United States Court of Appeals for the Federal Circuit
2009-1368
WYETH HOLDINGS CORPORATION
and WYETH (now known as Wyeth LLC),
Plaintiffs-Appellants,
v.
Kathleen Sebelius, SECRETARY OF HEALTH AND HUMAN SERVICES,
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
Dr. Margaret Hamburg, COMMISSIONER OF FOOD AND DRUGS,
UNITED STATES FOOD AND DRUG ADMINISTRATION,
David Kappos, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL
PROPERTY and DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK
OFFICE, and UNITED STATES PATENT AND TRADEMARK OFFICE,
Defendants-Appellees.
Randolph D. Moss, Wilmer Cutler Pickering Hale and Dorr LLP, of Washington,
DC, argued for plaintiffs-appellants. With him on the brief were Brian M. Boynton and
Brian H. Fletcher.
Howard S. Scher, Attorney, Appellate Staff, Civil Division, United States
Department of Justice, of Washington, DC, argued for defendants-appellees. With him
on the brief were Tony West, Assistant Attorney General, Channing D. Phillips, Acting
United States Attorney, and Scott R. McIntosh, Attorney. Of counsel on the brief were
David S. Cade, Acting General Counsel, Michael M. Landa, Acting Associate General
Counsel, Eric M. Blumberg, Deputy Chief Counsel, and James R. Johnson, Associate
Chief Counsel, Office of the General Counsel, Food and Drug Division, United States
Department of Health and Human Services, of Rockville, Maryland. Of counsel was
Drake S. Cutini, Office of Consumer Litigation, United States Department of Justice, of
Washington, DC.
Appealed from: United States District Court for the District of Columbia
Judge Henry H. Kennedy, Jr.
United States Court of Appeals for the Federal Circuit
2009-1368
WYETH HOLDINGS CORPORATION
and WYETH (now known as Wyeth LLC),
Plaintiffs-Appellants,
v.
Kathleen Sebelius, SECRETARY OF HEALTH AND HUMAN SERVICES,
DEPARTMENT OF HEALTH AND HUMAN SERVICES,
Dr. Margaret Hamburg, COMMISSIONER OF FOOD AND DRUGS,
UNITED STATES FOOD AND DRUG ADMINISTRATION,
David Kappos, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL
PROPERTY and DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK
OFFICE, and UNITED STATES PATENT AND TRADEMARK OFFICE,
Defendants-Appellees.
Appeal from the United States District Court for the District of Columbia in case no.
08-CV-00981, Judge Henry H. Kennedy, Jr.
___________________________
DECIDED: May 3, 2010
___________________________
Before BRYSON and MOORE, Circuit Judges, and FOLSOM, Chief District Judge. *
MOORE, Circuit Judge.
Wyeth Holdings Corporation and Wyeth LLC (Wyeth) appeal the judgment,
pursuant to summary judgment, of the United States District Court for the District of
Columbia rejecting Wyeth’s challenge to the United States Food and Drug
Administration’s (FDA’s) determination of the date on which the approval phase of its
*
The Honorable David Folsom, United States District Court for the Eastern
District of Texas, sitting by designation.
phased regulatory review process begins for purposes of calculating patent term
extensions. For the reasons discussed below, we affirm.
BACKGROUND
I. Regulatory Background
New animal drugs must receive FDA approval before they can be commercially
marketed. Because the regulatory process often spans several years, in 1988
Congress provided for patent term extensions to restore patent life lost during FDA’s
review of new animal drugs. See Generic Animal Drug and Patent Term Restoration
Act, Pub. L. No. 100-670, 102 Stat. 3971 (1988). Regulatory review proceeds in two
phases: a testing phase followed by an approval phase. The shift from the testing to the
approval phase occurs when a sponsor “initially submit[s]” an application for approval of
a new animal drug. See 35 U.S.C. § 156(g). A patent holder may obtain an extension
equal to half of the duration of the testing phase plus the entire duration of the approval
phase, not to exceed five years, exclusive of any regulatory review period occurring
before the patent issues. See 35 U.S.C. § 156(c), (g)(6). Thus, the date on which a
sponsor initially submits an application marks the beginning of the approval phase and
directly affects the length of a patent term extension. At issue on appeal is the proper
determination of that date in FDA’s phased review process.
The first phase of regulatory review, the testing phase, begins when the sponsor
obtains FDA’s permission to begin clinical testing of the drug or initiates a major health
or environmental effects test, whichever is earlier. See 35 U.S.C. § 156(g)(4)(B)(i); see
also 21 C.F.R. § 60.22(d)(1). During the testing phase, the sponsor submits
investigational data to FDA, which FDA files in an Investigational New Animal Drug
(INAD) file.
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The testing phase ends, and the approval phase begins, when the sponsor
submits a New Animal Drug Application (NADA) to FDA. See 35 U.S.C.
§ 156(g)(4)(B)(ii); see also 21 C.F.R. § 60.22(d)(2). The NADA must contain the
information required by 21 U.S.C. § 360b(b) and the corresponding FDA regulation, 21
C.F.R. § 514.1(b). Section 360b(b) requires, among other things, full reports of
investigations concerning the safety and efficacy of the drug, a description of the
methods and facilities used to manufacture the drug, and a description of a method to
determine the quantity of the drug that winds up in food. 21 U.S.C. § 360b(b)(1).
In the traditional regulatory review process, determining the date that a sponsor
submits a NADA is straightforward: the sponsor gathers all of the information required
by § 360b(b) and sends it all to FDA in a single submission, and this is the date that the
application is initially submitted. FDA may require additional information from the
sponsor in support of the NADA; but minor amendments will not affect the “initially
submitted” date or the onset of the approval phase.
In 1989, FDA began offering sponsors the choice of “phased review.” In phased
review, rather than gathering the information required by § 360b(b) and submitting it to
FDA in one package, the sponsor may submit various technical sections directly to the
section of FDA’s Center for Veterinary Medicine (CVM) responsible for evaluating the
technical material. FDA treats technical sections as submissions to the INAD file. As of
1995, FDA recognized six technical sections: (1) Effectiveness, (2) Environmental
Safety, (3) Manufacturing Methods and Controls, (4) Public Safety, (5) Residue
Chemistry and Regulatory Methods, and (6) Target Animal Safety. Center for
Veterinary Medicine Document Submission Information – An Update, 14 (Apr. 1995, as
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modified Nov. 1995) (CVM Phased Review Policy). FDA reviews the technical sections
on a concurrent as-received basis. In addition, “[w]ith prior agreement, the sponsor may
request review of less than one of the [technical sections] listed above.” Id. at 14.
Thus, sponsors may submit technical sections as they are completed or, by agreement,
they may submit “useful pieces of technical sections.” Id. at 13. When FDA completes
its review of a technical section, it sends the sponsor a “complete letter” for that section.
Once the sponsor compiles all of its complete letters, it may submit an administrative
NADA. The administrative NADA incorporates by reference all of the complete letters
and contains additional administrative information. In phased review, FDA marks the
beginning of the approval phase as the date that the sponsor submits the administrative
NADA.
FDA described phased review as a more “streamlined” process than traditional
review. CVM Phased Review Policy at 2. It summarized the choice between traditional
and phased review as follows:
If the sponsor wants to work interactively with each specialty group within
the Office of New Animal Drug Evaluation, then the data should be
submitted to the INAD for review. If the sponsor wants to submit all the
information at one time and receive a coordinated, comprehensive
response on the adequacy of all the data, the sponsor should submit an
NADA.
Id. at 1. FDA further explained that in phased review, submissions would not be
funneled through a primary reviewer; the sponsor would retain responsibility for
ensuring the compatibility of the technical sections. Id. at 2. FDA further explained that
“[t]he interrelationships between supporting data should be thoughtfully considered
when the sponsor elects to request phased review.” Id. at 17. FDA indicated that
phased review “should speed the drug development process.” Id. at 2.
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When a sponsor opts for phased review, it may switch over to traditional review
by filing a NADA. As explained by FDA, “[m]ost sponsors find it useful to use the more
fluid INAD structure during early development and, as more of the data is acceptable to
CVM [Center for Veterinary Medicine], an NADA is filed.” Id. at 2. The NADA may
incorporate by reference any complete letters that the sponsor has already received. Id.
Once FDA receives a NADA (either traditional or administrative), it evaluates the
application and determines whether to approve the drug. Filing an administrative NADA
will generally result in a much shorter approval period because FDA has already
completed review of the technical sections.
II. Cydectin
Wyeth sought and received FDA approval to market Cydectin for the treatment
and control of internal and external parasites in beef and dairy cattle. The regulatory
review period for Cydectin spanned nearly eight years. It began on April 5, 1990, when
at Wyeth’s request, FDA established an INAD file for Cydectin, marking the beginning of
the testing phase. Wyeth submitted various investigational information to FDA,
including information on drug formulation and protocols for clinical studies. On August
8, 1995, Wyeth opted for phased review and submitted its first technical section, which
addressed Residue Chemistry. In 1995 and 1996, Wyeth submitted technical sections
concerning Effectiveness, Manufacturing, Public Safety, and Target Animal Safety. By
agreement with FDA, Wyeth submitted its final technical section, Environmental Safety,
in three modules. Wyeth submitted the first of these modules on August 14, 1996. It is
unclear when Wyeth submitted the second and third modules. FDA ultimately approved
each section, and by January 13, 1998, Wyeth had received all of its complete letters.
2009-1368 5
Wyeth submitted an administrative NADA that same day. FDA approved Wyeth’s
NADA 16 days later on January 28, 1998.
The active ingredient in Cydectin, moxidectin, is claimed in U.S. Patent No.
4,916,154 (the ’154 patent), which issued on April 10, 1990. 1 On March 27, 1998,
Wyeth sought a patent term extension for the ’154 patent based on the regulatory
review period for Cydectin. According to Wyeth, this was the first patent term extension
request based on a NADA submitted via phased review. Wyeth attached a
memorandum to its request setting forth its position that it initially submitted a NADA for
Cydectin on August 8, 1995, when it submitted its first technical section (Residue
Chemistry). Wyeth argued in the alternative that it initially submitted a NADA no later
than August 14, 1996, when it submitted one component of its last technical section
(Environmental Safety).
The United States Patent and Trademark Office (PTO) requested FDA’s
assistance in determining whether Cydectin had been subject to regulatory review
within the meaning of 35 U.S.C. § 156(g). FDA informed the PTO that Cydectin had
been subject to regulatory review within the meaning of § 156(g). 2 FDA further
informed the PTO that Cydectin experienced a regulatory review period of 2,857 days,
beginning on April 5, 1990, and ending on January 28, 1998. FDA stated that of this
review period, 2,841 days occurred during the testing phase and 16 days occurred
during the approval phase. Based on these numbers, the PTO calculated a patent term
extension of 1,434 days, representing one half of the testing phase (exclusive of six
1
The ’154 patent is assigned on its face to Wyeth’s predecessor, American
Cyanamid Company, referred to herein as Wyeth.
2009-1368 6
days occurring prior to the issuance of the ’154 patent) plus the entire approval phase
(calculated as (2,841 – 6)/2 + 16).
Wyeth asked FDA to revise its determination of the regulatory review period.
Wyeth reiterated its position that it had initially submitted its NADA on August 8, 1995,
when it submitted its first technical section (Residue Chemistry). Wyeth reasoned that
at that point, FDA had sufficient information to commence its review.
FDA denied Wyeth’s request. It set forth its position that “the approval phase for
purposes of patent term extension begins when the marketing application is complete,
including all technical sections and the CVM complete letters.” J.A. 232. It explained
that “[a]lthough this approach can result in a very short approval phase, it is most
consistent with the idea that alternative drug development and review approaches are
intended to permit the applicant to respond to FDA input as the application is
developed, making FDA’s review more efficient, and shortening the time required for
review of the application.” Id. FDA further explained that the technical sections are
submitted to the INAD file, not to the NADA file, and thus FDA conducts its review of
these components as part of the testing phase. FDA therefore concluded that the
approval phase in phased review begins with the submission of an administrative
NADA. Id.
Wyeth filed a complaint in the United States District Court for the District of
Columbia challenging FDA’s interpretation of the date that its NADA was initially
submitted and seeking injunctive and declaratory relief under the Administrative
Procedure Act (APA), 5 U.S.C. §§ 701-706. FDA moved to dismiss or alternatively for
2
The PTO initially requested information from FDA on May 5, 1998. FDA,
2009-1368 7
summary judgment, and Wyeth cross-moved for summary judgment. The district court
granted FDA’s motion and entered judgment for FDA. Wyeth appeals that judgment.
We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
DISCUSSION
We review the district court’s grant of summary judgment de novo, applying the
same standard as the district court. Immunocept, L.L.C. v. Fulbright & Jaworski, L.L.P.,
504 F.3d 1281, 1286 (Fed. Cir. 2007). “Summary judgment is appropriate when there is
no genuine issue as to any material fact and the moving party is entitled to judgment as
a matter of law.” Id.
We review FDA’s decisions under the APA. See Mylan Labs., Inc. v. Thomson,
389 F.3d 1272, 1279 (D.C. Cir. 2004). We must uphold FDA’s decision unless it is
“arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”
5 U.S.C. § 706(2)(A).
This appeal concerns statutory interpretation, a matter of law that we review de
novo. See Glaxo Operations UK Ltd. v. Quigg, 894 F.2d. 392, 395 (Fed. Cir. 1990).
“Ordinarily we review an agency’s interpretation of a statute it is charged with
implementing under the familiar and deferential two-part framework of Chevron U.S.A.
Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 104 S. Ct. 2778, 81 L.Ed.2d 694
(1984).” Mylan, 389 F.3d at 1280.
Under Chevron, we first determine “whether Congress has directly spoken to the
precise question at issue.” Chevron, 467 U.S. at 842. If the intent of Congress is clear,
we must give effect to the unambiguously expressed intent of Congress. Id. at 843.
however, did not respond. The PTO sent an additional request on September 10, 2003.
2009-1368 8
However, “[i]f the statute is silent or ambiguous with respect to the specific issue, the
question for the court is whether the agency’s answer is based on a permissible
construction of the statute.” Id.
I. Chevron Step 1
We first address whether Congress spoke to the precise issue, specifically,
whether the date that a sponsor submits an administrative NADA marks the beginning
of the approval phase when the sponsor opts for phased review.
The district court concluded that the date an application is initially submitted for
purposes of 35 U.S.C. § 156(g) is ambiguous. The court noted that the parties agreed
that the approval phase begins when an application is initially submitted under 21
U.S.C. § 360b(b), but they disagreed over the proper interpretation of when an
application is initially submitted. The court explained that the parties emphasized
different text in support of their positions, with FDA contending that no “application”
exists prior to the submission of an administrative NADA, and Wyeth contending that an
application is “initially submitted” upon submission of the first technical section. Wyeth,
607 F. Supp. 2d at 31. The court determined that both parties had advanced plausible
interpretations. Id. The court reviewed the text of § 156(g) and determined that it
contained “no clear indication of Congressional intent because the statute defines
neither ‘application’ nor ‘initially submitted.’” Id. The court looked to the text of 21
U.S.C. § 360b(b) and determined that although it set forth requirements for the parts of
an application, “this section does not define ‘application’ or speak to the issue of when
an ‘application’ is ‘initially submitted.’” Id. The court also reviewed the legislative history
and noted that it provided little clarity. Id. at 32. The court concluded that in light of its
text, context, and legislative history, § 156(g) was ambiguous.
2009-1368 9
On appeal, Wyeth argues that the statutory text and legislative history
demonstrate that an application is initially submitted when a sponsor submits its first
technical section. Wyeth contends that the ordinary meaning of the term “initially”
makes clear that an application is initially submitted before it is complete, noting that
§ 156(g) does not require the sponsor to completely or finally submit an application.
Wyeth asserts that the legislative history supports its position, citing to a House Report
that states: “As long as the application was complete enough so that agency review
could be commenced, it would be considered to be ‘initially submitted.’” H.R. Rep. 98-
457, pt. 1, 44 (1984). Wyeth thus asserts that an application is initially submitted when
a sponsor submits its first technical section because at that point, FDA may commence
its review. Wyeth argues in the alternative that, at the very latest, an application is
initially submitted when the sponsor submits its last technical section because,
according to Wyeth, at that point, FDA has received all of the parts of an application
required by 21 U.S.C. § 360b(b). Finally, as discussed in the next section, Wyeth
argues that even if the text does not unambiguously support one of its interpretations,
we should not defer to FDA’s interpretation because it is not reasonable.
FDA argues that the statutory text compels FDA’s interpretation that an
application is initially submitted when the sponsor files an administrative NADA. FDA
explains that, contrary to Wyeth’s point of view, the date that it may commence review
of individual technical sections is irrelevant. According to FDA, for purposes of 35
U.S.C. § 156(g), what matters is the date that FDA may commence review of an
application meeting the requirements of 21 U.S.C. § 360b(b). FDA asserts that the
administrative NADA is the first document submitted to FDA that contains all of the parts
2009-1368 10
required by 21 U.S.C. § 360b(b). Thus, it argues that prior to the submission of an
administrative NADA, the sponsor has not initially submitted an application for purposes
of 35 U.S.C. § 156(g). In the alternative, FDA asserts that even if we conclude that the
statutory text is ambiguous, we should defer to its interpretation because it is
reasonable.
We agree with the district court that the plain language does not clearly indicate
when an application is initially submitted under 35 U.S.C. § 156(g). Section 156(g)
defines the regulatory review period as the sum of two periods, which the parties refer
to as the testing phase and the approval phase. See 35 U.S.C. § 156(g)(1)(B)(ii). The
testing phase covers:
the period beginning on the earlier of the date a major health or
environmental effects test on the drug was initiated or the date an
exemption under subsection (j) of section 512 [21 U.S.C. § 360b] became
effective for the approved new animal drug product and ending on the
date an application was initially submitted for such animal drug product
under section 512.
Id. at § 156(g)(4)(B). The approval phase covers:
the period beginning on the date the application was initially submitted for
the approved animal drug product under subsection (b) of section 512 and
ending on the date such application was approved under such section.
Id. Section 156(g) does not define the term application, however, it refers to an
application initially submitted under 21 U.S.C. § 360b(b). Thus, for purposes of
§ 156(g), an application must contain the information required by 21 U.S.C. § 360b(b).
Section 360b(b) requires that an application for a new animal drug include certain
categories of information, such as information on drug safety, efficacy, and
manufacturing.
2009-1368 11
In light of this requirement, we reject Wyeth’s argument that § 156(g)
unambiguously indicates that an application is initially submitted when a sponsor
submits its first technical section. A technical section addresses only one substantive
area, such as Residue Chemistry. A technical section does not contain all of the
information required by § 360b(b) and therefore it can not constitute “an application” for
purposes of 35 U.S.C. § 156(g). This interpretation conflicts with the statutory
language.
Although 21 U.S.C. § 360b(b) lists the required parts of an application, it does not
indicate whether an application must contain or reference all of the required information
in a single document (as asserted by FDA) or whether an application may be an
assemblage of technical sections submitted by the sponsor (as asserted by Wyeth).
Contrary to Wyeth’s assertion, the legislative history by no means renders the statutory
language unambiguous. We agree with the district court that both parties advanced
plausible interpretations, and we conclude that § 156(g) is ambiguous. 3
II. Chevron step 2
“If we conclude that ‘Congress either had no intent on the matter, or that
Congress’s purpose and intent is unclear,’ then we proceed to step two, in which we ask
‘whether the agency’s interpretation is based on a permissible construction of the
statutory language at issue.’” Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1338 (Fed.
Cir. 2008) (citations omitted).
3
Notably, Congress enacted § 156(g) in 1988, before FDA began offering
sponsors the option of phased review. See Generic Animal Drug and Patent Term
Restoration Act, Pub. L. No. 100-670 (1988) (adding 35 U.S.C. § 156(g) to the statute).
2009-1368 12
Because the text of § 156(g) is ambiguous with regard to when an application is
initially submitted, we must determine whether FDA’s interpretation falls within the
permissible range of interpretations left open by the statute. As an initial matter, we
note that our inquiry is on the permissibility of FDA’s interpretation, not Wyeth’s.
Wyeth’s assertion that an application should be deemed initially submitted when the
sponsor submits its final technical section may be reasonable if, as Wyeth asserts, FDA
has received all of the information required by § 360b(b). 4 However, “a court must defer
to an agency’s reasonable interpretation of a statute and must not substitute its own
judgment for that of the agency even if the court might have preferred another
interpretation and even if the agency's interpretation is not the only reasonable one.”
Wheatland Tube Co. v. United States, 495 F.3d 1355, 1360-61 (Fed. Cir. 2007). We
thus limit our analysis to the permissibility of FDA’s interpretation.
The district court determined that FDA’s “construction runs true to the text and
defines ‘initially submitted’ in a manner ‘that is reasonable in light of the legislature’s
revealed design.’” Wyeth, 607 F. Supp. 2d at 33 (citation omitted). It therefore
concluded that FDA’s interpretation was not an impermissible construction of the
statute. Id.
4
We note that, at least in the present case, Wyeth’s assertion that FDA has
all of the information required by 21 U.S.C. § 360b(b) when the sponsor submits its final
technical section may not be true. Wyeth states that it submitted its final technical
section on August 14, 1996. However, per agreement with FDA, Wyeth submitted its
final technical section as three modules. It submitted the first module on August 14,
1996, and it is not clear when it submitted the remaining two modules. Thus, we do not
agree that a sponsor necessarily submits all of the information required by § 360b(b)
when it submits its final technical section (or more specifically, as here, when it submits
the first of three modules of its final technical section).
2009-1368 13
On appeal, Wyeth argues that FDA’s interpretation impermissibly contravenes
the purpose of § 156(g). Wyeth notes that Congress sought to provide “[a] year-for-year
matching extension . . . for any time the drug approval process that the drug spends
awaiting a decision by the FDA.” H.R. Rep. 98-457, pt. 2, 4 (1984). Wyeth explains
that Congress initially considered providing patentees with a day-for-day extension for
the entire regulatory review period, but later struck a balance between the competing
interests of pioneer and generic drug manufacturers by dividing the review period into
two phases and providing a half-time extension for the testing phase. Wyeth argues
that FDA’s interpretation shifts time from the approval phase to the testing phase,
upsetting the balance.
FDA asserts that this is the trade-off for choosing the more fluid review process.
Phased review allows sponsors to “work interactively with each specialty group within
the Office of New Animal Drug Evaluation.” CVM Review Policy at 1. A sponsor may
seek review of individual technical sections or “useful pieces of technical sections,”
rather than delaying review until all information required by § 360b(b) is ready for
submission. Id. at 13. By contrast, in the more regimented traditional review, “all
submissions were funneled into the Center through a ‘primary’ reviewer who
coordinated the Center’s interaction with, and responses to, the sponsor.” Id. at 2. As a
result of its more “streamlined” process, phased review provides for potentially faster
approval and market entry. However, because the sponsor works directly with
individual CVM sections in phased review, FDA’s first notice that a sponsor believes it
has submitted all of the parts required by § 360b(b) occurs when the sponsor submits
an administrative NADA. At that point, according to FDA, it has an application that it
2009-1368 14
may review for approval. Under FDA’s interpretation, the approval phase is quite
short—here, 16 days. Treating these days as part of the testing rather than approval
phase results in a shorter patent term extension; however, if phased review does result
in a faster overall process, there is less delay in the process and quicker market entry.
A sponsor weighs these factors and decides whether to pursue phased or traditional
review.
FDA further notes that a sponsor may choose to pursue the more fluid phased
review during early development and file a traditional NADA later in the process. Id. at
2. A traditional NADA may reference technical sections that FDA has already reviewed
in the phased review program.
We conclude that FDA’s interpretation is permissible. Section 156(g) created a
range of ambiguity by not explicitly defining the term “application,” leaving that term
open to interpretation. FDA’s interpretation tracks the requirements of 21 U.S.C.
§ 360b(b). As explained by FDA, the administrative NADA is the first document
containing or referencing all of the parts required by 21 U.S.C. § 360b(b). Thus, it is
permissible to characterize the administrative NADA as the first application submitted
for purposes of 35 U.S.C. § 156(g). Because the administrative NADA is the first
application submitted, it is reasonable to interpret the date that it is submitted as the
“initially submitted” date. Prior to the submission of an administrative NADA, no
application has been submitted, initially or otherwise. Thus, FDA’s interpretation
“reasonably resolves the ambiguity in applying the relevant statutes to a factual situation
not fully foreseen or provided for by the Congress when it enacted the statutes or the
FDA when it promulgated regulations.” Mylan, 389 F.3d at 1284. It is permissible to
2009-1368 15
interpret § 156(g) to mean that “an application” is “initially submitted” when a sponsor
submits an administrative NADA in phased review.
Wyeth’s policy considerations regarding the shift in time between the testing
phase and the approval phase do not require a different result. Whatever balance may
have been struck envisioned traditional review, not phased review. A sponsor may now
choose to work more interactively with FDA using the more fluid phased review process
and submitting information, including testing data, to FDA on a rolling basis. It follows
that with this change in the review process, the respective lengths of the testing phase
and the approval phase have also changed.
III. APA Challenge
Wyeth argues that even if FDA’s interpretation is permissible, it is arbitrary and
capricious because it conflicts with FDA’s interpretation of the approval phase for new
human drugs in FDA’s “fast track” program. The district court determined that FDA’s
interpretation was not arbitrary and capricious for the same reasons that it concluded
FDA’s interpretation was permissible under Chevron. Wyeth, 607 F. Supp. 2d at 33. In
addition, the court noted that Wyeth’s claim that FDA’s treatment of animal drugs was
inconsistent with its treatment of human drugs had “no merit” because phased review is
not available for human drugs. Id. at 33 n.9.
The fast track program differs from the phased review program in many respects.
First, fast track sponsors must submit “a schedule for submission of information
necessary to make the application complete.” 21 U.S.C. § 356(c)(1)(A). If FDA agrees,
then the sponsor may submit portions of its application on a rolling basis. Guidance for
Industry, Fast Track Drug Development Program – Designation, Development, and
Application Review, 13, available at
2009-1368 16
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
nces/UCM079736.pdf (Fast Track Guidance). When the sponsor submits all of the
required information, it informs FDA that its application is complete. Id. at 14. FDA
marks the beginning of the approval phase when it receives notice that the fast track
application is complete. FDA asserts that this is consistent with its interpretation of the
approval phase in phased review, which also begins on the date that FDA first receives
notice that the application is complete. We perceive no inconsistency between FDA’s
interpretations. We conclude that the FDA interpretation challenged by Wyeth is not
arbitrary and capricious.
CONCLUSION
For reasons stated above, we affirm the judgment of the district court.
AFFIRMED
2009-1368 17