Here is an excerpt from the Momenta brief. The footnotes are particularly interesting.
Teva’s brief also seems to carefully avoid mentioning the portions of FDA’s citizen petition denials that: (1) explicitly criticize Teva’s scientific assertions where the facts allow, and (2) reject other assertions as “premature” on the grounds that the unique characteristics of each ANDA counsel against Teva’s umbrella approach to assessing all applications in exactly the same way. This last point is critically important. Teva knows nothing about the particular formulation of
Sandoz/Momenta’s generic (which is why it had to resort to the use of foreign product with no connection to the Sandoz/Momenta generic to attempt to cast doubt on FDA’s decision-making process). Teva is not privy to the thorough, highly innovative science submitted confidentially to FDA in Sandoz/Momenta’s ANDA, and so it is not yet aware of the advanced methodologies Sandoz/Momenta employ to characterize both Copaxone and their generic for purposes of establishing “sameness” under Hatch-Waxman.1 Nor is Teva privy to FDA’s recent requests for information or the specific data that Sandoz/Momenta developed to address gene expression and immunogenicity questions raised by Teva. That material will be part of the administrative record for the Sandoz/Momenta ANDA, and will be available to support any decision FDA ultimately reaches on that ANDA.
As demonstrated below, FDA has taken a sensible and lawful approach in addressing statutory and
regulatory requirements for both citizen petitions and pending ANDAs.2 Indeed, FDA’s longstanding guidance on this topic is fully consistent with the FDA ANDA approach upheld in Serono
Laboratories, Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) and Sanofi- Aventis U.S. LLC v. FDA, 842 F. Supp. 2d 195 (D.D.C. 2012). Asking FDA to make a one-size-fits-all determination on Teva’s citizen petition applicable to all pending and future ANDAs, no matter what specific scientific facts are or may be presented, would be nonsensical and unscientific. Likewise, it would be absurd to suggest (as Teva apparently does) that FDA must now ignore all new or developing information—good, bad, or indifferent—for any pending or future ANDA that relates to the topics raised by its citizen petition. Such a ruling could open the door to a whole new chapter of anti-generic gamesmanship, and would conflict with a core mission of the FFDCA—for FDA to make independent objective expert judgments in evaluating drug applications based on the best science available at the time. For these and other reasons set forth herein, Teva’s motion for preliminary injunction must be denied.
1 Teva admits (at 17) that it is incapable of fully characterizing Copaxone, but Momenta/Sandoz
have supplied FDA with information more than sufficient to demonstrate sameness.
2 If Teva is really arguing that the points raised in its petition are not genuinely “premature,” we can
assure the Court that FDA recently requested additional information from Sandoz/Momenta on gene expression issues, and Sandoz/Momenta very recently provided that information to FDA as a confidential submission to the ANDA administrative record. Thus, FDA can truthfully say that its determination regarding our ANDA is premature.
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