D.C. District Court Denies Preliminary Injunction In Generic SEROQUEL Litigation; Dismisses “Premature” Lawsuit Without Prejudice

By Kurt R. Karst –      

In a 33-page decision handed down late last Friday, Judge Colleen Kollar-Kotelly of the U.S. District Court for the District of Columbia denied AstraZeneca Pharmaceuticals LP’s (“AstraZeneca’s”) Application for Prelimiary Injunction and dismissed without prejudice the action AstraZeneca filed on March 12, 2012 seeking to enjoing FDA from granting final ANDA approval for a generic version of the company’s blockbuster antipsychotic drug SEROQUEL (quetiapine fumarate) Tablets (NDA No. 020639) as early as March 26, 2012 (as well as an extended-release version of the drug, SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets (NDA No. 022047)).  As we previously reported, AstraZeneca filed the lawsuit after FDA denied two citizen petitions the company submitted to FDA last year concerning labeling carve-out issues for generic versions of the drugs (Docket No. FDA-2011-P-0662 and Docket No. FDA-2011-P-0663).  FDA denied the petitions within the 180-day statutory period under FDC Act § 505(q) without comment on the merits of the issues raised in the petitions, stating that “[t]here is no evidence that in enacting [FDC Act § 505(q)], Congress intended to short-circuit the application review process or to vitiate an ANDA or NDA applicant’s procedural rights by requiring that the Agency make decisions that constitute final Agency action regarding the approvabilty of a certain aspects of pending applications on a piecemeal basis outside of the process established under the Act and regulations.” 

Afer reviewing FDA’s Opposition to AstraZeneca’s Application for Prelimiary Injunction, in which FDA argued that the action was not ripe for review and that AstraZeneca “must await an FDA decision before it can raise a judicially reviewable claim,” Judge Kollar-Kotelly directed AstraZeneca to “show cause” why the lawsuit should not be dismissed without prejudice if the court were to find that AstraZeneca’s claim is not yet ripe.  AstraZeneca promptly filed its brief addressing the issue (and replying to FDA’s opposition brief) and inviting the court to hold the action in abeyance for an indefinite period to wait and see whether it ripens into a justiciable case or controversy.  FDA filed a surreply to AstraZeneca’s brief reiterating the Agency’s position that the company’s claims are not ripe and saying that “FDA would voluntarily provide timely notice of approval of any ANDA for a generic version of Seroquel or Seroquel XR to AstraZeneca and the Court, even if this case were dismissed without prejudice.” 

Considering the record as a whole, Judge Kollar-Kotelly concluded that AstraZeneca failed to make the clear showing necessary to grant a preliminary injunction, and that each of the four factors a court considers in deciding whether or not to grant preliminary injunctive relief did not weigh in AstraZeneca’s favor.  Focusing much of her decision on the “likelihood of success on the merits” factor, Judge Kollar-Kotelly concluded that the action is not ripe:

[T]he Court has no doubt that the substantive issues raised by AstraZeneca in this action are not presently fit for judicial review.  AstraZeneca may have its own views as to the scope of its new patient population exclusivity and the relationship between that exclusivity and ANDAs submitted by potential generic competitors, but the FDA mayor may not decide to give final approval to competing generics and it mayor may not decide to give final approval in a manner that would interfere with AstraZeneca's interpretation of its new patient population exclusivity.  At this juncture, the Court simply is not in a position to project whether the FDA will ultimately decide to give final approval to a competing generic, when that hypothetical deci sion might happen, or what relationship the agency's proffered rationale for that hypothetical decision would have to the specific claim raised by AstraZeneca in this action. Absent further administrative action, the Court cannot say how the legal arguments tendered by AstraZeneca in this case will matter or even whether they will matter at all. . . .

Regardless of what AstraZeneca may believe, it is beyond cavil that this litigation does not involve the sort of “questions oflaw and undisputed facts” that might justify immediate judicial intervention.  Nor is the Court willing to assume, as AstraZeneca apparently is, that the outcome of, and basis for, the FDA's decisions on pending generic applications is preordained. . . .  This action is not, in short, presently fit for judicial review. If judicial intervention ever proves to be necessary, it should wait until the FDA's “decision has been fonnalized and its effects felt in a concrete way by the challenging parties.”  [(Internal citations omitted)]

While Judge Kollar-Kotelly noted that AstraZeneca might want to seek judicial intervention in an expedited proceeding if and when the FDA grants final ANDA approval, she commented that “any concern in this regard is ameliorated somewhat by the fact that the FDA has already voluntarily bound itself to provide AstraZeneca with advance notice of its intention to issue a final decision adverse to AstraZeneca and represents that it will consent to expedited briefing in the event preliminary relief is sought in the future.”

AstraZeneca had relied heavily in its briefs on the D.C. Circuit’s 2010 decision in Teva Pharmaceuticals USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), to support the company’s position that it was entitled to relief now, before ANDA approval and in light of FDA’s petition denials.  Judge Kollar-Kotelly, however, found AstraZeneca’s reliance on that decision to be misplaced and distinguished it from AstraZeneca’s case.

First, by the time the plaintiff brought suit in Teva, the FDA had already made its position abundantly clear. . . .  The same cannot be said here, where the FDA may or may not decide to give final approval to one or more competing generics and it may do so for any number of reasons. . . . Second, the single dispositive issue in Teva was a pure question of statutory interpretation and the parties’ competing interpretations were categorical and “impervious . . . to factual variation.”  By contrast, in this case, there are open questions about the status of pending applications for competing generics and their relationship to AstraZeneca’s interpretation of its new patient population exclusivity.  [(Internal citations omitted)]

Instead, wrote Judge Kollar-Kotelly, AstraZeneca’s case more closely resembles the D.C. Circuit’s 1999 decision in Pfizer Inc. v. Shalala, 182 F.3d 975 (D.C. Cir. 1999), in which the Court, in the context of a challenge to a citizen petition denial before final ANDA approval, “found the most prudent course was to await a final decision from the FDA, when the plaintiff would be in a position to address any other arguments ‘aris[ing] from the agency’s final approval- if and when it is given’” [(Internal citations omitted)].

In addition to denying AstraZeneca’s Application for Preliminary Injunction, Judge Kollar-Kotelly declined to hold the action in abeyance pending FDA’s decision on generic quetiapine approvals:

This Court simply is not in a position to prophesy whether the FDA will ultimately decide to give final approval to a competing generic, when that hypothetical decision might happen, or what relationship the agency’s proffered rationale for that hypothetical decision would have to the specific claim raised by AstraZeneca in this action.  Indeed, the Court is mindful that the precise “controversy” envisioned by AstraZeneca in this action may never ripen into a dispute amenable to judicial review. [(Emphasis in original)]

Will Monday, March 26, 2012 (today) see the fire drill-type procedures that we have seen before in Hatch-Waxman ANDA approval litigation?  We’ll all know soon enough.  In that regard, we will update this post with relevant information.

UPDATES:

• March 26th AstraZeneca Press Release – "Notwithstanding the Court’s decision, the Company continues to believe strongly in the merits of its position and is evaluating its options."
• On Monday morning, AstraZeneca filed a Motion To Amend March 23, 2012 Order To Require FDA To Provide Advance Notice of Final Decision Adverse to AstraZeneca.  The “advance notice” requested is at least two business days of any FDA decision to grant final ANDA approval.
• On Monday afternoon, FDA filed its Opposition to AstraZeneca’s motion (above).  FDA says: “Defendants oppose AstraZeneca’s motion to amend the order to require that FDA give advance notice of at least two business days before FDA approves a generic version of Seroquel or Seroquel XR.  To the extent that this Court misunderstood FDA’s voluntary offer to provide ‘timely’ notice as meaning ‘advance’ notice before an ANDA will be approved, the defendants suggest that the court’s decision be amended to reflect FDA’s intention, which is that timely notice means that FDA will provide notice within a short time after an ANDA has been approved.”
• AstraZeneca’s Reply to FDA’s Opposition: “FDA can give AstraZeneca advance notice without implicating [21 C.F.R. § 314.430(d)(1)]: a simple, ‘FDA intends to grant final approval to an ANDA for a generic version of Seroquel in two business days’ would suffice.”
• This afternoon, Judge Kollar-Kotelly issued an Order denying AstraZeneca’s Motion To Amend March 23, 2012 Order To Require FDA To Provide Advance Notice of Final Decision Adverse to AstraZeneca.