Replies to post #10041 on Momenta Pharmaceuticals, Inc. (MNTA)

[stockbettor]

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?)

A new law, preferably as "technical corrections" to Hatch-Waxman with a retroactive effective, is the only option I am aware of. Wheeler should have been hiring well-connected lobbyists immediately after the August 3 panel decision came out. I suspect, however, that Amphastar has already lined up its own lobbyists to counter any efforts undertaken by MNTA.

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

I have not looked for any decisions, but I suspect they would have been cited in Classen or MNTA even if they had reached the S.Ct. only as a pettion for cert. that was denied.

The blog linked below has recent commentary on the S.Ct.'s textual approach that may be of interest:

http://nowwithouthesitation.blogspot.com/2012_06_01_archive.html

Textualist interpretatiion as studied inattention
**********

I’m inclined to think that this is what has happened in the Supreme Court’s statutory interpretation jurisprudence. Today the Supreme Court seems to have achieved a measure of comfort with a largely textualist approach to statutory interpretation. Considerations of legislative purpose do get invoked, but rarely as the dominant guide to meaning.

[iwfal]

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.