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 |