Browsing by Author "Lee, Pin-Shen"

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Inter Partes Review: Patent Killer No More?
(2019-07-01)
Chen, Feng-Chi
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Lee, Pin-Shen
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科技法律學院
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College of Law
Inter Partes review (IPR) can efficiently invalidate drug patents and potentially convey strategic advantages to follow-on drug makers. However, recent changes in the IPR system foretell a tectonic shift in the landscape. Here we summarize these major changes and discuss the implications for the biopharmaceutical community.
Interactions between Inter Partes Review and Hatch-Waxman Litigations
(2019-01-01)
Chen, Feng-Chi
;
Lee, Pin-Shen
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Huang, Yun-Yu
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Wu, Huang-Chi
;
Lin, Hsuan-Yu
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.