摘要
美国1984年颁布Hatch-Waxman法案迄今已近40年,仿制药在此期间获得了巨大发展,说明促进仿制药发展具有重要意义。Hatch-Waxman法案颇为重要,但其并非美国仿制药发展机制的全貌。美国仿制药发展机制在该法案之后并非固守原状,而是持续在诸多方面进行动态调整,包括打击简略新药申请程序(ANDA)中的不当行为以规范ANDA,大幅提高ANDA的审批时效,建立仿制药替换机制,建立当事人间复审(IPR)和授权后复审(PGR)这2种专利无效宣告程序并修改橙皮书、独占期、遏制期等进而完善专利链接制度,建立药品价格谈判制度及药品通货膨胀惩罚制度。我国应缩短药品专利复审和无效宣告审查的期限,首仿药独占期制度应与反垄断相协调,建立使用者付费制度但可豁免创新药,药品审批审评机制以及专利法、反垄断法等各领域需要共同持续跟踪改进相关制度。
It has been nearly 40 years since the Hatch-Waxman Act was enacted in 1984.Generics have developed tremendously during this period,which shows the importance of promoting the development of generics.The Hatch-Waxman Act is important,but it is not the whole story of how generics develop in the United States.After the promulgate of Hatch-Waxman Act,the development mechanism of generic drugs in the United States did not stick to the original state,but continuously made dynamic adjustments in many aspects,including combating misconduct in abbreviated new drug application(ANDA)to standardize the procedures,greatly improving the time efficiency for ANDA,establishing a generic drug replacement mechanism,establishing two patent invalidation procedures[inter parte review(IPR)and post grant review(PGR)],revising the Orange Book,exclusivity period,containment period,etc.to improve patent links system,and establishing a drug price negotiation system and a drug inflation penalty system.China should shorten the period of drug patent reexamination and invalidation examination.The first generic drug exclusivity period system should be coordinated with anti-monopoly.A user payment system should be established in China,but innovative drugs can be exempted.The drug approval and review mechanism,patent law,anti-monopoly law and other fields need to work together to continuously track and improve relevant systems.
作者
彭运朋
徐毅华
PENG Yun-peng;XU Yi-hua(Faculty of Law,Macao University of Science and Technology,Macao 999078,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2023年第10期977-984,共8页
Chinese Journal of New Drugs
