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Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued March 21, 2013 Decided April 26, 2013

No. 12-5227

ASTRAZENECA PHARMACEUTICALS LP,

APPELLANT

v.

FOOD & DRUG ADMINISTRATION, ET AL.,

APPELLEES

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. 

USCA Case #12-5227 Document #1432745 Filed: 04/26/2013 Page 1 of 12
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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. 

See 21 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 

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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 also 21 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 

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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 application process and defining the statutory terms. See

21 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. 

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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. 

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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 

(1988). “Even where litigation poses a live controversy when 

filed, the mootness doctrine requires a federal court to refrain 

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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. See 21 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 beyond three years for an 

additional six months if the FDA requests and receives 

pediatric studies from the manufacturer. See id.

§ 355a(c)(1)(A)(i)(II). If applicable in this case, the longer 

period of exclusivity would not expire until June 2, 2013. 

The FDA argues that AstraZeneca waived this claim of longer 

exclusivity by failing to specifically argue it below. This is 

not, however, dispositive on the particular facts of this case. 

As the FDA concedes, it would have to consider the pediatric 

exclusivity period “if AstraZeneca prevails in its request for 

three-year exclusivity for Table 2.” Appellees’ Br. at 48. 

Because AstraZeneca has submitted some pediatric studies 

regarding Seroquel, if AstraZeneca were to prevail on the 

merits of its claim, exclusivity through June 2, 2013, might be 

available. See AstraZeneca, 872 F. Supp. 2d at 65 n.4. 

Therefore, our decision will affect AstraZeneca’s actual 

rights, and the case is not moot. Thus, we must determine the 

merits of the summary judgment.

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B. Summary Judgment

Under the Federal Rules of Civil Procedure, grant of 

summary judgment is appropriate where “there is no genuine 

dispute as to any material fact and the movant is entitled to 

judgment as a matter of law.” Fed. R. Civ. P. 56(a). Our 

review of the district court’s grant of summary judgment is de 

novo. See, e.g., Calhoun v. Johnson, 632 F.3d 1259, 1261 

(D.C. Cir. 2011). We therefore undertake the same 

examination as the district court to determine the presence or

absence of genuine disputes of material fact and legal 

entitlement to judgment of the movant, in this case the FDA. 

Sherley v. Sebelius, 689 F.3d 776, 780 (D.C. Cir. 2012). 

When summary judgment is at issue in a case of 

administrative review under the APA, we, like the district 

court, are required to “hold unlawful and set aside agency 

action, findings, and conclusions found to be . . . arbitrary, 

capricious, an abuse of discretion, or otherwise not in 

accordance with law.” 5 U.S.C. § 706(2)(A). Under the 

applicable standard the district court, and now this court, must 

allow summary judgment for the agency (in this case, the 

FDA), unless the appellants can demonstrate by record 

evidence that “a genuine dispute” exists as to some material 

fact supporting the proposition that the FDA’s actions under 

review were “arbitrary, capricious, an abuse of discretion, or 

otherwise not in accordance with law.” See Sherley, 689 F.3d 

at 780. 

There being no genuine dispute as to the facts of record, 

see id., our analysis is limited to the validity of the FDA’s 

interpretation and application of the statute. Since the 

determinative issue is one of an agency’s interpretation of a 

statute, we apply the familiar test of Chevron U.S.A. Inc. v. 

Natural Resources Defense Council, Inc., 467 U.S. 837 

(1984). See Mylan Labs., Inc. v. Thompson, 389 F.3d 1272, 

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1279–80 (D.C. Cir. 2004) (applying Chevron to FDA decision 

letters). “If the intent of Congress is clear, that is the end of 

the matter; for the court, as well as the agency, must give 

effect to the unambiguously expressed intent of Congress.” 

Chevron, 467 U.S. at 842–43. If the statute is ambiguous, 

“the question for the court is whether the agency’s answer is 

based on a permissible construction of the statute.” Id. at 843.

AstraZeneca contends that it should prevail at the first 

step of the Chevron test. That is, it contends that the statute 

clearly provides the exclusivity it seeks based on Table 2. 

AstraZeneca relies on the statutory language that provides for 

exclusivity where a supplement “contains reports of new 

clinical investigations . . . essential to the approval of the 

supplement.” 21 U.S.C. § 355(j)(5)(F)(iv). 

AstraZeneca argues that the statute clearly entitles Table 

2 to exclusivity on two grounds. First, Table 2 was “a change 

approved in” the pediatric supplements, and the supplements

included “reports of new clinical investigations . . . essential 

to the approval of the supplement[s].” Id. Second, some of 

the clinical studies that provided the data for Table 2 were 

“new clinical investigations” “essential to the approval” of the 

labeling changes so as to independently warrant exclusivity.

Either way, AstraZeneca claims, Table 2 is entitled to 

exclusivity, so the FDA’s approval of ANDAs incorporating 

Table 2 prior to June 2, 2013, was contrary to the statute. 

Because we disagree that the statute mandates exclusivity in 

these circumstances, and because we consider the FDA’s 

interpretation reasonable, we affirm the district court’s grant 

of summary judgment.

At the core of this dispute is the statutory language that 

limits exclusivity to “a change approved in the supplement”

and requires that “the supplement contain[] reports of new 

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clinical investigations . . . essential to the approval of the 

supplement.” 21 U.S.C. § 355(j)(5)(F)(iv). This language is 

permeated by ambiguities that, under Chevron, leave 

discretion in the FDA to adopt reasonable interpretations of 

the application process outlined by the statute. 

The statute leaves to the FDA the interpretation of a

“supplement” to a drug application. Under the statute, the 

FDA has power to implement the entire application and 

approval process, which necessarily gives the FDA discretion 

to determine the requirements of “applications” and 

“supplements” and how to handle changes that are not 

contained in such applications or supplements. Because the 

statute includes these ambiguities, the language “constitutes 

an implicit delegation from Congress to the agency to fill in 

the statutory gaps.” FDA v. Brown & Williamson Tobacco 

Corp., 529 U.S. 120, 159 (2000). 

The fundamental problem with both of AstraZeneca’s 

arguments is that the FDA has maintained that Table 2 was 

not “a change approved” in any supplement, and only changes 

approved in a supplement are entitled to a statutory period of 

exclusivity. See Public Joint Appendix 306; 21 U.S.C. 

§ 355(j)(5)(F)(iv). The FDA has exhaustive regulations 

detailing the parameters of the application process, including 

how to amend pending supplements and applications. See 21 

C.F.R. §§ 314.50, 314.60, 314.70. AstraZeneca makes no 

attempt to show that these procedures are contrary to the 

statute. Nor has AstraZeneca shown that the FDA’s 

application of the law to the relevant facts was arbitrary or 

capricious.

The supplements here dealt with new pediatric 

indications of Seroquel. AstraZeneca submitted the data for 

Table 2 in letters coded as general correspondence (not 

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supplements) prior to even filing those supplemental 

applications. See Public Joint Appendix 298. Further, no 

data for Table 2 was derived from the pediatric studies at 

issue in the supplements, and AstraZeneca cited only the 

pediatric studies in support of its request for exclusivity. 

Table 2 is only contained in the “Adult” section of Seroquel’s

labeling. Finally, though AstraZeneca makes much of the fact 

that the FDA approved the pediatric supplements and Table 2 

at the same time, the FDA explained that the “this timing was 

only coincidental, and there is no relationship between the 

exclusivity for the pediatric indications earned on December 

2, 2009, and the data in Table 2.” Id. at 306. We see nothing 

arbitrary or capricious about the FDA’s reasoned explanation 

for its actions. 

We have examined the remainder of the administrative 

record and find nothing that contradicts the FDA’s position 

that it considered Table 2 as separate from the pediatric 

supplements. As the district court explained, “the 

administrative record shows that the pediatric supplements 

were approved on their own merits based upon clinical 

investigations unrelated to the Table 2 labeling change, which 

standing alone does not entitle AstraZeneca to exclusivity.” 

AstraZeneca, 872 F. Supp. 2d at 83. The fact that 

AstraZeneca titled its eventual submission of Table 2 an 

“Amendment to a Pending Application” does not require the 

FDA to consider that submission an actual amendment to a 

completely unrelated supplemental application.

Therefore, the labeling changes in Table 2 were neither 

“a change approved” in the pediatric supplements nor 

submitted as a separate supplement. AstraZeneca states that 

Table 2 could have been submitted as a separate efficacy 

supplement, but AstraZeneca does not claim it ever was. 

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Because the statute only provides exclusivity for changes 

approved as part of a supplement, AstraZeneca’s claims fail.

AstraZeneca attempts to establish that the FDA was 

arbitrary or capricious by directing us to prior grants of 

exclusivity to label changes approved in supplements. See

Public Joint Appendix 119–22. However, the FDA’s 

explanation that it considered Table 2 independently of a 

supplemental application sufficiently distinguishes this case to 

defeat that claim. The consistency of the FDA’s denial of 

exclusivity in this case with prior FDA actions is strikingly 

underscored by the fact that the agency did not extend 

exclusivity in seven other recent labeling changes for drugs in 

Seroquel’s class. See AstraZeneca, 872 F. Supp. 2d at 86.

Because the FDA reasonably considered Table 2 as 

separate from the pediatric supplements, Table 2 was not “a 

change approved in the supplement,” and therefore the statute 

does not entitle AstraZeneca to exclusivity for Table 2.

III. CONCLUSION

For the foregoing reasons, the decision of the district 

court is

Affirmed.

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