Astrazeneca Pharms. LP v. Food

Citation713 F.3d 1134
Decision Date26 April 2013
Docket NumberNo. 12–5227.,12–5227.
CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)
PartiesASTRAZENECA PHARMACEUTICALS LP, Appellant v. FOOD & DRUG ADMINISTRATION, et al., Appellees.

OPINION TEXT STARTS HERE

Appeal from the United States District Court for the District of Columbia (No. 1:12–cv–00472).

Robert A. Long Jr. argued the cause for appellant. With him on the briefs were Timothy C. Hester, Benjamin C. Block, and Matthew J. Berns.

Gerald C. Kell, Senior Trial Counsel, U.S. Department of Justice, argued the cause for appellees. With him on the brief were Stuart F. Delery, Principal Deputy Assistant Attorney General, Maame Ewusi–Mensah Frimpong, Deputy Assistant Attorney General, William B. Schultz, Acting General Counsel, U.S. Department of Health and Human Services, and Eric M. Blumberg, Deputy Chief Counsel, Litigation.

Before: ROGERS and TATEL, Circuit Judges, and SENTELLE, Senior Circuit Judge.

Opinion for the Court filed by Senior Circuit Judge SENTELLE.

SENTELLE, Senior Circuit Judge:

AstraZeneca Pharmaceuticals LP, a manufacturer of pharmaceutical products, appeals from the district court's grant of summary judgment in an action praying a declaratory judgment that the Food and Drug Administration (FDA) could not approve generic versions of its Seroquel product and seeking to restrain the FDA from approving abbreviated new drug applications (“ANDAs”) for such competing products until the expiration of a period of exclusivity. The district court granted summary judgment in favor of the FDA, and AstraZeneca appealed. For the reasons set forth below, we agree with the district court that the FDA reasonably determined that AstraZeneca was not entitled to such period of exclusivity. We therefore affirm the grant of summary judgment.

I. BACKGROUND
A. Statutory Framework

The Federal Food, Drug, and Cosmetic Act (“FDCA”) governs the drug approval process for new and generic drugs. See21 U.S.C. §§ 301–99. A drug manufacturer, such as AstraZeneca, seeking to introduce a new, or pioneer, drug must file a new drug application (“NDA”) with the FDA. Id. § 355(b)(1). If the FDA approves the application, the statute entitles the manufacturer to a period of marketing exclusivity during which the FDA cannot approve bioequivalent generic drugs. See id. § 355(j)(5)(F). Once the exclusivity period has expired, the FDA can approve generic drugs bioequivalent to the pioneer drug through an abbreviated new drug application. See id. § 355(j). ANDAs need not include new clinical studies demonstrating the generic drug's safety or efficacy, but must propose the same basic labeling as approved for the pioneer drug. See id. § 355(j)(2)(A)(v); see also21 C.F.R. § 314.94(a)(8)(iv).

The FDCA provides for additional periods of exclusivity for pioneer drugs based on medical studies completed after the initial approval process if such studies support new indications of the drugs, which typically means that the drugs can be used in new patient populations or to treat different conditions. 21 U.S.C. § 355(j)(5)(F); see AstraZeneca Pharm. LP v. FDA, 872 F.Supp.2d 60, 64 (D.D.C.2012). Drug manufacturers can apply for this additional exclusivity through a supplemental new drug application (“sNDA”). The statutory provision governing such sNDAs provides:

If a supplement to an application ... contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under this subsection for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement....

21 U.S.C. § 355(j)(5)(F)(iv). Therefore, as provided in FDA regulations, the FDA cannot approve an ANDA for three years following the approval of an sNDA if the ANDA “relies on ... information supporting a change approved in the supplemental new drug application.” 21 C.F.R. § 314.108(b)(5)(ii). An amendment makes this exclusivity period “three years and six months rather than three years” in some circumstances where the manufacturer provides pediatric studies that the FDA requests. 21 U.S.C. § 355a(c)(1)(A)(i)(II). The statute leaves the word “supplement,” along with many of its other terms, undefined. The FDA has promulgated extensive regulations setting forth the applicationprocess and defining the statutory terms. See21 C.F.R. §§ 314.3, 314.50, 314.60, 314.70.

B. Factual and Procedural Background

AstraZeneca has marketed Seroquel, an atypical antipsychotic medication used to treat disorders such as schizophrenia, since 1997, largely without generic competition. Based on various sNDAs, the FDA has given supplemental exclusivity to AstraZeneca when it added indications to Seroquel. AstraZeneca has made other label changes which did not add indications to Seroquel, but only added safety information. With respect to these safety-related label changes, the FDA has not granted any additional period of exclusivity. AstraZeneca, 872 F.Supp.2d at 67.

One side effect of drugs like Seroquel is hyperglycemia, or high blood sugar. The FDA has added information about observed changes in blood sugar levels to labeling on all antipsychotic drugs. On June 26, 2008, in response to a request from the FDA, AstraZeneca submitted metabolic data regarding observed changes in blood sugar levels among patients taking Seroquel or Seroquel XR, an extended release version of Seroquel. The data came from fifteen clinical trials, all conducted for reasons other than generating this particular data and none conducted on pediatric patients.

Separately, AstraZeneca submitted two sNDAs in support of new pediatric indications of Seroquel on October 28, 2008, requesting three years of exclusivity for the new indications. The FDA considered those sNDAs while it was continuing review of the blood sugar labeling question. Correspondence between AstraZeneca and the FDA establishes that they discussed those two subjects and others in the same letters. On October 16, 2009, the FDA asked for a table summarizing the previously submitted glucose data, which AstraZeneca supplied, along with other labeling changes. This table, referred to as Table 2, is the basis of the current litigation.

On December 2, 2009, the FDA approved the pediatric sNDAs as well as the proposed labeling changes, including Table 2. The FDA sent AstraZeneca a single letter reflecting these approvals.

On September 2, 2011, AstraZeneca filed two citizen petitions with the FDA requesting exclusivity for Table 2 based on the clinical trials that provided the relevant data. The FDA denied the petitions without responding to AstraZeneca's request by, as the district court put it, “conveniently” ignoring the legal question regarding Table 2's eligibility for exclusivity. AstraZeneca, 872 F.Supp.2d at 74. AstraZeneca filed suit and moved for a preliminary injunction. The district court dismissed that action as unripe and denied the motion for a preliminary injunction because the FDA had not yet decided whether to grant ANDAs that included Table 2 in the labeling for generic versions of Seroquel and Seroquel XR. See AstraZeneca Pharm. LP v. FDA, 850 F.Supp.2d 230, 249–51 (D.D.C.2012). Four days after the district court's decision, on March 27, 2012, the FDA approved ANDAs for generic versions of Seroquel with Table 2 included as part of the labeling.

The FDA issued a letter to AstraZeneca on the same day explaining its decision that Table 2 was not entitled to a period of exclusivity. The letter points out that “changes in labeling that involve the addition of warnings or other similar risk information are generally not entitled to 3–year exclusivity.” Public Joint Appendix 304. It goes on to explain that Table 2 contains only “generally applicable safety information” and thus is not protected by any exclusivity. Id. In addition, the letter states that Table 2 does not include data from any indications for which Seroquel still had exclusivity, including the pediatric indications. Id. at 306. Finally, according to the letter, it was purely “coincidental” that the FDA approved Table 2 “in the course of approving” the pediatric sNDAs. The FDA's letter explicitly stated that “there is no relationship between the exclusivity for pediatric indications ... and the data in Table 2.” Id.

AstraZeneca again filed suit, seeking a temporary restraining order and further relief. The district court denied the motion for a temporary restraining order and later granted summary judgment in favor of the FDA, holding that the statute is ambiguous and the FDA's interpretation is reasonable. AstraZeneca filed this appeal.

II. DISCUSSION
A. Mootness

The FDA first argues that we should dismiss this case as moot. Article III of the Constitution gives federal courts jurisdiction to decide cases and controversies. This provides federal courts jurisdiction to decide only “actual, ongoing controversies.” See, e.g., Honig v. Doe, 484 U.S. 305, 317, 108 S.Ct. 592, 98 L.Ed.2d 686 (1988). “Even where litigation poses a live controversy when filed, the mootness doctrine requires a federal court to refrain from deciding it if events have so transpired that the decision will neither presently affect the parties' rights nor have a more-than-speculative chance of affecting them in the future.” LaRoque v. Holder, 679 F.3d 905, 907 (D.C.Cir.2012) (quoting Clarke v. United States, 915 F.2d 699, 701 (D.C.Cir.1990) (en banc)). According to the FDA, this case is now moot because any period of exclusivity attached to Table 2 would have expired by December 2, 2012, three years after the FDA approved the addition of Table 2 to Seroquel's labeling. See21 U.S.C. § 355(j)(5)(F)(iv).

However, the FDA is not correct that the possibility of relief has been extinguished. As we noted above, the period of exclusivity can be extended...

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