Replies to post #10167 on Momenta Pharmaceuticals, Inc. (MNTA)

[joethdo]

Thank you.

Would it be fair to say that in the Momenta decision that the court, in addition to wiping away the distinction between pre- and post-approval activities, also appears to wipe away (or ignore) the distinction between research and commercial activities?

In that context, this section appears to back MNTA's position:

A drug maker's use of a patented invention in routine commercial activity is not immune from infringement liability merely because, for example, the company may periodically report adverse reactions to the FDA. See 21 C.F.R. 314.80 and 600.80. That is because the ordinary commercial exploitation of a patented invention is not “reasonably related to the development and submission of information” for the FDA, even if such exploitation sometimes generates information useful to the FDA. That conclusion is reinforced by the ordinary meaning of the statutory term “development,” which implies more than merely the collection of information incidental to commercial transactions.