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政大機構典藏 > 商學院 > 科技管理與智慧財產研究所 > 期刊論文 > Item 140.119/127999

Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/127999

Title:	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)
Authors:	陳秉訓 Chen, Ping-Hsun
Contributors:	科管智財所
Date:	2019-05
Issue Date:	2019-12-25 10:25:48 (UTC+8)
Abstract:	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.
Relation:	Brooklyn Journal of Corporate, Financial & Commercial Law, Vol.13, No.2, pp.395-416
Data Type:	article
Appears in Collections:	[科技管理與智慧財產研究所] 期刊論文

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