The opinion of the court was delivered by: JAMES ROBERTSON, District Judge
Plaintiff Alphapharm Pty Limited challenges the Food and Drug
Administration's ("FDA") refusal to list the `884 patent for
citalopram (brand name Celexa®) in its Orange Book and FDA's
related refusal to receive Alphapharm's abbreviated new drug
application ("ANDA") for review. Before the Court are the
parties' cross-motions for summary judgment. For the reasons
stated below, defendant's motion must be granted, plaintiff's
cross-motion denied, and the case dismissed.
The Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et
seq., prohibits the introduction into interstate commerce of any
new drug unless FDA approves a New Drug Application ("NDA") for
that drug. See 21 U.S.C. § 355(a). An NDA must include "the
patent number and the expiration date of any patent which claims
the drug for which the applicant submitted the application or which claims a method of using such drug and with
respect to which a claim of patent infringement could reasonably
be asserted if a person not licensed by the owner engaged in the
manufacture, use, or sale of the drug." Id. § 355(b)(1); see
also id. § 355(c)(2) (addressing patent information that could
not be submitted before NDA approval). An applicant must amend an
NDA application "[i]f . . . a patent which claims such drug or a
method of using such drug is issued after the filing date but
before approval of the application." Id. § 355(b)(1). If FDA
approves the application, it must publish this information in the
"`Orange Book,' an FDA publication that includes all patent
information that companies have submitted to the agency."
Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 880 (D.C. Cir.
2004); see also 21 U.S.C. § 355(j)(7)(A)(ii) (requiring FDA to
update patent information in the Orange Book every 30 days).
In 1984, Congress enacted the "Hatch-Waxman" amendments to the
FDCA in order to expedite the process by which drug manufacturers
can obtain FDA approval of generic versions of already-approved
brand-name drugs, see Drug Price Competition and Patent Term
Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984);
Purepac, 354 F.3d at 879. "[T]he amendments allow companies
seeking such approval to submit Abbreviated New Drug
Applications, known as ANDAs, that `piggyback' on the
safety-and-effectiveness information that the brand-name manufacturers submitted in their NDAs." Purepac, 354 F.3d at
879 (citing 21 U.S.C. § 355(j)(2)(A); 21 C.F.R. § 314.94(a)(3)).
Lest drug innovation be discouraged, the Hatch-Waxman
amendments provide that NDA applicants may obtain exclusivity
periods for innovative drugs. During those exclusivity periods,
FDA may not accept or approve ANDAs for generic versions that
rely for approval on the innovative drug. See
21 U.S.C. § 355(c)(3)(E)(ii)-(iv); id. §§ 355(j)(5)(F)(ii)-(iv). A
five-year exclusivity period is granted to an NDA holder "for a
drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under [§ 355(b)]," although an ANDA applicant may
submit an application referencing a listed drug after four years
if the NDA holder of the drug has submitted patent listing
information for the drug pursuant to 21 U.S.C. § 355(b)(1) or
(c)(2). 21 U.S.C. § 355(j)(5)(F)(ii); see also
21 C.F.R. § 314.101(b), (e); 21 C.F.R. § 314.108(b)(2). A six-month extension
of a marketing exclusivity period may be granted for the
submission, at FDA's request, of studies about whether pediatric
use of the new drug will produce health benefits in that
population. See 21 U.S.C. § 355a.
The Hatch-Waxman amendments also "create[d] a strong incentive
for a generic competitor to be the first to file an ANDA and
receive FDA approval: a 180-day period of marketing exclusivity vis-à-vis other generic competitors." Valley Drug
Co. v. Geneva Pharms., Inc., 350 F.3d 1181, 1185 n. 10 (11th
Cir. 2003). "In other words, the first filer to receive FDA
approval is entitled to market the generic versions of the drug
for 180 days without competition from any other generic drug
manufacturers." Id.; see also 21 U.S.C. § 355(j)(5)(B)(iv).
However, "[l]ike NDAs, ANDAs must address patents that cover or
might cover the relevant drugs." Purepac, 354 F.3d at 879. For
each patent, ANDA applicants must file one of four
"certifications" explaining why the ANDA should be approved
despite a patent's claim on the drug: "[A] certification, in the
opinion of the applicant and to the best of his knowledge, with
respect to each patent which claims the listed drug . . . (I)
that such patent information has not been filed, (II) that such
patent has expired, (III) of the date on which such patent will
expire, or (IV) that such patent is invalid or will not be
infringed by the manufacture, use, or sale of the new drug for
which the application is submitted." Id.;
21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV). (The last certification is known as a
"paragraph IV" certification).
The facts presented by the instant case are these: FDA approved
Forest Laboratories, Inc.'s NDA application for citalopram (under
the brand name of Celexa®) on July 17, 1998. Forest was awarded a
five-year period of marketing exclusivity for an innovative drug under 21 U.S.C. § 355(j)(5)(F)(ii), and a
six-month pediatric exclusivity under 21 U.S.C. § 355a. In its
NDA application, Forest included patent information on three
patents. See Defs.' Mem., at 11. Before its application was
approved, however, Forest sent a letter to FDA discussing the
three patents and amending its application to declare that "there
are no patents which claim the drug or the drug product or which
claim a method of using the drug product and with respect to
which a claim of patent infringement could reasonably be
asserted. . . ." Admin. R., tab 1, at 2.
After the NDA was approved, Forest sent another letter to FDA,
again referencing the three patents mentioned in its application,
but also adding a reference to a fourth the `884 patent. Id.,
tab 2, at 2. This letter concluded with a declaration that "none
of these patents are relevant to [its] approved NDA," and, as
stated in the previous letter, that "there are no patents which
claim the drug or the drug product or which claim a method of
using the drug product and with respect to which a claim of
patent infringement could reasonably be asserted. . . ." Id.
The `884 patent had been issued and assigned to H. Lundbeck A/S
on March 17, 1987. As with NDAs, patents may be extended up to
five years if the patented item was subject to regulatory review
by FDA before the item was marketed. See 67 Fed. Reg. 8,546, 8,546 (Feb. 25, 2002); see also Drug Price
Competition and Patent Term Restoration Act of 1984, Pub.L.
98-417; Generic Animal Drug and Patent Term Restoration Act, Pub.
L. 100-670. In September 1998, Lundbeck filed an application with
the Patent and Trademark Office ("PTO") for a patent term
extension. In response to a request for additional information
from the PTO, Lundbeck stated:
Applicant has demonstrated that the preparation of
the citalopram intermediate . . .; the citalopram
intermediate itself . . .; and the process or
converting the citalopram intermediate to citalopram,
are used in the manufacture of the approved product.
Compl., Ex. C, at 2. The PTO then requested FDA's assistance in
determining the `884 patent's eligibility for an extension. See
67 Fed. Reg. at 8,547. Thereafter, FDA advised the PTO that the
human drug product patented at `884 "had undergone a regulatory
review period and that the approval of Celexa represented the
first permitted commercial marketing or use of the product."
Id. The PTO then requested that FDA determine the product's
regulatory review period, and FDA responded that the applicable
regulatory review period for Celexa is 5,498 days. Id.; Compl.,
Ex. D, at 1. FDA published notice of its findings and, receiving
no objection, informed the PTO that its determination was final.
See Compl., Ex. E.
On December 6, 2002, Alphapharm sent a letter to FDA requesting
that the `884 patent be listed in the Orange Book. See Admin. R., tab 3, at 1. Alphapharm argued that the FDCA
requires an NDA holder to submit to FDA for listing in the Orange
Book "any patent which claims the drug for which the applicant
submitted the application . . . and with respect to which a claim
of patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture, use or sale
of the drug," id. (quoting 21 U.S.C. § 355(b)(1)), and that
patent `884 claims the drug citalopram. Alphapharm stated:
The `884 patent was assigned by the inventor . . .
[to] H. Lundbeck A/S, which in turn has licensed the
rights to make, use and sell the drug citalopram
under this patent in the United States to the U.S.
pharmaceutical manufacturer Forest Laboratories, Inc.
. . .
[Lundbeck's] application for an extension of the term
of the `884 patent: (a) constitutes a representation
by the patent owner to the PTO that the `884 patent
claims the drug citalopram; and (b) demonstrates the
patent owner's reliance on this interpretation. . . .
Id., at 2 (emphasis omitted). Alphapharm also attached a letter
from Forest, and said of it that it "constitutes evidence that
Forest, the NDA holder and licensee under the `884 patent,
believes that the `884 patent (a) claims the drug citalopram and
(b) could reasonably be asserted against an unauthorized person
or entity engaged in the manufacture, use or sale of citalopram."
Id. (emphasis omitted). Alphapharm concluded its letter by
stating that "Forest Laboratories should have submitted
statutorily required patent information to FDA for the `884
patent, and has failed to do so." Id. On December 16, 2002, FDA sent a letter to Forest, attaching
Alphapharm's letter and requesting that Forest provide it with
"written confirmation that the challenged data is correct or not
correct pertaining to [its] Celexa NDA," and with "any
corrections that need to be made to the patent and exclusivity
information" relating to listing in the Orange Book. Id., tab
4. Forest responded on January 14, 2002, stating in a letter to
the submission of patent information for Celexa is
accurate, and complies with the requirements of
U.S.C. § 355(b)(1) and 21 C.F.R. § 314.50(h) and §
314.53(b). In addition, all of the information in the
Request for Patent Term Extension for U.S. Patent No.
[`884] is accurate.
U.S. Patent No. [`884] is eligible for Patent Term
Extension pursuant to 35 U.S.C. § 156, but is not eligible
for Orange Book listing (because it claims an
intermediate of citalopram hydrobromide and a method
of its manufacture).
Id., tab 5. FDA forwarded this response to Alphapharm. FDA did
not (and continues not to) list the `884 patent in the Orange
Four and a half years after approval of Forest's NDA, (on
January 17, 2003), Alphapharm submitted an ANDA application for
generic citalopram. The application included a paragraph IV
certification of invalidity and noninfringement of the `884
patent. On March 20, 2003, FDA informed Alphapharm that the
ANDA would not be received for substantive review
pursuant to 21 C.F.R. § 314.101(b)(1), because (a)
the application contained a paragraph IV
certification against the `884 patent which the agency had declined
to include in the Orange Book; and (b) only an ANDA
with a paragraph IV certification against a listed
patent could be received during the [five and a half]
year combined [innovative drug and pediatric]
exclusivity period awarded to this particular
reference listed drug.
Compl., Ex. I, at 3. Thereafter, Alphapharm sent FDA four letters
requesting reconsideration of its decision not to list the `884
patent and not to accept Alphapharm's ANDA. FDA responded on
September 16, 2003, again declining to list the `884 patent or to
receive Alphapharm's ANDA, and stating that, "[u]nless a patent
is listed for Celexa, no applicant may submit an ...