這裏麵有三方,專利藥品擁有者,FDA,平價藥品製造者。30 month stay 就是指推遲FDA approval of ANDA status. 原文報導不正確。
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