The Study On American Drug Patent Linkage Regulations And Reforms In China

After implementing drug patent linkage regulations,the U.S.has not only surpassed the E.U.in the research and development of brand drugs,but has also become a world pharmaceutical powerhouse.As well as U.S.generic competition facilitated by the 1984 Hatch Waxman Act,accounting for 90%of the global generic drug market share.Since 2015,Chinese government has already issued a series of policies on pharmaceutical reform and intellectual property protection,all of which have proposed the establishment of drug patent linkage regulations.Especially recently in the phase I of economic and trade agreement signed with the U.S.,it emphasizes the implementation of an effective mechanism for the early resolution of patent disputes.Therefore,as first Chinese generic company challenged patents successfully in U.S.and the pharmaceutical industry has developed rapidly,it’s necessary to explore how to create drug patent linkage regulations in accordance with China’s national conditions.This dissertation first describes what’s the US drug patent link regulations including the orange book,patent certification,the 30-month stay and market exclusivity,and then give suggestions on the applicable object and statutory measures of Chinese drug patent linkage regulations after analyzing the situation of Chinese pharmaceutical industry and referring to the experience of administering drug patent linkage regulations in U.S.through comparative research methods,empirical research methods,and historical research methods.At the same time the article will explain the complicated trial mode when a patent dispute enters both civil procedure and administrative litigation,so propose points involving the preparation time for patentee to sue and detailed rules for Paragraph Ⅳ,etc.In addition,the difference between drugs and biological products is introduced,and the author believes that at present Chinese drug patent link regulations should be applied only for drugs,temporarily excluding biological products.The establishment of patent linkage regulations is not only a response to external pressures,but also an inherent demand for further growth,innovation and progress for affordable medicines.These regulations aim to strike a balance between innovation and timely access.It rewards appropriate market exclusivities for innovators to recoup their investment and provides incentives for research and development for new treatment options.Also it is expected to improve the phenomenon that brand companies thwart generic competition by patents evergreening and create an opportunity to join generic companies and other stakeholders together for overcoming patentee’s strategies.In the future Chinese drug patent linkage regulations will promote the public health and ensure that lower-cost alternative products benefit patients so that citizens can have right to access safe and effective drugs equally as other people in developed countries.