Teva Pharmaceuticals USA, Inc. v. Azar, II ( 2019 )

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
TEVA PHARMACEUTICALS USA, INC.,
Plaintiff,
v. Civil Action No. 18-2394 (RDM)
ALEX M. AZAR, II, et al.,
Defendants.
MEMORANDUM OPINION
Plaintiff 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.
I. BACKGROUND
A. Statutory and Regulatory Background
The 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).
Prior 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
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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.
An ANDA 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 certification”],
(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 certification”].
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 “Mylan”].
When a 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
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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).
The 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).
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Because 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.
The 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
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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).
B. Factual Background
This 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).
Teva 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
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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:
1. ANDA Submissions and Patent Litigation
Allergan 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.
Teva 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
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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. ¶ 37).
While 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
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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.
According to Teva, there are at least eight other known ANDA applicants for
cyclosporine. 1 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).
In 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
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Pursuant to agency regulation, the FDA “will not publicly disclose the existence of an
application or [ANDA] before an approval letter is sent . . . or tentative approval letter is
sent . . . unless [its] existence . . . has been previously publicly disclosed or acknowledged.” 21
C.F.R. § 314.430(b).
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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 F.
App’x 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.
2. FDA Proceedings Regarding the 180-Day Exclusivity Period
As originally enacted, the Hatch-Waxman Amendments did not define the phrase, “first
applicant.” Rather, the 180-day exclusivity provision merely provided that, if an ANDA
contains a Paragraph IV certification and “is for a drug for which a previous application has been
submitted . . . cont[aining] such a certification, the application shall be made effective not earlier
than one hundred and eighty days after” the applicant “under the previous application” goes to
market or a district court holds the patent “invalid or not infringed,” whichever is earlier. 21
U.S.C. § 355(j)(5)(B)(iv) (2002 version). The Medicare Modernization Act of 2003 (“MMA”),
Pub. L. No.108-173, 117 Stat. 2066 (2003), amended the statute to add, inter alia, a definition of
“first applicant” and “180-day exclusivity period.” See 21 U.S.C. §§ 355(j)(5)(B)(iv)(II)(aa)–
(bb).
Prior to the enactment of the MMA, the FDA construed the Hatch Waxman Amendments
to recognize “180-day exclusivity . . . on a patent-by-patent basis, meaning that there could
be . . . multiple 180-day periods of exclusivity for a single drug product.” Dkt. 1-2 at 5
(Suboxone Ltr. Decision); see also Apotex Inc. v. FDA, 414 F. Supp. 2d 61, 64 (D.D.C. 2006).
In addition, as the D.C. Circuit recognized in Purepac Pharmaceuticals Co. v. Thompson, 354
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F.3d 877, 888–89 (D.C. Cir. 2004), the FDA employed a “first effective approach” to awarding
exclusivity—that is, the agency rewarded the first generic to file a substantially complete ANDA
containing a Paragraph IV certification and to effect notice. “Although Purepac was decided
after the MMA was enacted, the MMA did not apply to the amendments and patent certifications
at issue in the case[,] and the Court did not opine on whether the outcome would have been the
same post-MMA.” Dkt. 1-2 at 9 (Suboxone Ltr. Decision). The FDA acknowledges, however,
that “some subsequent FDA statements and decisions” made under “the post-MMA statute and
regulation with respect to amendments and supplements that contain a [P]aragraph IV
certification” continued to apply the “[f]irst [e]ffective approach.” Id.In February 2015, the FDA published a proposed rule implementing aspects of the MMA
“pertain[ing] to provision of notice . . . of certain patent certifications made by” ANDA
applicants and submission of amendments and supplements to ANDAs. See Proposed Rule,
Abbreviated New Drug Applications and 505(b)(2) Applications, 80 Fed. Reg. 6,802 (Feb. 6,
2015) (“Proposed MMA Rule”). Later that year, the FDA opened a docket to solicit comments
regarding the 180-day exclusivity period for generic cyclosporine. Dkt 26-1 at 2 (Ex. A)
(Cyclosporine Comment Request). The FDA revealed that “one or more” applicants had filed an
ANDA containing a Paragraph IV certification referencing the ‘979 patent before the ‘111 patent
was issued on January 14, 2014; however, notice was not provided to the patent owners and
NDA holder because the ‘979 patent expired before the FDA accepted any ANDA for review.
Id. at 4 (Cyclosporine Comment Request). The FDA then sought comment on two questions:
First, whether “[t]he one or more applicants that submitted ANDAs or patent amendments with
[P]aragraph IV certifications” with respect “to the ‘979 patent” are “first applicants” for purpose
of the 180-day exclusivity. Id. at 5 (Cyclosporine Comment Request). Second, whether that
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applicant (or those applicants) forfeited generic drug exclusivity “on May 17, 2014, when the
‘979 patent expired, such that no ANDA applicant for [c]yclosporine [o]phthalmic [e]mulsion,
0.05%, is eligible for 180-day generic drug exclusivity.” Id. Six companies responded. See Dkt.
26-2 (Ex. B) to Dkt. 26-7 (Ex. G). Four answered yes to both questions. Dkt. 26 at 16. Teva
and Akorn responded no. Id.; see also Dkt. 26-6 (Ex. F); Dkt. 26-7 (Ex. G). To date, the FDA
has yet to issue a decision addressing either of these questions in the cyclosporine ANDA docket,
and it has represented that it will not do so before it determines that an “ANDA applicant for
cyclosporine has . . . satisfied the requirements for approval.” Dkt. 26 at 17.
In October 2016, the FDA published its final rule implementing portions of the MMA.
See Final Rule, Abbreviated New Drug Applications and 505(b)(2) Applications, 81 Fed. Reg.
69,580 (Oct. 6, 2016) (“Final MMA Rule”). The parties disagree about whether the final rule
codifies the “first effective approach”—that is, they disagree about whether it precludes the FDA
from concluding that the “one or more” applicants that submitted ANDAs containing Paragraph
IV certifications with respect to the ‘979 patent were “first applicants,” even though the ‘979
patent expired before they could provide the patent owners and NDA holder with the required
notice. According to Teva, the Final MMA Rule clearly provides that “eligibility for 180-day
exclusivity requires timely notice of the exclusivity-qualifying Paragraph IV certification;”
therefore, only those who have provided notice can qualify as first applicants. Dkt. 2-1 at 32.
The FDA disagrees, arguing that the final rule “simply does not address the
circumstance . . . where an applicant with a substantially complete ANDA containing a
[P]aragraph IV certification is not able to provide valid notice . . . because the relevant patent
expires before the FDA sends [the applicant] an Acknowledgement Letter.” Dkt. 26 at 28.
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All agree, however, that in July 2018, the FDA issued a letter decision in an unrelated
matter, which addressed this question. Dkt. 1-2 at 2 (“Suboxone Letter Decision”). In that
matter, “[o]n May 14, 2013, one or more first applicants submitted a substantially complete
ANDA (or an amendment to a substantially complete ANDA)” for a generic version of
Suboxone® “with a [P]aragraph IV certification.” Id. at 7 (Suboxone Ltr. Decision). That
applicant (or those applicants), however, subsequently withdrew their application(s) and
“informed [the] FDA that [they] had not given notice to the NDA holder or patent owner.” Id.“At least one other applicant submitted a substantially complete ANDA (or an amendment to a
substantially complete ANDA)” referencing Suboxone® “after May 14, 2013, with a [P]aragraph
IV certification and provided notice to the NDA holder and patent holder.” Id. On those facts,
the FDA concluded that the May 14, 2013 applicant qualified as the “first applicant” and,
“[a]bsent forfeiture,” would have been “eligible for 180-day exclusivity.” Id. The applicant,
however, forfeited its right to exclusivity when it withdrew its application, and, because the “first
applicant” did not qualify for 180-day exclusivity, the FDCA imposed “no barriers to approval of
subsequent applicants.” Id. at 13 (Suboxone Ltr. Decision). Significantly, the FDA noted that
exclusivity did not roll over to the subsequent applicant. Id. at 18 (Suboxone Ltr. Decision).
As the FDA explained in the Suboxone Letter Decision, its conclusion turned on the
meaning of the statutory phrase “first applicant.” Id. at 8 (Suboxone Ltr. Decision). Prior to the
enactment of the MMA, and prior to the FDA’s Suboxone Letter Decision, the agency applied
the “first effective approach.” See Purepac Pharm. Co., 354 F.3d at 888–89. But, after studying
the issue, the FDA concluded that the “first effective approach” is inconsistent with “the
statutory definition of ‘[f]irst [a]pplicant’ as defined by Congress in the MMA,” Dkt. 1-2 at 10
(Suboxone Ltr. Decision), and that a “first submitted approach” better coheres with the current
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version of the FDCA, id. at 11 (Suboxone Ltr. Decision). According to that approach, the
definition of “first applicant” sets a specific “static date” on which an applicant must file in order
to achieve “first applicant” status, id.: that is, “the first day on which a substantially complete
application containing a” Paragraph IV certification “is submitted for approval of a drug.” 21
U.S.C. § 355(j)(5)(B)(iv)(II)(bb). As a result, the decision further explained, “[a]ny application,
whether an original application, amendment, or supplement submitted after this ‘first day’ cannot
satisfy the ‘when’ prong and cannot be a ‘[f]irst [a]pplicant,’ as there can be only one ‘first day
on which a substantially complete application containing a [P]aragraph IV certification is
submitted.’” Dkt. 1-2 at 11 (Suboxone Ltr. Decision). Nor was the FDA convinced that the
second half of the MMA statutory definition, which requires that the applicant “lawfully
maintain[] a [Paragraph IV] certification,” 21 U.S.C. § 355(j)(5)(B)(iv)(II)(bb), changes this
result. In the FDA’s view, that requirement, which entails providing notice to the patent owner
and NDA holder, does not change the “static date.” Dkt. 1-2 at 11 (Suboxone Ltr. Decision).
The Suboxone Letter Decision also concluded that the “first submitted approach” “is the
most consistent with the structure of the MMA.” Id. As the decision explains, a reading of “first
applicant” that would permit first applicant status to roll over to a subsequent filer would be in
“tension” with the MMA’s added provisions addressing the forfeiture of eligibility for
exclusivity. Id. at 12 (Suboxone Ltr. Decision). Finally, the decision observes that the “first
submitted approach” “is preferable from a policy perspective” because it “is outcome
determinative and not applicant-specific, and because once fixed, the date is immutable and does
not move based on later actions or inactions.” Id. The FDA, accordingly, concluded that “there
can only ever be one ‘first day on which a substantially complete application’” containing a
[P]aragraph IV certification “‘is submitted,’ regardless of whether the applicant . . . gives or fails
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to give timely notice of and/or otherwise lawfully maintains its [P]aragraph IV certification.” Id.
at 10 (Suboxone Ltr. Decision).
3. Status of ANDA Applicants
To date, no cyclosporine ANDA has received final (or even tentative) approval.
Although Teva alleges (and has alleged since mid-October 2018) that the FDA is poised to grant
final approval to Mylan’s ANDA, the FDA’s deliberations remain confidential. Teva simply
speculates that the FDA will imminently approve Mylan’s ANDA based on Mylan’s
representations during a quarterly earnings call. Dkt. 16 at 6–7 (Oct. 26, 2018 Hrg. Tr.). Teva
also alleges that it has expended significant resources in anticipation of the FDA’s impending
approval of Teva’s own ANDA. Teva attests, for example, that “the Company began planning
for an exclusive launch” in 2017, “placing orders for supplies and components,” “expand[ing] its
production capacity at the planned manufacturing site,” and “hir[ing] additional full-time
personnel.” Dkt. 1-1 at 7 (Groff Decl. ¶ 11). In 2018, Teva “commenced production activities in
anticipation of an upcoming commercial launch.” Id. (Groff Decl. ¶ 12).
C. Procedural History
Teva filed suit against the FDA on October 17, 2018, and moved for a preliminary
injunction that same day. Dkt. 1 (Compl.); Dkt. 2 (Mot. Prelim. Inj.). Three generic
manufacturers, in turn, moved to intervene as defendants: Mylan, Deva, and Famy Care. Dkt. 6;
Dkt. 10; Dkt. 33. In light of the intervenors’ representations that they had pending ANDAs for
cyclosporine, the Court granted their motions to intervene. See Minute Entry (Oct. 26, 2018)
(granting Mylan and Deva leave to intervene); Minute Order (Nov. 20, 2018) (granting Famy
Care leave to intervene).
15
At the initial status conference, the Court set a combined briefing schedule for Teva’s
preliminary injunction motion and the defendants’ combined opposition and motion to dismiss.
Minute Entry (Oct. 26, 2018). In order to ensure that Teva “ha[d] the opportunity to be heard”
before “it suffer[ed] an irretrievable loss of generic exclusivity,” while also protecting
confidential information and avoiding any undue intrusion into the FDA’s administrative
process, the Court entered an order establishing the following procedure: (1) the FDA was
required to “provide the Court with 48 hours’ notice before issuing a decision that would permit
any manufacturer, other than Teva, to market a generic version of [Restasis®];” (2) all counsel
were required to be available to appear in Court for a hearing on Teva’s “motion for a
preliminary injunction on four hours’ notice;” (3) both the FDA and the parties were precluded
from disclosing or releasing the FDA’s decision without authorization from the Court; (4) the
FDA was directed to bring copies of its decision to any such hearing; and (5) if summoned to a
hearing, the FDA and the parties were precluded from disclosing that a decision from the FDA
was “likely forthcoming.” Dkt. 15 at 1–2. The FDA objected that the Court lacked jurisdiction
to enter the order because Teva does not have standing to bring suit and the case is unripe. Dkt.
19 at 2. The Court subsequently ordered supplemental briefing on the jurisdictional issues and
held oral argument. See Minute Order (Nov. 1, 2018); Minute Entry (Nov. 5, 2019). The Court
then vacated its prior order but still required the FDA to “provide the Court with 48 hours’ notice
before taking any final action that would directly impact Teva’s claim to 180-day generic
exclusivity.” Minute Order (Nov. 5, 2018). Neither order has required any action to date.
II. LEGAL STANDARD
“A preliminary injunction is an extraordinary remedy never awarded as of right,” Winter
v. Natural Res. Def. Council, 555 U.S. 7, 24 (2008), but “only when the party seeking the relief,
16
by a clear showing, carries the burden of persuasion,” Cobell v. Norton, 391 F.3d 251, 258 (D.C.
Cir. 2004). To secure a preliminary injunction, a plaintiff “must establish that he is likely to
succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary
relief, that the balance of equities tips in his favor, and that an injunction is in the public
interest.” Winter, 555 U.S. at 20. Although the moving party may rely on “evidence that is less
complete than in a trial on the merits,” NRDC v. Pena, 147 F.3d 1012, 1023 (D.C. Cir. 1998)
(citation omitted), he nevertheless “bear[s] the burden[] of produc[ing] . . . credible” evidence
sufficient to demonstrate his entitlement to injunctive relief, R.I.L-R v. Johnson, 80 F. Supp. 3d
164, 173 (D.D.C. 2015) (quotation marks omitted) (first alteration in original).
Before applying the four-part test, however, the Court must address a threshold issue:
whether it has jurisdiction over Teva’s claim. See Calif. Ass’n of Private Postsecondary Schs. v.
Devos, 344 F. Supp. 3d 158, 167 (D.D.C. 2018) (“[A] court must—at each successive stage of
the proceeding—evaluate whether it has jurisdiction to provide the relief sought, and it must do
so through the lens of the standard applicable at that stage of the proceeding.” (citing Lujan v.
Defs. of Wildlife, 504 U.S. 555, 561 (1992))). As the party seeking to invoke the Court’s
jurisdiction, Teva bears the burden of establishing that it has standing to sue. Sierra Club v.
EPA, 292 F.3d 895, 900 (D.C. Cir. 2002). If Plaintiff “fails to show a ‘substantial likelihood’ of
standing,” then it “is not entitled to a preliminary injunction.” Food & Water Watch, Inc. v.
Vilsack, 808 F.3d 905, 913 (D.C. Cir. 2015) (citation omitted).
Defendants have also moved to dismiss the case for lack of standing pursuant to Federal
Rule of Civil Procedure 12(b)(1). To survive a 12(b)(1) motion, Plaintiff’s complaint “must state
a plausible claim that [it] has suffered an injury in fact fairly traceable to the actions of the
defendant that is likely to be redressed by a favorable decision on the merits.” Humane Soc’y of
17
the U.S. v. Vilsack, 797 F.3d 4, 8 (D.C. Cir. 2015). In this posture, the Court must accept the
factual allegations of the complaint as true but must nonetheless assess the “plausibility” of the
plaintiff’s standing allegations in light of the relevant context and the Court’s “judicial
experience and common sense.” Pub. Citizen, Inc. v. Trump, No. 17-cv-253, 2019 WL 498528,
at *6 (D.D.C. Feb. 8, 2019) (internal citations omitted) (quoting Humane Soc’y of the U.S., 797
F.3d at 8). Because predictions of future injury . . . are not normally susceptible to labeling as
‘true’ or ‘false,’” Arpaio v. Obama, 797 F.3d 11, 21 (D.C. Cir. 2015), the Court need not accept
any such allegations as “true” for purposes of evaluating a motion to dismiss for lack of standing.
III. ANALYSIS
Teva challenges the FDA’s interpretation of “first applicant” in the Suboxone Letter
Decision and contends that, if allowed to stand, that reading of the MMA will deprive Teva of its
statutory right to 180 days of generic exclusivity for cyclosporine. In Teva’s view, the FDA
erred as a matter of substance and process in defining “first applicant” as the first substantially
complete ANDA containing a Paragraph IV certification, regardless of whether the applicant
provided the required notice to the patent owner and NDA holder (i.e., the “first submitted
approach”). Teva contends that the Suboxone Letter Decision must, therefore, be set aside under
the Administrative Procedure Act (“APA”), 5 U.S.C. § 706.
According to Teva, the FDA erred as a matter of substance because the MMA definition
of “first applicant” not only requires that the applicant be the first to file a substantially complete
ANDA, but also requires that the applicant timely effect notice (i.e., the “first effective
approach”). Dkt. 1 at 32–33 (Compl. ¶ 55). Teva argues, moreover, that the statutory purpose of
rewarding those who take on the risk and cost of patent infringement litigation is not served by
according “first applicant” status to those who submit Paragraph IV certifications to the FDA but
18
never provide notice to the patent owners and NDA holders. Teva also argues that the Suboxone
Letter Decision must be set aside because it was issued in violation of the procedural
requirements of the APA. In particular, Teva maintains that the decision countermanded a
“legislative rule[] promulgated though the notice-and-comment process without undertaking a
new round of notice-and-comment rulemaking,” and it failed “to account for the reliance
interests” of those manufacturers that had acted based on the FDA’s prior account of the law.
Dkt. 2-1 at 34.
In support of its motion for preliminary relief, Teva contends that each of the relevant
factors tip in favor of issuing a preliminary injunction. For the reasons explained above, Teva
contends that it is likely to prevail on the merits. It further argues that, unless the FDA is
enjoined, “application of the [Suboxone] Letter Decision to Teva’s cyclosporine ANDA will
harm Teva irreparably by divesting the company of its statutory right to 180-day exclusivity and
imposing at least $50 million in losses that Teva can never recover.” Id. at 50. Finally, Teva
maintains that the balance of hardships and public interest weigh in favor of granting a
preliminary injunction. Id. at 52–53.
The Court cannot reach the merits of Teva’s APA challenge or its motion for a
preliminary injunction, however, without first addressing standing, and, as the record now
stands, Teva has failed to clear that threshold hurdle. The “irreducible constitutional minimum”
of standing requires: “(1) that the plaintiff have suffered an ‘injury in fact’—an invasion of a
judicially cognizable interest which is (a) concrete and particularized and (b) actual and
imminent, not conjectural or hypothetical; (2) that there be a causal connection between the
injury and the conduct complained of—the injury must be fairly traceable to the challenged
action of the defendant, and not the result of the independent action of some third party not
19
before the court; and (3) that it be likely, as opposed to speculative, that the injury will be
redressed by a favorable decision.” Bennett v. Spear, 520 U.S. 154, 167 (1997) (quoting Lujan,
504 U.S. at 560–61).
Teva contends that it has pled two types of injuries sufficient to establish standing:
“[F]irst, [it argues] that the [Suboxone Letter Decision] already has divested Teva of its statutory
right to exclusivity” and that, in any event, it has adequately alleged that it “will suffer even
greater harms when [the] FDA formally applies that decision and approves competing ANDAs in
violation of Teva’s statutory right to exclusivity.” Dkt. 36 at 14, 17. “[S]econd,” it argues that,
by jettisoning its “first effective approach” to awarding “first applicant” status in the Suboxone
Letter Decision, the FDA deprived Teva of procedural rights under the APA, including the right
to participate in a notice-and-comment rulemaking. Id. at 14. The Court will address each type
of alleged injury in turn.
A. Loss of Exclusivity
The parties agree that the loss of generic exclusivity is a concrete injury sufficient to
confer standing. They disagree, however, about whether Teva has met its burden of plausibly
alleging or otherwise showing that it will suffer an actual and imminent injury that is fairly
traceable to the Suboxone Letter Decision. Before addressing that question, a threshold matter
requires brief discussion.
The parties dispute whether Teva may bring “a pre-enforcement challenge to an agency
interpretation born of an adjudication”—the Suboxone Letter Decision—to which it was not a
party. 2 Teva v. Sebelius, 595 F.3d at 1312. The D.C. Circuit observed in Sea-Land Service, Inc.
2
For present purposes, the Court need not, and does not, address whether Teva can meet the
“final agency action” requirement under the APA because that requirement is non-jurisdictional,
see Trudeau v. FTC, 456 F.3d 178, 183–84 (D.C. Cir. 2006), and the Court must address
20
v. Department of Transportation, 137 F.3d 640. 648 (D.C. Cir. 1998), that “the mere precedential
effect” of an adjudication “within an agency is not, alone, enough to create Article III standing,
no matter how foreseeable the future litigation” involving the plaintiff. Although that principle
is undoubtedly correct, it is not very helpful in resolving the present dispute. It is unassailable
that the “mere potential precedential effect of an agency action” is not, alone, sufficient to
establish standing. Teva v. Sebelius, 595 F.3d at 1312–13 (quoting Shipbuilders Council of Am.
v. United States, 868 F.2d 452, 456 (D.C. Cir. 1989)). But it is equally true that “[a]n agency’s
imminent application of its established interpretation of a statute” to the plaintiff’s concrete
detriment is likely sufficient. Id. at 1313–14. Although both statements of the law are correct,
neither answers the central question presented by the defendants’ motions to dismiss: Has Teva
shown that it faces a “realistic danger” that the Suboxone Letter Decision’s interpretation of the
MMA, if let stand, will cause the company to suffer a concrete injury that is “actual or
imminent” and that “is likely” to be “redressed by a favorable judicial decision?” Lujan, 504
U.S. at 560–61. In other words, has Teva shown that it can satisfy the “irreducible constitutional
minimum” that Article III requires? Because the two concepts most relevant here, causation and
redressability, “overlap as two sides of the same causation coin,” Dynalantic Corp. v. Dep’t of
Defense, 115 F.3d 1012, 1017 (D.C. Cir. 1997); see also Carpenters Indus. Council v. Zinke, 854
F.3d 1, 6 n.1 (D.C. Cir. 2017) (same), the Court will treat them together.
1. Immediate Loss of Right to Exclude
Teva first argues that it has already suffered a concrete and redressable injury because the
FDA’s issuance of the Suboxone Letter Decision stripped the company of its right to 180-day
jurisdiction before reaching the merits, see Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83,
94–95 (1998).
21
exclusivity. Dkt. 36 at 14–15, 16. According to Teva, “the key point here is that the challenged
FDA decision already has destroyed the embedded value in Teva’s exclusivity right,” regardless
of whether Teva or another manufacturer ever receives FDA approval. Id. at 26. The Court is
unpersuaded.
Teva is, of course, correct that a first applicant can suffer a concrete injury before its
ANDA is approved. That is because, once a first applicant files an ANDA containing a
Paragraph IV certification (and, according to Teva, provides the required notice to the patent
owner and NDA holder), the FDA may not approve any subsequently-filed ANDA until at least
“180 days after the date of the first commercial marketing of the drug . . . by any first applicant.”
21 U.S.C. § 355(j)(5)(B)(iv)(I). Teva takes this principle a step further, however, and argues that
“first applicant status” constitutes a property right “no different from a patent” and that the right
exists “[r]egardless of whether the exclusivity holder uses the right itself.” Dkt. 36 at 19–20.
This “exclusionary right,” according to Teva, “[l]ike every other property right, . . . has
immediate, real, and tangible value to the first applicant.” Id. at 20. Most notably, Teva asserts
that the right is “alienable” and that the first applicant may “waive or relinquish its exclusivity in
exchange for valuable consideration.” Id. at 21–22. Although Teva acknowledges that it has no
intention of waiving its first applicant status, it maintains that the Suboxone Letter Decision
“already has eviscerated Teva’s current” property right and, “along with it, the embedded value
that otherwise-alienable property would have.” Id. at 23. Finally, Teva argues that the
immediate nature of this loss “forecloses the defendants’ suggestion” that “Teva must at least
show that another applicant’s ANDA will be approved” to establish a concrete injury. Id. at 26.
In other words, even if no cyclosporine ANDA is ever approved, Teva maintains that it has
nonetheless suffered a cognizable loss.
22
Teva’s theory of “embedded value” misconceives how the Hatch-Waxman Amendments
and the MMA function and what Article III demands. Teva fails to identify any precedent that
has ever held that a first applicant acquires a property interest akin to a patent as soon as it files a
substantially complete ANDA containing a Paragraph IV certification and provides the requisite
notice. That absence of authority is unsurprising for several reasons. First and foremost, a
patent differs in fundamental respects from first applicant status. A patent is issued to a
qualifying inventor, 35 U.S.C. § 154(a)(1), who may then bring an infringement action against
anyone who practices or sells the patent owner’s invention without her permission, id. § 271.
The Patent Act, moreover, provides that “patents shall have the attributes of personal property,”
id. § 261, and the Supreme Court has long recognized that “[a] patent for an invention is as much
property as a patent for land,” Consolidated Fruit-Jar Co. v. Wright, 94 U.S. 92, 96 (1876). First
applicant status, in contrast, dictates only the order and timing with which the FDA may approve
ANDAs. A first applicant, to be sure, obtains a benefit, but its rights are only enforceable
against the FDA for failing to abide by its statutory obligations, and not (at least directly) against
another manufacturer who may attempt to market its product prematurely. The benefit
conferred, moreover, is far more inchoate than the benefit conferred by a duly issued patent, and
neither history nor statutory text suggests that Congress intended to confer first applicants an
immediate property interest. Indeed, as discussed further below, an ANDA applicant may not
know for years after it files its Paragraph IV certification whether it will attain the ultimate
benefit of 180 days of generic exclusivity.
Nor is the Court convinced that a putative first applicant attains an alienable interest in its
status immediately upon submitting its ANDA and effecting notice of the Paragraph IV
certification. According to Teva, the FDA and courts have recognized that a “first applicant can
23
in certain circumstances ‘waive’ its right to another company in exchange for monetary
consideration, and that [a] first applicant always is free to ‘relinquish’ its exclusivity altogether
for such consideration.” Dkt. 36 at 20. In support of this contention, Teva cites to a letter
decision from the FDA, a proposed regulation that was never finalized, and three judicial
decisions. None of those sources, however, supports Teva’s sweeping view that an ANDA
applicant obtains an immediate property interest in its first applicant status.
To start, the FDA letter decision, which contains the most extensive discussion of the
issue, actually undercuts Teva’s asserted property interest. In that proceeding, the FDA was
asked by a brand-name manufacturer to preclude the first applicant from transferring or waiving
its right to 180-day exclusivity. See Dkt. 42-2 at 2. The FDA declined to do so, concluding that
it “is a public health agency” and “generally do[es] not interfere in business arrangements of
private parties” in the absence of a “public health impact” or a statutory prohibition. Id. at 3.
The FDA, nonetheless, drew a distinction between what an ANDA applicant may do before and
after the 180-day “exclusivity period has been triggered.” 3 Id. at 5–6. Before the date of the
first commercial marketing of the generic by a first applicant, a first applicant may relinquish,
but may not selectively waive, its claim to exclusivity. Id. After the exclusivity period is
triggered, however, a first applicant “may relinquish its exclusivity entirely[,] or [it may]
selectively waive [that] exclusivity in favor of a single ANDA, or multiple ANDAs, containing a
[P]aragraph IV certification.” Id.As the FDA explained, it “limited the availability of selective waiver” prior to the trigger-
date based on two concerns. Id. at 6 n.5. First, “there are many reasons why an ANDA applicant
3
The relevant trigger date changed with the enactment of the MMA. Compare 21 U.S.C.
§§ 355(j)(5)(B)(iv)(I)&(II) (2002) with 21 U.S.C. § 355(j)(b)(5)(iv)(I) (2018).
24
might lose its eligibility before the exclusivity period has been triggered;” for instance, “the
patent could expire necessitating a change to a Paragraph II certification.” Id. Second,
“permitting selective waiver before exclusivity is triggered could lead to the ‘commercialization’
of the first ‘seat’” and might, accordingly, “encourage applicants to submit only marginally
adequate ANDAs solely to obtain the economic benefit of waiving the exclusivity as to an
applicant with a more viable ANDA.” Id. The FDA stressed that, “[a]lthough [it] has stated that
it does not consider exclusivity to be a property right that transfers separately and apart from an
application,” it was concerned that it might be “drawn into complex private disputes regarding
the economic and competitive impacts of a selective waiver ‘right’ that is never ‘perfected’
because first the applicant loses eligibility for that exclusivity.” Id.Contrary to Teva’s “embedded value” theory, the FDA has declined to accord any
“embedded” right, beyond simple relinquishment, to first applicants before the exclusivity period
is triggered. The other authorities that Teva cites, moreover, provide no support to the contrary.
The proposed regulation addressing this issue mirrors the discussion in the FDA’s letter decision.
See 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications, 64 Fed. Reg.
42,873, 42,881 (Aug. 6, 1999). And none of the three cases hold that a first applicant can
selectively waive and thereby monetize the right to exclusivity before the 180-day period is
triggered. See Dr. Reddy’s Labs., Inc. v. Thompson, 302 F. Supp. 2d 340, 350 (D.N.J. 2003);
Boehringer Ingelheim Corp. v Shalala, 993 F. Supp. 1, 2 (D.D.C. 1997); Granutec, Inc. v.
Shalala, 1998 WL 153410, at *9 (4th Cir. Apr. 3, 1998). In both Boehringer and Granutec, the
180-day exclusivity period had already been triggered. See Boehringer, 993 F. Supp. 2d at 2;
Granutec, 1998 WL 153410, at *5. And in Dr. Reddy’s Laboratories, the court expressly noted
that Reddy would not “be able to sell [its] rights to . . . exclusivity” until “the FDA . . . awarde[d]
25
Reddy exclusivity.” 302 F. Supp. 2d at 349. The Court did not specify whether that restriction
was due to the law or the market, but, regardless, the decision does not support Teva’s contention
that the right to exclusivity can be sold before the trigger date.
In sum, Teva has failed to “show that [it] ‘has sustained or is immediately in danger of
sustaining some direct injury,’” City of Los Angeles v. Lyons, 461 U.S. 95, 102 (1983) (citation
omitted), as the result of the FDA’s Suboxone Letter Decision. Whatever “embedded value” that
might exist today in Teva’s alleged first applicant status is simply too inchoate and abstract to
support Teva’s claim that it has standing. 4
2. Future Loss of Right to Exclude
Teva argues, in the alternative, that it will likely suffer a concrete injury in the near
future if the Suboxone Letter Decision is allowed to stand and that this imminent harm is
sufficient to sustain its standing to sue. It asserts, in particular, that it will suffer “tens of
millions of dollars in lost sales due to the decreased market share it will have when [the] FDA
unlawfully approves its competitors during what Teva alleges to be its legally-protected
exclusivity period.” Dkt. 36 at 15. For support, Teva points to two lines of precedent, which it
contends establish that its alleged, putative losses readily satisfy the threshold requirement for
pleading standing. The Court is, again, unpersuaded.
4
Teva’s allegation that the Suboxone Letter Decision has “upended the Company’s ongoing and
previously-initiated ‘production activities in anticipation of an upcoming commercial launch,’”
Dkt. 36 at 14 (quoting Dkt. 1-1 at 7 (Groff Decl. ¶ 12)), also does not satisfy the injury-in-fact
requirement. The Supreme Court has cautioned that plaintiffs “cannot manufacture standing
merely by inflicting harm on themselves based on their fears of hypothetical future harm that is
not certainly impending.” Clapper v. Amnesty Int’l USA, 568 U.S. 398, 416 (2013). As
explained below, the harm that Teva seeks to avoid here—a determination by the FDA that it is
not entitled to 180-day exclusivity for cyclosporine—is not “certainly impending.” Accordingly,
to the extent that Teva has incurred any costs by preventatively “upending” its production
activities, that injury is self-inflicted, and it is “not fairly traceable” to the Suboxone Letter
Decision.
26
First, Teva relies on the Supreme Court’s decision in Bennett v. Spear, 520 U.S. 154. As
Teva correctly observes, Bennett held that the plaintiffs in that case had met their “relatively
modest [burden]” at the pleading stage, id. at 170, of alleging that a Biological Opinion issued by
the Fish and Wildlife Service (“FWS”) was likely to cause them a redressable injury, even
though the agency that would ultimately decide how to proceed—the Bureau of Reclamation—
was “technically free to disregard the Biological Opinion and [to] proceed with the proposed
action . . . at its own peril,” id. at 170. From this, Teva concludes that it is sufficient at the
motion to dismiss stage simply to allege a “future agency action and resulting harm.” Dkt. 36 at
16. That contention, however, both misreads Bennett and ignores subsequent precedent. It
misreads Bennett because the Court merely held that the plaintiffs in that case had alleged an
imminent and redressable injury. As the Court explained, the government itself conceded that,
even if technically advisory, the FWS’s Biological Opinion has “a powerful coercive effect” and
agencies “very rarely choose to engage in conduct that the [FWS] has concluded is likely to
jeopardize the continued existence of a listed species” because “any person who knowingly
‘takes’ an endangered or threatened species is subject to civil and criminal penalties.” Bennett,
520 U.S. at 169–70.
Teva also ignores developments in the law since Bennett was decided. Although it was—
and remains—the law that a plaintiff’s showing of standing must be evaluated in light of the
relevant stage of the proceeding, see Lujan, 504 U.S. at 561, the requirement for overcoming a
motion to dismiss has evolved since 1997. In describing the “modest” burden, Bennett cited to
Lujan, 504 U.S. 561, which in turn cited language that can be traced to Conley v. Gibson, 335
U.S. 41, 45–46 (1957). See Bennett, 520 U.S. at 168. The Supreme Court, however, overruled
Conley in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S.
27662 (2009). Under current law, unlike under Conley, a complaint must contain “more than an
unadorned, the defendant-unlawfully-harmed-me accusation.” Iqbal, 556 U.S. at 678.
“Threadbare recitals of the elements of [standing], supported by mere conclusory statements,
[will] not suffice.” Arpaio, 797 F.3d at 19 (internal quotations and citations omitted). Moreover,
as explained above, the Court “may reject as overly speculative those links which are predictions
of future events.” Id. at 21 (quoting United Transp. Union v. ICC, 891 F.2d 908, 913 (D.C. Cir.
1989)). Understood in this light, Bennett does not support Teva’s claim that it has standing.
Second, and more to the point, Teva relies on Teva v. Sebelius, 595 F.3d at 1311, for the
proposition that “courts in this circuit routinely reach the merits of generic manufacturers’ claims
to exclusivity before the FDA has granted final approval to any ANDA concerning the drug at
issue.” Dkt. 36 at 27 (quoting same). That is true, but it is also true that courts in this circuit
have routinely declined to reach the merits of disputes of this type because the plaintiff lacks
standing or because its claim is unripe. See, e.g., Pfizer Inc. v. Shalala, 182 F.3d 975, 980 (D.C.
Cir. 1999) [hereinafter “Pfizer v. Shalala”]; Mylan, 789 F. Supp. 2d at 2. The relevant question
is: on which side of this divide does Teva’s challenge fall?
The two leading D.C. Circuit cases are Pfizer v. Shalala, 182 F.3d 975, and Teva v.
Sebelius, 595 F.3d 1303. In Pfizer v. Shalala, Pfizer held an NDA for a drug used to treat angina
and hypertension. 5 182 F.3d at 976. Mylan filed an ANDA seeking approval for a generic
5
Although Pfizer addressed ripeness, and not standing, the two inquiries overlap. See Navegar,
Inc. v. United States, 103 F.3d 994, 998 (D.C. Cir. 1997) (“In deciding whether a case is ripe for
adjudication, federal courts generally consider the hardship to the parties of withholding court
resolution (a factor that overlaps with the “injury in fact” facet of standing doctrine), and the
fitness of the issues for judicial resolution (a factor that resembles the prudential concerns
applied in the standing context).” (citations omitted)); see also Am. Petroleum Inst. v. EPA, 683
F.3d 382, 386 (D.C. Cir. 2012) (“Part of [ripeness doctrine] is subsumed into the Article III
requirement of standing, which requires a petitioner to allege inter alia an injury-in-fact that is
28
version of the drug, although Mylan’s product used a “release mechanism different from
Pfizer’s.” Id. After unsuccessfully seeking relief from the FDA, Pfizer brought suit challenging
the FDA’s decision to accept Mylan’s ANDA for review on the ground that Mylan’s version of
the drug used a different delivery mechanism than the referenced drug. Id. at 977–78. The D.C.
Circuit held that the challenge was not ripe because it remained uncertain whether the FDA
would ever approve Mylan’s application. 6 Id. at 979. For two reasons, moreover, the court
rejected Pfizer’s contention that the FDA’s acceptance of Mylan’s ANDA for processing had an
immediate effect on “the legal rights of all subsequent applicants.” Id. First, the contention
“assume[d] its own conclusion” that Mylan would be entitled to 180-days of generic exclusivity.
Id. Second, “the legal rights that [were allegedly] affected [were] not Pfizer’s but those of
[Mylan’s] competitors, about which Pfizer is not in a position to complain.” Id.Teva v. Sebelius involved a very different context. In that case, Teva had received
tentative approval to market a generic version of a drug used to treat hypertension, and that
tentative approval was set to “become final once the ‘pediatric exclusivity period’ end[ed].” 595
F.3d at 1304. “Thwarting its receipt of that entitlement, however, [was] an FDA interpretation of
the [FDCA],” which would have allowed “not only Teva but all generic manufacturers to sell
their approved [versions of the drug] right out of the gate.” Id. Unlike in Pfizer, the D.C. Circuit
‘imminent’ or ‘certainly impending.’” (citations omitted)). Pfizer is instructive here for whether
Teva has alleged a sufficiently imminent injury-in-fact.
6
After oral argument, the FDA granted tentative approval for Mylan’s drug, but the D.C. Circuit
still concluded that the case was not ripe. Id. at 980. Although the tentative approval increased
the likelihood that the FDA would “eventually approve Mylan’s drug,” the court held that Pfizer
would not suffer any hardship if required to wait to sue because it was entitled to rely on the
thirty-month stay, and the case was not fit for review because, if required to wait, Pfizer could
renew its claim and also include “any other claim that might arise from the agency’s final
approval.” Id.
29
held that Teva’s claim was ripe and that the company had standing to sue, despite the fact that
Teva was not yet entitled to go to market and the FDA had not yet made its exclusivity
determination. Id. at 1305. As the court explained, Teva’s claim was ripe and it had standing
because there was “virtually no doubt” that the FDA would apply a policy forfeiting Teva’s
(otherwise certain) right to exclusivity. Id. at 1309.
Neither Pfizer v. Shalala nor Teva v. Sebelius are controlling for present purposes. Pfizer
v. Shalala differs from this case because Teva is suing to vindicate its own right to exclusivity.
Teva will, accordingly, have the right—if it is a bona fide first applicant—to challenge a decision
by the FDA permitting one its competitors (other than another first applicant) to proceed to
market even before Teva’s ANDA is approved. As a result, unlike in Pfizer v. Shalala,
uncertainty about whether and when Teva’s ANDA will receive approval, although a relevant
consideration, is not dispositive. Teva v. Sebelius also differs from the present case in significant
respects. Most notably, Teva v. Sebelius turned on the facts that (1) Teva had already received
tentative approval of its ANDA, and there was “no possible deficiency or uncertainty in Teva’s
ANDA that could [thwart] final approval,” 595 F.3d at 1309; (2) there was “no reason to doubt”
that, amongst the ANDA applicants, Teva had filed the first Paragraph IV certification, thereby
qualifying Teva as a “first applicant,” id.; (3) it was “virtually inconceivable” that a ‘forfeiture
event[]”—other than the one challenged—would “deprive Teva of exclusivity before final
approval,” id. at 1309–10; and (4) the FDA’s new policy “will almost certainly” forfeit Teva’s
exclusivity, id. at 1310.
Teva argues that “tentative approval” is a red herring in the present context. To begin,
Teva contends that tentative approval is unavailable here because there is currently no
impediment to the FDA granting final approval, Dkt. 36 at 27, such as another manufacturer’s
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entitlement to exclusivity or an existing patent that covers the drug, see 21 C.F.R. § 314.105(d).
The U.S. District Court for the Eastern District of Texas has declared all relevant Restasis®
patents invalid, see Allergan, Inc. v. Teva Pharms. USA, Inc., 2017 WL 4803941, at *65, and—if
Teva’s claim on the merits is correct—no other manufacturer has a superior claim to exclusivity.
Teva argues, moreover, that, even if its ANDA is not ready for approval when exclusivity is
triggered, as a first applicant, it is entitled to block other generic manufacturers, who are not
entitled to exclusivity, from marketing their drugs. Dkt. 36 at 18. Finally, Teva points to the
following dicta in Mylan, 789 F. Supp. 2d at 8: “Granting first filers pre-tentative-approval
standing to challenge the FDA’s approval of a competitor’s ANDA is at times necessary to
prevent imminent harm. Without this standing, first filers . . . would have no means of protecting
their hard-earned statutory interest in a period of marketing exclusivity.” See Dkt. 36 at 24
(quoting same).
With the exception of Teva’s conclusion, the Court agrees with much of this. In Mylan,
this Court held that a generic applicant that was, by its own admission, not a first applicant and
that had not yet received tentative approval, lacked standing to compel the FDA to act on a
competitor’s ANDA. 789 F. Supp. 3d at 9. The court noted, in dicta, however, that a “first filer”
might have “pre-tentative approval standing to challenge the FDA’s approval of a competitor’s
ANDA.” Id. at 8. That is not this case. Teva is neither an undisputed first filer nor is it
challenging the FDA’s imminent approval of a specific competitor’s ANDA. Moreover, as the
Mylan decision goes on to explain, what was “[c]ritical to” the D.C. Circuit finding that the
plaintiff in Teva v. Sebelius had standing “was the fact that ‘there [was] no material ambiguity
about [the] essential facts.’” 789 F. Supp. 2d at 8–9 (citation omitted). Although the presence of
tentative approval was not a sine qua non of Teva’s standing in that case, it was essential to the
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court’s finding that Teva’s alleged injury was certain and impending. Indeed, the D.C. Circuit
knew the exact date that the FDA’s exclusivity determination (and hence, Teva’s alleged injury)
would take place: the day that the brand-name drug’s pediatric exclusivity period expired. Id. at
1304. In short, as the Mylan decision itself recognizes, “Teva v. Sebelius . . . stands for the
narrow[] proposition that where there is no material ambiguity about essential facts—as
evidenced by Teva’s tentative approval and first filer status—a court may ‘reach the merits of [a]
generic manufacturer[’s] claim[] to exclusivity before the FDA has granted final approval to any
ANDA concerning the drug at issue.’” 789 F. Supp. 2d at 9 (quoting Teva v. Sebelius, 595 F.3d
at 1311).
For a variety of reasons, the same is not true here. First, there is no guarantee that the
FDA will approve any of the existing ANDAs. See 21 C.F.R. § 314.127 (setting forth numerous
reasons for which the FDA will refuse to approve an ANDA). Obtaining approval for an ANDA
is a demanding task, Amneal Pharms. LLC, 285 F. Supp. 3d at 333 (describing process); Dkt. 26
at 19, and approval is by no means a forgone conclusion. Without tentative approval as a signal
or any other indication about the status of the FDA’s review, the Court has no means of assessing
whether any ANDA is likely to receive approval, and if so, when that is likely to occur. Second,
even if the FDA eventually approves an ANDA for cyclosporine, the Court can only speculate
about whether Teva’s ANDA will still be under review at that point. Given the rigor of the
ANDA process, it is possible that Teva’s ANDA will be rejected before the FDA issues its first
approval. Third, and most significantly, the FDCA includes six “forfeiture events” that result in
a first applicant’s loss of “[t]he 180-day exclusivity period,” 21 U.S.C. § 355(j)(5)(D)(ii), two of
which are of particular relevance here.
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A dispositive factor in Teva v. Sebelius was Teva’s ability to demonstrate that none of
these forfeiture events would occur. See 595 F.3d at 1310. With respect to a number of the
statutory forfeiture events, Teva has done so here as well. But, with respect to two, Teva has not
cleared this hurdle. First, although Teva contends that much of the delay in the FDA’s review of
its ANDA is attributable to the FDA, it is too soon to tell whether Teva would, if otherwise
qualified, forfeit its entitlement to exclusivity because it has failed to obtain approval within
thirty months of the date its ANDA was received. See 21 U.S.C. § 355(j)(5)(D)(i)(IV). Teva
answers this contention by noting that the FDA will never make the thirty-month determination
absent the relief that Teva is seeking in this action because the forfeiture provision applies only
to first applicants, and, under the Suboxone Letter Decision, Teva is not a first applicant. Dkt. 36
at 28. But, even if the FDA was prepared to consider whether the thirty-month provision
forecloses Teva’s claim to exclusivity before considering the issue raised in the Suboxone Letter
Decision, it is not possible to determine, on the present record, whether Teva would have any
plausible basis for disputing the applicability of the forfeiture event. The Court cannot tell, for
example, whether Teva’s ANDA is weeks, months, or years away from approval—or, indeed,
whether it will ever be approved.
The second possible forfeiture event raises even greater uncertainty. Under that
provision, a first applicant loses any entitlement to market exclusivity if it fails to market its drug
within 75 days after the entry of a final court decision “from which no appeal (other than a
petition to the Supreme Court for a writ of certiorari)” is taken, finding the referenced patents
invalid or not infringed. Id. § 355(j)(5)(D)(i)(I)(bb). As explained above, that provision may
well apply here because the U.S. District Court for the Eastern District of Texas found that each
of the relevant Restasis® patents is invalid, Allergan, Inc. v. Teva Pharms. USA, Inc., 2017 WL
334803941, *65, and the Federal Circuit summarily affirmed that decision on November 13, 2018,
Allergan, Inc. v. Teva Pharms. USA, Inc., 742 F. App’x at 511. Since then, Allergan filed a
timely petition for rehearing and rehearing en banc, Dkt. 103, Allergan, Inc. v. Teva Pharms.
USA, Inc., No. 18-1130 (Fed. Cir. Dec. 21, 2018), and the Federal Circuit ordered a response to
that petition, Dkt. 108, Allergan, Inc. v. Teva Pharms. USA, Inc., No. 18-1130 (Fed. Cir. Jan. 17,
2019). If the Federal Circuit grants rehearing and reverses the district court’s decision
invalidating the Restasis® patents, Teva would forfeit its right to exclusivity because it will need
to amend its ANDA to assert a Paragraph III certification with respect to the ‘111 patent. 21
U.S.C. § 355(j)(2)(D)(i)(III). Alternatively, if the Federal Circuit denies rehearing, and Teva
fails to market cyclosporine within 75 days the Federal Circuit’s final entry of judgment, Teva
will forfeit any entitlement to exclusivity. Id. § 355(j)(5)(D)(i)(I)(bb). As a result, Teva’s
interest—or claim of injury—turns on the prospect that the FDA will grant final approval to an
ANDA before the Federal Circuit renders a final decision, or, assuming the Federal Circuit
enters a final judgment affirming the district court’s decision, that a first applicant will enter the
market within seventy-five days of that decision. That is, of course, possible. But it falls far
short of the lack of “material ambiguity” that informed the D.C. Circuit’s decision in Teva v.
Sebelius, 595 F.3d at 1310.
The Court, accordingly, concludes that Teva’s asserted loss of exclusivity due to the
FDA’s Suboxone Letter Decision fails to satisfy the causation and redressability requirements for
Article III standing.
B. APA Violation
Teva’s second claim to standing—that it was injured by the FDA’s failure to abide by the
procedural requirements set forth in the APA—fares no better. Teva alleges that, because the
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FDA’s Suboxone Letter Decision “adopted precisely the opposite position from the one taken in
its MMA regulations,” the FDA was required to (and did not) engage in notice-and-comment
rulemaking. Dkt. 1 at 28–29 (Compl. ¶¶ 48–49). The Supreme Court, however, has held that the
allegation of “a bare procedural violation, divorced of any concrete harm,” does not “satisfy the
injury-in-fact requirement of Article III.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1549 (2016);
see also Ctr. For Law and Educ. v. Dep’t of Educ., 396 F.3d 1152, 1159 (D.C. Cir. 2005); Fla.
Audubon Soc’y v. Bentsen, 94 F.3d 658, 664–65 (D.C. Cir. 1996) (en banc). Rather, a
“procedural-rights plaintiff” must also show that “it is substantially probable that the procedural
breach will cause the essential injury to the plaintiff’s own interest.” Ctr. For Law and Educ.,
396 F.3d at 1159 (quoting Fla. Audubon Soc’y, 94 F.3d at 665)). Although the requirements of
“imminence and redressability” are relaxed when a plaintiff alleges a procedural injury, a
procedural-rights plaintiff must still “satisfy the general requirements of the constitutional
standards of particularized injury and causation.” Id. In other words, “[a] prospective plaintiff
must demonstrate that the defendant caused the particularized injury (or is likely to cause) and
not just the alleged procedural violation.” Id. (second alteration in original).
Here, the “essential injury” to Teva’s “own interest” is the potential loss of exclusivity.
And, as explained above, the Court has concluded that the “chain of causation” between the
FDA’s Suboxone Letter Decision and Teva’s alleged loss of exclusivity “is speculative at best.”
Id. The Court, accordingly, holds that Teva’s asserted procedural injury also fails to satisfy the
constitutional minimum for standing to sue.
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CONCLUSION
The Court will, accordingly, DENY Plaintiff’s motion for a preliminary injunction, Dkt.
2, and GRANT the defendants’ motions to dismiss for lack of standing, Dkt. 25; Dkt. 27.
A separate order will issue.
/s/ Randolph D. Moss
RANDOLPH D. MOSS
United States District Judge
Date: February 26, 2019
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