the involved application, and limited dosage of new traditional Chinese medicinal materials are added in it; (2) the preparation steps, materials and methods of use of medicinal magnets are different.

In regard to the distinguishing technical feature 1, according to the common-sense evidence "Oncology of Traditional Chinese and Western Medicine", the internal treatment of traditional Chinese medicine includes two principles: strengthening the body resistance and eliminating pathogen. The former refers to supporting human body’s qi, strengthening the power of regulating qi and resolving stagnation, improve body’s anticancer ability. The latter refers to the treatment principal for cancer’s excessiveness of pathogen and interpretation of the cause, mainly including promoting the circulation of qi and blood, clearing dampness and reducing phlegm, clearing heat and detoxifying, resolving hard lump and dissipating stagnation, etc. According to the technical solutions disclosed in the reference documents, those skilled in the art can clearly know which Chinese herbal medicines to select from the perspectives of promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, and dredging collaterals and promoting the circulation of qi, and combine those with effect of nourishing yin, strengthening the body resistance, and improving yang and promoting qi,  which can effectively eliminate the lump and relieve the pain of tumor patients. The application involved, based on the same theory of traditional Chinese medicine treatment, selects Chinese medicinal materials with similar efficacy and combines them to obtain a traditional Chinese medicine composition with comparable efficacy. For those skilled in the art, the technical solution of the involved application can be obtained without any effort of inventive step, and it cannot be seen, from the contents recorded in the description of the application involved, that the replacement, increase and dosage of traditional Chinese medicinal materials have produced unexpected technical effects.

Regarding the distinguishing technical feature 2, the technical features that distinguish the application involved from the reference documents belong to the conventional technical means such as commonly used auxiliary materials and routine operations for preparing medicinal magnetic stickers in the art.

Above all, it is obvious for those skilled in the art to obtain the technical solution requesting for protection in claim 1 of the involved application based on the comparative documents in combination with common sense and routine techniques in the field, so the involved application does not involve inventive step.

Traditional Chinese medicine is a great creation of the Chinese nation. Strengthening the protection of intellectual property rights of traditional Chinese medicine must be based on the characteristics of traditional Chinese medicine. The judgment of this case has certain reference significance for the inventive step judgment of invention patents in the field of traditional Chinese medicine.

From CNIPA

May 11th, 2022