Please use this identifier to cite or link to this item:
https://ah.lib.nccu.edu.tw/handle/140.119/127999
DC Field | Value | Language |
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dc.contributor | 科管智財所 | |
dc.creator | 陳秉訓 | |
dc.creator | Chen, Ping-Hsun | |
dc.date | 2019-05 | |
dc.date.accessioned | 2019-12-25T02:25:48Z | - |
dc.date.available | 2019-12-25T02:25:48Z | - |
dc.date.issued | 2019-12-25T02:25:48Z | - |
dc.identifier.uri | http://nccur.lib.nccu.edu.tw/handle/140.119/127999 | - |
dc.description.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. | |
dc.format.extent | 396044 bytes | - |
dc.format.mimetype | application/pdf | - |
dc.relation | Brooklyn Journal of Corporate, Financial & Commercial Law, Vol.13, No.2, pp.395-416 | |
dc.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) | |
dc.type | article | |
item.cerifentitytype | Publications | - |
item.fulltext | With Fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.grantfulltext | open | - |
item.openairetype | article | - |
Appears in Collections: | 期刊論文 |
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