Replies to post #10155 on Momenta Pharmaceuticals, Inc. (MNTA)

[mouton29]

You are right and I am wrong, though there is a better quote to demonstrate my error. I read too quickly and still have not had time to go through it carefully. However, the SG does NOT say Amphastar v. Momenta was correctly decided:

The Momenta court additionally held
that, for purposes of Section 271(e)(1), information
may be deemed “submitted” to
FDA if it is preserved in records that FDA
regulations require a drug manufacturer to
make available for inspection by FDA on
request. See 686 F.3d at 1357. We express
no view on the correctness of that conclusion
or of the court of appeals' ultimate
disposition of Momenta.

Emphasis added.