1 Examination of the novelty of Chinese medicine patent application
Article 22, paragraph 2 of the Patent Law stipulates that: novelty means that there is no identical invention or utility model that has been published in domestic and foreign publications, used publicly in China or otherwise known to the public, and that there is no identical invention or utility model that has been applied for by another person to the Patent Office and has been recorded in the patent record published after the filing date. recorded in the patent application documents published after the filing date. The examination of the novelty of a patent application for traditional Chinese medicine shall follow the examination principle of complete equivalence of technical solutions, that is to say, only if the prior art before the filing date contains a technical solution which is identical to that of the patent application, the application will lose its novelty.
For example, Patent Application No. 90109821 claims: a process for preparing a therapeutic agent for blocking pre-cancerous lesions, characterized in that a certain dosage form is made by combining Huang Yao Zi (黄药子), Xia Ku Cao (夏枯草), Quan Shen (拳参), Wu Jia Cao (败酱草), Shan Dou Gen (山豆根), and Bai Shi Pei (白藓皮). The examiner retrieved the comparative literature "Anti-cancer Herbal Preparations" (People's Health Publishing House, 1981, first edition, p. 187), which recorded that: Anti-cancer B Pill, consisting of 60g of Huang Duo (i.e. Huang Yao Zi), 60g of Cao He Che (i.e. Fist Succinum), 120g of Yam Bean Root, 120g of Scabious Grass, 120g of White Moss Pi, and 120g of Xia Kucuo Cao each of the medicines*** was finely powdered, and was made into a pill by refining honey, and is used as a main treatment for cancer. Therefore the application does not have novelty.
2 Inventive Review of Chinese Medicine Patent Applications
2.1 Inventive Review of Chinese Medicine Product Patent Applications According to the composition of Chinese medicine products, they can be divided into compound products with multiple active components and single active component single product. For the application of compound products of traditional Chinese medicine, most of the applied products are made by the conventional technology in this field, and the medical effect of the products has a close relationship with the composition of the raw materials for producing the products, and the composition of the raw materials, which is an important technical feature, is the invention of most patent applications for compound traditional Chinese medicines, so it can be said that, in evaluating the creativity of the compound products of traditional Chinese medicine, the composition of the raw materials for preparing the products is the decisive factor. Therefore, it can be said that when evaluating the inventiveness of a compound Chinese medicine product, the composition of the raw materials used in the preparation of the product is the decisive factor. It should be noted here that most Chinese medicine products are mixtures whose composition is unclear, and it is difficult to describe the Chinese medicine products by their composition, and in the technical practice of the field, it is usually based on whether or not the composition of the raw materials used in the preparation of the products is the same to determine whether or not two Chinese medicine products are the same, so in this case, it is more suitable to adopt the method of expressing the products by the raw materials of the products in describing the compounded Chinese medicine products. technical characteristics of Chinese medicines.
2.1.1 Judgment of the creativity of a Chinese medicine compound product is divided into the following cases If the raw material composition of the product for which the applicant seeks protection is an improvement of an existing formula, and the preparation method belongs to the conventional method, the applicant shall provide credible comparative experimental data or comparative therapeutic effect information, indicating what kind of unexpected outstanding effect such an improvement has brought about as compared with the existing technology, and then the creativity of the product can be recognized. The applicant shall provide credible comparative experimental data or comparative therapeutic effect information to show what kind of unexpected outstanding effect this improvement has compared with the prior art, and its creativity can be recognized. Such unexpected outstanding effect may be a new use, a significant improvement in therapeutic efficacy, a reduction in toxic side effects, or a reduction in cost, etc. The improvement may be a modification of an existing formula, or an improvement in the efficacy of an existing formula. Such improvement can be an addition or subtraction to an existing formula or a substitution of drugs in an existing formula. If it is an addition to or subtraction from a known formula, the applicant should show with credible cited information what unexpected outstanding effect has been brought to the invention after such addition or subtraction. For example, the existing technology of the oral solution of shengwei drink is used for the treatment of palpitation, shortness of breath and other cardiac qi deficiency, if the addition of astragalus on the basis of a new oral solution, the applicant should have credible comparative experimental data or comparative efficacy data, explaining in the existing technology of the addition of astragalus on the basis of a new product compared with the known oral solution of shengwei drink with what outstanding unexpected effect.
Similarly, a new product made by subtracting a medicine from an existing formula would also require information as described above.
With regard to the substitution of a drug on the basis of a known formula, two cases can be distinguished: one case is that, after the substitution, a new formula is formed which is not materially different from the known formula, and the product made from such a formula, although it is already different from the known formula in terms of its components, or even has a larger number of drugs with different names, if such substitution is a general choice of a person of ordinary skill in the art , that is to say, it is expected by one of ordinary skill in the art to make such substitutions as taught by the textbook principles of composition, and, moreover, such substitutions do not bring about unexpected outstanding effects, such substitutions are considered to be non-inventive.
If the composition of the patent application is an entirely new formulation, and no similar or analogous product has been documented in the prior art, such an entirely new traditional Chinese medicine is inventive.
If a traditional Chinese medicine, due to the different preparation method makes the performance of the prepared product produce unexpected outstanding effect, this method of preparation of the product is creative. Here, special attention should be paid to, first of all, this product should have novelty. That is to say, after this different preparation method to produce products, in the product features should be different from the prior art, if the product is known, as the product does not have the novelty, in this case can only get a method patent.
2.1.2 Judgment of the creativity of Chinese medicine single product For a single Chinese medicine patent application, if a substance (plants, animals, minerals, etc.) has never been documented in the literature, or although documented, but has never been documented with the medicinal effect, as long as this substance made of Chinese medicine, with the diagnosis, treatment or prevention of disease, the drug made of this substance has the creativity. It should be noted that the substance is associated with a certain method, regardless of whether the method is conventional or non-conventional, and the substance must be prepared into a medicine through a certain method. A mere raw material substance cannot be patented, as such a substance is merely a discovery.
If a patent application for a traditional Chinese medicine product uses as an active ingredient an active part extracted from a known raw material of the traditional Chinese medicine, and this active ingredient is a newly isolated substance which has not been reported in the past, the product is inventive as a result of the isolation of a new substance from the known raw material as compared with the prior art as long as the applicant confirms its medical effect with credible information on its efficacy. Here, there is no special requirement as to whether the separation method is a conventional method.
2.2 Judgment of Inventiveness of Patent Applications for Chinese Medicine Methods For a method of preparing a known product (compound or single formula), if an extraction, separation process, concoction process or other preparation process different from that of the prior art is adopted during the production process, which is materially different from that of the prior art or produces an unexpected and outstanding effect, such method is inventive.
For an extraction, separation, concoction or other preparation process, it may be an improvement of a certain process method, or it may be a multi-step improvement, and, for each specific step of the method, it may be a conventional method, and as long as the beneficial effect of the patent application is due to the method of the process, the method as a whole combines to be inventive.
There are two kinds of beneficial effects: one is the improvement of the product performance due to the improvement of the method, such as adding a new use, or making the original therapeutic efficacy improved, or reducing the side effects, or prolonging the storage period, improving the purity, and improving the taste, etc. The other is the production process. Another situation is to bring improvements to the production process, such as the reduction of costs, the reduction of production risks, the reduction of production energy consumption, the protection and utilization of raw material resources, the reduction of environmental pollution, the simplification of the process, the improvement of the reproducibility of the quality control, and so on.
2.3 Judgment of Inventiveness of Patent Application for Chinese Medicine Use The judgment of inventiveness of use should be the comparison with the prior art, that is to say, a known product did not have such a use in the past, and the use could not be easily deduced from its composition or the prior art, and the patent application gives a new use, and as long as this new use is credible, it is considered to have inventiveness in comparison with the prior art. Inventive. Since the key point of the new use invention is the new pharmacological effect, this kind of application is more stringent in terms of the credibility of the information on the efficacy of the drug.
3 Utility Examination of Chinese Medicine Patent Applications
Utility means that the object of the invention must be capable of being made or used in industry and capable of producing positive effects. Moreover, the invention for which a patent is granted must be an invention capable of achieving a practical purpose and capable of being applied.
For traditional Chinese medicine, the invention of a drug, should be a product with medical effects, can reproducibly achieve its therapeutic purpose, this reproducibility includes the reproducibility of the product and the reproducibility of the medical effect, if the invention of the product is not fixed therapeutic effect, no reproducibility, can't achieve the purpose of the invention, then it does not have the practicality. It can be seen that a Chinese medicine product patent application, the invention of the drug with medical effect is in line with the minimum requirements of practicality; and for the method patent application, the method should be able to implement or use in the industry; for the use of the invention application, the application of the application can be realized in the industry.
3.1 Judgment of Utility of Chinese Medicine Patent Application For a patent application of compound Chinese medicine, if there is no similar medicine recorded in the prior art, in this case, it is necessary to prove that the medicine has a medical effect and the medicine can be industrially produced before its utility can be confirmed.
For the patent application of one-party traditional Chinese medicine, if a substance (plant, animal, mineral, etc.) has never been recorded in the literature, or has been recorded, but has never been recorded as having medicinal effects, as long as the applicant proves that the traditional Chinese medicine made of this substance has the effect of diagnosing, treating or preventing the disease with credible data or clinical information, and that the medicine can be industrially produced, the medicine made of this substance has the utility. The medicine made of this substance has practicality.
3.2 Several cases of Chinese medicine patent applications that do not have industrial practicability
3.2.1 The drugs in the patent applications do not have medical effects or the medical effects are not credible There are some applications that never disclose the function of the drugs applied for in the specifications and claims, but only give the composition of the drugs and the method of making the drugs, and this kind of application has no value and does not have practicality due to the fact that the drugs do not have medical effects; this kind of application has no value and does not have practicality. This application has no value because the drug does not have medical effects, and does not have utility; if the medical effects of the drug applied for are not credible, and the applicant does not have credible evidence to confirm the exact medical effects of the drug patented, in this case, the drug applied for does not have medical effects and does not have utility.
3.2.2 The patent application is for a drug that contains a raw material that cannot be industrially produced or reproduced in large quantities If the application is for a product, then the product must be capable of being manufactured in industry. If some of the ingredients in the raw materials for the preparation of a patent application are only suitable for handmade production, or if the output is so low that it cannot be produced on an industrial scale, the product is not practical. For example, application No. 93114646.1, one of whose ingredients is the use of insect blood, embodiments using the blood of ants or bees, such raw materials are difficult to obtain for industrial scale production, and therefore do not have industrial utility. As a further example, application No. 90106424 prepares an injection using human omentum as a raw material, which is not industrially practical due to the limited availability of human omentum, which prevents the injection from being industrially produced on a large scale.
3.2.3 Patent application drugs are detrimental to public **** interests There is a kind of drug, belongs to the smell drug, is through the human body to smell the smell of the drug and the role of the application of the invention is to provide a kind of so that the human body smells the smell of the drug can be able to fainting and lose the ability to fight back the drug, used for self-defense, but this drug can also be used for crime, detrimental to the interests of the public ****, and therefore, the does not have the practicality.
3.2.4 The method of the patent application is limited to manual operation and is not suitable for industrialized production. For example, application No. 94106997 is a kind of drug for the treatment of tetanus, and the method of preparation is to make tablets or capsules by burying the pumpkin seeds in the pigsty at the back of the wind and in the direction of the sun for a period of time, and then gunning them into a tablet or capsule. This preparation method is not practicable for industrial scale production.
Writing ideas analysis:
1. Preparation before analyzing the technical program
1) Understand the general technical knowledge of the relevant fields.
2) Familiarize yourself with the common types of traditional Chinese medicine inventions:
A. The invention of traditional Chinese medicine extracts: the invention of traditional Chinese medicine extracts extracted from a single raw material; traditional Chinese medicine extracts extracted from a variety of raw materials.
B. The invention of traditional Chinese medicine compositions: the invention of the active ingredient as a feature and the invention of the dressing as a feature.
a. Containing a single active ingredient and characterized by the active ingredient contained in the combination of traditional Chinese medicine;
b. Containing a variety of active ingredients in the combination of traditional Chinese medicine;
c. Invention of combinations of traditional Chinese medicine characterized by auxiliaries, such as cyclodextrins embedded in the method;
d. Dosage form of combinations of traditional Chinese medicine as the characteristics of the invention.
C. Inventions of methods for the production of traditional Chinese medicines.
D. Invention of the use of traditional Chinese medicines:
a. Medical use of new animals, plants or minerals or extracts thereof;
b. Second medical use of existing traditional Chinese medicines or extracts thereof.
2. Technical analysis of the technical solution
1) Determine the type of invention to which the technical solution belongs;
2) Check whether the technical solution is complete and clear;
3) Analyze the key technology of the technical solution.
3. Conducting patent literature and non-patent literature search on the technical solution
4. Legal analysis of the technical solution
1) Analyzing the feasibility of applying for a patent on the technical solution: The subjects not protected in the field of traditional Chinese medicines are as follows: newly-discovered traditional Chinese herbs, traditional Chinese medicine prescription, and methods of using traditional Chinese medicines such as umbilical cord therapy, and so on.
2) Analysis of the certainty of applying for patents on technical solutions.
3) Analysis of the effectiveness of patenting technical solutions.
First of all, based on the prior art, analyze the possibility of hiding technical know-how and extending the scope of protection. The premise is that both must enable the person of ordinary skill in the field to implement and can realize the purpose of the invention. Hidden know-how refers to the concealment of important additional technical points, without which a person of ordinary skill in the field can still carry out the invention, but the effect is not as good as that of the product or method which includes these additional technical points, and lacks market competitiveness. The concealment of technical know-how depends firstly on whether the technical solution consisting of the technical features can be implemented, and secondly on how many points of difference there are when the technical solution consisting of the technical features is compared with the prior art. As long as there are enough points of difference to prove the novelty and inventiveness of the invention, the remaining points of difference can be used as technical know-how or applied for another series of inventions to extend the actual term of protection of the patent. The hidden know-how must ensure that the applied-for technical solutions can be implemented and have key technical differences from the prior art.
Generally, in product inventions of traditional Chinese medicine formulations, only the selective components and the optimal dosage of the necessary components in the formulations to make them more effective can be hidden as the technical know-how; and in method inventions of traditional Chinese medicines, the optimal conditions of the process are generally hidden as the technical know-how.
It should be noted that this is relevant to the specific situation. If the key components of the formula components are hidden, the consequences are due to insufficient disclosure of the technical program and lead to the failure of the patent application, even if approved, their own technical program has not been truly protected, and can not play the role of patent protection.
After clarifying the difference between the technical solution and the prior art, and after excluding the technical know-how that can be hidden, the key technical difference is identified as the core of patent protection. How to effectively protect the core technology from being altered by others or using similar ways to implement the core technology, the core technology must be expanded from a technical point of view. The agent should usually consider, but also the technical personnel should consider the issues including, what is the king, the minister and the enabler, what is the effect of the specific formula, if the reduction of the components, whether it affects the effect; if you do not choose to use the above dosage, what will be the effect of reaching the minimum requirements of the next country, the amount of dosage required; whether it is necessary to be taken orally, and whether the components can be replaced by other traditional Chinese medicines. Thus, we can gradually determine which technical features are necessary, which are non-essential.
The following methods are generally used to technically extend the scope of protection:
? The method of elevation of the upper concept, such as the upper concept of the soup for oral dosage form;
? Equivalent substitution method, such as rhinoceros horn replaced by buffalo horn;
? Extension of the dosage range method, such as the extension of the component dosage to the conventional dosage range .
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