Traditional Chinese medicine patent internationalization four large block

ChenXueYu State food and drug supervision bureau south medicine economic research institute

China's traditional Chinese medicine to

        Our country is traditional Chinese medicine patent country, in recent years of patent application of traditional Chinese medicine (TCM) are among the world. However, China's patent in out of the country but faced with all kinds of embarrassment, the domestic traditional Chinese medicine patent international business is not high. In recent years, many "foreign Chinese medicine" with patent escort, in the international market has made very good performance, until 2012 has already formed the nearly $30 billion market scale. However, in the 30 billion market share, the Chinese medicine enterprises only 5%.

        Medicine enterprises in in the homeland gain of traditional Chinese medicine patent often faced in other countries to gain recognition dilemma. Although international legal environment, cultural differences, etc factors on traditional Chinese medicine patent internationalization process has a significant effect, but China's own traditional Chinese medicine patent system not perfect is the internationalization of traditional Chinese medicine patent the root cause of the slow. In recent years, the domestic experts and scholars on traditional Chinese medicine patent research mainly focus on patent examination rules, but the real influence Chinese medicine patent toward internationalization, in addition to the patent examination link besides, there are four large block.

        Supporting mechanism save defect

        One is the traditional Chinese medicine research and development mechanism lag. First of all, Chinese medicine industry in Chinese r&d investment too little. At present domestic pharmaceutical enterprise r&d investment, less innovation ability is weak, this is China's pharmaceutical industry with the key problems for the development of deep.

        According to economic observation network 2011 statistics, Chinese traditional medicine enterprises in science and technology, research and development into a few, even if there is, its input also accounted for only sales revenue of 3% ~ 5%, the domestic research and development of traditional Chinese medicine the overall investment is still as Europe and the United States a big enterprise's scientific research investment. Due to long time has not been able to break through the industrialization of some key technology led to most of the enterprise can't become competitive pharmaceutical research and development main body, and have restricted the development of the medicine industry. Therefore, in the traditional Chinese medicine product patent and even the entire field of traditional Chinese medicine industry, patent law should actively guide the enterprise and individual change the thought, in modern scientific research ideas and technology guidance will be more resources into traditional Chinese medicine in the modern development.

        Secondly, for clinical link to ignore. Our country patent system not very good to motivate Chinese medicine technology innovation is one of the important reasons for traditional medicine technical innovation relies mainly on the clinical application and the modern science and technology. Traditional Chinese medicine product patent chain should include animal and plant resources, thousands of years of clinical experience and traditional resources, doctors (including personal or specific groups) to create and personal or medical organization for product practical demonstration, apply for a patent, pharmaceutical enterprise industrialized production and commercial circulation six links.

        Only in the patent law safeguard the interests of the pharmaceutical enterprises and ignore to clinical application of the doctor's incentives, incentives for the traditional Chinese medicine product technology of continuous innovation is far from enough.

        The second is Chinese traditional medicine database not perfect. Our country has set up "the Chinese drug patent database". So far, the database of traditional Chinese medicine data has exceeded 70000 bars, and support formula similarity retrieval, and other functions, to promote the traditional Chinese medicine patent research level, and improve the quality of traditional Chinese medicine patent license is of great significance.

        However this database still need to improve. Drug patent database existence deficiency mainly lies in: first, the TCM documentation level is very high, the database only collect the patent literature, and for the patent literature of traditional Chinese medicine products and not included, and its content is far from enough. Secondly, many ancestral secret recipe, the doctor to the patient's clinical prescription and other products have been through the use of and other public way, these traditional Chinese medicine products also should not ignore.

        Protection thought have a misunderstanding

        A technical scheme can only in the patent claims and the specifications clearly and accurately, and fully demonstrated its own practical, novelty and creativity, are able to obtain patent, traditional Chinese medicine products is no exception.

        There are many scholars think to establish conform to the technical characteristics of traditional Chinese medicine of traditional Chinese medicine patentability standard shall be practiced is lower than the standard of chemical drug patents, the holder of the domestic easier access to patents. In such a patent protection of misleading ideas, many low technical content of traditional Chinese medicine patent products won the patent authorization. But for many years of patent licensing quality and medicine industry arrested development of proof: no science to reduce patent admittance threshold and can't realize the better support traditional Chinese medicine industry, simply make patent easier for people to obtain and unable to form a good innovation incentive. It was weakened the traditional Chinese medicine patent especially Chinese medicine product patent in the review process, the traditional Chinese medicine product modern medical evaluation of urgency, and ignore the patent law shall reflect the basic requirement of the modernization of traditional Chinese medicine.

        Traditional Chinese medicine product technical thought, such as a problem really is more difficult to express the content, because of this, even in the Chinese prescription drug patent protection high levels of Japan, South Korea and other countries, they in protecting Chinese prescription medicine thought is more conservative. In Japan, for example, Japan, the Chinese medicine research and development is the application of advanced technology, from the drug ingredients, such as a basic element set out, to the traditional Chinese medicine compatibility principle analysis, argumentation and innovation. Japan, the Chinese medicine product patent protection range of ancient China is limited to 210 Chinese prescription, and protection way is not directly protect the product itself, but the protection from the extract ingredients in research and development of new products, such as before aroused widespread concern "JiuXinWan" is the case.

        In fact, the Patent Office shall only to have full demonstration, mature technology, can form the technical standard of traditional Chinese medicine product patent, or to the Chinese traditional medicine industry is concerned will only spoil things by excessive enthusiasm.

        The literature writing level is low

        The scope of patent protection from the claims of the claim, and the effectiveness of the claim and lies in the instruction of support, therefore, the patent literature writing is the basic part of patent protection. However, in practice, to write a patent work is intellectual property industry link of profit the lowest link, at the same time is also the most easy problems link.

        In guangdong province as an example, it is in the income of the highest institution, patent agents need to write about a month 20 pieces of the invention or utility model to get 10000 yuan monthly salary. If the ratio is low, achieve all monthly salary even need to double the number of. Work every month 22 days, the average one day a even one day two. Such a high workload, how to ensure the quality? For a long time, lawmakers, practice boundary and theoretical circles on the traditional Chinese medicine product patent research not thorough, practice a lot of argument not scientific patent literature can also through the patent examination, make domestic patent literature writing quality request is not high also. In addition, due to the lack of TCM products to other countries patent license practice understanding, together with application of international patent patent few in number, so many patent people exist in accordance with past practice temporization abuse.

        At present domestic patent literature writing practice has many problems. To claim range, for example, claims the range is the description shall focus on discussion of the problem, usually by the technology characteristics of the express claim this range, and technical characteristics reflect that the technical scheme of novelty and creative place. However, many patent literature because we can not correctly through the full expression of their patentability conditions, difficult to explore the scope of protection of the rationality, which led to the scope of claims too wide or too narrow. Too wide of the claim, sometimes difficult to justify, easy to cause the patent because do not have repeatable implementation of sex and difficult to through the examination and approval. And too narrow claim, lead to slightly change can jump out of the scope of protection, the product against the protection of patent.

        A high level of patent literature writing, in the right request both should not be too broad also should not be too narrow. Due to the patent literature apply for international patent, can only be translation, not beyond the scope of the original text, if in the beginning of the patent literature writing is existence question, even if the patent to obtain domestic authorization, once tried to apply for international patent will be confronted with various question.

        International authorized less practice

        In recent years, many "foreign Chinese medicine" in the patent law under escort quickly occupied the international and domestic market, it makes a lot of envy of the domestic Chinese medicine professionals and scholars believe that, Chinese traditional medicine already more and more get international recognition, traditional Chinese medicine patent internationalization of the door is already open, but with their own patent to foreign application but often eat "given a cold shoulder". In fact, the domestic enterprise to the international patent licensing practice understanding is very limited, they did not find that the United States, France and Japan and other countries in essence is still western medicine according to the standard of the reality of the review.

        In traditional Chinese medicine patent quantity and high quality of the Japanese, for example, most of its Chinese prescription preparation have clear component standard, pharmacological research and clinical efficacy data, in the production process are into the modern new technology. Their study habits from concrete analysis all kinds of traditional Chinese medicine herbs of the effective components and pharmacological action of comprehensive research again after all kinds of medicinal materials of the combined action. Also because of this, the can in Chinese herbal medicine drugs in the pharmacological properties, quality control standards, etc to realize high level of standardization, even for those who structure, effective ingredients of traditional Chinese medicine drugs is not clear, the requirement to provide long-term clinical and experimental data to demonstrate the Chinese medicine to disease is the therapy effect too. America's "ginseng royal jelly" patent, South Korea "bezoar sedative pill" patent, and sell like hot cakes on the market of German and French ginkgo biloba preparation patent, Japan "JiuXinDan" patent in traditional Chinese medicine is based on the result of innovation.

        Thus it can be seen, foreign in the patent on practice, essentially still adhering to the idea of the western medicine to judge whether TCM products with patentability. Therefore, if you want to make our country patent Chinese medicine more easily to internationalization, the use of modern medical reform traditional Chinese medicine is the inevitable choice.

        Patent supporting mechanism of traditional Chinese medicine and the lack of influence of patent research for power, and patent protection ideological misunderstanding caused domestic traditional Chinese medicine patent licensing a drop in the quality of, the patent literature writing industry of a low level on the whole situation of Chinese traditional medicine is difficult to guarantee the patent product has sufficient legal basis, for other national patent practice lack of thorough understanding is led to the traditional Chinese medicine patent practical realm filled with the blundering mood. Domestic patent Chinese medicine practice circle should not continue to simply by China's thinking to understand Chinese medicine patent, more want to learn from the perspective of modern medicine to interpretation and reform traditional Chinese medicine patent. Only in this way, the internationalization of traditional Chinese medicine patent can be more smoothly.