                     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

                                            -2-
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

                                          -3-
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.
                                  -4-
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.




                                           -5-
      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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