Tuesday, November 20, 2012 10:13:19 PM
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
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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.
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