UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF COLUMBIA

TEVA PHARMACEUTICALS USA, INC.,

Plaintiff,

v.

ALEX M. AZAR, II, et al.,

Defendants.

Civil Action No. 18-2394 (RDM)

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
2

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 timeconsuming,” 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 
3

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 
4

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). 
5

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 
6

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 
7

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 
8

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 
9

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 

 1

 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). 
10

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
11

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 
12

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.
13

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 
14

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 
15

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).
16

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, 
17

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 
18

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 
19

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 
20

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 
21

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). 
22

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.
23

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 
24

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 triggerdate 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).
25

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] 
26

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.
27

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. 
28

662 (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 
29

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.
30

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 
31

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 
32

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. 
33

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 
34

4803941, *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 
35

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. 
36

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