It is not known why Bayer Healthcare disclaimed the patent. It is possible (though entirely speculative) that Bayer, at the time the patent was submitted to FDA for listing, knew the patent to be invalid or unenforceable, and when faced with this fact years later, chose to disclaim rather than litigate. If such evidence exists (and the author is not aware of such evidence), then the analysis might be different.
A Pediatric Exclusivity effectively requires FDA to behave as though listed patents expire six months beyond their actual expiration dates. This is only for FDA purposes, as the Pediatric Exclusivity is not a patent term extension.
8.
21 U.S.C. 355 (j)(5)(D)(i)(IV). An exception is available where delay in approval is attributable to a change or review of requirements for approval. Id..
9.
This article was written several months after FDA's 10th October, 2007, deadline for submission, and considered all comments accessible on FDA's website.
10.
Note 6 supra..
11.
See, for example, Mova v Shalala, 140 F.3d 160 (D.C. Cir. 1998) (overturning FDA regulations requiring an ANDA applicant to be sued, and win, in order to be eligible for the 180-day exclusivity, because those preconditions were not in the statute).
