United States District Court, District of Columbia
BERMAN JACKSON, United States District Judge.
Perrigo Research & Development Company
("Perrigo") brings this action against defendant
United States Food and Drug Administration ("FDA")
under the Administrative Procedure Act ("APA"), 5
U.S.C. §§ 501-706, the Food, Drug & Cosmetic
Act ("FDCA"), 21 U.S.C. § 301, et
seq., and the Declaratory Judgment Act, 28 U.S.C.
§§ 2201-02. It seeks redress for FDA's refusal
to answer Perrigo's request to confirm that a Consent
Judgment and Decree entered on September 20, 2017 is legally
insufficient to trigger the running of a 75-day period during
which Perrigo must begin marketing its product or risk
forfeiting its eligibility for a 180-day period of generic
drug marketing exclusivity. See Compl. [Dkt. # 1]
¶¶ 2-3. Perrigo claims in Count I that the FDA has
violated the APA by "fail[ing] to act, " and that
therefore, this Court should step in and rule on the question
Perrigo posed to the agency. Id. ¶¶ 32-34.
In Count II, it asks the Court to enter a declaratory
judgment stating that the Consent Judgment and Decree did not
trigger the 75-day period under the statute. Id.
Perrigo has failed to allege a violation of the APA,
defendant's motion to dismiss Count I will be granted.
And without a viable claim under the APA and in the absence
of a case or controversy, the Court lacks subject matter
jurisdiction to issue a declaratory judgment under Count II,
so that count will also be dismissed.
FDCA requires all new drugs to be approved by the FDA before
they are introduced into interstate commerce. 21 U.S.C.
§ 355(a). It provides two primary pathways for obtaining
approval: (1) the new drug application ("NDA"),
described in section 355(b); and (2) the abbreviated new drug
application ("ANDA") for generic products, set
forth in section 3550). The NDA procedure requires the
applicant to conduct a spectrum of safety and effectiveness
tests and to inform FDA of the results. See 21
U.S.C. § 355(b)(1). It also requires the applicant to
file information about any patents filed in connection with
the drug. See Id. Once the drug is approved, it is
referred to as a "listed drug." See 21
C.F.R. § 314.3(b).
added the truncated ANDA approval process to the FDCA as part
of the 1984 Hatch-Waxman amendments, which sought "to
make available more low cost generic drugs" by providing
a pathway that was less costly and time consuming than the
NDA process. Serono Labs., Inc. v. Shalala, 158 F.3d
1313, 1316 (D.C. Cir. 1998), quoting H.R. Rep. No. 98-857,
pt. 1, at 14 (1984). A drug manufacturer that follows the
ANDA pathway may rely on research conducted by a third party
- the maker of the listed drug - in order to meet the
approval requirements. See 21 U.S.C. §§
355(b)(2), j(2)(A). ANDA applicants must file information
showing that the conditions of use, active ingredient, route
of administration, dosage form, strength, and labeling of the
generic drug are "the same as" those of the listed
drug that was previously approved. 21 U.S.C. §§
355G)(2)(A)(i)-(iii), (v). They are thereby relieved of the
obligation to perform the extensive testing to demonstrate
safety and effectiveness that is the hallmark of the NDA
process. See § 355(b)(1)(A).
protect the patent rights of the makers of the listed drugs,
ANDA applicants must provide one of four
"certifications" for "each patent which claims
the listed drug . . . or which claims a use for such listed
drug for which the application is seeking approval."
§ 355(j)(2)(A)(vii); see also Andrx Pharms., Inc. v.
Biovail Corp. Int'l, 256 F.3d 799, 802 (D.C. Cir.
2001). Thus, for each relevant patent, ANDA applicants must
(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.
§ 355G)(2)(A)(vii)(I)-(IV). FDA may approve an ANDA
containing either of the first two certifications effective
immediately, § 355(])(5)(B)(i), and it may approve an
ANDA containing the third type of certification to be
effective as of the relevant patent's expiration date.
§ 355(])(5)(B)(ii). But the filing of the fourth type of
certification - referred to as a "paragraph IV
certification" - is an act of patent infringement on the
part of the ANDA applicant, see 35 U.S.C. §
271(e)(2)(A), and it can trigger patent infringement
litigation. The FDCA requires an ANDA applicant to notify the
patent holder of the filing of a paragraph IV certification,
21 U.S.C. § 355G)(2)(B), and the patent holder has 45
days from the receipt of notice to bring suit against the
applicant. § 355G)(5)(B)(iii). If the patent holder does
not file a lawsuit within that time period, the ANDA will
become effective immediately. Id.
FDCA provides an incentive and reward to generic drug
applicants willing to expose themselves to the litigation
risk. It grants the "first applicant" - the
applicant that is first to file a substantially complete ANDA
that contains and lawfully maintains a paragraph IV
certification to a listed patent - an opportunity to be the
only generic product in the market competing with the listed
drug for a period of time. See §§
3550)(5)(B)(iv)(II)(aa), (bb). During this 180-day period of
marketing exclusivity, FDA may not approve any competing
generic version of the drug if the ANDA for the subsequent
applicant also contains a paragraph IV certification.
See § 355G)(5)(B)(iv)(I). The 180-day period
begins to run when the first applicant begins marketing the
product. See id.
applicant can forfeit its 180-day exclusivity period, thereby
opening the market to other generic drug manufacturers.
See § 3550)(5)(D). A first applicant forfeits
its eligibility for 180-day generic exclusivity if it fails
to market the drug within certain time periods prescribed in
the statute. § 355(])(5)(D)(i)(I). Under the FDCA, a
forfeiture event occurs if a first applicant fails to market
the drug by the later of two dates. The parties agree that
the only date relevant to this dispute is the second
"bookend" date, which is defined as follows:
(bb) with respect to the first applicant or any other
applicant (which other applicant has received tentative
approval),  the date that is 75 days after the date as
of which, as to each of the patents with respect to which the
first applicant submitted and lawfully maintained a
certification qualifying the first applicant for the 180-day
exclusivity period ... at least 1 of the following has
(AA) In an infringement action brought against the applicant
with respect to the patent or in a declaratory judgment
action brought by that applicant with respect to the patent,
a court enters a final decision from which no appeal (other
than a petition to the Supreme Court for a writ of
certiorari) has been or can be taken that the patent is
invalid or not infringed.
(BB) In an infringement action or a declaratory judgment
action described in subitem (AA), a court signs a settlement
order or consent decree that enters a final judgment that
includes a finding that the patent is invalid or not
specific provision at issue in this dispute is (bb)(BB),
under which a first generic applicant can forfeit its 180-day
exclusivity period if it fails to market the drug within 75
days of a consent decree in the second applicant's
lawsuit against the patent holder.
March 30, 2012, Perrigo submitted an ANDA for approval to
market a generic version of AstraZeneca's Prilosec OTC
Delayed-Release Tablets. Compl. ¶ 4. Perrigo's ANDA
included paragraph IV certifications for both U.S. patents
listed in the Orange Book for AstraZeneca's drug.
Id. ¶ 5. FDA approved Perrigo's ANDA on
July 30, 2015, and it informed Perrigo that it was eligible
for 180-day marketing exclusivity because it was the first
company to file a substantially complete ANDA for the product
with a paragraph IV certification. Id. ¶ 6.
While more than two years have gone by, Perrigo has not yet
marketed its generic omeprazole magnesium drug product.
16, 2016, FDA granted tentative approval to a second ANDA
filed by Aurobindo Pharma Limited and Aurobindo Pharma Inc.
(collectively, "Aurobindo") for Omeprazole
Magnesium Tablets (OTC). Compl. ¶ 8. Aurobindo's
application cannot receive final approval "until the
expiration of Perrigo's 180-day generic exclusivity,
unless Perrigo forfeits that exclusivity." Id.
August 18, 2016, Aurobindo filed an action against
AstraZeneca in the United States District Court for the
District of New Jersey under 21 U.S.C. § 3550)(5)(C),
the FDCA provision authorizing civil actions for patent
certainty. See Aurobindo Pharma Ltd. v. AstraZeneca
AB, No. 3:16-cv-05079 (D.N.J. Aug. 18, 2016). It sought
a declaratory judgment that Aurobindo's omeprazole
magnesium product does not infringe the two unexpired patents
listed in the Orange Book for Prilosec OTC, or that those
patents are invalid. See id; Certification of Marc
D. Youngelson [Dkt. # 8] ("Youngelson
Certification") ¶ 3; Ex. A to Youngelson
Certification [Dkt. # 8] ("Aurobindo Compl."). In
its complaint, Aurobindo specifically referenced its need to
obtain a judgment that would trigger the 75-day period in
which Perrigo would have to begin marketing its omeprazole
magnesium AND A product to avoid forfeiture of its
eligibility for 180-day exclusivity. See Aurobindo
Compl. ¶¶ 34, 48, 50, 53.
court entered a Consent Judgment and Decree in the Aurobindo
lawsuit on September 20, 2017, ...