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Re: iwfal post# 10041

Wednesday, 11/21/2012 4:17:29 AM

Wednesday, November 21, 2012 4:17:29 AM

Post# of 20689
Further data on Scalia and Eli Lilly vs Medtronic - providing a little insight into why Scalia did NOT interpret the Safe Harbor language literally:

Scalia on Eli Lilly vs Medtronic:

No interpretation we have been able to imagine can transform §271 (e)(1) into an elegant piece of statutory draftsmanship



And note that Textualism does allow for use of the public understanding of the law if the strict interpretation of the language and surrounding law context does not resolve the ambiguity.


On the downside - in Integra the USSC unanimously interpreted the Safe Harbor clause, which was intended to be about preparing to get a generic out, to cover all research prior to FDA submissions (NDA or ANDA). E.g. Momenta can use any and all patents in the preparation for getting out a new IVIG.

PS Just gathering my notes on the board.