专利视角下的中药国际化与标准化战略

【作者】 许超；

【导师】 苏喆；

【作者基本信息】 扬州大学 ， 法律， 2014， 硕士

【摘要】 随着人们对化学药物不良反应和抗药性认识的不断加深,再加上近年来“天然药物”“健康保健”等概念热潮的兴起,我国传统中药也逐渐受到国际市场的关注和认可。然而,与中药在全球范围内不断升温的趋势相比,我国的中药产业却令人担忧：我国中药的销量远比不上日韩等国,一些发达国家更是依仗其先进的科技肆无忌惮地掠夺我国传统的中药资源,制造中药产品,然后套上专利的外衣,远销各国,获取独占利益。2003年,我国就提出了“人才、专利和技术标准”的战略构想,以应对加入WTO后所要面对的机遇和挑战,提升我国国际竞争力和创新能力。我国是中药的发源地,有着及其丰富的中药知识资源,中药产业也是我国少数几个拥有独立自主知识产权的产业,本该是我国最具竞争优势的产业,是我们占据世界医药市场的一件利器,可为何会落得如此境地?究其原因,主要是以下几个方面：一是现行的专利制度是起源于西方,是在西方的科技文化和逻辑思维框架下建立的,专利制度对化学药品可以起到很好的保护和促进作用,而中药几乎可以说是中国的“特产”,中药与化学药分属两个不同的医学理论体系,因此专利制度对于中药的保护就显得有不够到位;二是我国知识产权保护意识淡薄,再加上对国际专利申请的程序不熟悉,导致我国中药技术对外申请积极性不高,从而使得我国好多拥有自主产权的中药资源,被他国抢先注册,最惨痛的经历莫过于青蒿素事件,每年损失近亿美元。据统计,我国中药在国外申请专利的数量不足国外在我国中请专利的十分之一；三是我国中药标准与国际相关中药标准还有很大的差距,尤其中药的质量标准,其对于重金属、农药残留物等含量规定上限远低于西方发达国家,很难得到国际社会的认可。其围绕中药建立的相关标准也是在参照化学药物的管理模式建立,没有考虑到中药的特点。本文在对中药行业存在问题分析的基础上和借鉴一些高新产业及国际跨国公司发展战略的成功经验,为中药产业的发展捉出一个思路：中药技术专利化—中药专利国际化—中药专利标准化,希望能对我国的中药行业早日实现国际化有借鉴之用。更多还原

【Abstract】 As people have deepening their understanding about chemical drug adverse reactions and drug resistance, accompany with the booming of "natural medicine","health care" and other concepts recently. China’s traditional herb therapies are capturing more and more attentions and obtained many recognitions globally. However, comparing with the continually flourishing of China herb therapies, more disconcerting is the situation that traditional herb pharmaceutical industry struggling with today. First of all, the sales of traditional Chinese medicine (TCM) we made is far less compare with the sales of either Japan or Korea; secondly, some of the developed countries relying on certain advanced technologies indulge in plundering china’s traditional herb resources, manufacturing Chinese herb products, grabbing exclusive profits by selling those product globally in the name of patent.In2003, China put forward the "talent, patents and technical standards," the strategic vision to address the opportunities and challenges to face after joining the WTO, and to enhance international competitiveness and innovation capacity in China. Our country is the birthplace of traditional Chinese medicine, has a wealth of knowledge and resources. Traditional Chinese medicine industry is also one of the few industries, which have independent intellectual property rights; it is suppose to be china’s most competitive industry, a powerful core competence to help the industry occupy a significant share in the world pharmaceutical market. But. how could it stuck in such a situation? It caused by many reasons, mainly the following aspects:first, the current patent system was originated in the West, is established in western style logical thinking framework and deeply affected by western cultures as well as sciences and technologies. The existed patent system performs well in protecting chemicals drug products, but not exactly for TCM. TCM almost could be considered as China’s "specialty", herbal and chemical drugs belong to two different theoretical systems of medicine, so the patent system appears less effective. Second, weak awareness of intellectual property protection plus less familiar with the "Paris Convention", PCT, PPH and other international patent application procedures directly leading the industry players are not enthusiastic in applying for patent protection and many independent property rights of traditional Chinese medicine resources were registered by other countries, the most painful experience is Artemisinin events, which causes a loss of near hundred million dollars annually. According to statistics, the number of patent applications Chinese made aboard is less than ten percent of the number of foreign made in China. Third, there is a big gap between traditional Chinese medicine standards and international standards related to traditional Chinese medicine, especially in traditional Chinese medicine quality standards, which for heavy metals. content of pesticide residues and other regulations limit is much lower than Western countries.it is difficult to be recognized by the international community. Its built around a traditional Chinese medicine is also in reference to the relevant standard chemicals management model is built, without taking into account the characteristics of Chinese medicine.This paper analyzed some of the problems china traditional herb pharmaceutical has, and draw lessons from the successful experiences that some high-tech industries and multinational companies had in their strategy development. Base on these analyses, the work finally identified an effective strategy road for Chinese traditional herb pharmaceutical industry that is:Chinese technology patents-patents internationalization of Chinese medicine-Chinese patent standardization. The author believes this comprehensive develop strategy will be great help in realizing of the internationalization of Chinese medicine industry.更多还原