Allergan, Inc. v. Athena Cosmetics, Inc. , 738 F.3d 1350 ( 2013 )

United States Court of Appeals
for the Federal Circuit
______________________
ALLERGAN, INC., AND DUKE UNIVERSITY,
Plaintiffs-Appellees,
AND
MURRAY A. JOHNSTONE, M.D.,
Plaintiff,
v.
ATHENA COSMETICS, INC.,
Defendant-Appellant,
AND
PHARMA TECH INTERNATIONAL, INC.,
PRODUCT INNOVATIONS, LLC,
NORTHWEST COSMETIC LABORATORIES, LLC,
AND R & G BUSINESS LLC,
Defendants.
______________________
2013-1286
______________________
Appeal from the United States District Court for the
Central District of California in consolidated Nos. 07-CV-
1316 and 09-CV-0328, Judge James V. Selna.
______________________
Decided: December 30, 2013
______________________
2 ALLERGAN, INC. v. ATHENA COSMETICS, INC.
MARK A. PERRY, Gibson, Dunn & Crutcher LLP, of
Washington, DC, argued for plaintiffs-appellees. With
him on the brief were JEFFREY T. THOMAS and BLAINE H.
EVANSON, of Irvine, California.
STEVEN A. ZALESIN, Patterson Belknap Webb & Tyler
LLP, of New York, New York, argued for defendant-
appellant. With him on the brief were TRAVIS J. TU,
JONAH M. KNOBLER and JANE M. METCALF. Of counsel
was STEPHEN P. BENSON, Katten Muchin Rosenman, LLP,
of Chicago, Illinois.
______________________
Before RADER, Chief Judge, MOORE, and WALLACH,
Circuit Judges.
MOORE, Circuit Judge.
Athena Cosmetics, Inc. (Athena) appeals from the dis-
trict court’s grant of summary judgment that Athena
violated California’s unfair competition law (UCL) by
marketing, distributing and selling, without regulatory
approval, products that qualify as drugs. Athena also
challenges the court’s entry of a nationwide injunction
and the denial of a motion for judgment on the pleadings
that the Federal Food, Drug, and Cosmetic Act (FDCA)
preempts Allergan, Inc.’s (Allergan) UCL claim. We hold
that the FDCA does not preempt Allergan’s UCL claim
and that there is no genuine dispute that the products at
issue are drugs under California law, and thus affirm the
grant of summary judgment. We also hold that the dis-
trict court abused its discretion by entering an overbroad
injunction, and thus vacate the injunction and remand.
BACKGROUND
The products at issue in this appeal are formulations
of Athena’s RevitaLash line, all of which contain a
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 3
prostaglandin derivative as an active ingredient. The
Food and Drug Administration (FDA) has not taken
enforcement action against, or otherwise regulated, the
products at issue. Allergan sells a product called Latisse,
which also contains a prostaglandin derivative. Latisse is
a FDA-approved prescription drug used for the treatment
of a condition that affects eyelash growth.
Allergan sued Athena for patent infringement and a
violation of the UCL, California Business and Professions
Code § 17200 et seq. Allergan alleged that Athena
competed unfairly by violating, inter alia, California’s
Health and Safety Code (California Health Code)
§ 111550 1 by “marketing, selling, and distributing [its]
hair and/or eyelash growth products without [a new drug]
application approved by the FDA or California State
Department of Health Services.” Complaint at ¶¶ 82, 84,
Allergan, Inc. v. Athena Cosmetics, Inc., No. 8:07-cv-1316
(C.D. Cal. Sept. 30, 2011).
The district court denied Athena’s motion for
judgment on the pleadings that the FDCA preempts
Allergan’s UCL claim. Allergan moved for summary
judgment that the products at issue qualify as new drugs
that lack the requisite approval under the California
Health Code, giving rise to a UCL violation. The court
granted summary judgment and entered a permanent
injunction. Athena appeals.
1 “No person shall sell . . . any new drug . . . unless
it satisfies either of the following: (a) It is . . . [a] new
drug, and a new drug application has been approved for it
and that approval has not been withdrawn or suspended
under Section 505 of the [FDCA] . . . . [or] (b) The [Cali-
fornia Health Department] has approved a new drug
application for that new drug . . . .”
4 ALLERGAN, INC. v. ATHENA COSMETICS, INC.
JURISDICTION
While this appeal does not present any patent issues,
Allergan’s amended complaint alleged infringement of
three patents of which it is the exclusive licensee,
including U.S. Patent No. 6,262,105. The parties did not
initially contest our jurisdiction, but “every federal appel-
late court has a special obligation to satisfy itself . . . of its
own jurisdiction.” Bender v. Williamsport Area Sch. Dist.,
475 U.S. 534, 541 (1986) (internal quotation marks omit-
ted). Therefore, we ordered supplemental briefing on our
jurisdiction.
Athena argued that we have jurisdiction over this ap-
peal. Sept. 20, 2013 Supp. Br. It argued that, as a result
of actions in the underlying district court litigation, the
parties’ legal relations were altered with respect to the
patent claims. Id. Allergan disputed our jurisdiction.
Sept. 20, 2013 & Oct. 11, 2013 Supp. Brs.
We have exclusive jurisdiction over an appeal from a
final decision of a district court (including one unrelated
to patent issues) when “patent law is a necessary element
of one of the well-pleaded claims” in the complaint.
Christianson v. Colt Indus. Operating Corp., 486 U.S. 800,
809 (1988); 28 U.S.C. § 1295(a)(1). In some circumstanc-
es, a district court’s dismissal without prejudice of a
patent claim serves as a constructive amendment to the
complaint, effectively removing the patent claim. See
Chamberlain Grp. v. Skylink Techs., Inc., 381 F.3d 1178,
1189–90 (Fed. Cir. 2004). We have explained, however,
that “[d]ismissals divest this court of jurisdiction only if
‘[t]he parties were left in the same legal position with
respect to [all] patent claims as if they had never been
filed.’” Id. at 1190 (quoting Nilssen v. Motorola, Inc., 203
F.3d 782, 785 (Fed. Cir. 2000)). Moreover, “[n]either the
specific rule under which the District Court dismissed the
claims nor the wording of the dismissal alters the funda-
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 5
mental basis of our jurisdiction.” Chamberlain, 381 F.3d
at 1190.
In this case, following the district court’s issuance of a
Final Claim Construction Order, the parties proposed
that the court grant summary judgment of noninfringe-
ment of the ’105 patent, while preserving their full appel-
late rights regarding claim construction. Allergan, No.
8:07-cv-1316, ECF No. 679 (C.D. Cal. May 9, 2012). The
court entered summary judgment “in accordance with the
terms of the Stipulation.” Id., ECF No. 691 (C.D. Cal.
May 29, 2012). Thereafter, pursuant to the parties’
further agreement, the court dismissed all of the patent
claims “without prejudice.” Id., ECF No. 1075 (C.D. Cal.
Mar. 28, 2013).
We have jurisdiction over this case because the par-
ties were not left in the same legal position as if the ’105
patent claim had never been filed. The court’s dismissal
“without prejudice” merely reflects the parties’ agreement
that the ’105 patent claim could be re-filed in future
litigation between these parties. Should that occur,
however, the parties will be bound by the court’s sum-
mary judgment ruling—which the court did not vacate.
Indeed, Allergan, whose decision it is whether to reassert
the ’105 patent against Athena, concedes on appeal that
the summary judgment ruling “would bind the parties in
future district court litigation against each other.” Oct.
11, 2013 Supp. Br. at 2. The court’s dismissal of the ’105
patent claim did not undo this alteration in legal status,
and therefore we have jurisdiction over this appeal pur-
suant to 28 U.S.C. § 1295(a)(1). 2
2 Athena contends that the district court altered the
legal status of the parties with respect to each of the other
6 ALLERGAN, INC. v. ATHENA COSMETICS, INC.
ANALYSIS
Where an issue is not unique to patent law, we apply
the law of the regional circuit from which the case arises.
Sulzer Textil A.G. v. Picanol N.V., 358 F.3d 1356, 1363
(Fed. Cir. 2004). The Ninth Circuit reviews grants of
summary judgment and determinations regarding
preemption de novo. Engine Mfrs. Ass’n v. S. Coast Air
Quality Maint. Dist., 498 F.3d 1031, 1035 (9th Cir. 2007).
The Ninth Circuit reviews the decision to grant a perma-
nent injunction, as well as its scope, for abuse of discre-
tion, and underlying factual findings for clear error.
Columbia Pictures Indus., Inc. v. Fung, 710 F.3d 1020,
1030 (9th Cir. 2013).
I. Preemption
The California Health Code incorporates various pro-
visions of the FDCA, which does not itself allow a private
right of action. See 21 U.S.C. § 337(a). The district court
held that the FDCA did not preempt Allergan’s UCL
claim. It stated that “mentions of the FDCA throughout”
its order were “referential” because “[i]n order to deter-
mine if the [California Health Code] is violated, the Court
looks to whether the federal regulations incorporated
therein are violated.” Allergan, No. 8:07-cv-1316, slip op.
at 4 (C.D. Cal. Oct. 11, 2012). On appeal, the parties
agree that the FDCA does not expressly preempt Aller-
gan’s claim—the dispute before us concerns implied
preemption.
two patent claims. Sept. 20, 2013 Supp. Br. at 2–3.
Because the change in legal status with respect to the
’105 patent claim is sufficient to supply our jurisdiction,
we need not address the other patents.
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 7
Athena argues that the FDCA impliedly preempts Al-
lergan’s UCL claim. It contends that, under Buckman Co.
v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), a state
law claim is impliedly preempted if it does not implicate a
traditional state law tort principle and exists solely by
virtue of a federal statute. Athena argues that Allergan’s
claim involves the violation of a California statute that
simply incorporates FDCA provisions and is not rooted in
state law tort principles.
Athena argues that the Ninth Circuit’s application of
Buckman in PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th
Cir. 2010) governs this case. In that case, the court found
that the plaintiff’s claim based on alleged misrepresenta-
tions to the FDA about a medical device was impliedly
preempted because it would have impermissibly circum-
vented the agency’s exclusive enforcement authority. Id.
at 926–30. Athena argues that Allergan’s claim interferes
with the FDA’s discretionary authority whether to regu-
late an article in interstate commerce as a drug. Athena
also argues that, under the prudential doctrine of primary
jurisdiction, the district court abused its discretion by
declining to stay this case pending the FDA’s determina-
tions about the products at issue.
Allergan responds that the FDCA does not impliedly
preempt its UCL claim. It argues that the FDCA contains
express preemption provisions for “certain narrow topics
inapplicable,” including medical devices and non-
prescription drugs. Resp. Br. at 17–18 (citing 21 U.S.C.
§§ 360k(a), 379r). Allergan argues that there are no
similar preemption provisions for prescription drugs,
indicating that Congress intended that the FDCA should
not preempt by implication state law claims related to
this category.
Allergan argues that, under Wyeth v. Levine, 555 U.S.
555 (2009), there is no implied preemption where simul-
8 ALLERGAN, INC. v. ATHENA COSMETICS, INC.
taneous compliance with state and federal law is possible,
and the state law is not an obstacle to the realization of
federal goals. It argues that the California Health Code’s
requirements parallel the FDCA’s, making compliance
with both regimes possible. Allergan also argues that the
district court did not abuse its discretion by retaining
jurisdiction because the resolution of this case did not
require the FDA’s specialized knowledge.
We agree with Allergan and hold that the FDCA does
not impliedly preempt its UCL claim. “[T]he purpose of
Congress is the ultimate touchstone in every pre-emption
case.” Id. at 565 (quoting Medtronic, Inc. v. Lohr, 518
U.S. 470, 485 (1996)). “‘In all pre-emption cases, and
particularly in those in which Congress has legislated in a
field which the States have traditionally occupied, we
start with the assumption that the historic police powers
of the States were not to be superseded by the Federal Act
unless that was the clear and manifest purpose of Con-
gress.’” Id. (quoting Medtronic, 518 U.S. at 485) (altera-
tions omitted).
The fact that the California Health Code parallels cer-
tain FDCA provisions does not mean that it does not
implicate an historic state power that may be vindicated
under state law tort principles. The Supreme Court
acknowledged “the historic primacy of state regulation of
matters of health and safety,” Buckman, 531 U.S. at 348,
which is precisely the California Health Code’s subject
matter.
We do not find a clear purpose by Congress to
preempt the state law claim at issue. Congress expressed
its intent to preempt state-law causes of action regarding,
for example, non-prescription drugs and medical devices.
Allergan’s contention, however, is that the products at
issue must ultimately be regulated as prescription
drugs—about which Congress “declined to enact such a
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 9
provision.” Wyeth, 555 U.S. at 567; see also Farm Raised
Salmon Cases, 175 P.3d 1170, 1179 (Cal. 2008)
(“[D]eference should be paid to Congress’s detailed at-
tempt to clearly define the scope of preemption under the
FDCA.”). Moreover, the California Health Code is not an
obstacle to realizing federal objectives. To the contrary, it
contains provisions that parallel the FDCA, such that the
statutes have consistent goals.
Athena’s principal authorities are distinguishable.
Buckman involved a claim based on fraud before the FDA,
which existed—unlike Allergan’s claim—“solely by virtue
of the FDCA disclosure requirements.” 531 U.S. at 352–
53. The Court described fraud on the FDA as—unlike
state regulation of health and safety—“hardly a field
which the States have traditionally occupied . . . such as
to warrant a presumption against finding federal pre-
emption of a state law cause of action.” Id. at 347 (inter-
nal quotation marks omitted). PhotoMedex concerned an
issue that does not involve federal preemption of a state
law claim: “whether the FDCA limits claims under the
[federal] Lanham Act.” 601 F.3d at 924. The decision was
limited to “particular circumstances” that are also not
before us: alleged misrepresentations to the FDA about a
medical device, which implicated the Medical Device
Amendments of 1976 to the FDCA. Id. at 922, 924–28.
We see no error in the district court’s determination
that the FDCA does not preempt Allergan’s UCL claim.
II. Summary Judgment
The California Health Code incorporates the FDCA’s
definition of “drugs” to include “any article other than
food that is used or intended to affect the structure . . . of
the body of human beings.” Cal. Health Code § 109925(c);
cf. 21 U.S.C. § 321(g)(1)(C). An article’s intended use is
determined based on “the objective intent of the persons
legally responsible for the labeling of drugs.” 21 C.F.R.
10 ALLERGAN, INC. v. ATHENA COSMETICS, INC.
§ 201.128. Objective intent “is determined by such per-
sons’ expressions or may be shown by the circumstances
surrounding the distribution of the article,” including
“labeling claims, advertising matter, or oral or written
statements by such persons or their representatives.” Id.
The district court found no genuine dispute that
Athena objectively intended to market past and present
formulations of the products at issue to affect the struc-
ture of eyelashes—i.e., as drugs. The court found that
Athena’s founder, a physician, developed an initial formu-
lation using a prostaglandin derivative with the intent to
cause users’ eyelashes to grow longer and fuller. It found
that Athena’s marketing of subsequent formulations
containing different derivatives continued to discuss
eyelash growth. The court acknowledged that Athena’s
marketing of the most recent formulation discussed
eyelash appearance, but concluded this did not negate an
objective intent to cause growth.
Athena argues that there is a genuine issue of mate-
rial fact about its objective intent. Athena argues that its
intent should turn only on labeling and marketing mate-
rials related to its most recent formulation, and that the
physical properties of the products at issue and marketing
of past formulations are irrelevant. Athena contends
that, within a year of its founding, it limited its marketing
to claims about eyelash appearance. It argues that
statements by resellers about eyelash growth do not
reflect Athena’s objective intent. Athena points to the
testimony of a former employee that she always referred
to eyelash appearance when training resellers about the
products at issue. It argues that authorized resellers
must acknowledge that the products at issue may only be
sold as cosmetics and may not be marketed for eyelash
growth.
Allergan responds that there is no genuine factual
dispute that Athena objectively intends for the products
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 11
at issue to be used as drugs. It argues that the physical
properties and claims about past and present formula-
tions are relevant, particularly because Athena has not
materially altered the properties of, or marketing about,
its various formulations. Allergan argues that Athena
and its resellers advertise that the products at issue were
developed by Athena’s founder to treat his wife’s eyelash
loss. It argues that Athena’s founder testified that he had
reason to think the product he developed would cause
eyelashes “to grow thick and long,” J.A. 670–71, and
sought to sell the product for that purpose. J.A. 684, 687.
Allergan argues that Athena’s marketing consistently
references eyelash length, which depends on growth.
We agree with Allergan and hold that there is no gen-
uine dispute that Athena objectively intends for the
products at issue to be used to affect the structure of
eyelashes—i.e., as drugs. Athena’s intent as to its line-up
of products may be “derived or inferred from labeling,
promotional material, advertising, or any other relevant
source.” United States v. Storage Spaces Designated Nos.
“8” & “49”, 777 F.2d 1363, 1366 (9th Cir. 1985). As an
initial matter, we disagree with Athena that the only
relevant evidence is labeling and marketing, or that the
only relevant formulation is the most recent one. Athe-
na’s website collectively refers to the RevitaLash “line-up
of products,” and describes formulation changes as “im-
prove[ments]” to the intended use of “one or more of our
products.” J.A. 878.
Athena’s marketing of the products at issue consist-
ently discusses physical changes to eyelashes. There is no
dispute that Athena made drug-related claims about an
early formulation—and it never expressly disavowed such
claims as it reformulated its products. Instead, the com-
pany continued to suggest that the products at issue
change eyelash structure. For example, the company’s
website contained a message from the founder referring to
12 ALLERGAN, INC. v. ATHENA COSMETICS, INC.
his wife’s “fragile, sparse and thin” eyelashes, and his
development of a formula to achieve “the look of renewed
health, strength and beauty.” J.A. 875 (emphasis added).
An advertisement about the most recent formulation
states that the product is “both dermatologist and oph-
thalmologist reviewed,” and describes “improved appear-
ance” of eyelashes in the context of a “clinical study.” J.A.
750; see also J.A. 871.
Athena’s training of resellers similarly references eye-
lash structure. An Athena representative led a webinar
for resellers in which she discussed achieving “fuller and
thicker” eyelashes. J.A. 820. She discussed a “mainte-
nance program” to retain “the desired length” after
“achiev[ing] longer, fuller-looking eyelashes.” J.A. 822.
She stated that “eyelashes will grow naturally or with
RevitaLash.” J.A. 824. One reseller’s marketing materi-
als displayed a before-and-after photograph of eyelashes
and promoted “dramatically thicker, longer, and lusher
lashes.” J.A. 960. Athena’s claims invariably link eyelash
appearance to physical changes caused by the products at
issue.
Athena’s argument that it markets only cosmetic ben-
efits fails. We need not decide whether the products at
issue could also be cosmetics—it is sufficient to resolve
this case that there is no dispute that Athena objectively
intends that the products at issue be used as drugs. We
therefore affirm the district court’s grant of summary
judgment.
III. Injunction
The district court entered a permanent injunction
barring Athena from manufacturing, marketing, selling,
and/or offering for sale “any and all” “eyelash growth
product(s)” “anywhere within the United States.” Aller-
gan, No. 8:07-cv-1316, slip op. at 15 (C.D. Cal. Mar. 6,
2013). It determined that nationwide coverage was
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 13
justified because Athena’s UCL violation resulted from
sales and advertising “throughout the United States,” and
“wherever the unfair competition occurs, it affects Aller-
gan in California.” Id. at 7–8. The court concluded that
the injunction’s regulation of out-of-state commerce did
not violate the Commerce Clause of the United States
Constitution. Id. at 8–10. Specifically, it found “substan-
tial indications that other jurisdictions define ‘drug’” like
the California Health Code. Id. at 9–10. The court stated
that Athena did not “demonstrate that there would be a
conflict with other states’ laws,” and “proffer[ed] no facts
to suggest that [it] would encounter contrary” law in other
states. Id. at 7, 9–10.
Athena argues that it was an abuse of discretion for
the court to issue a nationwide injunction. It argues that
the injunction impermissibly reaches outside of California
to remedy a violation of California law. Athena argues
that the injunction violates the Commerce Clause by
regulating commerce that occurs wholly outside of Cali-
fornia. It emphasizes that California is not part of the
supply chain for the most recent formulation of the prod-
ucts at issue.
Allergan responds that the court did not abuse its dis-
cretion. It argues that the injunction properly applies to
out-of-state conduct that causes Allergan an injury under
the UCL in California. Allergan argues that the record
evidence demonstrated that the injunction’s nationwide
scope was a practical necessity. It argues that, after
Athena volunteered to stop sales of the products at issue
in California before the court issued an injunction, such
sales persisted within the state. Allergan also argues
that there is no Commerce Clause violation because the
injunction does not impose obligations on Athena that
conflict with another state’s law and Athena has not
shown any conflict with the laws of other states. It con-
tends that, in any event, other states could not adopt laws
14 ALLERGAN, INC. v. ATHENA COSMETICS, INC.
that are inconsistent with the California Health Code
because it incorporates a regulatory floor set by the
FDCA.
We agree with Athena and hold that the district court
abused its discretion by entering an injunction that
regulates any and all out-of-state conduct. As the Cali-
fornia Supreme Court has stated, “[n]either the language
of the UCL nor its legislative history provides any basis
for concluding the Legislature intended the UCL to oper-
ate extraterritorially.” Sullivan v. Oracle Corp., 254 P.3d
237, 248 (Cal. 2011). The injunction impermissibly im-
poses the UCL on entirely extraterritorial conduct regard-
less of whether the conduct in other states causes harm to
California. This injunction is so broad that it would bar
Athena from making its product in Idaho, distributing it
from a facility in Nevada, and selling it to Connecticut
consumers.
Allergan argues that Norwest Mortgage, Inc. v. Supe-
rior Court of San Diego County, 72 Cal. App. 4th 214
(1999), supports the court’s imposition of a nationwide
injunction in this case. It does not. In Norwest Mortgage,
the California Court of Appeals held that UCL claims
could be filed by California residents regardless of where
they purchased their mortgage product and by non-
California residents who purchased it in California, but
not by non-California residents who purchased it outside
of California (entirely extraterritorial conduct). Id. at
222–24. The conduct enjoined here is exactly the sort of
purely extraterritorial conduct that the California Court
of Appeals expressly held could not be regulated by the
UCL. This injunction prevents sales that are entirely
extraterritorial. It is not limited to purchases made by
California residents that are being shipped into California
or to sales emanating from California.
Neither the California courts nor the California legis-
lature are permitted to regulate commerce entirely out-
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 15
side of the state’s borders. To do so would violate the
Commerce Clause, which “precludes” such extraterritorial
application of state law “whether or not the commerce has
effects within the state.” Healy v. Beer Inst., Inc., 491
U.S. 324, 336 (1989) (quoting Edgar v. MITE Corp., 457
U.S. 624, 642–43 (1982)). The Commerce Clause “dictates
that no State may force an out-of-state merchant to seek
regulatory approval in one State before undertaking a
transaction in another.” Id. at 337. This rule applies
regardless of whether Athena can demonstrate that the
laws of other states do—or even could—conflict with the
UCL or the California Health Code. In short, California
may, as it has in this case, conclude that its own unfair
competition law has been violated, and it may prohibit
any future conduct within its borders that would cause
continued violation of its law. California is not permitted,
however, to extend its unfair competition law to other
states. 3
The FDA—and the FDA alone—has the power and
the discretion to enforce the FDCA. 21 U.S.C. § 337(a)
(“[A]ll such proceedings for the enforcement, or to restrain
violations, of this chapter shall be by and in the name of
the United States”). California does not have the authori-
3 There may be instances when a court in one state
may issue an injunction that applies beyond the state’s
boundaries such as when a federal law has been violated.
The Ninth Circuit recognized such a possibility in United
States v. AMC Entertainment, Inc., 549 F.3d 760 (9th Cir.
2008), but nonetheless vacated the nationwide injunction
because the Fifth Circuit had a different interpretation of
the federal law at issue. Id. at 770–73. Such is not the
case here. California has no obligation or right to enforce
the FDCA. The only law at issue here is California’s
UCL.
16 ALLERGAN, INC. v. ATHENA COSMETICS, INC.
ty to stand in the shoes of the FDA to determine whether
Athena’s sale of the products at issue amounts to the sale
of an unapproved drug under the FDCA. This enforce-
ment authority relies exclusively with the FDA. Califor-
nia has chosen to enact the UCL, which prevents
marketing, distributing, and selling, without regulatory
approval, products that qualify as drugs. While it is true
that a state is not free to enact laws that do not meet the
minimum requirements of the FDCA, a state is free to
have no comparable state law if it chooses. The FDA does
not require states to enact laws that parallel federal
requirements. Thus, if other states have no laws that
parallel relevant provisions of the UCL and California
Health Code, there would be no mechanism at all in those
states to challenge Athena’s sales of the products at issue.
In short, imposing the UCL on other states would violate
their sovereignty, and usurp the discretionary enforce-
ment authority of the FDA.
Allergan’s reliance on Athena’s purported failure to
voluntarily cease sales of the products at issue in Califor-
nia does not justify a nationwide injunction. After sum-
mary judgment, Athena offered to voluntarily cease sales
to California. An attorney for Allergan submitted a
declaration stating that, after Athena’s purported cessa-
tion of sales in California, she was still able to purchase a
product at issue from Athena’s and a reseller’s website for
delivery in California, as well as directly from a reseller’s
store in California. See J.A. 2729–34. This record
demonstrates that these sales were isolated occurrences.
Athena recognized these infractions and instituted better
procedures to ensure no further sales of the products at
issue in California, instructed its online resellers not to
sell those products for delivery in California, and ceased
to ship those products to brick-and-mortar resellers in
California. See J.A. 3098–101. If Athena violates a
properly tailored injunction, Allergan’s remedy lies in a
contempt proceeding. But Athena’s failure to entirely
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 17
stop sales in California pursuant to its voluntary efforts
cannot, as Allergan argues, justify a nationwide injunc-
tion that violates the Commerce Clause.
We vacate the permanent injunction. On remand, the
district court should limit the scope of the injunction to
regulate conduct occurring within California. 4
CONCLUSION
We have considered the parties’ remaining arguments
and do not find them persuasive.
AFFIRMED-IN-PART, VACATED-IN-PART, AND
REMANDED
4 Athena also argues that the district court did not
make findings to support irreparable harm, and abused
its discretion by drafting the injunction to cover any
product containing a prostaglandin derivative applied to
eyelashes. We hold that the district court made an ex-
press finding of irreparable harm that was not clearly
erroneous, see, e.g., J.A. 1542–43, and the scope of the
products covered was not an abuse of discretion.