Replies to post #10037 on Momenta Pharmaceuticals, Inc. (MNTA)

[iwfal]

As to how the S.Ct. will decide, I would assign a 60/40 probabilty that the court will affirm Classen and reverse MNTA. The legislative history as recounted by Chief Judge Rader strongly favors MNTA's position. But the statute can be literally read, as Judge Moore did in MNTA without resort to legislative history, to favor Amphastar. Scalia has long advocated disregarding legislative history if the statutory language is clear. I belive this is called the "textualist" view of statutory interpretation. Presumably Scalia could pull along a few colleagues if he considers the Hatch-Waxman language to be clear.

Thanks for the context - further comments... if the USSC decides both Classen and M v A on the basis of a "Textual" reading then they are likely to decide them the same way. I.e. Safe Harbor voids all patents used in any testing required by the FDA. The interesting thing about that is that you'd think that would be broad enough to provoke some kind of congressional response. (Does Congress have any options other than a new law?)


And one other comment on Scalia and Textualism (what I previously referred to as 'literalism' - thanks for the correct nomenclature):

In Eli Lilly vs Medtronic the USSC voted to hold that the Safe Harbor applied to patents used pre-approval to obtain approval for a medical device. Despite that fact that the safe harbor language is completely explicit that it is for 'drugs' (no mention of devices). Now, here is the interesting part: Scalia voted with the majority - i.e. not a literal interpretation at all. Just food for thought.

Question: Has the USSC let stand any decisions bearing on Safe Harbor?