Wednesday, May 27, 2015 10:50:40 AM
<<ORDER The court invites the Attorney General to present the views of the United States as amicus curiae on the statutory interpretation issues raised in these cases within 45 days of this Order, including the meaning of the statute’s “submission” and “solely” language and also including whether performing a process and retaining process records after initial FDA approval for the purposes of demonstrating compliance with FDA requirements is protected by the safe harbor of § 271(e)(1) if that activity also has a commercial purpose.>>
Will the SG not have to visit the original Hatch Waxman act, its language and its intent, to provide clarity here? The recorded comments by Judge Raider (a minority opinion unfortunately), indicted something to the effect that "I was there" for the construction of the HW act and the intent clearly was not honored by the previous CAFC injunction etc. Will the SG brief be posted and where? Thanks and regards, bp
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