標題: Interactions between Inter Partes Review and Hatch-Waxman Litigations
作者: Chen, Feng-Chi
Lee, Pin-Shen
Huang, Yun-Yu
Wu, Huang-Chi
Lin, Hsuan-Yu
科技法律學院
College of Law
關鍵字: Inter Partes Review;Hatch-Waxman Act;generic drug;patent linkage
公開日期: 1-一月-2019
摘要: Generic drug development in the United States is governed by the Hatch-Waxman Act (HWA), which sets forth the "patent linkage" system requiring resolution of patent disputes before a generic drug can be approved for marketing. The emergence of Inter Partes Review (IPR), an effective administrative proceeding to weed out low-quality patents, is believed by some to have endangered the HWA balance between brand-name and generic drug makers. Here we describe an empirical analysis profiling the influences of IPR on patent linkage. Our results indicate that fewer than 10% of the HWA-litigated patents are subject to parallel IPR challenges. Importantly, IPR yields a slightly higher claim invalidation rate but a much lower settlement rate than court litigations, which may not benefit generic drug makers. Furthermore, IPR is employed by non-first generic drug makers, presumably to break into the market occupied by brand-name and the first generic makers. Overall, IPR seems not to play a dominant role, but to serve strategic functions in HWA disputes.
URI: http://hdl.handle.net/11536/153692
ISBN: 978-1-7281-1462-0
期刊: 2019 16TH IEEE INTERNATIONAL CONFERENCE ON COMPUTATIONAL INTELLIGENCE IN BIOINFORMATICS AND COMPUTATIONAL BIOLOGY - CIBCB 2019
起始頁: 352
結束頁: 355
顯示於類別:會議論文