AstraZeneca Pharmaceuticals LP, v. Food and Drug Administration

April 09, 2012

GENERICally Speaking
Case Name: AstraZeneca Pharmaceuticals LP, v. Food and Drug Administration, Civ. No. 12-472-BAH, 2012 U.S. Dist. LEXIS 28112 (D.D.C. March 28, 2012) (Howell, J.).  (FDA was given deference in finding that AstraZeneca's new data did not warrant further exclusivity period.).

Drug Product and Patent(s)-in-Suit: Seroquel® and Seroquel XR® (quetiapine); U.S. Pat. Nos. 4,879,288 and 5,948,437.

Nature of the Case and Issue(s) Presented: The issue here was whether plaintiff AstraZeneca Pharmaceuticals LP ("AZ") could establish that it was entitled to a temporary restraining order preventing the Food and Drug Administration ("FDA") from reviewing any ANDAs related to generic versions of its Seroquel drugs, and also vacating the FDA's approval of any ANDAs already submitted, pending resolution of AZ's application for a preliminary injunction.

Plaintiff AZ holds new drug applications in relation to its branded Seroquel and Seroquel XR drugs.  On March 26, 2012, a pediatric exclusivity period for those drugs was set to expire.  AZ believed that it was entitled to an additional "new patient population" period of exclusivity that would extend its exclusivity up to December 2, 2012.  AZ filed two citizen petitions with the FDA in September of 2011 requesting the FDA to refrain from approving any ANDAs related to generic versions of its Seroquel drugs until after the December 2, 2012 date.  On March 7, 2012, the FDA denied the citizen petitions and indicated that it had not yet decided if it would approve or deny any ANDAs submitted before that date.  In response to those denials, AZ filed suit against the FDA on March 12, 2012, alleging that the FDA had violated the Administrative Procedure Act in denying the citizen petitions, and seeking a preliminary injunction preventing the FDA from approving any ANDAs submitted prior to the resolution of the suit.  The court denied AZ's motion for a preliminary injunction on March 23, 2012, on the basis that it was not yet ripe for judicial review (see separate case summary).  In response, AZ filed a motion for a temporary restraining order, instructing the FDA to vacate any ANDAs that had already been approved by the FDA in relation to generic Seroquel, and to prevent the FDA from approving any additional ANDAs.

Why the FDA Prevailed:  AZ argued that it was entitled to a temporary restraining order because the FDA had misinterpreted 21 U.S.C. § 355(j)(5)(F)(iv), which, according to AZ, provided it with an additional three-year exclusivity period for the use of certain labeling information in relation to its Seroquel drugs.  AZ provided a table of metabolic effects data derived from clinical studies it conducted in conjunction with a supplemental new drug application filed on December 2, 2009.  The FDA also approved two pediatric uses of Seroquel in conjunction with AZ's supplemental new drug application.  Because generic versions of Seroquel must carry the same labeling as the branded product, AZ argued that any FDA approval of generic versions would violate its exclusive rights.  In order for the temporary restraining order to issue, AZ was required to establish that it had a likelihood of success on the merits in relation to its argument that the FDA had made clear errors of law with respect to its interpretation of the Hatch-Waxman Act.

The Court first noted that its review of agency actions was limited to setting aside actions taken in excess of the agency's statutory jurisdiction, authority or limitations.  In order to make  this assessment, the Court applied the two-step inquiry established under the Supreme Court's Chevron decision, which first instructs the courts to determine whether the statute in question is clear, and if not, to determine whether the agency's action is based upon a permissible construction of the statute.

The Court upheld the FDA's position that the clinical data AZ submitted did not constitute "new clinical investigations" "essential to approval of the" supplemental new drug application, on the basis that such a determination was well within the FDA's expertise, and did not appear to be an arbitrary or capricious interpretation.  The court decided that, due to the fact that it had to provide appropriate deference to an agency's interpretation of the statute, AZ could not establish a likelihood that it would prevail on the merits of the case, and accordingly denied its motion for a temporary restraining order.

Although the court denied AZ's motion for a temporary restraining order, it took issue with the FDA's legal tactics.  Although the FDA had claimed in submissions to the court that it not yet given formal approval to a generic competitor, the court noted that there was evidence that the FDA had approved a number of ANDAs for generic Seroquel as of March 27, 2012. 

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