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On The Medicine Patent System And The Traditional Chinese Traditional Medicine Patent Protection In TRIPs Agreement

Posted on:2006-08-16Degree:MasterType:Thesis
Country:ChinaCandidate:J AnFull Text:PDF
GTID:2166360182957093Subject:Law
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As China has become a participating member state of WTO, it must follow a total of agreements, and at the same time, the TRIPs Agreement is also one that we must obey. Although there are a lot of deficiencies in the agreement itself, an international intellectual property protection system has been established based on the TRIPs Agreement with the supplement of the Doha Proclamation and other contracts. However, with the growingly fierce international competition, many patents for the Chinese traditional medicine are registered first by the foreign medicine enterprises in the following way, though China is the birthplace of the Chinese traditional medicine. The foreign medicine enterprises try every means to obtain the traditional ancient and secret recipe and then take up the domestic market and international market with the little altered ones. This phenomenon has been springing up in China, which makes the situation more and more severe of the intellectual property protection for the Chinese traditional medicine. Beginning with the characteristics of the Chinese traditional medicine itself, the thesis discusses the difficulties, characteristics and patent feasibility of the Chinese traditional medicine under the patent system of the TRIPs Agreement, which are mainly analyzed from the following two perspectives: the medicine patent objects and the essential conditions for authorizing the medicine patent regulated in the TRIPs Agreement. Then the thesis analyzes the present situation and problems of the Chinese traditional medicine patent protection system in our country. Finally, it puts forward the countermeasures of the Chinese traditional medicine patent protection. Chapter I makes an introduction to how the patent object is defined in the TRIPs Agreement and to the special requirements related with the medicine patent. It points out that a series of international treaties such as WTO regulations, etc have constitute a comparatively scientific and complete system of the intellectual property protection which all the member states must follow. Chapter II elaborates the particularity of the Chinese traditional medicine patent protection compared with other kinds of medicine patent protection. First, the modern research finds out that it is not successful to make the Chinese traditional medicine westernized. The western medicine emphasizes the influence of the external causes, so it pays attention to the effect of a single active chemical compound on a single target with the hope that the medicine can bring a quick cure. It mainly takes the way of aggressiveness and exclusiveness. However, the Chinese traditional medicine puts emphasis on the root cause of the disease or aims at treating the disease by looking into its root cause and symptoms. It emphasizes more the effect of the whole. It maintains that kinds of ingredients in the Chinese traditional medicine prescription can regulate the body in kinds of respects. It aims at activating internal causes of the organism, regulating the balance of the organism, and dispelling the disease or preserving one's health. Therefore, the Chinese traditional medicine and the western medicine are different products of different medical systems and cannot be replaced by each other. Second, the object of the Chinese traditional medicine patent protection is special. This is mainly shown by the fact that the effective ingredients of the Chinese traditional medicine are indefinite. As the patent protection object, the topic of techniques in the Chinese traditional medicine field also has its particularities. The most obvious one is that its ingredients with medical effect cannot be represented exactly by a limited number of technical parameters, just as the chemical compound does. The former patent may become the basic patent that is the research result with a higher level at any time. Chapter III analyzes the difficulties with the Chinese traditional medicine protection under the medicine patent system of the TRIPs Agreement. The modern system of intellectual property is set up on the basis of the development of the modern civilization and the achievement of the modern science and technology. As a derivative of the traditional medicine, Chinese traditional medicine is inconsistent with the modern intellectual property system, no matter in the theory, research and development, or in the production and application. There are such problems as lack of effective data, unclearly stated active components, and need for necessary clinical tests, etc.All of the above are the bottleneck problems that prevent Chinese traditional medicine from obtaining the patent in TRIPs rules. The first one is that the effective ingredients are unknown and that the protection object is limited. Because of the unclear ingredients and structure, the extracts cannot receive the material protection, but only can express its right by means of preparation. Therefore, the scope of the patent protection becomes more limited. The second one is that it cannot be applied to the industry and is short of practicability. In the sense of forms of prepared drugs and production method, pills, medicinal powder, medicinal extract, pellet, and decoction are almost concepts exclusive to China in the medicine field. This kind of forms of forms of prepared drugs and production method are not practical in industry because its manual operation. The third is the features of administering drugs for each individual. Unlike western medicine, Chinese traditional medicine is characterized by individualization usage. It takes an individual as single unity. Different Chinese traditional medicines will be prescribed for different patients with the same disease. Although Chinese traditional medicine can meet the needs of stability, repetition and reappearance, the curative effect cannot be proved, which makes Chinese traditional medicine unable to obtain patent at home, let alone abroad. Chapter IV illustrates that the Chinese traditional medicine protection is patent feasible. Although there are some difficulties in achieving this because of the unclear curative effect and medical ingredients, many cases have proved the fact that the modern research on the compound of the Chinese traditional medicine can meet the need to apply for the patent. That's because the Chinese traditional medicine can use technical words to describe what is the material with medical effect, and what is the medical effect of the traditional medicine. It can also prove that the formulation of the medicine is scientific, which makes preparation for obtaining the Chinese traditional medicine patent. Besides, let's take the history of aspirin applying for the patent for example. It shows that the unclearness of the curative effect mechanism of the Chinese traditional medicine will not prevent it from obtaining the patent. So it is known that the medicine whose mechanism of curative effect is not explained can be applied to industrial production, too.Chapter V makes a summery of the present situation of the Chinese traditional medicine patent protection in China, and then makes an analysis of the problems existing in the Chinese traditional medicine patent protection in our country. There is no patent legislation special for the Chinese traditional medicine in our country, and all the patent systems of the Chinese traditional medicine are established in the medicine patent. However, as the domestic medicine enterprises have a weak sense of Chinese traditional medicine patent protection for a long time and they still take the ways of "secrete recipe"and newly invented medicine as protection, the Chinese traditional medicine strongly depends on the protection of the administration, which is inconsistent with the TRIPs Agreement. At the same time, the present patent system in our country stems from the western countries so open system for applying for the patent cannot be adapted to the historical and pharmacological features of the Chinese traditional medicine. At present, the patent system of the Chinese traditional medicine is mostly similar to the patent way of the western medicine. Combined with the patent feasibility of the Chinese traditional medicine and the paten system of the TRIPs Agreement, Chapter V also suggests strengthening the Chinese traditional medicine patent protection from two perspectives. On the one hand, a patent system for the Chinese traditional medicine must be set up that is fit for the features of the Chinese traditional medicine. First, the "three natures"criteria of the Chinese traditional medicine patent must be adjusted. Since the traditional knowledge that the Chinese traditional medicine depends on comes from the Chinese ancient medical documents and it has been open to everybody, it is no longer "new"according to the examination principles of the modern patent law. It is suggested that the ancient recipe should be reused by means of the modern technology, and then considered as a new medical usage of a known material in order to adapt to the nature of novelty. As for the nature of creativity, we regard "not obvious but easy to see"as principle of judgment. The nature of practicality is judged by the fact whether the "active effect"adapts to the features of the Chinese traditional medicine itself. Only by establishing the "three natures"requirements that are suitable for the features of the Chinesetraditional medicine can we make the patent protect the Chinese traditional medicine and develop the system of the Chinese traditional medicine. Second, the crucial secret steps must be clarified. The present patent system of "public first, protection later"in our country makes it difficult to define the tort of the patent of the Chinese compound medicine in the Chinese traditional medicine application. Therefore, it is advised to allow the Chinese traditional medicine enterprises to apply for no recipe illustration procedure by reasons of secret recipe. The focus of work should be shifted to the comment on the pharmacological and clinical tests. Or we can define the technical scope of being public or left clearly by law. If so, as for those that are not forced public, the patent examination department can keep some data according to the reasonable requests of the applicant. If there are objections in the future, the patent review committee can examine and approve it secretly. Third, the patent can be applied for by taking the effective part of the Chinese traditional medicine as technical feature, which is consistent with the features of the Chinese traditional medicine and the present technical level. Therefore, it is probably feasible. On the other hand, some techniques to protect the Chinese traditional medicine by means of commercial secrets can be considered as supplement to the patent system. Then the problem can be solved that some ancient traditional prescriptions have been past the protection deadline in TRIPs Agreement. In this way, the Chinese traditional medicine as valuable as treasure can be passed on and developed.
Keywords/Search Tags:Traditional
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