Replies to post #146558 on Biotech Values

[stockbettor]

The Chief Judge in his dissent expressly invited Momenta to request reconsideration en banc:

"This decision (“post-approval studies”; “after ap-proval”; “not restricted to pre-approval activities”) cannot be genuinely reconciled with Classen (“pre-marketing approval”). Instead, the court in this decision uses the same language as the dissent in Classen (“post-approval”; “I conclude that the safe harbor extends to all uses that are reasonably related to submitting any information under the FDCA, including information regarding post-approval uses”). This decision should instead request the entire court to resolve the issue en banc."

FWIW, he seemed furious at the majority's decision (lots of bold text). He also observes (again as he did in oral argument) that he particiapted in the drafting of the Hatch-Waxman exception. I expect he will lobby hard for further en banc proceedings.

[DewDiligence]

Unless Momenta can get the Court to reconsider the case en banc, this is over.

I think that’s a slight overstatement. The ruling from the Appellate Court does not categorically preclude the District Court from holding the patent trial as scheduled, although it does make such an outcome less likely.