Hui Yuk Fung
University of Houston Law Center, USA.
Ann Health Law. 2003 Summer;12(2):325-40, table of contents.
In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui discusses the contents of the proposed regulations and provides an analysis of the proposed rule's legal authority, implications on patent rights, and impact on the pharmaceutical industry.
为了堵住仿制药审批程序中的漏洞，即品牌药专利持有人仅通过技术手段就能拖延或挫败仿制药申请，美国食品药品监督管理局（FDA）最近提议修改其规定。这些提议影响新药申请的专利列名要求，以及在专利侵权诉讼情况下仿制药申请可能被搁置的时间长度。通过修改规则，FDA预计仿制药的可及性将会提高，最终将降低药品成本。Hui女士讨论了拟议法规的内容，并对拟议规则的法律权威、对专利权的影响以及对制药行业的影响进行了分析。
