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題名 A Brand-Name Drug Company May Violate Section Two of the Sherman Act by Mislabeling a Submitted Patent in the Orange Book: An Implication from In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017)
作者 陳秉訓
Chen, Ping-Hsun
貢獻者 科管智財所
日期 2019-05
上傳時間 25-Dec-2019 10:25:48 (UTC+8)
摘要 The Hatch-Waxman Act encourages generic drug companies to submit an abbreviated new drug application (“ANDA”) for a generic version of a drug approved by the U.S. Food and Drug Administration (“FDA”). Nevertheless, a mechanism exists for a brand-name drug company to adjudicate a patent infringement dispute before the FDA approves an ANDA. The mechanism includes the regulatory scheme of patent information submission implemented by the FDA. 21 U.S.C. § 355(b)(1) requires that patent information be correct. False patent information destroys the objectives of the Hatch-Waxman Act. In re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), may demonstrate a new formoffalsepatentinformation,becausethedefendanttheremislabeledthe disputedpatents asdrugproductpatents ratherthanmethod-of-usepatents. The mislabeling caused one generic drug company not to use a Section viii statement to speed up approval of its ANDA. As a result of the mislabeling, the marketing of generic drugs was delayed, and patients were forced to pay monopoly prices for their drugs. This Article argues that such mislabeling violates Section 2 of the Sherman Act, which criminalizes monopolizationachievedthroughanticompetitiveconduct.
關聯 Brooklyn Journal of Corporate, Financial & Commercial Law, Vol.13, No.2, pp.395-416
資料類型 article
dc.contributor 科管智財所
dc.creator (作者) 陳秉訓
dc.creator (作者) Chen, Ping-Hsun
dc.date (日期) 2019-05
dc.date.accessioned 25-Dec-2019 10:25:48 (UTC+8)-
dc.date.available 25-Dec-2019 10:25:48 (UTC+8)-
dc.date.issued (上傳時間) 25-Dec-2019 10:25:48 (UTC+8)-
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/127999-
dc.description.abstract (摘要) The Hatch-Waxman Act encourages generic drug companies to submit an abbreviated new drug application (“ANDA”) for a generic version of a drug approved by the U.S. Food and Drug Administration (“FDA”). Nevertheless, a mechanism exists for a brand-name drug company to adjudicate a patent infringement dispute before the FDA approves an ANDA. The mechanism includes the regulatory scheme of patent information submission implemented by the FDA. 21 U.S.C. § 355(b)(1) requires that patent information be correct. False patent information destroys the objectives of the Hatch-Waxman Act. In re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), may demonstrate a new formoffalsepatentinformation,becausethedefendanttheremislabeledthe disputedpatents asdrugproductpatents ratherthanmethod-of-usepatents. The mislabeling caused one generic drug company not to use a Section viii statement to speed up approval of its ANDA. As a result of the mislabeling, the marketing of generic drugs was delayed, and patients were forced to pay monopoly prices for their drugs. This Article argues that such mislabeling violates Section 2 of the Sherman Act, which criminalizes monopolizationachievedthroughanticompetitiveconduct.
dc.format.extent 396044 bytes-
dc.format.mimetype application/pdf-
dc.relation (關聯) Brooklyn Journal of Corporate, Financial & Commercial Law, Vol.13, No.2, pp.395-416
dc.title (題名) A Brand-Name Drug Company May Violate Section Two of the Sherman Act by Mislabeling a Submitted Patent in the Orange Book: An Implication from In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017)
dc.type (資料類型) article