Analysis of key revisions of new Guidelines for Patent Examination: New Rules For Traditional Chinese Medicine Related Invention

View: 159     Date: 2024-01-04 11:28

Author: Wenwen MA

As an important part of the outstanding traditional culture of China, traditional Chinese medicine has increasingly become the focus of global attention. In today's world, more and more people accept traditional Chinese medicine as a choice for the prevention and treatment of diseases, and the protection of intellectual property rights of traditional Chinese medicine has attracted the public's attention. There is a unique system of theories and technical methods in the field of traditional Chinese medicine. Guided by the theories of traditional Chinese medicine, there is a relationship between the diseases and syndromes of traditional Chinese medicine and the diseases or mechanism of drug action of Western medicine, but it is not completely corresponding. Moreover, the name of traditional Chinese medicine is relatively complex, there are many kinds of names. In addition, the effective components of traditional Chinese medicine are difficult to identify, and are usually characterized by raw materials.

In combination with the characteristics of the field of traditional Chinese medicine, under the framework of the general rules of the Patent law and its Implementation Regulations, the part II of the version 2023 of Guidelines for Patent Examination (hereinafter referred to as the "the Guidelines") added a chapter 11, which specifically stipulated for the specific and special circumstances in the field of traditional Chinese medicine.

I. The patent protection objects of traditional Chinese medicine inventions

The Guidelines clearly listed the suitable objects of protection that can be granted patent rights, including 5 types of products and 4 types of methods.

For an invention conforming to the types of products or methods mentioned above, it must meet the constraints of Article 5 and Article 25 of the Patent Law at the same time. The Guidelines listed circumstances of non-compliance with Article 5 or Article 25 of the Patent Law.

II. Special provisions on sufficient disclosure of invention by the specification

1. The names of traditional Chinese medicinal materials

If the names of traditional Chinese medicinal materials exist in the forms of proper name, synonym, alias and common name, the specifications should generally record the proper name of the traditional Chinese medicinal materials. If the name of the traditional Chinese medicinal materials is not clearly recorded in the prior art, the relevant information of the traditional Chinese medicinal materials should be described sufficiently in the specification, such as plant origin, Latin name, medicinal parts, flavor and meridian tropism, efficacy, etc., so that the technical personnel in the field can clearly know what it is

2. Composition and dosage ratio of traditional Chinese medicine composition

For the invention of traditional Chinese medicine composition, as the relationship between the dosage ratio of traditional Chinese medicine raw materials determines the composition structure and primary and secondary effects, which has a direct impact on the efficacy of the composition, the specification should not only describe the composition of the traditional Chinese medicine composition, but also describe the dosage ratio relationship of the traditional Chinese medicine raw materials.

3. The medicinal use of traditional Chinese medicine composition

For new traditional Chinese medicine composition, the specification should record its specific medicinal use. When the technical personnel in the field cannot predict that the invention can achieve the said medicinal use according to the prior art, the specifications shall also disclose experimental data proving that the technical scheme of the invention can solve the technical problem or achieve the technical effect, which may be laboratory experiment data (including animal experiment), or clinical therapeutic effect data (including clinical medical record or clinical case).

For traditional Chinese medicine composition used to treat diseases or syndromes, if the technical personnel in the field cannot predict that the traditional Chinese medicine composition have the effect of treating the said diseases or syndromes according to the prior art, the efficacy or effect of each medicine etc., the experimental data proving that the invention can be treated shall be given in the specification.

III. Special provisions regarding whether claim is clarity and fully supported by the specification

1. The expression of claims for traditional Chinese medicine composition

Similar to the claims of chemical invention, the claims of traditional Chinese medicine composition can also have two ways of expression: open and closed. "Be made of…" is a common expression for the invention of a traditional Chinese medicine composition to qualify a product claims by preparation method, indicating that the traditional Chinese medicine composition is prepared from the indicated component as a traditional Chinese medicine raw materials. This means that in addition to the traditional Chinese medicine raw materials, other auxiliary raw materials can also be added.

2. Summary of claims of traditional Chinese medicine composition

For traditional Chinese medicine composition, the dosage ratio of each traditional Chinese medicine raw material defined in the claims should be based on the specification.

IV. Special provisions on examination of novelty

In the judgment of novelty, attention should be paid to the relationship between the diseases and syndromes treated by traditional Chinese medicine and the diseases or mechanisms of drug action of Western medicine, and whether they are the same. For example, an invention involving the pharmaceutical use of a traditional Chinese medicine, in which the disease treated is limited by the traditional Chinese medicine, and the comparison document disclosed that the mentioned traditional Chinese medicine can treat a certain syndrome type of the diseases, the disease defined by this traditional Chinese medicine belongs to the syndrome type of the diseases, which is in the scope of the syndrome type of the diseases, so that it does not have the novelty.

V. Special provisions on examination of inventiveness

The three-step method is still adopted for the judgment of inventiveness, but combined with the characteristics of the field of traditional Chinese medicine, there are several points when judging the inventiveness of traditional Chinese medicine composition:

(1) When determining the closest prior art, it is necessary to consider the "principle, method, formula and medicine" of the composition and the prior art, and analyze the composition structure from the essence of the invention, select the prior art whose technical field, technical problem to be solved, technical effect or use are closest, and/or the raw materials of traditional Chinese medicine that play a major role are similar.

(2) When determining the distinguishing features, it is necessary to classify and stratify. The distinguishing drug can be stratified according to the primary and secondary status. If the composition structure of the invention is not clear, or there are more traditional Chinese medicine raw materials at the same level, they can be classified according to efficacy or effect.

(3) When judging whether it is obvious, it should be judged from the perspective of the technical personnel in the field, taking the closest prior art and the technical problem solved by the invention as a starting point, and judging from the whole whether the distinguishing technical feature exists in the prior art, and the technical enlightenment of applying the distinguishing technical feature to the closest prior art to solve the technical problem.

VI. Special provisions on practical applicability

Clarifying that doctor's prescription and the method of obtaining traditional Chinese medicine raw materials from animals have no practical applicability.