和你讲,这个法律很复杂

来源: 柠檬椰子汁 2017-05-12 11:54:15 [] [博客] [旧帖] [给我悄悄话] 本文已被阅读: 次 (2390 bytes)

这里面有三方,专利药品拥有者,FDA,平价药品制造者。30 month stay 就是指推迟FDA approval of ANDA status. 原文报导不正确。

http://www.finnegan.com/resources/articles/articlesdetail.aspx?news=dfef53ed-54e4-491a-802a-01becb1f47bb?

E. Automatic Injunction 
The 30-month stay (also referred to as an automatic injunction) of FDA-approval of ANDAs following a generic manufacturer's paragraph IV certification and the institution of a patent infringement action provides patent owners an opportunity to press their patent rights before the generic products enter the market. That is a valuable benefit to brand manufacturers because it prevents market share dilution by generic drug entry. The 30-month stay period begins when the patent owner receives notice from the ANDA-applicant regarding the paragraph IV certification.90 Moreover, the Hatch-Waxman Act authorizes a presiding judge to lengthen or shorten the stay if a party has failed to "reasonably cooperate in expediting the action."91 In a recent example of such a situation, the Federal Circuit affirmed a district court judge's decision to extend the 30-month stay because the generic manufacturer altered its proposed generic product late in the litigation.92

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