Lakeland Regional Medical Center, Inc. v. Astellas US, LLC et al
Filing
66
ORDER denying 16 Motion to dismiss. See Order for details. Signed by Judge Virginia M. Hernandez Covington on 7/25/2011. (KAK)
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION
LAKELAND REGIONAL MEDICAL CENTER,
INC.,
Plaintiff,
v.
Case No. 8:10-cv-2008-T-33TGW
ASTELLAS US LLC,
PHARMA US, INC.,
and
ASTELLAS
Defendants.
________________________________/
ORDER
This matter comes before the Court pursuant to Astellas’s
Motion to Dismiss (Doc. # 16), which was filed on November 19,
2010.
Lakeland Regional Medical Center filed a Response in
Opposition to the Motion (Doc. # 34) on January 21, 2011.
Astellas filed a Reply Memorandum (Doc. # 42) on February 11,
2011. For the reasons that follow, the Court denies the Motion
to Dismiss in this antitrust case.
I.
Factual and Procedural Background
Lakeland Regional, a “full-service hospital,” is a not-
for-profit
Florida
corporation
with
its
Lakeland, Florida. (Doc. # 11 at ¶ 7).
US,
LLC
and
Astellas
Pharma
US,
headquarters
in
Defendants Astellas
Inc.
(collectively,
“Astellas”) are Delaware corporations with headquarters in
Deerfield, Illinois. Id. at ¶ 8.
licensee
of
two
patents
Astellas is the exclusive
involving
the
administration
of
adenosine
Lakeland
unlawful,
to
patients
Regional
undergoing
alleges
anticompetitive,
that
cardiac
stress
Astellas
monopolistic,
has
and
tests.
engaged
in
exclusionary
activity with respect to adenosine in violation of the Sherman
Antitrust Act, 15 U.S.C. §§ 1 and 2, the Clayton Antitrust
Act, 15 U.S.C. § 14, Florida antitrust law, and Florida common
law.
A.
Stress Tests and Use of Adenosine
Physicians use a test known as myocardial perfusion
imaging to diagnose a condition known as cardiac artery
disease, one of the leading causes of death in the United
States. Id. at ¶ 9.
Myocardial perfusion imaging is usually
done while the patient is placed under “stress” in order to
maximize the accuracy of the test. Id. at ¶ 10.
induce
stress
treadmill. Id.
by
requiring
patients
to
Physicians
exercise
on
a
When patients are unable to exercise on a
treadmill, physicians create “pharmacological stress” through
the administration of adenosine. Id. Adenosine is a naturally
occurring compound that induces the dilation of blood vessels.
Id. at ¶ 12.
Even when patients are capable of exercise, physicians
often use adenosine to further stress the heart, in order to
increase the accuracy of the stress test. Id.
-2-
Administration
of adenosine is the medically recognized standard of care when
pharmacologic
perfusion
stress
imaging.
is
Id.
required
When
to
perform
adenosine
is
myocardial
required
for
myocardial perfusion imaging, more than 90% of the adenosine
is
suppled
by
Astellas.
Further,
Id.
adenosine
is
administered to cardiac patients in more than 90% of cardiac
stress tests conducted nationwide. Id.
In addition to stress
tests, adenosine is also used to treat a condition known as
paroxysmal supraventricular tachycardia. Id.
Two patents are implicated here.
The patents are owned
by King Pharmaceuticals, Inc., but Astellas is the exclusive
licensee
of
such
patents:
the
5,070,877
5,731,296 patent. Id. at ¶¶ 17-18.
solely
to
the
use
of
patent
and
the
The ‘877 Patent relates
Astellas’s
adenosine
product
“Adenoscan®,” for its vasodilative properties when used in
conjunction with myocardial imaging. Id. at ¶ 18.
Patent expired on May 18, 2009. Id.
The ‘877
The ‘296 Patent covers a
method of continuous adenosine infusion, and it will expire on
March 24, 2015. Id. Both patents encompass the process of
using adenosine during myocardial imaging. The patents do not
cover
Astellas’s
adenosine
product,
unpatentable. Id. at ¶ 22.
-3-
because
adenosine
is
Several other companies sell an adenosine product that is
not meaningfully distinguishable from Astellas’s adenosine
product. Id.
compared
with
Astellas charges $8.05 per ml. of Adenoscan,
$1.76
per
ml.
for
generic
adenosine--
approximately 450% more per unit than its generic counterpart.
Id. at ¶ 23.
It is Astellas’s position that the ‘296 Patent grants
Astellas exclusivity for the only medically recognized process
to administer adenosine during myocardial perfusion imaging,
even after the expiration of the ‘877 Patent.
Id. at ¶ 19.
The majority of all myocardial perfusion imaging stress tests
are administered using the process patented by the ‘296
Patent.
Id.
No
other
medically
recognized
process
for
inducing stress for myocardial perfusion imaging is available.
Id.
B.
Astellas’s Communications with Lakeland Regional
On July 31, 2008, Astellas transmitted a letter to
Lakeland
Regional
indicating
that
Lakeland
Regional
must
purchase Adenoscan for use in myocardial perfusion imaging
procedures after expiration of the ‘877 Patent and that use of
generic adenosine during such procedures would constitute
infringement of the ‘296 Patent. Id. at ¶ 24.
things, the letter stated:
-4-
Among other
[S]ale of . . . an Adenoscan® substitute for that
use [in myocardial perfusion imaging] is currently
protected by two independent United States patents
. . . . When Adenoscan® is purchased from Astellas,
the purchaser is given permission to use the drug
as an adjunct for MPI. But when adenosine from an
unauthorized source is used for MPI . . . the
seller and the user are infringing both the ‘877
and the ‘296 patents and thus could be liable for
patent infringement . . . . [E]ven after May 18,
2009, only Astellas . . . will be legally permitted
to use adenosine as an adjunct for MPI.
Id. at ¶ 26.
In a letter dated September 14, 2009, Astellas explained
to Lakeland Regional:
While there is no patent that covers the
composition, adenosine, this method of use patent
precludes the use of generic adenosine for MPI as a
substitute for Adenoscan®.
Astellas is the only
party that can authorize the patented use of an
adenosine infusion for MPI studies.
Such
permission is only granted when Adenoscan® is
purchased . . . from Astellas.
Id. at ¶ 28 (emphasis in original).
C.
Lakeland Regional’s Complaint
Lakeland Regional contends that Astellas “has attempted
to effectively extend its ‘877 Patent beyond its expiration
date by requiring the use of only Adenoscan®, or an Adenoscan®
substitute, purchased through an Astellas-authorized company
for use as an adjunct therapy to MPI.” Id. at ¶ 35.
Lakeland
Regional characterizes Astellas’s conduct as “anticompetive.”
Id. at ¶ 36.
-5-
Lakeland Regional initiated this action against Astellas
on September 13, 2010, and filed an amended class action
complaint on October 19, 2010. (Doc. ## 1, 11).
Lakeland
Regional’s amended complaint arrays the following counts
against
Astellas:
unlawful
tying
(count
one),
exclusive
dealing (count two), attempted monopolize (count three),
unreasonable
restraint
of
trade
(count
four),
attempted
monopolization (count five), and tortious interference with a
prospective economic advantage(count six).
Astellas responded to the amended complaint by filing a
55 page Motion to Dismiss pursuant to Rule 12(b)(6) of the
Federal Rules of Civil Procedure. (Doc. # 16).
Generally,
Astellas asserts that dismissal is warranted because Lakeland
Regional lacks standing, has failed to demonstrate an injury
in fact, and has failed to state a claim upon which relief may
be granted. The Court will address these arguments and others
below.
II.
Legal Standard
On a motion to dismiss, this Court accepts as true all
the allegations in the complaint and construes them in the
light most favorable to the plaintiff.
Jackson v. Bellsouth
Telecomms., 372 F.3d 1250, 1262 (11th Cir. 2004).
Further,
this Court favors the plaintiff with all reasonable inferences
from the allegations in the complaint.
-6-
Stephens v. Dep’t of
Health & Human Servs., 901 F.2d 1571, 1573 (11th Cir. 1990)
(“On a motion to dismiss, the facts stated in [the] complaint
and all reasonable inferences therefrom are taken as true.”).
However, in Twombly, an antitrust case, the Supreme Court
cautioned:
While a complaint attacked by a Rule 12(b)(6)
motion to dismiss does not need detailed factual
allegations, a plaintiff’s obligation to provide
the grounds of his entitlement to relief requires
more than labels and conclusions, and a formulaic
recitation of the elements of a cause of action
will not do. Factual allegations must be enough to
raise a right to relief above the speculative
level.
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)(internal
citations omitted).
Further, courts are not “bound to accept
as true a legal conclusion couched as a factual allegation.”
Papasan v. Allain, 478 U.S. 265, 286 (1986).
This Court’s analysis is confined to the four corners of
the complaint.
Astellas has filed an assortment of documents
as exhibits to the Motion to Dismiss.
The Court has not
reviewed the exhibits and is therefore not required to convert
the Motion to Dismiss into a motion for summary judgment
pursuant
to
Procedure.
Rule
12(d)
of
the
Federal
Rules
of
Civil
Without the benefit of discovery, it would be
premature for the Court to conduct summary judgment analysis.
-7-
Furthermore, the Eleventh Circuit has cautioned that
“Rule 12(b)(6) dismissals are particularly disfavored in factintensive antitrust cases.” Spanish Broad. Sys. v. Clear
Channel
Commc’ns,
376
2004)(citations omitted).
F.3d
1065,
1070
(11th
Cir.
Moreover, as explained in Amey,
Inc. v. Gulf Abstract & Title, Inc., 758 F.2d 1486, 1502 (11th
Cir. 1985), “‘summary procedures should be used sparingly in
complex antitrust litigation where motive and intent play
leading roles, the proof is largely in the hands of the
alleged
conspirators,
plot.’”
(quoting
and
Norfolk
hostile
Monument
witnesses
Co.
v.
thicken
Woodlawn
the
Mem’l
Gardens, 394 U.S. 700, 704 (1969)).
III. Analysis
A.
Standing
As a threshold matter, this Court must determine whether
Lakeland Regional has standing to bring this action. Pierson
v. Orlando Reg’l Healthcare Sys., Inc., 619 F. Supp. 2d 1260,
1274
(M.D.
Fla.
2009).
Astellas
challenges
Lakeland
Regional’s standing by arguing that Lakeland Regional has not
alleged an Article III “injury in fact,” has not alleged an
“antitrust injury” and has not satisfied the Illinois Brick
rule.
-8-
1.
Injury in Fact
As explained in Lujan v. Defenders of Wildlife, 504 U.S.
555, 560-61 (1992), “[T]he irreducible constitutional minimum
of standing contains three elements.
First, the plaintiff
must have suffered an injury in fact . . . . [s]econd, there
must be a causal connection between the injury and the conduct
complained of . . . . [t]hird, it must be likely, as opposed
to mere speculative, that the injury will be redressed by a
favorable decision.” Id. (internal citations and quotation
marks omitted).
Astellas contends that Lakeland Regional
lacks Article III “case or controversy” standing because
Lakeland Regional has failed to allege an “injury in fact.”
Under Lujan, an injury in fact is “an invasion of a legally
protected interest which is (a) concrete and particularized
and (b) actual or imminent, not conjectural or hypothetical.”
Id. at 560 (internal citations and quotation marks omitted).
The Court finds that Lakeland Regional has alleged an
injury in fact.
In its amended complaint, Lakeland Regional
alleges that it has suffered monetary damages resulting from
Astellas’s alleged exclusive dealing and unlawful tying of its
patented process to its unpatentable adenosine drug. Lakeland
Regional
also
alleges
that
Astellas
has
specifically
threatened to sue Lakeland Regional if Lakeland Regional
purchases alternatives to Adenoscan.
-9-
At this stage of the proceedings, the Court would be
mistaken to dismiss the amended complaint for lack of Article
III standing when the complaint alleges that Lakeland Regional
has suffered a specific economic injury due to Astellas’s
alleged conduct and that Astellas has threatened to sue
Lakeland
Regional
for
patent
infringement
concerning
Astellas’s unpatentable drug. Astellas relies on a bounty of
cases that affirm the dismissal of antitrust actions due to
lack of standing. However, upon close inspection, these cases
were decided at the summary judgment stage.1 The Court will
not make the misstep of deciding the intricate and factually
complex matters before it prematurely.
Satisfied that Lakeland Regional meets the standing
requirements of Article III, the Court must determine whether
Lakeland Regional has suffered an antitrust injury and whether
Lakeland Regional’s amended complaint satisfies the Illinois
Brick rule. “Harm to the antitrust plaintiff is sufficient to
satisfy the constitutional standing requirement of injury in
fact, but the court must make a further determination whether
the plaintiff is a proper party to bring a private antitrust
1
See E.g., Midwestern Waffles, Inc. v. Waffle House,
Inc., 734 F.2d 705 (11th Cir. 1984) and Krypta v. McDonald’s
Corp., 671 F.2d 1282 (11th Cir. 1982). Both cases involved
review of antitrust claims at the summary judgment stage.
-10-
action.”
Assoc.
Gen.
Contractors
of
Cal.
v.
Cal.
State
Council, 459 U.S. 519, 535 at n.31 (1983).
2.
Antitrust Injury
As explained by the Eleventh Circuit in Gulf States
Reorganization Group, Inc. v. Nucor Corp., 466 F.3d 961, 966
(11th Cir. 2006), in addition to the Article III standing
requirements that apply to all federal plaintiffs, those
“challenging violations of the antitrust laws must also show
that they have suffered [an] ‘antitrust injury’ or ‘injury of
the type the antitrust laws were intended to prevent and that
flows from that which makes defendants’ acts unlawful.’”
(citing Brunswick Corp. v. Pueblo Bowl-O-Mat, Inc., 429 U.S.
477, 489 (1977)).
The
Eleventh
Circuit
defined
the
parameters
of
an
antitrust injury in Midwestern Waffles: “The injury must
reflect the anticompetitive effect of either the violation of
antitrust law or of the anticompetitive acts made possible by
the violation, and it should be the type of loss which a
violation of antitrust law would be likely to cause.” 734 F.2d
at 710.
To have suffered an antitrust injury, “a person must
be one against whom anticompetitive activity is directed, and
not one who has merely suffered indirect, secondary, or remote
injury.” Id.
-11-
Although
pleadings,
both
the
parties
Court
must
have
submitted
restrict
its
voluminous
analysis
to
the
complaint to determine whether Lakeland Regional has asserted
an antitrust injury.
In the amended complaint, Lakeland
Regional claims that Astellas perpetrated an illegal tying
arrangement. According to the amended complaint, Astellas has
tied the purchase of an unpatented product with multiple uses
to the patented license to perform a medical procedure.
Lakeland Regional also alleges that Astellas has excluded
potential competitors from the market for the tied product.
The amended complaint alleges a antitrust injury within
its four corners.
Regional
has
Without delving into whether Lakeland
evidence
necessary
to
support
its
amended
complaint and without considering the voluminous documents
attached to Astellas’s Motion, the Court determines that
Lakeland Regional has adequately alleged an antitrust injury
in its amended complaint.
3.
Illinois Brick Standing
At this preliminary stage, the Court is also satisfied
that Lakeland Regional’s amended complaint does not run afoul
of the standards set forth in Illinois Brick v. Illinois, 431
U.S. 720 (1977) curtailing relief in indirect injury cases.
There, the Court addressed the issue of whether plaintiffs
asserting
“pass-on”
damages
have
-12-
standing
to
bring
an
antitrust action under the Clayton Act.
government
entities
manufacturers
conspired
alleging
to
that
engage
in
The plaintiffs were
defendant
price
brick
fixing,
thus
raising the price of cement bricks and eventually leading to
inflation
buildings.
of
the
prices
paid
for
finished
government
The Court determined that the plaintiffs were
“indirect purchasers of concrete block, which passes through
two separate levels in the chain of distribution before
reaching [the plaintiffs].” Id. at 726.
The Court ruled that
the plaintiffs lacked standing because “[t]he legislative
purpose in creating a group of private attorneys general to
enforce the antitrust laws . . . is better served by holding
direct purchasers to be injured to the fill extent of the
overcharge paid by them than by attempting to apportion the
overcharge among all that may have absorbed a part of it.” Id.
at 746 (citations omitted).
Stated another way:
An antitrust violation may be expected to cause
ripples of harm to flow through the Nation’s
economy; but despite the broad wording of Section 4
[of the Clayton Act] there is a point beyond which
the wrongdoer should not be held liable.
It is
reasonable to assume that Congress did not intend
to allow every person tangentially affected by an
antitrust violation to maintain an action to
recover threefold damages for the injury to his
business or property.
Assoc. Gen. Contractors of Cal., 459 U.S. at 534-35.
-13-
The Court has recognized several rationales for the
direct purchaser rule of Illinois Brick: (1) it eliminates the
complication of apportioning overcharges among purchasers in
the chain of distribution; (2) it eliminates a pass-on defense
for manufacturers, which would reduce the effectiveness of
Clayton Act actions by diminishing the recovery available to
plaintiffs;
and
recoveries.
(3)
it
eliminates
the
risk
of
multiple
Kan. v. Utilicorp United, Inc., 497 U.S. 199,
206-207 (1990).
However, as with many “brightline” rules, the Supreme
Court has carved out exceptions to the Illinois Brick direct
purchaser rule and has limited application of Illinois Brick
under certain factual scenarios.
See UtiliCorp, 497 U.S. at
216 (“The rationales underlying Hanover Shoe and Illinois
Brick will not apply with equal force in all cases.”).
This
Court finds Lowell v. Am. Cyanamid Co., 177 F.3d 1228 (11th
Cir. 1999) instructive.
an
antitrust
action
There, the district court dismissed
under
Illinois
Brick
due
to
the
plaintiffs’ failure to join various cyanamid distributors.
The plaintiffs (a group of farmers) were not direct purchasers
of the crop protection product at issue in the case, rather,
the farmers purchased the products from a distributor.
The
Eleventh Circuit reversed the dismissal of the case holding
-14-
“Illinois Brick has no application in this case.” 177 F.3d at
1229.
The Lowell court explained:
Illinois Brick was an extension of the Court’s
earlier prohibition against the defensive use of
passing on in Hanover Shoe, Inc. v. United Shoe
Machinery, Corp., 392 U.S. 481, 491-94 (1968). In
concluding that the indirect government purchaser
of a product may not sue distant manufacturers,
Illinois Brick cited two rationales. The first of
these was that allowing offensive but not defensive
use of pass-on would create a serious risk of
multiple liability for defendants. Even though an
indirect purchaser had already recovered for all or
part of an overcharge passed on to it, the direct
purchaser would still recover automatically the
full amount of the overcharge that the indirect
purchaser had shown to be passed on. . . . Second,
as in Hanover Shoe, the Court was worried about the
uncertainties and difficulties in analyzing price
and out-put decisions in the real economic world
rather than an economist’s hypothetical model and
of the costs to the judicial system and the
efficient enforcement of the antitrust laws of
attempting to reconstruct those decisions in the
courtroom.
Lowell,
177
citations
F.3d
at
omitted).
1229
In
(internal
Lowell,
quotation
the
marks
Eleventh
and
Circuit
determined that the aforementioned rationales underpinning
Illinois Brick did not apply to the facts presented because
the complaint did not contain allegations of “passing on,”
there were “no problems of double recovery” (because only one
illegal act was alleged) and there was “only one set of
potential plaintiffs.” 177 F.3d at 1230.
-15-
Furthermore, the
Eleventh Circuit determined that “the economic and legal
complexities outlined in Illinois Brick [were] absent.” Id.
Lakeland
Regional’s
amended
complaint
contains
allegations tending to describe direct purchase from Astellas,
possibly eliminating the Illinois Brick inquiry.
these
allegations
are
somewhat
tenuous.
As
However,
to
direct
purchase, Lakeland Regional alleges: “Defendant Astellas has
distributed and continues to distribute adenosine products
valued
in
the
millions
of
dollars
annually
from
their
headquarters in Illinois to plaintiff LRM’s place of business
in Florida, and to other purchasers throughout the country.
Payments
are
remitted
from
across
the
country
to
the
defendant.” (Doc. # 11 at ¶ 6) Lakeland Regional also alleges
that Astellas “manufactures and sells” its adenosine products.
Id. at ¶ 22. Further Lakeland Regional alleges that it (along
with other healthcare providers) has been forced to “agree to
purchase their needed supplies of adenosine from defendant
Astellas and not from competing adenosine providers, as they
would prefer to do.” Id. at ¶ 59.2
2
The Court rejects Astellas’s argument, pursuant to
Warren Gen. Hosp. v. Amgen, Inc., Case No. 09-cv-4935, 2010 WL
2326254 (D.N.J. June 7, 2010), that Lakeland Regional’s
allegations are insufficient. In Warren, the court dismissed
the antitrust case pursuant to Illinois Brick because the
complaint failed to allege direct purchase, alleged that the
product at issue was purchased through a wholesaler, and
(continued...)
-16-
Although these allegations do not use the words “direct
purchase” the Court accepts them as alleging direct purchase
from Astellas at this preliminary stage of the proceedings.3
However,
even
if
these
allegations
were
insufficient
to
support the direct purchase requirement of Illinois Brick, the
Court is still justified in denying the Motion to Dismiss to
the extent it is based on Illinois Brick because Lakeland
Regional has argued that Illinois Brick is inapplicable, as
was the case in Lowell.
In addition, Lakeland Regional
correctly points out that Illinois Brick applies only to
antitrust damages and does not stand as a bar to any party
seeking injunctive relief and attorney’s fees, which Lakeland
Regional seeks in its amended complaint.
2
(...continued)
attached to the complaint was a copy of the wholesale
agreement.
In stark contrast, Lakeland Regional’s amended
complaint does not mention a wholesaler. If it is Astellas’s
position that Lakeland Regional purchases its adenosine
product from a wholesaler, Astellas may present that argument,
along with evidence in support of such argument, in a motion
for summary judgment.
3
Furthermore, neither Astellas nor Lakeland Regional
attempts to categorize the allegations contained in the
amended complaint as a “horizontal” or a “vertical” antitrust
violation. In Lowell, the Eleventh Circuit indicated that
Illinois Brick does not apply to certain vertical antitrust
conspiracies: “The inapplicability of Illinois Brick to
vertical conspiracies with no allegations of pass-on (what
some have called the ‘vertical conspiracy exception’) has long
been recognized.” Lowell, 177 F.3d at 1231.
-17-
At this point, the Court is satisfied that Lakeland
Regional is the proper plaintiff to bring this action, and it
does not find that Illinois Brick is a bar to pursuing this
action.
arguments
However, the parties are free to reassert their
during
the
summary
judgment
stage,
after
the
completion of discovery.
B.
Tying
Astellas seeks dismissal of Lakeland Regional’s federal
and state law tying claims asserted under the Sherman Act, the
Clayton Act, and Florida Statute Section 542.18, as asserted
in counts one and four of the amended complaint. The elements
of a tying claim are:
1) that there are two separate products, a “tying”
product and a “tied” product; 2) that those
products are in fact “tied” together – that is, the
buyer was forced to buy the tied product to get the
tying product; 3) that the seller possesses
sufficient economic power in the tying product
market to coerce buyer acceptance of the tied
product;
and
4)
involvement
of
a
“not
insubstantial” amount of interstate commerce in the
market of the tied product.
Thompson v. Metro. Multi-List, Inc., 934 F.2d 1566, 1574 (11th
Cir. 1991)(internal citation omitted).
Astellas does not contend that Lakeland Regional failed
to allege the essential elements for a tying claim in the
amended complaint.
Rather, Astellas argues that Lakeland
Regional’s tying claims are subject to dismissal because
-18-
Lakeland
Regional
markets,
two
failed
separate
and
to
allege
“plausible
distinct
product
relevant
markets,
or
anticompetitive effects in the tied product market.” (Doc. #
16 at 50).
As explained in Thompson, “antitrust law is concerned
with abuses of power by private actors in the marketplace.”
934 F.2d at 1572.
“The plaintiff bears an initial burden of
demonstrating that the alleged agreement produced adverse,
anti-competitive effects within the relevant product and
geographic markets, i.e., market power.” Schering-Plough Corp.
v. FTC, 402 F.3d 1056, 1065 (11th Cir. 2005).
Astellas contends that Lakeland Regional cannot prove
market power because the FDA has not approved any drug other
than
Astellas’s
adenosine
drugs
for
use
in
myocardial
perfusion imaging. In addition, Astellas argues that Lakeland
Regional
cannot
unpatentable
show
adenosine
that
the
product
patented
are
license
separate
and
the
products.
Furthermore, Astellas remarks that Lakeland Regional cannot
prove anticompetitive effects.
However, Lakeland Regional
adequately alleges:
Defendant Astellas has monopoly power - the power
to control price or exclude competition - in the
market for adenosine used in MPI in the United
States . . . . The defendant also controls greater
than 60% of sales of adenosine for all purposes in
the United States. Defendant Astellas, plaintiff
LRMC, and other health care providers recognize and
-19-
perceive that “adenosine used for MPI” is a
relevant product submarket, which the defendant
controls. The defendant, the plaintiff, and other
health care providers also recognize and perceive
that the process used to administer adenosine to
patients during MPI is a relevant product market,
which patent defendant Astellas controls in the
United States. The relevant geographical market .
. . is the United States of America and its
territories. The patented process used to perform
continuous adenosine infusion in MPI, and the
unpatented product, adenosine, are recognized and
perceived by providers and purchasers as two
distinct products.
(Doc. # 11 at ¶¶ 13-16).
In Gulfstream Park Racing Association v. Tampa Bay Downs,
Inc., 294 F. Supp. 2d 1291, 1306-07 (M.D. Fla. 2003), the
court explained, “In constructing a product market, an expert
is to identify producers that provide customers of a defendant
firm . . . with alternative sources for the defendant’s
product or services.”
This case has not reached the stage of
the proceedings where expert testimony may be elicited. The
Court rejects Astellas’s argument that Lakeland Regional must
provide the contours of the relevant markets at the complaint
stage.
At this stage, Lakeland Regional is not required to
come forward with any evidence to prove that the allegations
in its complaint are true.
Here, Lakeland Regional has set
forth adequate allegations to sustain a tying claim against
Astellas, particularly with respect to the definition of
plausible
relevant
markets
and
-20-
anticompetitive
effects.
For the same reasons, the Court also declines to dismiss
Lakeland Regional’s state tying claim. State antitrust claims
are generally governed by Federal antitrust law, and Astellas
has not asserted separate grounds for dismissal of the state
law antitrust claims.
“Florida antitrust law defers to
federal interpretation of Section 1 of the Sherman Antitrust
Act in interpreting what conduct violates Florida Statute
Section 542.18.” Gulfstream Park Racing, 294 F. Supp. at 1306,
n.38; see also Florida Statute Section 542.32 (“It is the
intent of the Legislature that, in construing this chapter,
due
consideration
and
great
weight
be
given
to
the
interpretations of the federal courts relating to comparable
federal antitrust statutes. . . .”); Levine v. Cent. Fla. Med.
Affiliates,
Inc.,
72
F.3d
1538,
1556
n.20
(11th
Cir.
1996)(“the Florida courts held that the Florida legislature
has, in effect, adopted as the law of Florida the body of
anti-trust law developed by the federal courts under the
Sherman Act.”)(internal citation omitted).
C.
Exclusive Dealing
In count two, Lakeland Regional asserts a claim for
exclusive dealing under Section 1 of the Sherman Act and
Section 3 of the Clayton Act.
In an effort to vanquish this
claim, Astellas asserts four distinct arguments.
First,
Astellas reasserts its argument that “Lakeland Regional has
-21-
not alleged injury-in-fact, antitrust standing, or Illinois
Brick standing.” (Doc. # 16 at 40).
However, the Court has
determined that Lakeland Regional has alleged an injury-infact and has otherwise established standing to assert its
antitrust claims.
Accordingly, Astellas’s first argument is
unavailing.
Second,
Astellas
argues
that
Lakeland Regional’s
exclusive dealing count is “simply a re-packaging of its
defective tying theory.”
Id. at 51.
The Court rejects this
argument because, as noted above, the Court has declined to
dismiss Lakeland Regional’s tying claims and does not find
that such tying claims are “defective.”
Similarly, Astellas
contends that the exclusive dealing count should be dismissed
because Lakeland Regional has failed to “allege a plausible
relevant market in which Adenoscan competes;” however, as
noted above, the Court has determined that Lakeland Regional’s
market allegations are sufficient.
Fourth, Astellas argues that the exclusive dealing count
must be dismissed because it fails the “rule of reason.”
explained in Levine:
Under the rule of reason, the test of legality is
whether the restraint imposed is such as merely
regulates and perhaps thereby promotes competition
or whether it is such as may suppress or even
destroy competition.
Rule of reason analysis
requires
the
plaintiff
to
prove
(1)
an
anticompetitive effect of the defendant’s conduct
-22-
As
on the relevant market, and (2) that the conduct
has no procompetitive benefit or justification. In
order to prove an anticompetitive effect on the
market, the plaintiff may either prove that the
defendant’s behavior had an actual detrimental
effect on competition, or that the behavior had the
potential
for
genuine
adverse
effects
on
competition. In order to prove the latter, the
plaintiff must define the relevant market and
establish that the defendants possessed power in
that market.
Levine, 72 F.3d at 1551 (internal citations omitted).
In
Spanish Broadcasting Systems of Florida, the Eleventh Circuit
clarified that “in alleging the anticompetitive effect of the
defendant’s conduct, an antitrust plaintiff must show harm to
competition
rather
than
to
competitors.
That
is,
the
anticompetitive effects are measured by their impact on the
market rather than by their impact on competitors.” 376 F.3d
at 1072. (internal citations omitted).
The
Court
is
satisfied
that
Lakeland
properly asserted its exclusive dealing claim.
allegations,
Lakeland
Regional
alleged
in
Regional
Among other
the
amended
complaint:
[A]s a result of the exclusive dealing agreement,
actual and potential competitors in the adenosine
market have been foreclosed from selling to the
plaintiff and other of defendant’s customers, which
represent a majority of the purchasers for
adenosine. Competition in the adenosine market has
been
unreasonably
and
dramatically
reduced
nationwide, and that market is controlled by
defendant Astellas, which has the power to control
price and exclude competition in the market for
adenosine.
-23-
has
(Doc. # 11 at ¶ 61).
Lakeland Regional also alleges, “as a
result of defendant Astellas’s unlawful conduct, health care
costs among plaintiff LRMC’s patients, within this District
and nationwide, have increased unreasonably above what they
would have been in a competitive market.” Id. at ¶ 62.
Nothing so far presented to the Court persuades the Court that
Lakeland
Regional’s
claim
fails
the
rule
of
reason.
Accordingly, the Court declines to dismiss Lakeland Regional’s
exclusive dealing count at this stage of the proceedings.
D.
Attempt to Monopolize
“A patent gives its owner the right to grant licenses, if
it so chooses, or it may ride its wave alone until the patent
expires.” Schering-Plough Corp., 402 F.3d at 1067.
“What
patent law does not do, however, is extend the patentee’s
monopoly beyond its statutory right to exclude.” Id.
In this
case, Lakeland Regional alleges in count three that Astellas
has attempted to monopolize in violation of Section 2 of the
Sherman Act, which states:
Every person who shall monopolize, or attempt to
monopolize, or combine or conspire with any other
person or persons, to monopolize any part of the
trade or commerce among the several States, or with
foreign nations, shall be deemed guilty of a
felony, and on conviction thereof, shall be
punished by fine not exceeding $100,000,000 if a
corporation, or, if any other person, $1,000,000,
or by imprisonment not exceeding 10 years, or both
said punishments, in the discretion of the court.
-24-
15 U.S.C. § 2.
alleges
that
Likewise, in count five, Lakeland Regional
Astellas
has
attempted
to
monopolize
under
Florida Statute Section 542.19, which states, “It is unlawful
for any person to monopolize, attempt to monopolize, or
combine or conspire with any other person or persons to
monopolize any part of trade or commerce in this state.” Id.
The Eleventh Circuit has ruled that, “to establish a
violation
of
Section
2
for
attempted
monopolization,
a
plaintiff must show (1) an intent to bring about a monopoly
and (2) a dangerous possibility of success.” Levine, 72 F.3d
at 1555 (internal citation omitted). The Eleventh Circuit has
further explained that “to have a dangerous probability of
successfully monopolizing a market the defendant must be close
to achieving monopoly power.
Monopoly power is the power to
raise prices to supra-competitive levels or . . . the power to
exclude
competition
in
the
relevant
market
either
by
restricting entry of new competitors or by driving existing
competitors out of the market.” U.S. Anchor Mfg. v. Rule
Indus., 7 F.3d 986, 994 (11th Cir. 1993).
The Court determines that Lakeland Regional’s complaint
allegations are sufficient to state a claim for attempted
monopolization under the governing authorities.
Lakeland
Regional alleges, among other things, that: “[D]efendant
Astellas charges customers, such as plaintiff LRMC, 450% more
-25-
for its adenosine than customers would pay for adenosine from
alternative providers.
Defendant Astellas is able to control
the cost for adenosine, and is able to foreclose competitors
from customers for adenosine.” (Doc. # 11 at ¶ 69).
Lakeland Regional also submits:
There is a dangerous probability that defendant
Astellas will successfully attain and retain
monopoly power in the . . . market and submarket.
This dangerous probability is demonstrated by
defendant Astellas’ high and sustaining market
shares, by the perception in the health care
community that use of defendant Astellas’ process
patent for administering adenosine is the medically
accepted standard of care, which creates barriers
to entry, and by defendant Astellas’ threatening
and misleading communications regarding its process
patent and the alleged extension of the patent to
the product, Adenoscan®.
Id. at ¶ 74.
These allegations are sufficient at this juncture to
survive the Motion to Dismiss.
E.
Tortious
Interference
with
Prospective
Economic
Advantage
Astellas has asserted generalized and specific arguments
in pursuit of the dismissal of count six, for tortious
interference with a prospective economic advantage.
Astellas
suggests
exercise
that
the
Court
should
decline
to
supplemental jurisdiction over this state law claim.
The
Court; however, has an unflagging duty to address the cases
-26-
before it, and it will not avoid this duty by declining to
exercise jurisdiction over this count.
Astellas also maintains that Lakeland Regional has failed
to properly allege two elements required to state a claim.
The
Florida
Supreme
Court
has
enumerated
the
following
required elements to state such a claim: “(1) the existence of
a business relationship
. . . ; (2) knowledge of the
relationship on the part of the defendant; (3) an intentional
and unjustified interference with the relationship by the
defendant; and (4) damage to the plaintiff as a result of the
breach of the relationship.” Ethan Allen, Inc. v. Georgetown
Manor, Inc., 647 So. 2d 812, 814 (Fla. 1994)(alteration in
original).
Specifically, Astellas asserts that Lakeland Regional has
failed to sufficiently plead elements three and four.
In the
amended complaint Lakeland Regional alleges, inter alia,
“Defendant Astellas’ interference with contractual relations
between plaintiff LRMC and generic adenosine manufacturers is
unjustified. Any purported pro-competitive justification for
the tie is substantially outweighed by the anticompetitive
effects in the adenosine market.
Defendant Astellas’ conduct
resulted in an economic loss to the Plaintiff.” (Doc. # 11 at
¶¶ 105-06).
-27-
Astellas also asserts affirmative defenses to Lakeland
Regional’s
tortious
interference
claim.
Particularly,
Astellas argues: “Astellas’s alleged ‘interference’ amounts to
nothing more than the lawful exercise of its patent right to
protect its own business interests.” (Doc. # 16 at 53).
Justification or privilege to interfere with a contract is an
affirmative defense to a tortious interference action. See
Abele v. Sawyer, 750 So. 2d 70, 75 (Fla. 4th DCA 1999).
However, the mere presence of a possible affirmative defense,
which has not yet been proven, does not present a basis for
the dismissal of this claim.
IV.
Conclusion
As adeptly stated in Schering-Plough Corp., “Although the
exclusionary power of a patent may seem incongruous with the
goals of antitrust law, a delicate balance must be drawn
between the two regulatory schemes.” 402 F.3d at 1067.
In
deciding the present Motion, the Court has attempted to strike
an
appropriate
interests.
and
balance
between
the
parties’
conflicting
This Court has evaluated the parties’ arguments
determines
that
dismissal
of
the
complaint
is
not
warranted.
Many of the arguments presented by Astellas are directed
to
matters
outside
of
the
four
corners
of
the
amended
complaint. In passing on these arguments without delving into
-28-
them, the Court has not determined that they are meritless.
Rather, the Court finds that these arguments are prematurely
asserted,
and
will
be
given
due
consideration
at
the
appropriate stage of the proceedings if reasserted.
Accordingly, it is
ORDERED, ADJUDGED, and DECREED:
Astellas’s Motion to Dismiss the Complaint (Doc. # 16) is
DENIED.
DONE and ORDERED in Chambers in Tampa, Florida, this 25th
day of July, 2011.
Copies:
All Counsel of Record
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