United States District Court, District of Columbia
KESSLER UNITED STATES DISTRICT JUDGE.
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.
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.
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.
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 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.
the first requirement, Eagle primarily points to the fact
that it filed its Complaint in April 2016 and completed
summary judgment briefing in October 2 016 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.
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 hurdle in its path to market its generic product
before seeking to intervene in a case that could directly
affect its interests. Eagle's arguments to the contrary
overlook the Hatch-Waxman Act regulatory framework concerning
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.
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 will be foreclosed from marketing
its generic product until 2022. See Mot. at 5.
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.
the Court finds that Apotex has sufficiently-demonstrated
that it may intervene as a right pursuant to Rule 24(a) (2)