United States District Court, E.D. California
ALFASIGMA USA, INC.; BRECKENRIDGE PHARMACEUTICAL, INC., Plaintiffs,
NIVAGEN PHARMACEUTICALS, Inc., Defendant.
MEMORANDUM AND ORDER
MORRISON C. ENGLAND, JR.UNITED STATES DISTRLCT JUDGE
of this action, Plaintiffs Alfasigma USA, Inc.
(“Alfasigma”) and Breckenridge Pharmaceutical,
Inc. (“Breckenridge”) (collectively,
“Plaintiffs”) seek an injunction and damages
arising from Defendant Nivagen Pharmaceuticals, Inc.'s
(“Defendant” or “Nivagen”) allegedly
misleading advertising associated with its product, Niva-Fol.
Plaintiffs allege the following causes of action: (1) false
advertising in violation of the Lanham Act, 15 U.S.C. §
1125(a); (2) fraud; (3) unfair competition in violation of
Cal. Bus. & Prof. Code § 17200, et seq.,
and (4) false advertising in violation of Cal. Bus. &
Prof. Code § 17500, et seq. Presently before
the Court are Plaintiffs' Motion for Preliminary
Injunction and Defendant's Motion for an Extension of
Time (“EOT”) to Complete Rule 26(f) Conference.
An order addressing Defendant's Motion to Dismiss, ECF
No. 13, is forthcoming. For the reasons set forth below,
Plaintiffs' Motion for Preliminary Injunction, ECF No.
11, is DENIED and Defendant's Motion for EOT, ECF No. 31,
produces “medical foods, ” which are consumables
subject to medical supervision, but distinct from both
prescription drugs and dietary supplements. Medical foods do
not require a prescription, but, because they are intended to
be used under a doctor's supervision, subscriptions for
their use are common. Even so, they are not eligible for
reimbursement by Medicaid, Medicare, or many private
insurers. As is relevant to this action, Alfasigma formulated
one of its medical foods, Foltx, “to meet the distinct
nutritional requirements of persons with certain diseases and
medical conditions that may benefit from administration of
vitamins B6, B12, and folic acid . . . .” Pls' Mot.
is a pharmaceutical company that produces a generic version
of Foltx called Folbic. According to Plaintiffs, the
pharmaceutical industry maintains a database in which generic
foods can be linked to their name brand equivalent. This
linking is done by way of an honor system in which the
pharmaceutical company itself represents that it is the
generic equivalent of a certain branded product and is not
verified by any independent source or agency. As a result, if
a generic company represents to industry databases that its
generic medical food contains the same active ingredients in
the same amounts as a certain branded product, the databases
will link the generic to the brand. No outside testing or
sampling is done to verify; the databases simply compare the
claims made on the products labels to see that they contain
the same active ingredients in the same amounts.
produces generics, and in 2015 began marketing a generic that
it represented was equivalent to Alfasigma's branded
product and Breckenridge's generic, causing it to be
linked to those products on industry databases. But Nivagen
also characterized its product as a prescription drug that
requires an “Rx” on the label, thereby entitling
users to reimbursement. Nivagen additionally caused Niva-Fol
to be shown as having a National Drug Code or National Health
Related Items Code number, which identifiers are provided for
approved drugs and medical devices only, of which Niva-Fol is
neither. Those identifiers also qualify Niva-Fol for federal
reimbursement. Plaintiffs allege that this conduct has given
Nivagen a competitive advantage over nonreimbursable products
offered by Plaintiffs, and has allowed it to capture market
Motion for Preliminary Injunction
preliminary injunction is an extraordinary and drastic
remedy.” Munaf v. Geren, 553 U.S. 674, 690
(2008). “[T]he purpose of a preliminary injunction is
to preserve the status quo between the parties pending a
resolution of a case on the merits.” McCormack v.
Hiedeman, 694 F.3d 1004, 1019 (9th Cir. 2012). A
plaintiff seeking a preliminary injunction must establish
that he is (1) “likely to succeed on the merits;”
(2) “likely to suffer irreparable harm in the absence
of preliminary relief;” (3) “the balance of
equities tips in his favor;” and (4) “an
injunction is in the public interest.” Winter v.
Natural Res. Defense Council, 555 U.S. 7, 20 (2008).
“If a plaintiff fails to meet its burden on any of the
four requirements for injunctive relief, its request must be
denied.” Sierra Forest Legacy v. Rey, 691
F.Supp.2d 1204, 1207 (E.D. Cal. 2010) (citing
Winter, 555 U.S. at 22). “In each case, courts
‘must balance the competing claims of injury and must
consider the effect on each party of the granting or
withholding of the requested relief.'”
Winter, 555 U.S. at 24 (quoting Amoco Prod. Co.
v. Gambell, 480 U.S. 531, 542 (1987)). A district court
should enter a preliminary injunction only “upon a
clear showing that the plaintiff is entitled to such
relief.” Winter, 555 U.S. at 22 (citing
Mazurek v. Armstrong, 520 U.S. 968, 972 (1997)).
under the so-called sliding scale approach, as long as the
plaintiff demonstrates the requisite likelihood of
irreparable harm and shows that an injunction is in the
public interest, a preliminary injunction can still issue so
long as serious questions going to the merits are raised and
the balance of hardships tips sharply in the plaintiffs'
favor. Alliance for the Wild Rockies v. Cottrell,
632 F.3d 1127, 1134-35 (9th Cir. 2011) (concluding that the
“serious questions” version of the sliding scale
test for preliminary injunctions remains viable after
the moving party seeks a preliminary injunction that is
mandatory, rather than prohibitory, the moving party must
meet an even higher standard; no injunction should issue
unless the facts and law clearly favor the moving
party. As the Ninth Circuit explains:
Mandatory preliminary relief, which goes well beyond simply
maintaining the status quo Pendente lite, is particularly
disfavored, and should not be issued unless the facts and law
clearly favor the moving party.... Courts are more reluctant
to grant a mandatory injunction than a prohibitory one and
... generally an injunction will not lie except in
prohibitory form. Such mandatory injunctions, however, are
not granted unless extreme or very serious damage will result
and are not issued in doubtful cases.
v. United States, 612 F.2d 1112, 1114-15 (9th Cir. 1980)
(internal citations omitted); see also Stanley v. Univ.
of S. Cal., 13 F.3d 1313, 1319 (9th Cir. 1994)
(“In cases such as the one before us in which a party
seeks mandatory preliminary relief that goes well beyond
maintaining the status quo pendente lite, courts
should be extremely cautious about issuing a preliminary
Motion for ...