EAGLE PHARMACEUTICALS, INC. v. BURWELL et al

Filing 53

MEMORANDUM OPINION to the Order granting Apotex's Motion to Intervene. Signed by Judge Gladys Kessler on 8/30/17. (CL)

Case 1:16-cv-00790-GK Document 53 Filed 08/30/17 Page 1 of 6

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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Case 1:16-cv-00790-GK Document 53 Filed 08/30/17 Page 2 of 6

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

interest in the property or transaction at issue;
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a
(3)

cognizable
that the

Case 1:16-cv-00790-GK Document 53 Filed 08/30/17 Page 3 of 6

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,

timeliness

"is

to

561 F.2d 904,
be

determined

907

(D.C.

from

all

Cir. 1977).
the

Instead,

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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Case 1:16-cv-00790-GK Document 53 Filed 08/30/17 Page 4 of 6

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.
Apotex' s

Federal Defendants have not opposed

request to intervene or otherwise suggested that they

would be harmed by the addition of Apotex to the case.
Rule

24 (a) (2)

intervention

also

demonstrate

requires
a

that

cognizable

the
or

applicant

legally

for

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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Case 1:16-cv-00790-GK Document 53 Filed 08/30/17 Page 5 of 6

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.
Apotex emphasizes,

it need only "show[]

As

that representation of

[its] interest 'may be' inadequate; and the burden of making that
showing should be treated as minimal." Trbovich v.
Workers of Am.,
specific

404 U.S.

financial

528,

538 n.10

United Mine

(1972). Because Apotex's

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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Case 1:16-cv-00790-GK Document 53 Filed 08/30/17 Page 6 of 6

Accordingly,

the Court

finds

that Apotex has

demonstrated that it may intervene as a

sufficiently

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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