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dc.contributor.authorChen, Feng-Chien_US
dc.contributor.authorLee, Pin-Shenen_US
dc.contributor.authorHuang, Yun-Yuen_US
dc.contributor.authorWu, Huang-Chien_US
dc.contributor.authorLin, Hsuan-Yuen_US
dc.date.accessioned2020-02-02T23:55:35Z-
dc.date.available2020-02-02T23:55:35Z-
dc.date.issued2019-01-01en_US
dc.identifier.isbn978-1-7281-1462-0en_US
dc.identifier.urihttp://hdl.handle.net/11536/153692-
dc.description.abstractGeneric 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.en_US
dc.language.isoen_USen_US
dc.subjectInter Partes Reviewen_US
dc.subjectHatch-Waxman Acten_US
dc.subjectgeneric drugen_US
dc.subjectpatent linkageen_US
dc.titleInteractions between Inter Partes Review and Hatch-Waxman Litigationsen_US
dc.typeProceedings Paperen_US
dc.identifier.journal2019 16TH IEEE INTERNATIONAL CONFERENCE ON COMPUTATIONAL INTELLIGENCE IN BIOINFORMATICS AND COMPUTATIONAL BIOLOGY - CIBCB 2019en_US
dc.citation.spage352en_US
dc.citation.epage355en_US
dc.contributor.department科技法律學院zh_TW
dc.contributor.departmentCollege of Lawen_US
dc.identifier.wosnumberWOS:000502841000052en_US
dc.citation.woscount0en_US
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