中药在美国的专利申请与专利适格性探讨

Discussion on Chinese Medicines' Patent Application and Eligibility in the United States

目的:为中药在美国通过专利申请提供参考。方法:阐述美国对专利适格性的要求,分析近年来2起具有较大影响的专利案("Mayo案""Myriad案")与"专利适格性指南"对中药在美国申请专利的影响,并结合中药申请专利的现状提出建议。结果与结论:美国的专利适格性,要求专利保护客体在专利法规定的可授予专利权的客体范围内。通过对"Mayo案""Myriad案"与"专利适格性指南"的分析表明,中药相关专利要想在美国通过专利申请,必须明确指出该发明与自然规律、天然产物的显著区别,重点突出其技术属性,且不同类型的发明采用不同的专利申请思路,以确保其具有专利适格性。目前,我国在美国的中药专利数量较少,企业应走出"中药不具有专利适格性"这一认识误区。建议在申请有关中药专利时,应避免将第一独立权利要求写得过于具体,同时对药材进行更加全面的申请,加强对经典中药方剂的专利保护,突出中药的专利适格性。

OBJECTIVE：To provide reference for the approval of Chinese medicines＇ patent application in the United States.METHODS：The requirements of patent eligibility in the United States were interpreted;two important patent cases（＂Mayo case＂and＂Myriad case＂）were analyzed in recent years,and the effects of＂patent eligibility guideline＂on Chinese medicines＇ patent application in the United States were also analyzed;the suggestions were put forward according to the situation of Chinese medicines＇ patent application.RESULTS CONCLUSIONS：Patent eligibility required that patent protection objects should be included in object range which could be vested patent right stated in patent law.The analysis of＂Mayo case＂＂Myriad case＂and patent eligibility guideline indicated that if related Chinese medicines＇ patent was to obtain patent approval in the United States,notable difference between the medicine and natural products as well as the order of nature must be clearly stated;technical attributes should be emphasized,and different patent application ideas were adopted for different types of invention in order to guarantee patent eligibility.At present,small number of Chinese medicine＇s patent in the United States come from China,and relevant enterprises should liberate themselves from the misperception that Chinese medicines do not hold patent eligibility.Hence,it is suggest that the first claim in the patent should not be too definite in Chinese medicines＇ patent application,afford more comprehensive application,strengthen patent protection of classic Chinese medicine recipe and stress patent eligibility.