November 12, 2015
[Copyrighted Material Omitted]
[Copyrighted Material Omitted]
appeal concerns two distinct questions: the circumstances
under which the filing of a citizen petition with the Food
and Drug Administration provides grounds for an antitrust
claim, and the scope of false advertising liability under the
Lanham Act. Plaintiffs Apotex Incorporated and Apotex
Corporation appeal from the judgment of the United States
District Court for the Southern District of New York (Swain,
J.) that granted defendant Acorda Therapeutics, Inc.'s
motion to dismiss plaintiffs' Sherman Act claim and that
granted summary judgment in favor of defendant on the Lanham
Act claims (Torres, J.). Because each of these conclusions
was sound, we affirm.
D. PARR (with Joseph N. Froehlich, Scott B. Feder, Hugh S.
Balsam, James T. Peterka, and Andy J. Miller on the brief),
Locke Lord LLP, Chicago, Illinois, for Appellants Apotex
Incorporated & Apotex Corporation.
NIELDS, JR. (with Jason C. Raofield and Colin P. Watson on
the brief), Covington & Burling LLP, Washington, D.C. for
Appellee Acorda Therapeutics, Inc.
JACOBS, LIVINGSTON and DRONEY, Circuit Judges.
JACOBS, Circuit Judge:
parties are rival manufacturers of tizanidine, a drug for
treating spasticity. Plaintiffs Apotex Incorporated and
Apotex Corporation (collectively " Apotex" ) allege
that defendant Acorda Therapeutics, Inc. (" Acorda"
) (i) filed a sham citizen petition with the Food and Drug
Administration (" FDA" ) to hinder approval of
Apotex's competing formulation in violation of Section
Two of the Sherman Act, and (ii) violated the Lanham
Act's proscription on false advertising. As relevant
here, the competition between the manufacturers focused on
the relative efficacy of tablets or capsules in controlling
somnolence, one of the side effects of tizanidine.
United States District Court for the Southern District of New
York (Swain, J.) ruled that the simultaneous approval by the
FDA of Apotex's drug application and its denial of
Acorda's citizen petition (raising concerns about the
application) was by itself insufficient to support a Sherman
Act claim. After discovery, the district court (Torres, J.)
granted summary judgment and dismissed all of Apotex's
false advertising claims on the grounds that (with the
exception of one graph) no representation was literally false
or likely to mislead consumers; and that, as to that one
graph, Apotex failed to show that the false depiction would
meaningfully impact consumers' purchasing decisions.
appeals both rulings, arguing that precedent from this Court
allows its antitrust claim to survive dismissal and that
material issues of fact pertinent to Acorda's
representations remain for a jury to decide. We affirm these
precedent supports an inference that a citizen petition is an
anticompetitive weapon if it attacks a rival drug application
and is denied the same day that the application is approved,
that inference has been undercut by recent FDA
guidance. As to false advertising, we agree with the district
court that no reasonable jury could have found that Acorda
made literally false or misleading representations in its
advertisements, with the exception of a single representation
that Apotex has failed to show affected decisions to
tablets are used to treat spasticity, a symptom of multiple
sclerosis and Parkinson's disease. One of the
tablets' most common side effects is somnolence:
sleepiness or drowsiness. Tizanidine tablets were first
marketed in the United States by Elan Pharmaceuticals, Inc.
(" Elan" ), under the trade name "
Zanaflex." (Elan later sold its rights to Acorda.)
tablets were initially approved for sale by the FDA on
November 27, 1996. In October 2001, Elan submitted a New Drug
Application (" NDA" ) to the FDA seeking approval
to market tizanidine in capsule form. During its review, the
FDA concluded that the absorption of the drug was delayed
when tizanidine capsules were taken with food (rather than
without), and that the delay was associated with a mean 20
percent decrease in Cmax, the peak amount of the drug in a
subject's bloodstream. More importantly, the FDA found
that " [w]hen bioequivalence of the capsule relative
to the tablet is examined under fed conditions [i.e.,
with food], there is a delay in absorption and the mean Cmax
for the capsule is approximately 2/3 of the mean Cmax for the
tablet (Figure 1)." Joint Appendix at 2230 (emphasis
added). The FDA subsequently approved Elan's NDA on
August 29, 2002.
significance of this phenomenon, in plain terms, is that the
faster the drug is absorbed, the more drowsy the patient may
become, whereas the side effect may be reduced if absorption
the NDA was pending, Elan filed a patent application for
methods of administering tizanidine capsules to reduce
somnolence and Cmax. Less than a month after the FDA approved
the NDA, Elan's patent issued as United States Patent No.
6,455,557 (" the '557 patent" ). Elan then
received permission to market its newly approved tizanidine
capsules under the trade name " Zanaflex Capsules."
In July 2004, Acorda acquired the rights to Zanaflex tablets
and Zanaflex Capsules; in April 2005, it launched the sale of
Zanaflex Capsules. Apotex had begun selling its generic
tizanidine tablet product in 2004, and was one of about ten
companies to do so. At the time Acorda began selling Zanaflex
Capsules, Apotex's tizanidine tablet product had a five
percent market share.
Capsules on the open market carried an FDA label pertaining
both to the Capsules and the tablets. The preamble to this
label invites doctors to distinguish between tablets and
Capsules, and between the drug when taken with food and
PHARMACOKINETIC DIFFERENCES BETWEEN ZANAFLEX CAPSULES[TM] AND
ZANAFLEX® TABLETS: ZANAFLEX CAPSULES[TM] ARE NOT
BIOEQUIVALENT TO ZANAFLEX® TABLETS IN THE FED STATE. THE
PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH THE COMPLEX
EFFECTS OF FOOD ON TIZANIDINE PHARMACOKINETICS (see
PHARMACOKINETICS and DOSAGE AND ADMINISTRATION).
Joint Appendix at 643. The Pharmacokinetics section of the
label, under the subheading " Pharmacokinetic
differences between Zanaflex Capsules[TM] and Zanaflex®
Tablets," advises (consistent with the
FDA review of the Zanaflex Capsules NDA)
tat there is a 30 percent increase in Cmax when the tablets
are administered with food, but that when the Capsules are
administered with food, Cmax decreases by 20 percent. "
Consequently, the mean Cmax for the [C]apsule when
administered with food is approximately 2/3's the Cmax
for the tablet when administered with food."
label contains a graph that figures in a number of the false
advertising claims. Referred to as " Figure 1," the
graph is titled " Mean Tizanidine Concentration vs. Time
Profiles for Zanaflex Tablets and Capsules (2 × 4 mg)
Under Fasted and Fed Conditions." It displays the mean
plasma tizanidine concentration at various hours from dosing.
The peak for the curve representing tizanidine capsules
(taken with food) is lower, and occurs later than the peak
for the curve charting concentration over time for tizanidine
tablets (taken with food).
label then explains, in the Dosage and Administration
section, that pharmacokinetic differences between the fed and
fasted state may affect the frequency and onset of certain
adverse events. (The text is in the margin.) Somnolence
is explicitly identified as one of these adverse
2007, Apotex filed an Abbreviated New Drug Application
(" ANDA" )--a filing that seeks generic drug
approval for an existing licensed medication or approved
drug--in order to sell generic tizanidine capsules which
would provide competition to Acorda's Zanaflex Capsules.
In the ANDA, Apotex certified that it was not encroaching on
any validly claimed intellectual property rights because the
'557 patent was invalid. In predictable response, Acorda
filed a patent-infringement suit in 2007. After a seven-day
bench trial, the United States District Court for the
District of New Jersey (Brown, J.) ruled in September 2011
that the '557 patent was invalid. See Acorda
Therapeutics Inc. v. Apotex Inc., No. 07-4937 (GEB-MCA),
2011 WL 4074116, at *27 (D.N.J. Sept. 6, 2011).
after that ruling, Acorda filed a citizen petition with the
FDA raising problems with Apotex's ANDA. The citizen
petition is a means afforded by the FDA for raising concerns
about products the FDA reviews; any individual may file such
a petition concerning scientific or legal issues before or
while the product is on the market. See 21 C.F.R. §
10.30. Conceptually, citizen petitions provide an avenue for
public input into the drug approval process; but the process
has been abused by pharmaceutical companies that file
meritless petitions intended to delay approvals sought by
their competitors and inhibit competition. Acorda's
citizen petition objected to (1) Apotex's statement that
its product was bioequivalent to Reference Listed Drugs
(RLDs) in the fed state; and (2) allegedly misleading or
in the proposed label for the Apotex ANDA.
denied Acorda's citizen petition on February 3, 2012.
That same day, the FDA approved Apotex's ANDA. The
Sherman Act claim relies principally on the FDA's
the green light from the FDA, Apotex launched its product.
Acorda countered with its own authorized generic version of
Zanaflex Capsules. Apotex contends that in the course of
Acorda's marketing: (1) its representatives
misrepresented to doctors that Zanaflex Capsules reduced
Cmax--in comparison with the tablets--and then improperly
used reduction in Cmax as a proxy for a corresponding
decrease in somnolence; and (2) Acorda distributed written
promotional materials to the same effect. In total,
Acorda's advertising efforts contributed to sales of more
than $240 million attributable to its version of Zanaflex
commenced this lawsuit in December 2011, amending its
complaint in February 2012 to include the FDA's denial of
Acorda's citizen petition. Acorda countered with a motion
to dismiss, which the district court (Swain, J.) granted with
respect to the Sherman Act claim and denied with respect to
the Lanham Act claims. The district court observed that
Apotex's Sherman Act claim relied purely on temporal
proximity--the denial of Acorda's citizen petition on the
same day the Apotex ANDA was approved--and concluded that was
insufficient to state a claim in view of recent legislation
making the requirements for delaying an ANDA application more
stringent: " Congress'[s] explicit directive that
ANDA processing should not ordinarily be delayed by a citizen
petition, coupled with its narrowing for the grounds for any
such delay and the statutory notice requirement, strongly
undermines any inference that mere simultaneity of ANDA and
citizen petition decisions is indicative of the delay of one
by reason of ...