Case Name: AstraZeneca Pharma. LP v. Food and Drug Administration, Civ. No. 12-00388 (CKK), 2012 U.S. Dist. LEXIS 39611 (D.D.C. March 23, 2012) (Kollar-Kotelly, J.). (Preliminary injunction analysis concerning FDA's consideration of pediatric exclusivity and ANDA applicants is not ripe until FDA issues Final Approval of the ANDA at issue.).
Drug Product and Patent(s)-in-Suit: Seroquel® and Seroquel® XR (quetiapine fumurate); U.S. Pat. No. 5,948,437 ("the '437 patent")
Nature of the Case and Issue(s) Presented: AstraZeneca ("AZ") pediatric exclusivity was set to expire on March 26, 2012. AZ believed that it was also entitled to "new patient population" exclusivity, which would have extended the bar for generic entry into the market until December 2, 2012. In September 2011, AZ filed two citizens petitions with the FDA asking the agency to represent that, before the March 26 expiration of AZ's pediatric exclusivity, it did not intend to give final approval to any generic competitors until after the December 2, 2012 date. FDA denied both petitions, taking the position that it had not yet made a final determination to approve or disapprove any applications by potential generic competitors. AZ filed suit against the FDA claiming that the agency's decision was contrary to the Administrative Procedure Act ("APA"), and also sought to enjoin FDA from giving final approval to a generic version of Seroquel or Seroquel XR before this action was decided on the merits. The Court found that AZ had failed to make a clear showing that it was entitled to a preliminary injunction, and further dismissed AZ's claim as not ripe for judicial review.
Why FDA Prevailed: AZ was unable to discharge the burden of showing a likelihood of success on the merits because its only claim in the action-that FDA had run afoul of the APA-was not ripe for judicial review. While the FDA's decision to deny AZ's citizens petitions may be regarded as "final" for purposes of the APA, the Court found that such a decision "may not be ripe until the agency makes a concrete determination on the related applications." FDA may or may not decide to give final approval to competing generics and it may or may not decide to give final approval in a manner that would interfere with AZ's interpretation of its new patient population exclusivity.
AZ claimed that FDA had already given tentative approval to a handful of generic competitors, and that final approval would come as a matter of course. But the Court, relying in part on AZ's own materials, found that "a potential generic competitor may secure tentative approval from the FDA years before it is eligible for final approval, [and] the FDA makes it clear that its tentative determination is based on the information available at the time and remains subject to change." Moreover, the evidence showed that the FDA gave tentative approval to two generic manufacturers before the FDA approved the supplemental NDAs under which AZ's interpretation of its new patient population exclusivity period was based and before the FDA approved AZ's labeling that sets forth the data included in the supplemental NDAs.
Next, the Court determined that the hardship to the parties of withholding the court's consideration-in this case, AZ's concern that it might be required to seek judicial intervention in an expedited proceeding if the FDA grants final approval to a generic manufacturer-only makes it more clear that the action is not ripe. FDA has already agreed to provide AZ with advance notice of its intention to issue a final decision adverse to AZ and further represented that it would consent to expedited briefing in the event preliminary relief is sought in the future. Moreover, the Court found that further factual development (i.e., permitting the FDA to reach a final, reasoned decision on the approvability of pending ANDAs) "will afford a reviewing court the benefit of the agency's informed and documented consideration of the scope of, and relationship between, the various exclusivities claimed by AZ and their relationship to specific applications at the time of final approval."
As to irreparable harm, AZ contended that it would suffer significant economic injury in the event that FDA ultimately decides to grant final approval to a competing generic. But the Court found that such harm, at this point in time, is "theoretical" and not "certain." Because AZ "has failed to establish that the injury it has identified is likely, and not a mere possibility," the Court did not weigh this factor in favor of granting injunctive relief.
Lastly, although the public has an interest in protecting the patent and exclusivity rights allocated to pioneer drug companies, it also has an interest in seeing that generic competitors are allowed access to the market. Generic manufacturers have in interest in the FDA reviewing their applications on the merits of the specific circumstances in which they are presented. The FDA has an interest in being able to discharge its duties free from judicial interference, and as reflected in the ripeness doctrine, the Judiciary has an interest in waiting until an administrative decision has been formalized and its effects felt in a concrete way before conducting judicial review. For these reasons, the Court denied AZ's request for injunctive relief.
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