In determining whether to grant a litigant injunctive relief via a
temporary restraining order or a preliminary injunction, district courts
must balance four factors: (1) whether the litigant is substantially
likely to succeed on the merits; (2) whether the litigant would suffer
irreparable injury if the injunction is not granted; (3) whether an
injunction would substantially injure other interested parties; and (4)
whether the public interest would be furthered by the injunction. See
Mova Pharm. Corp., 140 F.3d at 1066 (citing CityFed Financial Corp. v.
Office of Thrift Supervision, 58 F.3d 738, 746 (D.C.Cir. 1995)).
A. Substantial Likelihood of Success on the Merits
In order to demonstrate a substantial likelihood of success, ABI must
show that the FDA's interpretation of the statute is arbitrary,
capricious, not in accordance with the law, or unwarranted by the facts.
See 5 U.S.C. § 706 (2). To do so, ABI may illustrate the adoption of
improper regulations or highlight the faulty application of statutory
In order to determine whether the FDA's interpretation of the statute
is valid, the Court must ask whether "Congress has directly spoken to the
precise question at issue;" if so, "the court, as well as the agency, must
give effect to the unambiguously expressed intent of Congress." Chevron,
467 U.S. at 842-43, 104 S.Ct. 2778; Mova, 140 F.3d at 1067. If, however,
"the statute is silent or ambiguous with respect to the specific issue,
the question for the court is whether the agency's answer is based on a
permissible construction of the statute." Chevron, 467 U.S. at 842-43, 104
S.Ct. 2778; Mova, 140 F.3d at 1067. So long as the agency's
interpretation is "reasonable and consistent with the statute's purpose,"
the Court must defer to the agency's interpretation. See Chemical Mfrs.
Ass'n v. EPA, 217 F.3d 861, 866 (D.C.Cir. 2000) (quoting Independent
Ins. Agents of Am., Inc. v. Hawke, 211 F.3d 638, 643 (D.C.Cir. 2000)).
1. BMY Did Not List the '331 Patent Within 30 Days
In this case, ABI argues that the FDA acted arbitrarily and
capriciously by granting BNP final approval for its generic version of
paclitaxel. More specifically, ABI asserts that (1) BMY listed the '331
patent on August 11; (2) BNP, seeking ANDA approval, filed a Paragraph IV
certification with FDA in reaction to that listing; and (3) in response
to that Paragraph IV certification, ABI filed a patent infringement
lawsuit. ABI argues that, under these circumstances, the FFDCA requires
the FDA to withhold final approval until thirty months have passed or the
court considering the patent action determines that the patent is invalid
or not infringed. See Pl.'s Mot. at 16-17. In their opposition, the FDA
argues that BMY never properly listed the '331 patent and that,
therefore, none of the rights and obligations that derive from such a
listing have taken effect. See Defs.' Opp'n at 21-26.
In brief, ABI's likelihood of success on the merits depends on whether
it will be able to show that the FDA's determination that BMY had not
listed ABI's patent within thirty days of the patent's issuance was
contrary to the plain meaning of the statute, or, in the alternative,
that the statutory language is ambiguous and the FDA's interpretation is
not based on a "permissible construction" of the statute. Under the
statute in question, the holder of an approved NDA
shall file with the Secretary the patent number and
the expiration date of any patent which claims the
drug for which
the application was submitted or which claims a method
of using such drug and with respect to which a claim
of patent infringement could reasonably be asserted
. . . not later than thirty days after the date the
patent is issued.
21 U.S.C. § 355 (c)(2).