United States District Court, District of Columbia
RANDOLPH D. MOSS UNITED STATES DISTRICT JUDGE
Teva Pharmaceuticals USA, Inc. (“Teva”) brings
this action to obtain “immediate injunctive and
declaratory relief” barring the Food and Drug
Administration (“FDA”) from “depriving
[Teva] of its statutory right to 180 days of marketing
exclusivity for its generic version of the brand-name drug
Restasis®.” Dkt. 1 at 2 (Compl. ¶ 1). Teva
seeks a preliminary injunction. Dkt. 2. The FDA and
intervenor defendants-Mylan Pharmaceuticals Inc.
(“Mylan”), Deva Holding AS (“Deva”),
and Famy Care Private Limited (“Famy Care”)-
oppose that motion and move to dismiss the case for lack of
subject matter jurisdiction. Dkt. 25; Dkt. 27. Because Teva
has failed to demonstrate that it has standing, the Court
will DENY Teva's motion for a
preliminary injunction and will GRANT the
defendants' motions to dismiss for lack of standing.
Statutory and Regulatory Background
Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C.
§ 301 et seq., sets forth the procedures that
manufacturers must follow to obtain FDA approval to sell
pharmaceutical products. To obtain approval for a brand-name
or pioneer drug, a pharmaceutical manufacturer must file a
New Drug Application (“NDA”) demonstrating the
drug's safety and efficacy using scientific data.
Id. §§ 355(a)-(b). The NDA must also
include “the patent number and the expiration date of
any patent . . . 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). If the patent is
issued after the NDA is filed, the applicant or holder of the
approved NDA must notify the FDA of the patent number and
expiration date. Id. § 355(c)(2). The FDA then
lists this patent information in the “‘Orange
Book: Approved Drug Products with Therapeutic Equivalence
Evaluations' or, as it is commonly known, simply the
‘Orange Book.'” Amneal Pharms. LLC v.
FDA, 285 F.Supp.3d 328, 332 (D.D.C. 2018).
to 1984, companies that manufactured generic medicines, like
Teva, also had to file NDAs supported by full investigative
studies. See Serono Labs., Inc. v. Shalala, 158 F.3d
1313, 1316 (D.C. Cir. 1998) (recognizing that “the NDA
process, ” which is “costly and time-consuming,
” impedes the “availab[ility] of low cost generic
drugs”). In 1984, however, Congress enacted the Drug
Price Competition and Patent Term Restoration Act, Pub. L.
No. 98-417, 98 Stat. 1585 (1984), popularly known as the
“Hatch-Waxman Amendments.” Among other things,
the Amendments were designed “to increase competition
in the drug industry by facilitating the approval of generic
copies of drugs.” Mead Johnson Pharm. Grp. v.
Bowen, 838 F.2d 1332, 1333 (D.C. Cir. 1988). To that
end, the Amendments eliminated the requirement that generic
manufacturers submit full NDAs and allowed generic
manufacturers to “seek FDA approval by submitting an
abbreviated new drug application (‘ANDA').”
Serono Labs., Inc., 158 F.3d at 1316; see
also 21 U.S.C. § 355(j). Under the ANDA process, a
manufacturer may “piggyback on the original
manufacturer's evidence of safety and efficacy, ”
Teva Pharms. USA, Inc. v. Leavitt, 548 F.3d 103, 104
(D.C. Cir. 2008), and need demonstrate only that the generic
drug has the same active ingredient(s), route of
administration, dosage form, conditions of use, and strength
as the approved drug, and that the generic drug has an
appropriate label and is bioequivalent to the approved drug.
See 21 U.S.C. § 355(j)(2)(A); id.
§ 355(j)(4). Although far less demanding than the full
NDA process, “obtaining FDA approval for an ANDA
remains a prolonged” and demanding “task, ”
which “can take years to complete.” Amneal
Pharms. LLC, 285 F.Supp.3d at 333.
must also contain one of four certifications “with
respect to each” of the Orange Book patents claimed by
the brand-name drug. 21 U.S.C. § 355(j)(2)(A)(vii). The
four certifications are as follows:
(I) that such patent information has not been filed [a
“Paragraph I certification”],
(II) that such patent has expired [a “Paragraph II
(III) of the date on which such patent will expire [a
“Paragraph III certification”], 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 [a “Paragraph IV
Id. A generic applicant may not enter the market
until every patent in the Orange Book implicated by the
generic product has expired, unless it files a Paragraph IV
certification. See Mylan Pharms., Inc. v.
FDA, 789 F.Supp.2d 1, 3 (D.D.C. 2011) [hereinafter
generic applicant submits a Paragraph IV certification in its
original ANDA, the applicant must provide notice to the
patent owner and holder of the approved NDA “not later
than 20 days after the date” on which the FDA
“informs the [ANDA] applicant that the [ANDA] has been
filed.” 21 U.S.C. § 355(j)(2)(B)(ii)(I). The FDA
issues an acknowledgement letter informing an applicant that
its ANDA has been “received” after it reviews the
ANDA and concludes that the application is sufficiently
complete to permit substantive review. 21 C.F.R. §
314.101(b)(2); see also SB Pharmco P.R., Inc. v. Mutual
Pharm. Co., 552 F.Supp.2d 500, 507 (E.D. Pa. 2008). When
an applicant submits a Paragraph IV certification through
“an amendment or supplement to the”
applicant's ANDA, the applicant must notify the patent
owner and holder of the NDA “at the time at which the
[ANDA] applicant submits the amendment or supplement”
to the FDA. 21 U.S.C. § 355(j)(2)(B)(ii)(II).
filing of an ANDA containing a Paragraph IV certification is
treated as an act of patent infringement. 35 U.S.C. §
271(e)(2)(A); see also Eli Lilly & Co. v. Medtronic,
Inc., 496 U.S. 661, 677-78 (1990). If the patent owner
fails to sue for infringement within forty-five days of
receiving notice, the generic applicant may bring a
declaratory judgment action against the patent owner. 21
U.S.C. § 355(j)(5)(C)(i)(I)(aa). If, however, the patent
owner brings an infringement action, the FDA's approval
of the ANDA “shall be made effective upon the
expiration of the thirty-month period beginning on the date
of the receipt of” the required notice to the patent
owner and holder of the NDA. Id. §
355(j)(5)(B)(iii). This period is referred to as the
“thirty-month stay.” Eli Lilly & Co. v.
Teva Pharms. USA, Inc., 557 F.3d 1346, 1348-49 (Fed.
Cir. 2009). During this time, the agency is limited to
issuing “tentative approval”-a
“notification . . . that [an] application . . . meets
the requirements [for approval]. . . but cannot receive
effective approval” because of a patent issue or
outstanding period of exclusivity. 21 U.S.C. §
355(j)(2)(B)(iv)(II)(dd). If the ANDA applicant prevails in
district court before the thirty-month stay expires, the FDA
may immediately approve the ANDA. Id. §
355(j)(5)(B)(iii)(I). The thirty-month stay is unavailable,
moreover, if the relevant patent was listed after the ANDA
was submitted. Id. § 355(j)(5)(B)(iii).
patent litigation is both expensive and risky, Congress
created an incentive to encourage generic manufacturers to
submit well-founded Paragraph IV certifications. See Teva
Pharms. USA, Inc. v. Sebelius, 595 F.3d 1303, 1318 (D.C.
Cir. 2010) [hereinafter “Teva v.
Sebelius”]. The statute provides that the
“first applicant”-that is, the first generic
manufacturer to file a “substantially complete”
ANDA containing a Paragraph IV certification and to
“lawfully maintain” that certification-is
entitled to 180 days of generic market exclusivity. 21 U.S.C.
§ 355(j)(5)(B)(iv). A “substantially
complete” ANDA is defined as an application that is
“sufficiently complete” on “its face”
to “permit a substantive review” and that
“contains all the [requisite] information.”
Id. § 355(j)(5)(B)(iv)(II)(cc). The FDA
represents that it does not designate a first applicant until
it is ready to approve the first ANDA. See Dkt. 26
at 9. At that time, if the first applicant is approved and
ready to go to market, it is entitled to 180 days of generic
exclusivity. When more than one generic manufacturer meets
the definition of “first applicant, ” the
manufacturers will share the right to exclude other generics
(but not each other) from the market.
FDCA, however, contains six “forfeiture events”
under which a first applicant may forfeit eligibility for the
180-day exclusivity period. Under the first, forfeiture
occurs if the first applicant “fails to market the
drug” by a certain date. Id. §
355(j)(5)(D)(i)(I). As is relevant here, that date is 75 days
after “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, ” holding that
“the patent [listed in the Paragraph IV certification]
is invalid or not infringed.” Id. §
355(j)(5)(D)(i)(I)(bb)(AA). Forfeiture also occurs if the
first applicant withdraws its ANDA or the FDA
“considers the application to have been
withdrawn” because it does not meet the requirements
for approval, id. § 355(j)(5)(D)(i)(II); the
first applicant “amends or withdraws the certification
for all of the patents with respect to which [the] applicant
submitted a certification qualifying [it] for the 180-day
exclusivity period, ” id. §
355(j)(5)(D)(i)(III); the first applicant “fails to
obtain tentative approval of the application within 30 months
after the date on which the application is filed” and
that delay was not “caused by a change in or a review
of the requirements for approval of the application imposed
after the date on which the application was filed, ”
id. § 355(j)(5)(D)(i)(IV); the first applicant
enters into “an agreement with another applicant[, ] .
. . the holder of the application for the listed drug, or an
owner of the patent that is the subject of the [Paragraph IV]
certification” and that agreement is found to violate
antitrust laws, id. § 355(j)(5)(D)(i)(V); or
“[a]ll of the patents as to which the applicant
submitted a certification qualifying it for the 180-day
exclusivity period have expired, ” id. §
355(j)(5)(D)(i)(VI). The FDCA further provides that, if all
first applicants forfeit their exclusivity, then “no
applicant shall be eligible for the 180-day exclusivity
period.” Id. § 355(j)(5)(D)(iii)(II).
case concerns the 180-day exclusivity period for the generic
version of Restasis®, a drug used to stimulate tear
production. Dkt. 1 at 2 (Compl. ¶ 1). In 2017, the
brand-name manufacturer of Restasis®, Allergan, Inc.
(“Allergan”), earned more than $1.4 billion in
net revenues for the drug. Id. at 12 (Compl. ¶
21). Teva estimates that the 180-day exclusivity period for
the generic version, cyclosporine ophthalmic emulsion
(“cyclosporine”), is worth “more than $50
million dollars in net revenues.” Dkt. 1-1 at 8 (Groff
Decl. ¶ 14).
alleges that it qualifies as the “first
applicant” to submit a Paragraph IV certification for
Restasis® and that, as a result, it is entitled to 180
days of generic exclusivity. Dkt. 1 at 2 (Compl. ¶ 1).
Teva fears, however, that its statutory right will be
extinguished once the FDA applies the interpretation of
“first applicant” it recently espoused in a
letter decision relating to another drug. Dkt. 1 at 25
(Compl. ¶ 41). To avoid that loss, Teva seeks a
declaratory judgment that (1) the FDA's interpretation of
“first applicant” in that letter decision is
invalid under the Administrative Procedure Act
(“APA”) and that (2) Teva is entitled to the
180-day exclusivity period. Id. at 37 (Compl.
Prayer). Teva also seeks to enjoin the FDA from
“approving any [ANDA] that references Restasis® . .
. other than Teva's ANDA” during the pendency of
this litigation unless that ANDA meets Teva's definition
of “first applicant.” Dkt. 2-2 at 2. The relevant
events are as follows:
ANDA Submissions and Patent Litigation
received FDA approval to market Restasis®, a pioneer drug
to treat dry eye, on December 23, 2002. Dkt. 1 at 17 (Compl.
¶ 29). Allergan originally listed two patents associated
with Restasis® in the Orange Book: U.S. Patent No. 4,
839, 342 (“the ‘342 patent”) and No. 5,
474, 979 (“the ‘979 patent”). Id.
The ‘342 patent expired on August 2, 2009, and the
‘979 patent expired on May 17, 2014. Id.
Shortly before the ‘979 patent expired, Allergan added
five new Restasis®-related patents to the Orange Book,
beginning with U.S. Patent No. 8, 629, 111 (“the
‘111 patent”), which issued on January 14, 2014.
Dkt. 26-1 at 4 (Ex. A) (Cyclosporine Comment Request). In
February 2016, Allergan added a sixth patent. Dkt. 27-1 at 13
n.4; see also Allergan, Inc. v. Teva Pharms. USA,
Inc., No. 2:15-cv-1455, 2017 WL 4803941, at *12 (E.D.
Tex. Oct. 16, 2017) (Bryson, J., sitting by designation). The
‘111 patent is the subject of the Paragraph IV
certification at issue here.
filed its ANDA for cyclosporine on January 23, 2012. Dkt. 1
at 17 (Compl. ¶ 30). At the time, the “only
unexpired patent listed in the Orange Book” for
Restasis® was the ‘979 patent. Id. That
patent was due to expire in May 2014, and Teva filed a
Paragraph III certification, indicating that it intended to
enter the market after the ‘979 patent
expired. Id. (Compl. ¶¶ 29, 30). Once Teva
submitted its ANDA, the FDA began “its customary
pre-filing review . . . for ‘substantial
completeness.'” Id. at 18 (Comp. ¶
31) (citing 21 U.S.C. § 355(j)(5)(B)(iv)(II)(cc)).
Pursuant to the FDA's regulations, the agency “may
not consider an ANDA to be received” if the application
is incomplete “on its face.” 21 C.F.R. §
314.101(d)(3). According to Teva, the FDA's initial
review of its ANDA was “plagued by
irregularities.” Dkt. 1 at 18 (Compl. ¶ 31). Teva
alleges that the FDA failed to act on its ANDA for nearly
fifteen months. Id. at 17-18 (Compl. ¶¶
30-31). The agency then allegedly delayed the review process
further by requesting “additional information from
Teva, ” “nearly all of which had been provided in
Teva's original ANDA.” Id. Finally, the
FDA issued a letter “notif[ying] Teva that it was
refusing” to receive “the company's ANDA,
” id. (Compl. ¶ 32)-a decision the agency
later rescinded in June 2015, id. at 21 (Compl.
Teva “was considering its response to the [FDA's
letter], ” the Patent and Trademark Office issued the
‘111 patent. Id. at 19-20 (Compl. ¶ 34).
That same day-January 14, 2014-Teva amended its ANDA to
include a Paragraph IV certification with respect to the
'111 patent. Id. at 20 (Compl. ¶ 35).
Although the FDCA requires an ANDA applicant to provide
notice of a Paragraph IV certification at the same time it
“submits [an] amendment or supplement” to its
ANDA, see 21 U.S.C. § 355(j)(2)(B)(ii)(II),
Teva “informed the FDA” that it would wait until
“[the] FDA reversed its . . . decision and received
Teva's ANDA for review, ” citing the
“FDA's judicially-affirmed rule” that
“legally-required notice will be considered
timely-provided only . . . after [the] FDA's
acknowledgment letter receiving [the] ANDA” is issued.
Dkt. 1 at 21 (Compl. ¶ 36) (citing Allergan, Inc. v.
Actavis, Inc., Nos. 14-cv-638 & 14-cv-188, 2014 WL
7336692, at *11-12 (E.D. Tex. Dec. 23, 2014)). On July 9,
2015, thirty months after Teva submitted its ANDA, the FDA
issued a formal acknowledgment letter deeming Teva's ANDA
“received . . . as of January 23, 2012.”
Id. (Compl. ¶ 37). Teva, in turn, timely
dispatched its Paragraph IV notices to Allergan and the
‘111 patentees. Id. at 22 (Compl. ¶ 37).
Teva also filed Paragraph IV certifications with respect to
the five other Restasis® patents and timely effected
notice. Dkt. 27-1 at 13; see also Allergan, Inc. v. Teva
Pharms. USA, Inc., 2017 WL 4803941, at *12, *15.
to Teva, there are at least eight other known ANDA applicants
for cyclosporine. Dkt. 1-1 at 8 (Groff Decl. ¶ 14). The
FDA has indicated that “[o]ne or more” ANDAs
containing “[P]aragraph IV certifications to the
‘979 patent” were submitted “before January
14, 2014.” Dkt 26-1 at 4 (Ex. A) (Cyclosporine Comment
Request). No. applicant in this group, however, received an
acknowledgment letter from the FDA before “the
‘979 patent expired.” Id. In addition,
four generic manufacturers confirmed that they have pending
ANDAs for cyclosporine in public submissions to the FDA, all
of which presumably reference the ‘111 patent.
See Dkt. 26-2 (Ex. B) (InnoPharma, Inc.); Dkt. 26-3
(Ex. C) (Apotex Inc.); Dkt. 26-4 (Ex. D) (Axar
Pharmaceuticals); Dkt. 26-6 (Ex. F) (Akorn Pharmaceuticals).
Finally, the intervenors Mylan, Deva, and Famy Care have all
represented that they filed ANDAs for generic cyclosporine.
Dkt. 6-1 at 3 (Mylan); Dkt. 10-1 at 5 (Deva); Dkt. 33-1 at
6-7 (Famy Care).
August 2015, Allergan filed suit against Teva (and other
Paragraph IV ANDA applicants) for infringing the six
unexpired Restasis® patents listed in the Orange Book.
See Allergan, Inc. v. Teva Pharms. USA, Inc., 2017
WL 4803941, at *12. Allergan granted the defendants a
covenant not to sue for two of the patents. Id. at
*15. The district court then invalidated the remaining four
patents, including the ‘111 patent. See Id. at
*65. Allergan appealed the district court's decision,
and, on November 13, 2018, the Federal Circuit summarily
affirmed the district court's decision. See Allergan,
Inc. v. Teva Pharms. USA, Inc., 742 Fed.Appx. 511 (Fed.
Cir. 2018). Allergan then petitioned for panel rehearing and
rehearing en banc. Dkt. 104, Allergan, Inc. v. Teva
Pharms. USA, Inc., No. 18-1130 (Fed. Cir. Dec. 21,
2018). That petition is still pending.
FDA Proceedings Regarding the 180-Day ...