國家衛生研究院 NHRI:Item 3990099045/12174
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    题名: Interactions between Inter Partes Review and Hatch-Waxman Litigations
    作者: Chen, FC;Lee, PS;Huang, YY;Wu, HC;Lin, HY
    贡献者: Institute of Population Health Sciences
    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.
    日期: 2019-08-08
    關聯: 16th IEEE Conference on Computational Intelligence in Bioinformatics and Computational Biology, CIBCB 2019. 2019 Aug 8:352-355.
    Link to: http://dx.doi.org/10.1109/CIBCB.2019.8791240
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000502841000052
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85071414143
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