Problem description:
What are the current situation, problems, measures and significance of the protection of related traditional Chinese medicines?
Analysis:
Present situation and thinking of patent application for traditional Chinese medicine in China
Shen Liling bird
According to incomplete statistics, in recent years, about 90% patent applications for traditional Chinese medicine were filed by individuals, and applications from pharmaceutical factories, universities and scientific research institutes accounted for about 10%. The authorization rate of individual application is about 30%, and the authorization rate of pharmaceutical companies, universities and research institutes is about 70%.
After the patent law of our country opened the patent application for drugs in 1993, the number of Chinese medicine applications in that year reached about 1700, which promoted the innovation of Chinese medicine to some extent. In recent ten years, patents of traditional Chinese medicine have gone through the stages of substantial growth, significant decline and gradual recovery. The author will make the following analysis and thinking on the current situation of patent application for traditional Chinese medicine.
Characteristics and existing problems of patent application for traditional Chinese medicine
First, patent applicants are mostly individuals. According to incomplete statistics, in recent years, about 90% of Chinese medicine applications are individual applications, and pharmaceutical factories, universities and scientific research institutes account for about 10%. The authorization rate of individual application is about 30%, and the authorization rate of pharmaceutical companies, universities and research institutes is about 70%. Because the applicants are mostly individuals, there are often only formulas in the application, and there are neither animal tests nor clinical observation reports. It can be said that the applicant submitted an unfinished invention, which led to the application not being approved. Although these applications have not been patented, their technical contents have been made public, which is unfavorable to the applicants. But also to the Chinese medicine industry in China. Because these technical contents can be retrieved all over the world, it has virtually caused the "loss" of traditional Chinese medicine information resources.
Second, the invention is mostly in compound preparations, and there are relatively few applications involving the extraction and purification of effective components of traditional Chinese medicine, especially patent applications for extracting effective components into pure compounds. However, the latter patent application is of greater value. Especially after joining WTO, it is particularly prominent in the face of the impact of foreign drugs and technical monopoly. At the same time, the extraction of pure pharmaceutical compounds to prepare drugs is also beneficial for Chinese medicine to go global. Because pure compounds avoid the problems of heavy metals and quality control in Chinese medicine products, which are the main factors that hinder Chinese medicine products from going global.
Third, the proportion of patent application agents is not high, and few of these agents have a professional background in traditional Chinese medicine. Therefore, in the process of writing application documents, the names of drugs used are often confused, some of which can be used as a proper name, several different names, and some even local common names, which have never been recorded in public publications. Moreover, the applicant can't prove that the raw materials with this name are in the public state before the application date, which leads to the technical scheme of the application being unable to be implemented. This kind of patent application that cannot be authorized because of the drug name problem also accounts for a certain proportion.
Thoughts and suggestions on patent application of traditional Chinese medicine
The current situation reminds us that pharmaceutical companies, medical institutions with scientific research capabilities, universities and scientific research units all need to enhance their awareness of patent protection. Because these units have strong scientific research ability and economic strength, it is easier to develop high-level patented Chinese medicine products. If there is no patent protection, the products will be copied after listing and the economic losses will be very heavy. Only by putting these Chinese medicine products under patent protection can we better reflect the value of these products, and at the same time, we can also reflect the advantages of patented products, that is, we can prevent others from manufacturing, using, selling, promising to sell and importing the patented products for the purpose of production and operation. At the same time, the price of patented products can be higher than that of generic products. In this way, on the one hand, the patent system can really play its legal protection role in the field of Chinese medicine, on the other hand, it can encourage the development of high-level Chinese medicine products, thus entering a virtuous circle.
(1) Time of patent application
Because China implements the first application system, that is to say, if two or more applicants apply for a patent for the same invention-creation, the patent right will be granted to the applicant who applied first. Therefore, the applicant should apply for a patent as soon as possible. On the other hand, since the protection period of invention patents, including medicines, is 20 years from the date of application, the applicant should choose the best application time according to his own actual situation. Generally speaking, you can apply for a patent after making a conclusion about the curative effect, even before the clinic. The reason is that the patent protection is a technical scheme with three characteristics (practicality, novelty and creativity), which meets the necessary conditions for patent application after the conclusion of curative effect, and does not have to wait until clinical trials or even new drugs are approved before applying. Moreover, applying in advance can also avoid the possibility of losing novelty when the technical scheme is made public in the process of new drug approval and announcement.
(2) Writing of application documents
When applying for a pharmaceutical patent, the new pharmaceutical composition or the specific medical use, pharmacological efficacy, effective dosage and application method of the drug shall be disclosed in the specification, and data sufficient to prove that the technical scheme of the invention can achieve the technical problems or effects expected by the technicians in this field shall be provided. The effective amount, method of use or preparation method should be disclosed to the extent that those skilled in the art can implement it. Applicants should pay special attention to this point to avoid the application being rejected due to insufficient disclosure.
(3) the contents of the patent application
At present, there are relatively few patent applications for the extraction and purification of effective components of traditional Chinese medicine, especially for the compounds of effective components of traditional Chinese medicine. On the one hand, the applicant should actively study and protect its technical scheme; On the other hand, more effective forms of protection should be taken as far as possible. Product patents have a wide range of protection, including the right to prohibit others from manufacturing, using, selling, promising to sell and importing their patented products for the purpose of production and operation. No matter how this behavior is prepared and used, it must be approved by the patentee. Therefore, the form of product patent protection should be adopted as far as possible. However, the protection of some patents is sometimes relatively strong. For example, it is found for the first time that a Chinese herbal medicine has a new medical use for treating a certain disease, which can be protected by using a patent, because the scope of protection of this patent claim is also very wide, and the applicant should pay attention to it.
Traditional Chinese medicine is a unique resource in China, and its industry has always occupied an important position in China's national economy. With China's entry into the World Trade Organization, patents will play an increasingly important role in the protection of traditional Chinese medicine. How to give full play to the role of patent system in the protection of traditional Chinese medicine will be a problem that our colleagues engaged in patent and traditional Chinese medicine face and need to think about.
Under the current situation, improving the awareness of intellectual property protection of TCM technicians is a problem that the whole society should pay attention to.