Mylan Pharmaceuticals Inc. v. United States Food and Drug Administration ( 2011 )

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
MYLAN PHARMACEUTICALS INC.
and MATRIX LABORATORIES LTD.,
Plaintiffs,
v.
UNITED STATES FOOD AND DRUG
ADMINISTRATION, Civil Action No. 11-566 (JEB)
Defendant,
and
RANBAXY LABORATORIES LIMITED,
Interven0r-Defendant.
MEMORANDUM OPINION
The Food and Drug Administration is currently reviewing the application of Ranbaxy
Laboratories to have temporary exclusive rights to market a generic drug. Matrix Laboratories, a
competitor that has a subsequent application pending for the same drug, eagerly wishes to know
the result of Ranbaxy’s application. ln fact, Matrix and its distributor Mylan Pharmaceuticals
have now brought this injunctive action to force the FDA to act on Ranbaxy’s application.
Because the interrelated concepts of standing and ripeness preclude such expansive subject
matter jurisdiction, the Court declines the invitation.
I. Factual and Pr0cedural Background
A. The ANDA Process
Mylan Pharmaceuticals, Inc. and Matrix Laboratories, Ltd. are the would-be distributor
and manufacturer of generic atorvastatin, a cholesterol-lowering medicine commonly known by
its brand name, LIPITOR®. Compl. at 1111 2, 4. Pfizer, Inc. has sold LIPITOR® without
competition from generic versions for 15 years. id at 1111 2, 34. The pediatric exclusivity period
associated with certain LIPITOR® patents expires, however, on June 28, 201 l, at which time
drug manufacturers who are able to obtain the Food and Drug Administration’s approval for their
generic versions of LIPITOR® may begin to market and distribute their products. M._ at 11 4 n.l.
FDA approval is required before any drug can be marketed in the United States. §
F ederal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 355(a). In order to obtain
approval for a "pioneer" or "innovator" drug, a drug manufacturer must submit a new drug
application ("NDA") to the FDA in accordance with the requirements of § 355(b). An NDA
necessarily contains the results of extensive scientific testing performed on the drug to ensure
that it is safe and effective. I_d_; Once approved, patents for the pioneer drug are listed in
Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as the "Orange
Book," available at http://www.fda.gov/cder/ob/. § § 355(b)(l). Since Congress enacted the
Hatch-Waxman Amendments to the FDCA in 1984, manufacturers of gLri_c versions of
approved drug products may seek FDA approval by filing an abbreviated new drug application
("ANDA"). _S_L § 355@)1; Mova Pharmaceutical Corp. v. Shalala, 140 F.?>d 1060, 1063 (D.C.
Cir. l998). An ANDA applicant must show that its generic drug is the bioequivalent of the
1 The parties agree that, because the Ranbaxy ANDA was submitted to the FDA prior to
December 8, 2003, the Medicare Modemization Act of 20()3’$ amendments to § 355(]) do not
govern the present action. See Compl. at 11 41; FDA Mot. at 6 n.6. All references in this Opinion
to § 355@) are thus references to the 2002 version of that statute.
pioneer drug and has the same active ingredient, strength, dosage form, route of administration,
labeling, and conditions of use. § 355(]).
An ANDA must also include, for each Orange Book patent implicated by the generic
drug, one of four certifications indicating whether the proposed generic drug would infringe that
patent and, if not, why not. § 355G)(2)(A)(vii); Mova, l40 F.3d at 1063. If an ANDA applicant
seeks to market its generic drug prior to the expiration of the patents for the brand name drug, it
must make a "paragraph IV" certification. Such certification states 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." § 355(j)(2)(A)(vii)(IV). Once a generic drug manufacturer files an ANDA with a
paragraph IV certification, however, the ANDA applicant has by law infringed the underlying
patent and may be sued by the patent-holder for infringement. gee 35 U.S.C. § 27l(e)(2)(A).
As an incentive to encourage generic drug manufacturers to challenge existing drug
patents - often a lengthy and expensive process - and bring generic drugs to the market, the
Hatch-Waxman Amendments offer the first generic drug manufacturer to file an ANDA
containing a paragraph IV certification (and ultimately obtain FDA approval for its drug) a 180-
day period of marketing exclusivity free from competition from other generic drug
manufacturers. g 21 U.S.C. § 355(j)(5)(B)(iv). Numerous cases in this Circuit involving
disputes over the 180-day exclusivity period indicate it is a coveted advantage and the cause of
heated competition among generic drug manufacturers to secure their status as "first." §§g gg;,
Hi-Tech Pharmacal Co., Inc. v. FDA, 587 F. Supp. 2d l, 4 (D.D.C. 2008) (collecting cases).
The FDA may also grant meritorious ANDA applicants tentative approval, even though
the applicants may not have been the first to file and even though a competitor may have
exclusivity rights. §§§ FDA Mot. at 7 ("FDA grants ‘tentative approval’ to an ANDA when all
scientific and procedural conditions for approval have been met, but the application cannot be
fully approved because approval is blocked by a 30-month stay, some form of marketing
exclusivity, or some other barrier to approval arising from patent infringement litigation.")
(citing 21 C.F.R. § 314.105(d)).
B. Matrix and Ranbaxy
Plaintiff Matrix submitted its own atorvastatin ANDA more than two years ago, and
Plaintiffs recently settled their patent infringement litigation with Pfizer. § at 1111 4, 34. -
! Plaintiffs allege that Matrix’s ANDA should be eligible for approval as early as June 28,
201 l, when the pediatric exclusivity period associated with certain LIPITOR® patents expires.
Ld. at 1111 4 n.l, 35. Matrix’s ANDA, however, has not yet received FDA approval, either
tentative or final. g at 11 53 ("FDA has failed to, and continues to refuse to, provide Plaintiffs
with any indication or other information concerning whether Matrix’s ANDA will be approvable
as early as June 28, 2011, or if such approval will be delayed as a result of 180-day marketing
exclusivity.").
Although the FDA keeps the status of a pending ANDA confidential, Plaintiffs allege that
another generic drug manufacturer, lntervenor-Defendant Ranbaxy Laboratories Ltd., was the
first generic drug company to file an ANDA containing a paragraph IV certification and to
challenge Pfizer’s LIPITOR® patents. I_d_. at 1111 6-7, 40. Plaintiffs allege that this Ranbaxy
ANDA has been pending before the FDA for nearly nine years. § at 11 7 n.2. Plaintiffs further
allege that, under the terms of a settlement agreement with Pfizer, Ranbaxy’s ANDA is eligible
for approval no earlier than November 2011. Ld. at 11 7. Accordingly, Plaintiffs allege, if
Ranbaxy’s ANDA is approved in November 2011 and Ranbaxy is eligible for a 180-day period
of marketing exclusivity, then the market for atorvastatin will not be open to other generic
competitors (such as themselves) until at least May 201 2. Ld. The FDA has not, however,
granted Ranbaxy’s ANDA tentative approval and has also not announced whether Ranbaxy is
entitled to the exclusivity period. § at 1111 7 n.2, 10.
Plaintiffs also allege that Ranbaxy’s ANDA is subject to a notice issued by the FDA to
Ranbaxy invoking the FDA’s Application integrity Policy ("AIP"). l_617 F.2d 605, 608 (D.C. Cir. 1979)) (internal
2 ln deciding the pending Motions, the Court has reviewed Plaintiffs’ Complaint,
Plaintiffs’ Motion for a Preliminary lnjunction, the FDA’s Opposition to a Preliminary
Injunction and Motion to Dismiss, Ranbaxy’s Motion to Dismiss, Plaintiffs’ Reply in Support of
a Preliminary Injunction and Opposition to the Motions to Dismiss, the FDA’s Reply in Support
of its Motion to Dismiss, Ranbaxy’s Reply in Support of its Motion to Dismiss, and Plaintiffs’
Surreply in Opposition to the FDA’s Motion to Dismiss. In addition, the Court held a hearing on
April 28, 201 1.
citation omitted); se_e also Jerome Stevens Pharms., Inc. v. FDA, 402 F.3d 1249, 1253 (D.C. Cir.
2005). This standard governs the Court’s considerations of Defendants’ Motions under both
Rules 12(b)(1) and l2(b)(6). §eg Scheuer v. Rhodes, 416 U.S. 232, 236 (1974) ("in passing on a
motion to dismiss, whether on the ground of lack of jurisdiction over the subject matter or for
failure to state a cause of action, the allegations of the complaint should be construed favorably
to the pleader"); Walker v. Jones, 733 F.2d 923, 925-26 (D.C. Cir. 1984) (same). The Court
need not accept as true, however, "a legal conclusion couched as a factual allegation," nor an
inference unsupported by the facts set forth in the Complaint. Trudeau v. Fed. Trade Comm’n,
456 F.3d 178, 193 (D.C. Cir. 2006) (quoting Papasan v. Allain, 478 U.S. 265, 286 (1986)
(internal quotation marks omitted).
To survive a motion to dismiss under Rule l2(b)(l), Plaintiffs bear the burden of proving
that the Court has subject matter jurisdiction to hear their claims. _S_@ Lujan v. Defenders of
Eilc§f_`_e, 504 U.S. 555, 561 (1992); U.S. Ecologv, Inc. v. U.S. Dep’t oflnterior, 231 F.3d 20, 24
(D.C. Cir. 2000). A court has an "affirmative obligation to ensure that it is acting within the
scope of its jurisdictional authority." Grand Lodge of Fratemal Order of Police v. Ashcroft, 185
F. Supp. 2d 9, 13 (D.D.C. 2001). For this reason, "‘the [p]laintiff’s factual allegations in the
complaint . . . will bear closer scrutiny in resolving a 12(b)(1) motion’ than in resolving a
12(b)(6) motion for failure to state a claim." Li_. at 13-14 (quoting 5A Charles A. Wright &
Arthur R. Miller, Federal Practice and Procedure § 1350 (2d ed. 1987) (alteration in original)).
Additionally, unlike with a motion to dismiss under Rule l2(b)(6), the Court "may consider
materials outside the pleadings in deciding whether to grant a motion to dismiss for lack of
jurisdiction." Jerome Stevens, 402 F.3d at 1253; § also Venetian Casino Resort, L.L.C. v.
E.E.O.C., 409 F.3d 359, 366 (D.C. Cir. 2005) ("given the present posture ofthis case - a
dismissal under Rule 12(b)(1) on ripeness grounds ~ the court may consider materials outside the
pleadings").
III. Analysis
The FDA moves to dismiss Plaintiffs’ Complaint on the grounds that Plaintiffs lack
standing, their claims are not ripe for adjudication, the FDA’s enforcement discretion is not
reviewable, and Plaintiffs have failed to state a claim for unreasonable delay under the APA.
The Court need only reach the first two.
A. Standing
Article 111 of the United States Constitution limits the jurisdiction of the federal courts to
resolving "Cases" and "Controversies." U.S. CONST. art. 111, § 2, cl. 1. A party’s standing "is an
essential and unchanging part of the case-or-controversy requirement of Article 111." L_uj@, 504
U.S. at 560. To have standing, a party must, at a constitutional minimum, meet the following
criteria. First, the plaintiff "must have suffered an ‘injury in fact’ - an invasion of a legally-
protected interest which is (a) concrete and particularized . . . and (b) ‘actual or imminent, not
"conjectura1" or "hypothetical[.]""’ §§ at 560 (citations omitted). Second, "there must be a
causal connection between the injury and the conduct complained of - the injury has to be ‘fairly
. . . trace[able] to the challenged action of the defendant, and not . . . th[e] result [of] the
independent action of some third party not before the court."’ Ld. (alterations in original) (citation
omitted). Third, "it must be ‘likely,’ as opposed to merely ‘speculative,’ that the injury will be
‘redressed by a favorable decision."’ 1_d. at 561 (citation omitted). A "deficiency on any one of
the three prongs suffices to defeat standing." U.S. Ecology, 231 F.3d at 24.
The FDA argues that Plaintiffs lack standing because they have not, and cannot, allege
imminent injury: "Because Mylan’s ANDA is not yet ready to be approved, it faces no imminent
injury from the prospect that a competitor might obtain 180-day exclusivity." FDA Mot. at 15 .
1ndeed, "Mylan’s ANDA . . . has not received even tentative approval from FDA, indicating that
there remain issues concerning whether the application is scientifically approvable," and it is not
"by any means certain that Mylan’s ANDA will be tentatively approved by June 28, 201 1." §
As a result, "Mylan cannot be injured by any other ANDA holder’s exclusivity period if it cannot
obtain approval to market its own product for other reasons." li at 16.
Plaintiffs maintain that the FDA’s failure to notify them whether their potential June 28,
2011, launch will be delayed by a Ranbaxy exclusivity period is causing them irreparable harm.
Compl. at 1111 48-49. More Specifically, should Plaintiffs prepare to launch generic LIPITOR® on
June 28, only to learn that they will be prevented from doing so by a Ranbaxy exclusivity period,
they will have wasted significant resources producing medication that will expire before it can be
sold. I_182 F.3d 975 (D.C. Cir.
10
1999); Purepac Pharm. Co. v. Thompson, 238 F. Supp. 2d 191 (D.D.C. 2002); Teva Pharms.
USA Inc. v. FDA, No. 99-67, 1999 WL 1042743 (D.D.C. Aug. 19, 1999);3 and TorPharm, Inc.
v. Thompson, 260 F. Supp. 2d 69 (D.D.C. 2003).
Yet in all of these cases, the plaintiff s standing can be distinguished on one of two
grounds. Either the case, unlike here, involved FDA action relating to a plaintiff’ s g pending
ANDA, see Pfizer, 182 F.3d 975 (allowing generic manufacturer Mylan to intervene in suit in
which brand-name manufacturer Pfizer challenged the FDA’s acceptance of Mylan’s ANDA for
processing); Pu_repa_c, 238 F. Supp. 2d 191 (allowing Purepac to seek review of FDA decision to
deny its ANDA); TorPharm, 260 F. Supp. 2d 69 (allowing TorPharrr1 to appeal decision denying
it exclusivity), or the plaintiff, unlike here, was a first filer seeking to protect the period of
marketing exclusivity it expected to receive upon approval. § Teva v. FDA, 1999 WL
1042743. 1n none of these four cases did the government even raise a standing challenge. This
is because these distinctions carry legal significance.
The legally protected interest in the first category of cases is straightforward: an ANDA
applicant has a legally protected interest in the FDA’s consideration of its own ANDA, and it
might suffer harm as a result of the FDA’s denial or neglect. ln this case, unlike _PLf`Ler, Lpac_,
and TorPharm, Plaintiffs do not directly challenge FDA action or inaction with respect to their
own ANDA, Neither would Plaintiffs’ requested relief - FDA action on Ranbaxy’s ANDA -
directly affect the status of Plaintiffs’ pending ANDA,
The legally protected interest in the second category of cases arises from the statutory
grant of a period of marketing exclusivity to the first generic manufacturer to file an ANDA for a
3 To avoid confusion, this case will be cited as Teva v. FDA, while Teva Pharms. USA,
Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), will be cited as Teva v. Sebelius.
11
particular drug - the first filer. S_e§ 21 U.S.C. § 355(j)(5)(B)(iv). Just as manufacturers of
approved drugs possess an interest in preventing unlawful competition in their markets, g
o, 140 F.3d at 1074 ("numerous cases have found that a finn has constitutional standing to
challenge a competitor’s entry into its market"), a generic drug manufacturer, by being first to
file, similarly acquires a legally protected interest in the 180-day exclusivity period to which it is
statutorily entitled if and when the FDA approves its paragraph 1V ANDA. _S_e_e_, ;g;, ill
S_ebeli£, 595 F.3d at 1311 ("This ‘first-mover advantage’ is a valuable asset."). This interest
can be the basis for a generic drug manufacturer’s standing in a suit over entitlement to
exclusivity. _S_e_e i_d; at 1312 ("the impending prospect of allegedly unlawful competition in the
relevant market" is "the same harm that has sufficed for Article-111 injury purposes in all of our
past drug-approval cases") (citing Bristol-Mvers Squibb Co. v. Shalala, 91 F.3d 1493, 1497
(D.C. Cir. 1996) ("[W]here . . . a statutory provision reflects a legislative purpose to protect a
competitive interest, the protected competitor has standing to require compliance with that
provision.")).
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 who become enmeshed in protracted legal battles with brand-name patent-holders - the
very market-opening behavior § 355G)(5)(B)(iv) was designed to encourage - would have no
means of protecting their hard-earned statutory interest in a period of marketing exclusivity. lt
bears repeating here that the 180-day exclusivity period belongs to the paragraph IV ANDA
applicant who files first _an_d then obtains approval, rather than the first paragraph 1V ANDA
applicant to simply obtain approval. I_d.; g al:so Teva v. Sebelius, 595 F.3d at 1311. lt is for
this reason 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." I_d_.
Plaintiffs cite the above-quoted language from Teva v. Sebelius as a "key point," ge
Hearing 'l`r. at 32:24-33:10, in support of their claim to standing, Yet the Court must view the
D.C. Circuit’s comments in Teva v. Sebelius in the factual and procedural context of that case.
Critical to that court’s analysis was the fact that "there [was] no material ambiguity about
essential facts." 595 F.3d at 131 1. Teva was both the first filer and had already been granted
tentative approval. lt is against this factual background that the court found that Teva had
standing to bring its exclusivity claim. Teva v. Sebelius thus stands for the narrower proposition
that where there is no material ambiguity about essential facts - as evidenced in that case by
Teva’s tentative approval and clear first-filer status - a court may "reach the merits of generic
manufacturers’ claims to exclusivity before the FDA has granted final approval to any ANDA
concerning the drug at issue." l_d.
Plaintiffs in the present case were not the first to file for approval of a generic version of
LIPITOR®, and Matrix’s ANDA has not received even tentative approval from the FDA.
Plaintiffs have not identified, and conceded at the hearing that they are not aware of, § Hearing
Tr. at 17:12-17, any case in which a court in this Circuit has found a subsequent ANDA filer
without tentative approval to have standing to compel the FDA to take or not take action with
respect to a competitor’s pending ANDA. This Court does not believe such an expansion of
standing is warranted here,
2. Rights ofThird Party
Plaintiffs’ task of establishing standing is "‘substantially more difficult"’ because they
allege the FDA unlawfully delayed acting on Ranbaxy’s ANDA rather than on their own.
Chamber of Commerce v. EPA, No. 09-1237, slip op. at 13 (D.D.C. Apr. 29, 2011) (quoting
13
L_u¥@n_, 504 U.S. at 562) (finding no standing in case filed on behalf of car dealers who sought to
challenge emission standards for car manufacturers). lt may be possible, under Article 111, to
establish standing in such a case, @; as a matter of prudential standing, however, courts have
adopted a "general prohibition on a litigant’s raising another person’s legal rights." Elk Grove
Unified Sch. Dist. v. Newdow, 542 U.S. 1, 12 (2004) (quoting Allen v. Wright, 468 U.S. 737,
751 (1984) (internal quotation omitted)); § also Wvoming Outdoor Council v. U.S. Forest
§elicg, 165 F.3d 43, 48 (D.C. Cir. 1999) ("Litigants seeking to assert the rights ofthird parties .
. . have been found to lack standing on prudential grounds."); Pfizer, 182 F.3d at 979 ("the legal
rights that will be affected are not Pfizer’s but those of its competitors, about which Pfizer is not
in a position to complain").
Here, Ranbaxy correctly protests that ajudicial decision that acts to abort its FDA review
process would violate Ranbaxy’s own due process rights. § Ranbaxy’s Reply at 6. At the
hearing, Ranbaxy articulated its hope that the FDA would act on its ANDA expeditiously, but
expressly indicated that it has joined this suit as a defendant, not a plaintiff`, because, at least in
part, it did not desire to force agency action. Hearing Tr. at 29:18-30:22.
Plaintiffs mistakenly assert that "[r]equiring a plaintiff to have a tentative approval in
order to seek relief such as that requested under the circumstances here would mean that FDA
could never be held accountable for its delay in rendering a decision." Plfs. Opp. at 6-7. This
argument misses the important point that standing depends not only on the existence of a legally
protected interest, but also on whose interest it is. Plaintiffs cite § 355@)(5)(A) as the basis for
their claim that the FDA has unreasonably delayed making a decision on Ranbaxy’s ANDA.
Plfs. Opp. at 16. Yet § 355(j)(5)(A) states: "Within one hundred and eighty days of the initial
receipt of an application . . . or within such additional period as mav be agreed upon bv the
Secretarv and the applicant, the Secretary shall approve or disapprove the application."
(Emphasis added). The right to a timely ANDA review thus belongs to the ANDA applicant - in
this case, Ranbaxy. Plaintiffs may fervently wish for the FDA to act on Ranbaxy’s ANDA; such
desires, however, do not equate with standing.
3. Effect on Business Decz'sz'ons
Nor can Plaintiffs successfully allege the injury necessary to obtain standing based on
their allegations that the FDA’s delay in deciding whether Ranbaxy is entitled to a period of
marketing exclusivity "directly affects business decisions that must be made now." Compl. at 11
55. J ust last month, another court in this Circuit held that standing is not conferred by agency
action that creates uncertainties detrimental to a would-be plaintiff’ s strategic business planning
abilities. § ViroPhanna, Inc. v. Hamburg, No. 10-1529, 2011 WL 1438400, at *5 (D.D.C.,
Apr. 15, 201 1) (Huvelle, J.). 1n ViroPharma, the plaintiff alleged, among other injuries, "harms
to ViroPharma’s ongoing business operations." I_cL Specifically, "plaintiff claims that the FDA’s
regulatory change generally ‘impacts ViroPharma’s operations, investment decisions, and
strategic planning"’ and that "ViroPharma’s ‘ability to construct strategic plans’ has been
‘impacted’ by FDA’s actions ‘as a result of cash flow uncertainties’ . . . and that the ‘uncertainty’
associated with FDA’s actions has caused ViroPharma’s stock price to be lower tha[n] it
otherwise would be." I_¢ (intemal citations omitted). The Court concluded:
ViroPhanna’s allegations present a number of problems, each of
which would be sufficient to undercut its rationale for standing.
ViroPhanna complains that its operations have been variously
changed or ‘impacted,’ . . . and that it suffers from ‘uncertainties’
regarding the future regulatory and competitive environment.
These ‘hanns’ are highly nebulous in both character and degree,
and are a far cry from the type of ‘concrete and particularized’
injury required for Article 111 standing.
This Court believes that Judge Huvelle’s reasoning is persuasive here, too. Not only are
Plaintiffs’ alleged hanns speculative, but they are so generalized as to be applicable to almost
any competitive business situation. To grant standing because of this broad type of potential
injury would grossly distort the concept. C_f¢ E_f_i;_e,_r, 182 F.3d at 979 ("Pfizer voluntarily incurred
the expense of preemptive patent litigation in order to get a substantial statutory benefit, namely,
a stay of the FDA’s approval of Mylan’s ANDA. 1n sum, Pfizer suffers no hardship because it
953
‘is not required to engage in, or to refrain from, any conduct. ) (quoting Texas v. United States,
523 U.S. 296, 301 (1998)).
4. Lack of Redress
Finally, Plaintiffs have not pled facts sufficient to suggest that their injuries are likely to
be redressed by the relief they seek. Even were this Court able to force the FDA to 1) enforce
the AIP against Ranbaxy - a dubious proposal at best, g Heckler v. Chaney, 470 U.S. 821, 832
(1985) ("an agency’s decision not to take enforcement action should be presumed immune from
judicial review") - 2) immediately deny Ranbaxy’s ANDA, and 3) extinguish Ranbaxy’s 180-
day marketing exclusivity period, Plaintiffs, whose own ANDA has yet to receive even tentative
approval, would still have no more certainty as to whether they may begin to market generic
Ln>lroR® on June 28, 2011.
The Court, therefore, finds that Plaintiffs lack standing to maintain the present action,
thereby warranting dismissal under Rule 12(b)(1).
B. Ripeness
A second related ground also requires granting the FDA’s Motion to Dismiss - namely,
the doctrine of ripeness. §§ Wvoming Outdoor Council, 165 F.3d at 48 ("C1osely akin to the
standing requirement, and indeed not always clearly separable from it, is the ripeness doctrine.").
1n order to detennine whether a controversy is ripe, a court must "evaluate both the fitness of the
16
issues for judicial decision and the hardship to the parties of withholding court consideration."
Pfizer, 182 F.3d at 978 (quoting Texas, 523 U.S. at 301 (internal quotation omitted)).
1 . Fz`tness
A claim "‘is not ripe for adjudication if it rests upon contingent future events that may not
occur as anticipated, or indeed may not occur at all."’ l_d. (quOting _T_e§§, 523 U.S. at 300). 1n
other words, the "‘fitness’ prong of the analysis generally addresses ‘whether the issue is purely
legal, whether consideration of the issue would benefit from a more concrete setting, and
whether the agency’s action is sufficiently final."’ Teva v. Sebelius, 595 F.3d at 1308 (quoting
National Ass’n ofHome Builders v. U.S. Annv Corps of Engineers, 440 F.3d 459, 463 (D.C.
Cir. 2006)).
a. Factual Uncertainty
The FDA argues first that "Mylan’s claims are not fit for review for the same reasons it
lacks standing - its own application has not even been tentatively approved." FDA Mot. at 18.
ln addition, the FDA argues, "detennination of Ranbaxy’s eligibility for exclusivity will
necessarily be intensely fact-driven . . . . Mylan’s claims thus raise issues that are not ‘purely
legal,’ and that require FDA’s further factual resolution." I_cL at 19.
Plaintiffs, on the other hand, contend that "Matrix’s ANDA is on a clear and reliable path
to approval," rendering their claims ripe for judicial review. Plfs. Opp. at 5. 1n support, they
allege that "Plaintiffs have not been informed by FDA of ‘any open deficiencies with the Matrix
ANDA."’ l_d. at 8 (quoting Declaration of W. Talton, 11 ll (attached to Plfs.’ Mot. for P.1.) (filed
under seal)). Citing an FDA memo, Plaintiffs allege: "
The last questions that FDA posed have been
answered. FDA promises in its unsworn Exhibit D and in its brief that it is conducting a review
of Matrix’s ANDA and other atorvastatin ANDAs in as expeditious a manner as possible, but it
17
has not yet issued tentative approvals on any of the atorvastatin ANDAs." Plfs. Opp. at 8 (citing
Exhibit D to FDA’s Motion to Dismiss, Memorandum from Keith O. Webber, Acting Director,
Office of Generic Drugs, to Matrix Laboratories LTD, re: Status of ANDA Review (April 1,
201 1) (filed under seal).
A review of this memorandum, however, reveals that Plaintiffs’ characterizations are too
sanguine~
They cannot, however, so represent with any confidence to the Court. Continued uncertainty
therefore remains as to if and when Plaintiffs’ ANDA will be ready for approval, be it tentative
or final.
Two D.C. Circuit cases, Pfizer, 182 F.3d 975, and Teva v. Sebelius, 595 F.3d 1303, are
instructive for evaluating when a claim involving a generic drug manufacturer’s pending ANDA
is ripe for review. 1n _llfiz:er, the FDA accepted for review an ANDA petition submitted by
Mylan for a generic version of Procardia XL®. 182 F.3d at 977. Pfizer challenged the FDA’s
acceptance of Mylan’s ANDA for review. 1n finding a lack of subject matter jurisdiction, the
666
Court of Appeals applied the maxim that a claim is not ripe for adjudication if it rests upon
contingent future events that may not occur as anticipated."’ 1¢ at 978 (quoting Texas, 523 U.S.
at 300). Pfizer thus could not challenge the agency’s action of accepting Mylan’s ANDA for
review:
The decision to accept Mylan’s ANDA for processing as a
pharmaceutical equivalent to Procardia XL® is, however, merely
the first step in the agency’s approval process. The critical fact
remains that the FDA may never approve Mylan’s app1ication-
whether because it decides in the end that the dosage fonn of
Mylan’s drug is different from that of Procardia XL® or for some
entirely different reason, such as a lack of bioequivalence.
Therefore, ‘depending upon the agency’s future actions . . . review
now may turn out to have been unnecessary’ and could deprive the
agency of the opportunity to apply its expertise and to correct any
mistakes it may have made.
id (quoting Ohio Forestrv Ass’n v. Sierra Club, 523 U.S. 726, 736 (1998)).
At the other end of the ripeness spectrum, Teva v. Sebelius did not involve such factual
uncertainty, and the D.C. Circuit distinguished it from Pfizer on this ground. Teva had already
received tentative approval for its ANDA, and the Court observed: "The absence of any
colorable factual dispute in Teva’s case compels a different outcome from P_fiz_e_r;. The FDA
makes no suggestion that any possible deficiency or uncertainty in Teva’s ANDA could thwart
final approval." id at 1309. Rather, "the substantive issues Teva raise[d were] undoubtedly
‘purely legal’ in the relevant sense." ld_. at l308.
The posture of the case here more closely resembles Pfizer than Teva v. Sebelius.
F actual questions exist with respect to not only the status of Plaintiffs’ ANDA, but also to
Ranbaxy’s eligibility for exclusivity. The FDA contends that "FDA’s determination of
Ranbaxy’s eligibility for exclusivity will necessarily be intensely fact-driven, entailing, among
other things, an evaluation of whether the data in Ranbaxy’s atorvastatin application are
unreliable." FDA Mot. at 19. Plaintiffs do not appear to materially dispute this contention,
asserting: "Neither Ranbaxy nor FDA denies that the AIP applies to Ranbaxy’s atorvastatin
ANDA. 1_f` it does, and f Ranbaxy cannot establish that the data in that ANDA are reliable, the
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application should be withdrawn and Ranbaxy should not be granted 180-day marketing
exclusivity for atorvastatin." Plfs. Opp. at 3 (emphasis added). lt appears, as the record stands
now, that both of these are open factual questions that the FDA needs to detennine. This Court
should not prematurely intrude in that process, but rather afford "the agency . . . the opportunity
to apply its expertise." i, 182 F.3d at 978.
b. Final Agency Action
The FDA additionally argues that "the exclusivity issue is not fit for review because there
has been no final agency action." FDA Mot. at 19. Although addressing this in the context of
standing rather than ripeness, Plaintiffs respond that "[f]inal agency action, under the
circumstances presented here, is not required . . . ." Plfs. Opp. at 5. The Court disagrees, as did
another district court in a similar case three years ago.
Hi-Tech Phannacal Co., Inc. v. FDA, 587 F. Supp. 2d 1 (D.D.C. 2008), involved a
generic drug manufacturer that both was a first filer and had received tentative approval. § at
5-6. Hi-Tech sought a declaratory judgment that it was entitled to 180 days of marketing
exclusivity and a preliminary injunction enjoining the FDA from granting final approval to Hi-
Tech’s competitors. Ld. at 6-7. Hi-Tech, like Plaintiffs here, alleged that the FDA had, in
violation of the APA, unreasonably failed to act - in this case, by declining to make a decision
regarding Hi-Tech’s entitlement to exclusivity prior to the date any generic manufacturer
(including itself) could first receive final approval. LL at 7, 9. 1n denying Hi-Tech’s motion for
a preliminary injunction, the court concluded that Hi-Tech was unlikely to succeed on the merits
of its APA claim because, since there had been no final agency action, Hi-Tech’s claims were
not yet ripe. I;d. at 10.
Contrary to Plaintiffs’ argument, final agency action - or its functional equivalent - is a
prerequisite tojudicial review, even for claims brought under § 706(1) of the APA for
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unreasonable delay. As the Hi-Tech court explained, "[A] claim under Section 706(1) ‘can
proceed only where a plaintiff asserts that an agency failed to take a dilte agency action that it
is required to take."’ li at 9 (emphasis in original) (quoting Norton v. Southern Utah
Wilderness Alliance, 542 U.S. 55, 64 (2004)). After evaluating Hi-Tech’s claim, the court
concluded, "[R]esolving Hi-Tech’s entitlement to exclusivity is not a discrete agency action that
the FDA is required to take, pursuant to statute or regulation, by a time certain." l_d_. at 9. 1f a
plaintiff cannot seek judicial review of the FDA’s failure to decide the plaintiffs §
entitlement to exclusivity by a certain time, Plaintiffs in this case, who seek to force an FDA
decision on a competitor’s entitlement to exclusivity, certainly cannot present a claim that is fit
for review. Similarly, while the Hi-Tech court recognized that a plaintiff may assert a claim
when an agency’s failure to act "is the functional equivalent of final agency action," the "FDA’s
failure to act with respect to the issue of exclusivity does not amount to final agency action
here." ld_.at 10.
The Hi-Tech court also related the requirement of final agency action back to the
question of the plaintiff" s hann, stating: "Quite clearly, the FDA’s inaction has not had the same
impact on Hi-'I`ech as an express denial of relief (i.e., a finding of forfeiture), which would
presumably detennine the scope of the parties’ rights. ln fact, the FDA’s inaction has hadjust
the opposite effect, as Hi-Tech asserts that the FDA’s failure to act perpetuates ‘unnecessary
uncertainty’ as to the parties’ rights." ld_. As the FDA here, too, has not made a decision
regarding exclusivity (either in Plaintiffs’ favor or Ranbaxy’s), the current state of uncertainty
similarly translates into a lack of ripeness. Plaintiffs have thus not stated a claim of unlawful
failure to act that is fit for review under either § 706(1) or § 706(2).
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2. Hardshz‘p
As to the second ripeness factor - hardship to the parties of withholding court
consideration - the D.C. Circuit "has frequently suggested that hardship is not a sine qua non of
ripeness." Teva v. Sebelius, 595 F.3d at 1310. A brief inquiry is nevertheless appropriate.
Plaintiffs allege they will suffer financial losses as a consequence of not knowing
whether Ranbaxy will be entitled to a period of atorvastatin marketing exclusivity because they
cannot knowledgeably prepare for a potential launch of their generic drug on June 28, 2011. As
discussed above, however, Plaintiffs’ ability to launch on June 28 is dependent not only on
whether Ranbaxy is entitled to 180 days of marketing exclusivity, but also on whether Plaintiffs’
own ANDA has been approved, Until the FDA approves (at least tentatively) Matrix’s ANDA,
any hardship Plaintiffs might suffer as a result of the FDA’s failure to decide the exclusivity
issue is hypothetical.
By dismissing Plaintiffs’ claims now, the Court does not foreclose the possibility that
Plaintiffs may seek ajudicial remedy at a future date - e.g., when Plaintiffs’ claims are truly fit
for review. § P_fiz_e_r, 182 F.3d at 979 ("This case might nonetheless be ripe if the FDA’s
acceptance of Mylan’s ANDA for processing somehow foreclosed Pfizer’s right ever to get
meaningful judicial review, but it does not. 1f the FDA eventually approves Mylan’s application,
Pfizer may then challenge the reasons underlying its final decision . . . ."). As the FDA points
out, "Nothing prevents Mylan from seeking judicial recourse if and when FDA renders a final
exclusivity decision that is not to Mylan’s liking." FDA Mot. at 22. This is not to say, however,
that an approval of Ranbaxy’s exclusivity period would necessarily confer standing on Plaintiffs
if their own ANDA had not progressed.
1n addition to a lack of standing, therefore, the Court finds that Plaintiffs’ claims are not
ripe for judicial review. This alternate ground also mandates that the Court grant the FDA’s
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Motion to Dismiss under Rule 12(b)(1). Because the Court finds that it lacks subject matter
jurisdiction to hear Plaintiffs’ claims, analysis under Rule 12(b)(6) is not warranted.
IV. Conclusion
The Court, therefore, ORDERS that:
1) The Defendants’ Motions to Dismiss are GRAN'I`ED;
2) Plaintiffs’ Motion for Preliminary Injunction is DENIED; and
3) Plaintiffs’ Complaint is D1SM1SSED for lack of subject matterjurisdiction.
SO ORDERED.
/s/ fumes f. Boasberg
JAMES E. BOASBERG
United States District Judge
Date: May 2, 2011
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