AstraZeneca Loses TRO Bid in Second Generic SEROQUEL Lawsuit

von freakoutcrazy

By Kurt R. Karst

In litigation that moved at breakneck speed on March 28, 2012, Judge Beryl A. Howell of the U.S. District Court for the District of Columbia denied AstraZeneca Pharmaceuticals LP’s (“AstraZeneca’s”) Motion for Temporary Restraining Order(Complaint here) seeking to vacate FDA’s March 27, 2012 approval of more than 10 ANDAs for generic versions of AstraZeneca’s blockbuster antipsychotic drug SEROQUEL (quetiapine fumarate) Tablets (NDA No. 020639), and to enjoin FDA from granting any further final ANDA approvals for the drug until the court decides the case on the merits.

Judge Howell’s decision follows a March 23, 2012 (Friday) decision handed down by Judge Colleen Kollar-Kotelly denying AstraZeneca’s Application for Prelimiary Injunction and dismissing the case without prejudice.  In that case, AstraZeneca sought to enjoin FDA from granting final ANDA approvals for generic SEROQUEL as early as March 26, 2012, after FDA denied without comment two citizen petitions AstraZeneca submitted to FDA last year concerning labeling carve-out issues for generic versions of SEROQUEL (as well as an extended-release version of the drug, SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets (NDA No. 022047)) – see our previous post here.

On Monday, FDA and AstraZeneca fought over whether FDA must provide “advance notice” or “timely notice” to AstraZeneca of ANDA approvals.  That resulted in the issuance of an Order in which Judge Kollar-Kotelly noted that FDA must provide AstraZeneca timely notice after approving any ANDAs.  That notice was sent to AstraZeneca later in the day on Tuesday in the form of a Letter Decision in which FDA also addressed labeling carve-out and three-year exclusivity issues, stating:

AstraZeneca identified three portions of labeling that it argued are essential to the safe use of quetiapine for any purpose: (1) Table 2, which consists of metabolic effects data; (2) the boxed warning on suicidality; and (3) Section 5.2 warnings on clinical worsening and suicide risk. (For ease of reference, the boxed warning and Section 5.2 warnings are referred to collectively throughout as “suicidality warnings.”)  AstraZeneca has also asserted that Table 2 is protected by 3-year exclusivity such that approval of an ANDA referencing Seroquel may not occur until on or after December 2, 2012, when the last exclusivity period on a different AstraZeneca product – – Seroquel XR – expires.

FDA concurs that these portions of the labeling are essential to safe use of a generic quetiapine product referencing Seroquel for any indication, and the agency would not approve a quetiapine ANDA referencing Seroquel that omitted them.  FDA does not concur, however, that an ANDA referencing Seroquel is precluded from including Table 2 or the suicidality warnings by virtue of AstraZeneca’s 3-year exclusivity on certain indications for Seroquel XR.

AstraZeneca filed its TRO papers on Wednesday morning and the parties met in court later that day.  Later that night, Judge Howell issued her Order concluding that AstraZeneca “has not demonstrated a likelihood of success on the merits, particularly given the deference the Court must provide to agency actions and interpretations of its own organic statute, here, the [FDC Act].”

Although Judge Howell denied AstraZeneca’s TRO motion, FDA did not escape unscathed.  Judge Howell commented in her Order that:

The record in this case strongly suggests that the FDA has made “tactical decision[s]” to prevent the plaintiff “from seeking judicial review of FDA’s legal position,” Pl.’s Mot TRO, ECF No. 3, at 4, starting with the FDA denying, without comment on the merits, the plaintiff’s Citizen Petitions on the last day of the statutory deadline, 21 U.S.C. §355(q), and subsequently urging denial of the plaintiff’s application for a preliminary injunction on grounds that would avoid reaching the merits of the plaintiff’s complaint about the FDA’s legal position. . . .  Yet, a mere four days later, by March 27, 2012, the FDA had approved a number of ANDAs for generic versions of Seroquel.  Government counsel at the hearing on the TRO defended the FDA’s prior representations to the Court, without any apparent recognition that those representations could appear to be less than forthright about the status of FDA decision-making, since regardless of any representation made by the FDA, deference is due to the agency’s interpretation of the FDCA.  The consequences of the FDA’s tactics of “hiding the ball” of its position until March 27, 2012 are two-fold: consideration of the merits of the legal issues presented by the plaintiff’s complaint have been delayed, with the opportunity for judicial review of those issues last week lost and the expenditure of judicial resources of yet another Judge this week required.

Judge Howell’s comments are somewhat reminiscent of the frustration Judge John Bates expressed in another case in which exclusivity was disputed (see here).

In addition to denying AstraZeneca’s TRO motion, Judge Howell ordered FDA to supplement the administrative record by Friday with any additional relevant records and ordered FDA and AstraZeneca to submit by 5:00 PM this Friday an expedited briefing schedule.

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