1 novelty examination of patent application for traditional Chinese medicine
Paragraph 2 of Article 22 of the Patent Law stipulates that novelty means that no identical invention or utility model has been published in domestic and foreign publications before the filing date, has been publicly used in China or is known to the public in other ways, and no identical invention or utility model has been applied to the Patent Office by others and recorded in the patent application documents published after the filing date. The novelty examination of an application for a patent for traditional Chinese medicine should follow the principle that the technical scheme is completely equivalent, that is, the application will lose its novelty only if the technical scheme exactly the same as the patent application is recorded in the existing technology before the application date.
For example, the patent application with the application number of 90 10982 1 claims to be a preparation process of a precancerous lesion blocking therapeutic drug, which is characterized in that Dioscorea zingiberensis, Prunella vulgaris, Rhizoma bistortae, Patrinia scabiosaefolia, Radix Sophorae Tonkinensis and Cortex Dictamni Radicis are made into certain dosage forms. The comparative document Anticancer Chinese Herbal Medicine Preparation (People's Medical Publishing House, first edition, 198 1, page 187) retrieved by examiners records that Anticancer Pill B is composed of 60g yam, 60g Cynanchum atratum, Radix Sophorae Tonkinensis 120g and Patrinia. Therefore, this application is not new.
2. Creative review of patent application for traditional Chinese medicine
2. 1 creative examination of patent application for traditional Chinese medicine products According to the ingredients of traditional Chinese medicine products, they can be divided into compound products containing multiple active ingredients and unilateral products containing a single active ingredient. For the application of traditional Chinese medicine compound products, most of the applied products are made by conventional processes in this field, and the medicinal function of the products is closely related to the composition of raw materials for producing the products. The important technical feature of raw material composition is the innovation of most compound Chinese medicine patent applications. Therefore, it can be said that the composition of raw materials is the decisive factor in evaluating the creativity of traditional Chinese medicine compound products. What needs to be explained here is that most Chinese medicine products are mixtures with unknown ingredients, so it is difficult to describe Chinese medicine products with ingredients. In the technical practice in this field, it is usually judged whether two Chinese medicine products are the same according to whether the raw materials for preparing the products are the same. Therefore, in this case, using raw materials to describe the product is more suitable for the technical characteristics of traditional Chinese medicine compound products.
2. 1.65438+ The outstanding effect of this accident can be a new use, which can significantly improve the curative effect, reduce the toxic and side effects and reduce the cost. This improvement can be the addition and subtraction of the existing prescription, or the substitution of drugs in the existing prescription. If it is an addition or subtraction of a known prescription, the applicant should use credible evidence to explain what unexpected and outstanding effects this addition or subtraction has brought to the invention. For example, in the prior art, Shengmaiyin oral liquid is used to treat heart-qi deficiency syndrome, such as palpitation and shortness of breath. If Astragalus membranaceus is added to make a new oral liquid on this basis, the applicant should have reliable comparative experimental data or comparative curative effect data, indicating what outstanding unexpected effects the new product made by adding Astragalus membranaceus on the basis of the existing technology has compared with the known Shengmaiyin oral liquid.
Similarly, if a single drug is subtracted from the existing prescription, the new product also needs the above evidence.
There are two situations about drug substitution on the basis of known prescriptions: one is that there is no substantial difference between the new prescription and the known prescription after substitution. Although the product made from this prescription is different from the known prescription in composition, and even has different names of many drugs, if this substitution is the general choice of ordinary technicians in the field, that is, according to the prescription principle of textbooks, ordinary people in the field expect to make this substitution, and this substitution has not brought unexpected outstanding effects, this substitution is considered to be not creative.
If the ingredients of patented Chinese medicine are a brand-new formula, and similar or similar products are not recorded in the prior art, this brand-new Chinese medicine is creative.
If the performance of a traditional Chinese medicine is unexpectedly outstanding due to different preparation methods, then the product prepared by this method is creative. What needs special attention here is that, first of all, this product should be novel. That is to say, the product produced by this different preparation method should be different from the existing technology in product characteristics. If it is a known product, there is no novelty as a product. In this case, only the method patent can be obtained.
2. 1.2 creative judgment of unilateral products of traditional Chinese medicine for a unilateral patent application of traditional Chinese medicine, if a substance (plants, animals, minerals, etc. ) It has never been recorded in the literature, or it has been recorded, but it has never been recorded as having medicinal effects. As long as the Chinese medicine made of this substance has the function of diagnosing, treating or preventing diseases, the medicine made of this substance is creative. It should be noted that this substance is associated with a certain method, whether conventional or unconventional, it must be made into drugs by some method. Only raw materials cannot be patented, because this material is just a discovery.
If a patent application for a Chinese medicine product takes the effective part extracted from the known Chinese medicine raw materials as the active ingredient, and this active ingredient is a newly separated substance, which has never been reported before, compared with the prior art, if a new substance is separated from the known raw materials, the product is creative as long as the applicant proves its medical function with credible pharmacodynamic data. Here, there is no special requirement on whether the separation method is a conventional method.
2.2 Creative Judgment of Patent Application for Traditional Chinese Medicine Method For the preparation method of a known product (compound or unilateral), if the extraction, separation, processing or other preparation processes different from the prior art are adopted in the production process, there are substantial differences or unexpected outstanding effects compared with the prior art, then the method is creative.
For the process of extraction, separation, processing or other preparations, it can be an improvement of a certain process or a multi-step improvement. In addition, for each specific step of the method, it may belong to a conventional method. As long as the beneficial effect of the patent application is due to the method, the method is creative when combined into a whole.
There are two beneficial effects: one is to improve the product performance due to the improvement of the method, such as increasing new uses, improving the original curative effect, reducing side effects, or prolonging the storage period, improving purity and improving taste. On the other hand, it has brought about the improvement of production technology, such as the reduction of cost, production risk, production energy consumption, the protection and utilization of raw materials and resources, the reduction of environmental pollution, the simplification of technology and the improvement of quality control reproducibility.
2.3 The creative judgment of the patent application for the use of traditional Chinese medicine should be compared with the existing technology, that is, a known product has no such use in the past, and it cannot be easily inferred from its composition or existing technology. The patent application gives a new use, and as long as the new use is credible, it is considered creative compared with the existing technology. Because the key to the invention of new uses lies in new pharmacological effects, this application requires strict and credible pharmacodynamic data.
3. Practical review of patent application for traditional Chinese medicine
Practicality means that the object of the invention must be able to be manufactured or used in industry and can produce positive effects. Moreover, the invention that is granted a patent right must be an invention that can achieve practical purposes and be applied.
For Chinese medicine, the invention of a medicine should be a product with medical function, which can achieve its therapeutic purpose in a reproducible way. This reproducibility includes the reproducibility of products and the reproducibility of medical effects. If the therapeutic effect of the invented product is not fixed and repeatable, it will not be practical. It can be seen that an application for a patent for Chinese medicine products and the invention of drugs with medical effects meet the minimum requirements of practicality; For the method patent application, the method should be able to be implemented or used in industry; The application of utility model can be realized in industry.
3. 1 judgment on the practicability of patent application for traditional Chinese medicine For a compound patent application for traditional Chinese medicine, if there is no similar medicine in the prior art, in this case, it is necessary to confirm that the medicine has medical effect and that the medicine can be industrialized to confirm its practicability.
For a unilateral patent application for traditional Chinese medicine, if a substance (plants, animals, minerals, etc. ) It has never been recorded in the literature, or it has been recorded, but it has never been recorded as having medicinal effects. As long as the applicant proves with reliable data or clinical data that the traditional Chinese medicine made of this substance has the function of diagnosing, treating or preventing diseases and the drug can be industrialized, the drug made of this substance is practical.
3.2 Chinese medicine patent application does not have the industrial applicability of several situations
3.2. 1 The drug in the patent application has no medical effect or the medical effect is not credible. In the specification and claims, the function of the applied medicine has never been disclosed, but the composition and preparation method of the medicine are given. This application has no use value and is not practical, because the medicine has no medical effect; If the medical effect of the applied drug is not credible, and the applicant has no credible evidence to prove the exact medical effect of the patented drug, in this case, the applied drug is not practical because it has no medical effect.
3.2.2 The drug for which a patent is applied contains substances that cannot be industrially produced or reproduced in large quantities. If the application is for a product, the product must be able to be manufactured in industry. If some ingredients in the raw materials of patented drugs are only suitable for manual production, or its output is too low to be produced on an industrial scale at all, this product has different practicability. For example, in the application NO93114646.1,one of the raw materials is the blood of insects, in this case, the blood of ants or bees is used. It is difficult to produce this raw material on a large scale in industry, so it has no industrial practicability. For another example, the application number is 90 106424, which is an injection made from human omentum. Because the source of human omentum is limited, it is impossible to produce injections on a large scale, so this method is not industrially practical.
3.2.3 The drug in the patent application is harmful to the public interest * * * There is a drug that works by the human body smelling the smell of the drug. The purpose of this application is to provide a medicine which can make people faint and lose their resistance after smelling the medicine, and is used for self-defense. But this medicine can also be used in crime, which is harmful to the public's interests, so it is not practical.
3.2.4 The method of patent application is limited to manual operation and is not suitable for industrial production. For example, application No.94 106997 is a medicine for treating tetanus. The preparation method comprises burying the pumpkin pedicle in a leeward pigsty for a period of time, and then processing into tablets or capsules. This preparation method can not be used for industrial scale production and is not practical.
Analysis of writing thinking:
1. Preparation before technical scheme analysis
1) Understand the general technical knowledge in related fields.
2) Familiar with the common types of Chinese medicine inventions:
A. Invention of traditional Chinese medicine extract: invention of traditional Chinese medicine extract extracted from a single bulk drug; Traditional Chinese medicine extracts extracted from various raw materials.
B inventions of traditional Chinese medicine compositions: inventions characterized by active ingredients and inventions characterized by dressings.
A. A Chinese medicinal composition containing a single active ingredient, characterized by containing the active ingredient;
B, a Chinese medicinal composition containing various active ingredients;
C) Inventing a Chinese medicinal composition characterized by auxiliary materials, such as cyclodextrin embedding method;
D, inventing a traditional Chinese medicine composition characterized by dosage forms.
C. the invention of the production method of traditional Chinese medicine.
D. Invent the use of traditional Chinese medicine:
Medical use of new animals, plants or minerals or their extracts;
B. Second medical use of existing Chinese medicinal materials or their extracts.
2. Technical analysis of technical scheme
1) Determine the invention type to which the technical scheme belongs;
2) Check whether the technical scheme is complete and clear;
3) Analyze the key technologies of the technical scheme.
3. Search the patent literature and non-patent literature of the technical scheme.
4. Legal analysis of technical scheme
1) Feasibility analysis of patent application for technical scheme: The topics that are not protected in the field of traditional Chinese medicine include: newly discovered traditional Chinese medicine, traditional Chinese medicine prescriptions, and methods of using traditional Chinese medicine such as umbilical therapy.
2) Deterministic analysis of technical scheme patent application.
3) Validity analysis of patent application for technical scheme.
Firstly, based on the existing technology, the possibility of hiding technical secrets and expanding the scope of protection is analyzed. Provided that they all enable those skilled in the art to practice and achieve the purpose of the present invention. Hidden technical know-how refers to hiding important additional technical points. Without these technical points, ordinary technicians in the field can still implement the invention, but its effect is not as good as that of products or methods including these additional technical points, and it lacks market competitiveness. The concealment of technical know-how depends firstly on whether the technical scheme composed of technical features can be implemented, and secondly on the number of differences between the technical scheme composed of technical features and the existing technology. As long as there are enough differences to prove the novelty and creativity of the invention, the remaining differences can be used as technical know-how or apply for another series of inventions to extend the actual protection period of the patent. Concealing technical secrets must ensure that the applied technical scheme can be implemented and has key technical differences with the existing technology.
Generally, in the product invention of traditional Chinese medicine formula, the optimal dosage of optional components and essential components in the formula can only be hidden as technical know-how; In the invention of traditional Chinese medicine methods, the best technological conditions are generally hidden as technical know-how.
It should be noted that this is related to the specific situation. If the key ingredients in the formula are hidden, the result will be that the patent application fails because the technical scheme is not fully disclosed. Even if it is approved, its technical scheme will not be truly protected and will not play the role of patent protection.
After knowing the difference between the technical scheme and the existing technology, and excluding the technical know-how that can be hidden, the difference between key technologies is determined as the core of patent protection. How to effectively protect the core technology from being changed by others or realized in a similar way, we must expand the core technology from the technical point of view. The problems that agents and technicians usually have to consider include: what is the monarch, minister and assistant, what is the effect of the specific formula, and whether the reduction of ingredients will affect the effect; If you don't choose the above dosage, what effect will it have, and the dosage that meets the minimum requirements required by the state; Whether it must be taken orally, and whether the ingredients can be replaced by other traditional Chinese medicines. So as to gradually determine which technical features are necessary and which are not.
Usually, the following methods are adopted to expand the scope of protection technically:
? The promotion method of the upper concept, such as the upper concept of decoction is oral dosage form;
? Equivalent replacement method, such as replacing rhinoceros horn with water horn;
? Expansion of dosage range, such as expanding the dosage of components to the conventional dosage range.
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