Eagle Pharmaceuticals, Inc. v. Burwell

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
EAGLE PHARMACEUTICALS, INC.,
Civil Action No. 16-790(GK)
Plaintiff,
v.
THOMAS PRICE, in his official
Capacity as Secretary of
Health and Human Services;
U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES;
SCOTT GOTTLIEB, in his
official capacity as .
Commissioner of the U.S. Food
and Drug Administration;
U.S. FOOD AND DRUG
ADMINISTRATION,
Defendants.
MEMORANDUM OPINION
This matter is before the Court on Apotex, Inc.'s Motion to
Intervene. Upon consideration of the Motion [Dkt. No. 48],
Opposition [Dkt. No. 50], Reply [Dkt. No. 51], the entire record
herein, and for the reasons discussed below, the Court concludes
that the Motion should be granted.
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I. BACKGROUND
In the underlying case, Plaintiff Eagle Pharmaceuticals, Inc.
("Eagle") brings suit against the U.S. Department of Health and
Human Services, the U.S. Food and Drug Administration, and their
respective directors (collectively "Federal Defendants") following
the denial to Eagle of a seven-year period of orphan drug
exclusivity for the cancer treatment drug, Bendeka. On October 7,
2016, the Parties completed summary judgment briefing. Apotex, a
producer of a generic form of Bendeka, has filed an Abbreviated
New Drug Application ("ANDA") for its generic product that is
currently pending before the FDA and seeks to intervene in this
case to safeguard its ability to market and produce its generic
product.
II. DISCUSSION
Apotex has moved to intervene as of right, pursuant to Federal
Rule of Civil Procedure 24 (a) (2) "to participate and to protect
its interests in this case and also to preserve its rights to
participate in any appeal ... or to file its own notice of appeal in
the event of an adverse decision." Mot. at 3.
Under Rule 24(a) (2), an intervening party must demonstrate:
(1) that its motion is timely; (2) that it has a cognizable
interest in the property or transaction at issue; (3) that the
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interest will be impaired or impeded if intervention is denied;
and (4) that the applicant's interest is not adequately represented
by an existing party. Fund for Animals, Inc. v. Norton, 322 F.3d
728, 731 (D.C. Cir. 2003). Nor is the Court persuaded that
Apotex's intervention would cause unnecessary delay in disposition
of the case. The Court concludes, for the following reasons, that
Apotex has met these requirements.
Regarding the first requirement, Eagle primarily points to
the fact that it filed its Complaint in April 2016 and completed
summary judgment briefing in October 2016 to argue that
intervention is untimely. See Opp. at 1. Although Eagle is correct
that this case has been pending for over a year, "the amount of
time which has elapsed since the litigation began is not in itself
the determinative test of timeliness." Natural Resources Defense
Counsel v. Costle, 561 F.2d 904, 907 (D.C. Cir. 1977). Instead,
timeliness "is to be determined from all the circumstances,
including the purpose for which intervention is sought ... and the
improbability of prejudice to those already in the case." Id.
The circumstances in this case favor a finding that the Motion
is timely. Apotex filed the Motion only a month after receiving
notice from the FDA that its ANDA had been accepted. It is logical
that Apotex would wait to ensure that it had cleared the first
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hurdle in its path to market its generic product before seeking to
intervene in a case that could directly af feet its interests.
Eagle's arguments to the contrary overlook the Hatch-Waxman Act
regulatory framework concerning ANDAs. 1
Moreover, Apotex's intervention would not prejudice the
existing parties or cause an unnecessary delay in the disposition
of this case. If permitted to intervene, Apotex "seek[s] to defer
filing an answer until resolution of the pending summary judgment
motions." Mot. at 2-3. As such, the Court assumes that Apotex is
not requesting to submit additional motions concerning the pending
summary judgment pleadings. Federal Defendants have not opposed
Apotex' s request to intervene or otherwise suggested that they
would be harmed by the addition of Apotex to the case.
Rule 24 (a) (2) also requires that the applicant for
intervention demonstrate a cognizable or legally protected
interest in the action. In its Opposition, Eagle does not appear
to dispute that Apotex has a cognizable interest in opposing a
competitor's efforts to obtain orphan drug exclusivity over a
product for which Apotex has produced a generic. See generally
Opp. Indeed, if Eagle prevails on the merits in this case, Apotex
1
Notably, the cases upon which Eagle relies to argue that the Motion
is untimely do not concern ANDAs.
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will be foreclosed from marketing its generic product until 2022.
See Mot. at 5.
Furthermore, Rule 24(a) (2) requires that the cognizable
interest of the applicant for intervention will be impaired or
impeded if intervention is denied. Given the present posture of
this Motion, the answer to that question is related to the fourth
requirement of Rule 24(a), namely that no party in the action can
be an adequate representative of the applicant's interests. As
Apotex emphasizes, it need only "show[] that representation of
[its] interest 'may be' inadequate; and the burden of making that
showing should be treated as minimal." Trbovich v. United Mine
Workers of Am., 404 U.S. 528, 538 n.10 (1972). Because Apotex's
specific financial interest in the grant or denial of Eagle's
orphan drug exclusivity is not an interest shared by the general
public, the Federal Defendants are not in a position to adequately
represent Apotex's interests. See Apotex Inc. v. U.S. Food & Drug
Admin., 508 F. Supp. 2d 78, 80 n.2 (D.D.C. 2007). The Court
recognizes that if Eagle prevails on the merits in the case and
the Federal Defendants elect not to appeal, Apotex would have no
appeal in which to intervene at a later date. See Reply at 5.
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Accordingly, the Court finds that Apotex has sufficiently
demonstrated that it may intervene as a right pursuant to Rule
24(a)(2). 2
III. CONCLUSION
For the foregoing reasons, Apotex's Motion to Intervene shall
be granted. An Order shall accompany this Memorandum Opinion.
August 30, 2017
Copies to: attorneys on record via ECF
2 Because the Court concludes that Apotex may intervene as a
right, it need not consider Rule 24(b) 's permissive intervention
standards.
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