UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
WYETH HOLDINGS CORP., et al.,
Plaintiffs,
v.
Civil Action 08-00981 (HHK)
UNITED STATES DEPARTMENT OF
HEALTH AND HUMAN SERVICES, et
al.,
Defendants.
MEMORANDUM OPINION
Wyeth Holdings Corporation and Wyeth (“Wyeth”) bring this action against defendants
U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and others
(together, “FDA”) under the Administrative Procedure Act, 5 U.S.C. § 551 et seq. (“APA”)
seeking a longer patent term extension for their animal drug product (“Cydectin”) than that which
the FDA has provided. Before the court are the FDA’s motion to dismiss or alternatively for
summary judgment [#22], and Wyeth’s cross-motion for summary judgment [#32]. Upon
consideration of the cross-motions, the oppositions thereto, and the record of this case, the court
concludes that the FDA’s motion to dismiss or alternatively for summary judgment must be
granted and that Wyeth’s motion for summary judgment must be denied.
I. BACKGROUND
Before a new animal drug may be marketed its sponsor must submit, and the FDA must
approve, a New Animal Drug Application (“NADA”). The NADA process proceeds in two
phases. First, the applicant must conduct testing and an investigation concerning the drug
(“Testing Phase”) with respect to seven “technical sections” and submit its findings to the FDA.1
Second, the FDA must evaluate and approve the technical sections (“Approval Phase”), and
thereby approve the drug. The sponsor may submit the technical sections together (triggering
“Traditional Review”) or in stages (triggering “Phased Review”). In Traditional Review, the
Testing Phase ends and the Approval Phase begins when the sponsor completes its investigation
and submits all of the technical sections as its final NADA. In Phased Review, the sponsor
submits the technical sections on a rolling basis into an Investigational New Animal Drug file
(“INAD File”). The FDA then evaluates the sections on a rolling basis, issuing a “Complete
Letter” as to each one. Once the FDA has approved all the technical sections, the sponsor may
submit the final NADA, known as the Administrative NADA.2 In a Phased Review, it is less
clear when the Testing Phase ends and the Approval Phase begins. It is this uncertainty that
presents the question that underlies this action. It is a pivotal question because certain animal
drug patents, such as the one in this case, are eligible for a patent term extension if patent life was
lost while the drug was under regulatory review. The extension length is half of the Testing
Phase, 35 U.S.C. §§ 156(c)(2) and (g)(4)(B)(i), plus all of the Approval Phase, not exceeding five
years, see 35 U.S.C. § 156(g)(4)(B)(ii).
1
The seven technical sections are: Chemistry; Manufacturing and Controls;
Effectiveness; Target Animal Safety; Human Food Safety; Environmental Impact; Labeling;
Freedom of Information Summary; and All Other Information.
2
“An ‘Administrative NADA’ is a new animal drug application that is submitted after all
of the technical sections that fulfill the requirements for the approval of the new animal drug
under 21 C.F.R. § 514.1 have been reviewed by the Center for Veterinary Medicine and the
CVM has issued a technical section complete letter for each of those technical sections.” U.S.
Dept. of Health and Human Services, Food and Drug Administration, Center for Veterinary
Medicine (CVM), The Administrative New Animal Drug Application Process: Guidance for
Industry, FDA000107-14, FDA000109 (Nov. 6, 2002) (“Guidance #132”).
2
In March 1990, Wyeth asked the FDA to establish an INAD File for Cydectin, a drug
designed to treat and control parasites in beef and dairy cattle. In April 1990, the FDA
established the INAD File, which initiated the Administrative NADA process for Cydectin as a
Phased Review. Wyeth submitted the first technical section (Chemistry) for Cydectin in August
1995. The FDA issued a Complete Letter for this section in December 1997. Thereafter, Wyeth
submitted each technical section. For the duration of the Phased Review, there was no time
when a technical section was not pending; thus, there was no lag in the submission of technical
sections. (See Pl. Mot. for Summ. J. [#32], at 15.) In August 1996, Wyeth submitted the final
technical section (Environmental Impact), and the FDA issued a Complete Letter for it in
December 1997. At that time, however, at least one other section (Public Safety) was still
pending, and the FDA requested supplemental information from Wyeth. By January 1998,
Wyeth had submitted all the necessary technical information, and the FDA issued the final
Complete Letter on January 13, 1998. Wyeth submitted the Administrative NADA for Cydectin
that same day. On or about January 28, 1998, the FDA issued the marketing approval letter for
Cydectin.
The dispute in this case arises in connection with Wyeth’s application for a patent term
extension based on the regulatory review process for Cydectin. The FDA determined that the
Testing Phase began on April 5, 1990, (the date the FDA established the INAD file), and that the
Approval Phase began on January 13, 1998, (the date Wyeth submitted the Administrative
NADA). The FDA thus determined the Testing Phase was 2,841 days, and the Approval Phase
was 16 days. Based on these determinations, the U.S. Patent and Trademark Office (“PTO”)
extended the Cydectin patent from April 10, 2007, to March 14, 2011 — an extension of nearly
3
four years. Wyeth disputed the FDA’s determinations and thus the length of its patent term
extension. Accordingly, Wyeth filed a Request for Revision of the Regulatory Review Period
with the FDA. Specifically, Wyeth contended that the Approval Phase began upon submission of
the first technical section in August 1995, and that the Cydectin patent should be extended from
April 10, 2007, until January 28, 2012 — approximately ten months longer than Wyeth’s current
extension. Alternatively, Wyeth contended that the Approval Phase began no later than upon
submission of its final technical section in August 1996, which would extend the patent until
November 26, 2011 — approximately eight months longer than Wyeth’s current extension. The
FDA denied Wyeth’s request. Wyeth now seeks a court order that would set aside the FDA’s
final determination of the regulatory review period for Cydectin.
II. ANALYSIS
The sole question before the court is the following question of law: whether the FDA
rightly decided that the Approval Phase began upon submission of the Administrative NADA for
Cydectin. Because the court must review this question under the APA, the court only will set
aside the FDA’s decision if it finds that decision to be “arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with the law.” 5 U.S.C. § 706(2)(A). Applying this
standard, the court turns to the following statutory provisions, which establish when the
Approval Phase for Cydectin began, and thus determine the appropriate length of the patent term
extension for Cydectin:
(g) For the purposes of this section, the term regulatory review period has the
following meanings:
***
4
(4)(A) In the case of a product which is a new animal drug, the term
means the period described in subparagraph (B) to which the
limitation in paragraph (6) applies:
(B) The regulatory review period for a new animal drug product is
the sum of –
(i) [Testing Phase] 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 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, and
(ii) [Approval Phase] 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.
35 U.S.C. § 156(g)(4) (emphasis added).3
The parties and the court agree that in reviewing this question of statutory interpretation,
the court must follow the two-step inquiry set forth in Chevron U.S.A. Inc. v. Natural Resources
Defense Council, Inc., 467 U.S. 837, 842-43 (1984). Under Chevron, the court first inquires as
3
As discussed in Section I, supra, any patent term extension would include all of the
Approval Phase but only half of the Testing Phase:
(c) The term of a patent eligible for extension under subsection (a) shall be extended
by the time equal to the regulatory review period for the approved product which
period occurs after the date the patent is issued, except that--
(2) after any reduction required by paragraph (1), the period of extension shall
include only one-half of the time remaining in the periods described in paragraphs
(1)(B)(i), (2)(B)(i), (3)(B)(i), (4)(B)(i), and (5)(B)(i) of subsection (g); . . .
35 U.S.C. § 156(c)(2).
5
to “whether Congress has directly spoken to the precise question at issue.” Id. at 842. “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.” Id. at 842-43. Second, “[if] the
court determines [that] Congress has not directly addressed the precise question at issue, the
court does not simply impose its own construction on the statute . . . .” Id. at 843. “Rather, if the
statute is silent or ambiguous with respect to the specific issue, the question for the court is
whether the [FDA’s interpretation] is based on a permissible construction of the statute.” Id. If
the FDA’s interpretation “fills a gap or defines a term in a way that is reasonable in light of the
legislature's revealed design, [the court gives] the FDA’s judgment ‘controlling weight.’”
NationsBank of N.C. v. Variable Annuity Life Ins. Co., 513 U.S. 251, 257 (1995) (quoting
Chevron, 467 U.S. at 844).
A. Chevron Step One
The FDA determined that the Approval Phase for Cydectin began on January 13, 1998,
the date on which Wyeth submitted the Administrative NADA. The FDA contends that this
interpretation follows from the unambiguous language of 35 U.S.C. § 156(g)(4)(B)(ii).
Specifically, the FDA emphasizes that the Approval Phase does not commence until “the
application [i]s initially submitted . . . for the approved animal drug product under subsection (b)
of section 512 [of the Food, Drug, and Cosmetic Act (“FDCA”).” Id. (emphasis added).
According to the FDA, an application does not constitute an “application” within the meaning of
section 512 of the FDCA, 21 U.S.C. § 360b(b), unless it contains all of the information, samples,
6
and specimens that are required for FDA approval.4 See 21 U.S.C. § 360b(b); see also 21 C.F.R.
§ 514.1(b) (describing application as consisting of all required technical sections). Accordingly,
the FDA contends that an “application” is not “initially submitted” under the Phased Review
process until the FDA confirms all technical sections are complete and the applicant submits an
Administrative NADA.
Wyeth counters that the Approval Phase corresponds to the entire period of time that the
FDA actually spends performing its substantive review of an application, not just the amount of
time required to review an Administrative NADA. According to Wyeth, this interpretation
follows from the unambiguous language of 35 U.S.C. § 156(g)(4)(B)(ii). Specifically, Wyeth
4
Section 512(b) of the FDCA provides:
(1) Any person may file with the Secretary an application with respect to any
intended use or uses of a new animal drug. Such person shall submit to the Secretary
as a part of the application (A) full reports of investigations which have been made
to show whether or not such drug is safe and effective for use; (B) a full list of the
articles used as components of such drug; (C) a full statement of the composition of
such drug; (D) a full description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of such drug; (E) such
samples of such drug and of the articles used as components thereof, of any animal
feed for use in or on which such drug is intended, and of the edible portions or
products (before or after slaughter) of animals to which such drug (directly or in or
on animal feed) is intended to be administered, as the Secretary may require; (F)
specimens of the labeling proposed to be used for such drug, or in case such drug is
intended for use in animal feed, proposed labeling appropriate for such use, and
specimens of the labeling for the drug to be manufactured, packed, or distributed by
the applicant; (G) a description of practicable methods for determining the quantity,
if any, of such drug in or on food, and any substance formed in or on food, because
of its use; and (H) the proposed tolerance or withdrawal period or other use
restrictions for such drug if any tolerance or withdrawal period or other use
restrictions are required in order to assure that the proposed use of such drug will be
safe . . . .
21 U.S.C. § 360b(b).
7
emphasizes that the Approval Phase does not commence until “the application [i]s initially
submitted . . . for the approved animal drug product under subsection (b) of section 512 [of the
FDCA].” 35 U.S.C. § 156(g)(4)(B)(ii) (emphasis added). According to Wyeth, Congress has
explained that an application is initially submitted when an applicant submits sufficient
information to allow the FDA to commence its substantive review:
[The term “initially submitted”] is used instead of the term “filed” because an
application is often not considered to be filed, even though agency review has begun,
until the agency has determined that no other information is needed and a decision
on the application can be made. For purposes of determining the regulatory review
period and its components periods, an application for agency review is considered to
be “initially submitted” if the applicant has made a deliberate effort to submit an
application containing all information necessary for agency review to begin. The
Committee recognizes that the agency receiving the application might decide it needs
additional information or other changes in the application. As long as the application
was complete enough so that the agency action could be commenced, it would be
considered to be “initially submitted.”
H.R. Rep. No. 98-857, pt. 1, at 44 (1984). Wyeth also points out that the review of an
Administrative NADA does not require the FDA to perform a substantive review at all because
an applicant only may submit an Administrative NADA after the FDA already has approved all
the technical sections. Thus, according to Wyeth, the FDA’s interpretation effectively would
read the word “initially” out of the statutory text thereby instituting a “filing” requirement rather
than an “initially submitted” requirement, which Wyeth contends is contrary to Congress’s intent.
Pointing to the same Report, the FDA argues that the legislative history supports its
reading that an application is not an “application” unless all technical sections are complete:
For purposes of determining the regulatory review period and its component periods,
an application for agency review is considered to be “initially submitted” if the
applicant has made a deliberate effort to submit an application containing all
information necessary for agency review to begin.
8
H.R. Rep. No. 98-857, pt. 1, at 44 (1984) (emphasis added). The FDA asks the court to interpret
this section as evidencing Congress’s intent that the submission of partial information to an
INAD File, such as one technical section, could not begin the Approval Phase because the
Approval Phase cannot begin until an “application contain[s] all information necessary for
agency review to begin.” Id. This argument notwithstanding, the FDA also contends that
Wyeth’s reliance on H.R. Rep. No. 98-857 is misplaced because the House Report was issued in
1984 and pertains only to Traditional Review considering that Phased Review was not instituted
until five years later in 1989.
Although the parties agree that the Approval Phase commences when “the application [i]s
initially submitted for the approved animal drug product under [21 U.S.C. § 360b(b)],” 35 U.S.C.
§ 156(g)(4)(B)(ii), they disagree as to the proper interpretation of this statutory provision and
emphasize different text therein in support of their positions: the FDA contends that there was
no “application” until Wyeth submitted its Administrative NADA; and Wyeth contends that the
application was “initially submitted” upon its submission of the first technical section.5 Because
the court finds that both parties have advanced plausible readings of the statute at issue, the court
holds that the statute is ambiguous.
The court begins by looking to the plain text of the provision at issue — 35 U.S.C. §
156(g)(4)(B)(ii). See U.S. Dep’t of Treasury v. Fabe, 508 U.S. 491, 500 (1993); Stewart v. Nat’l
Shopmen Pension Fund, 730 F.2d 1552, 1561 (D.C. Cir. 1984). There, the court finds no clear
5
Wyeth seeks to allay any concerns that, under its interpretation, nearly any filing would
trigger the approval process by noting that the FDA may reject a deficient technical section, (see
FDA000004; FDA000019), and that only those periods during which an applicant is acting with
reasonable diligence are included in a patent term extension, see 35 U.S.C. § 156(c)(1).
9
indication of congressional intent because the statute defines neither “application” nor “initially
submitted.” Looking to 21 U.S.C. § 360b(b), the court acknowledges the FDA’s position that
this section sets forth the required “part[s] of the application,” but this section does not define
“application” nor does it speak to the issue of when an “application” is “initially submitted.”
Indeed, the words “initially submitted” suggest that something less than a complete or final
application may be sufficient to trigger the Approval Phase. Yet, the statute does not plainly
state that it must be so.
Because the court cannot discern the meaning of the provision at issue from its plain text,
the court must look beyond the text to “examine the meaning of certain words or phrases in
context and also ‘exhaust the traditional tools of statutory construction, including examining the
statute’s legislative history to shed new light on congressional intent’[.]” Sierra Club v. E.P.A.,
551 F.3d 1019, 1027 (D.C. Cir. 2008) (quoting Am. Bankers Ass’n v. Nat’l Credit Union Admin.,
271 F.3d 262, 267 (D.C. Cir. 2001)). Considering the context and legislative history of the
statutory provision at issue, however, provides little clarity. As the parties have shown, the court
may read H.R. Rep. No. 98-857, pt. 1, at 44 (1984) to support either of their interpretations.
Accordingly, the court holds that 35 U.S.C. § 156(g)(4)(B)(ii) is ambiguous based on its text,
context, and legislative history.6
6
Wyeth also relies on certain regulations in support of its contentions with respect to
Chevron step one. (Pl. Mot. Summ. J. [#32], at 23-29 (citing 21 C.F.R. §§ 60.22(f) and
514.1(a).) Wyeth does not explain, however, how FDA regulations that were promulgated after
the enactment of 35 U.S.C. § 156(g)(4)(B)(ii) should bear on the court’s interpretation of that
statute under Chevron step one. Nevertheless, the court has examined these regulatory
provisions and determined that they, like the statutory provisions at issue, are sufficiently
ambiguous to allow the FDA’s interpretation that the Approval Phase commences upon
submission of an Administrative NADA. The court reaches this conclusion having given due
consideration to the significant deference that courts must afford to an agency’s interpretation of
10
B. Chevron Step Two
The FDA contends that even if the court were to find that 35 U.S.C. § 156(g)(4)(B)(ii) is
ambiguous, the court should defer to the FDA’s reasonable interpretation of the statute. In
addition to reiterating its arguments with respect to Chevron Step One, the FDA advances
numerous policy arguments,7 and it contends that its interpretation reflects long-standing practice
and precedent.8 Wyeth argues that even if the court finds that § 156(g)(4)(B)(ii) is ambiguous,
the court must find the FDA’s interpretation to be unreasonable and thus unworthy of deference.
In addition to reiterating its arguments with respect to Chevron Step One, Wyeth argues that it is
its own regulation. Capital Network Sys., Inc. v. FCC, 28 F.3d 201, 206 (D.C. Cir. 1994)
(observing that the deference afforded to an agency’s interpretation of its own regulation may be
greater than the deference afforded to an agency’s interpretation of a statute it is entrusted to
administer).
7
Specifically, the FDA contends that its interpretation is entitled to deference because
the FDA reasonably balanced the complex policy considerations of patent term restoration and
Phased Review. The FDA contends that the purpose of Phased Review is to create greater
efficiencies in the approval process for new drugs thereby allowing them to enter the market
faster. The trade-off, according to the FDA, is that drugs which in the Phased Review process
generally receive a shorter patent term extension because the Approval Phase for an
Administrative NADA is far shorter than the Approval Phase for a traditional NADA. The FDA
argues that accepting Wyeth’s interpretation would frustrate the policy balance by allowing
Phased Review applicants not only to bring their drugs to market faster but also to increase their
patent term extension by a disproportionally-long Approval Period. Wyeth discounts these
policy objectives and accuses the FDA of supporting its interpretation with non-existent
distinctions between the Traditional and Phased Review processes. The court cannot sustain
Wyeth’s efforts to undercut the FDA’s policy arguments because it finds that the FDA’s
construction of 35 U.S.C. § 156(g)(4)(B)(ii) does not “frustrate the policy that Congress sought
to implement.” Shays v. Fed. Election Comm’n, 528 F.3d 914, 919 (D.C. Cir. 2008) (quoting
Cont’l Air Lines, Inc. v. Dep’t of Transp., 843 F.2d 1444, 1453 (D.C. Cir. 1988)).
8
The FDA points out that it has consistently determined that the Approval Phase begins
upon submission of the Administrative NADA, and that such determinations have produced
similarly short Approval Phases: Neutersol (34 days); Anipryl (54 days); Ivomec (17 days).
(Defs.’ Mot. to Dismiss [#22], at 8.)
11
inconsistent for the FDA to admit it is engaging in substantive review by issuing a Complete
Letter while maintaining that the Approval Phase has not yet begun. Such an interpretation,
according to Wyeth, effectively carves out the entire period of substantive review from the
Approval Phase and runs contrary to congressional intent to credit the entire substantive review
period toward patent term restoration.9 The FDA rejoins that Wyeth’s interpretation conflates the
Approval Phase with the Testing Phase. In particular, the FDA points out that Wyeth cannot
deny that while it submitted a technical section as early as 1995, Wyeth continued its
investigation and testing with respect to other sections through 1998. Thus, according to the
FDA, Wyeth’s interpretation would have the court declare that the Testing Phase ended at a time
when the bulk of the requisite testing still remained to be done.
Under Chevron step two, Wyeth bears the burden of showing that the FDA’s
interpretation is unreasonable. See Sweet Home Chapter of Communities for a Great Oregon v.
Babbitt, 17 F.3d 1463, 1473 (D.C. Cir. 1994), rev’d on other grounds, 515 U.S. 687 (1995).
Wyeth has not met its burden here because the court finds the FDA’s arguments to be more
persuasive than those made by Wyeth. Indeed, the 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.” NationsBank, 513 U.S. at 257. Accordingly, the court cannot say that the FDA’s
interpretation is based on an impermissible construction of the statute, nor can the court find that
the FDA’s interpretation violates the APA. See Chevron, 467 U.S. at 843; 5 U.S.C. § 706(2)(A).
9
Wyeth also contends that the FDA’s treatment of animal drugs is inconsistent with its
treatment of human drugs, which is contrary to Congressional intent that they be treated
similarly. The FDA counters that there is no merit to this allegation because Phased Review is
not available for human drugs. The court agrees with the FDA.
12
III. CONCLUSION
For the foregoing reasons, FDA’s motion to dismiss or alternatively for summary
judgment [#22] is GRANTED and Wyeth’s cross-motion for summary judgment [#32] is
DENIED.
An appropriate order accompanies this Memorandum Opinion.
Henry H. Kennedy, Jr.
United States District Judge
13