Lakeland Reg'l Med. Ctr. Inc. v. Astellas US LLC

• Court: U.S. District Court — Middle District of Florida
• Writing for the Court: VIRGINIA M. HERNANDEZ COVINGTON
• Decision Date: 25 July 2011
• Docket Number: Case No. 8:10-cv-2008-T-33TGW
• Citation: Lakeland Reg'l Med. Ctr. Inc. v. Astellas US LLC, Case No. 8:10-cv-2008-T-33TGW (M.D. Fla. Jul 25, 2011)
• Parties: LAKELAND REGIONAL MEDICAL CENTER, INC., Plaintiff, v. ASTELLAS US LLC, and ASTELLAS PHARMA US, INC., Defendants.

LAKELAND REGIONAL MEDICAL CENTER, INC., Plaintiff, v. ASTELLAS US LLC, and ASTELLAS PHARMA US, INC., Defendants.

Case No. 8:10-cv-2008-T-33TGW

UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA TAMPA DIVISION

DONE and ORDERED: July 25, 2011

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 headquarters in Lakeland, Florida. (Doc. # 11 at ¶ 7). Defendants Astellas US, LLC and Astellas Pharma US, Inc. (collectively, "Astellas") are Delaware corporations with headquarters in Deerfield, Illinois. Id. at ¶ 8. Astellas is the exclusive licensee of two patents involving the administration ofadenosine to patients undergoing cardiac stress tests. Lakeland Regional alleges that Astellas has engaged in unlawful, anticompetitive, monopolistic, and 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. Physicians induce stress by requiring patients to exercise on a treadmill. Id. 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. Administrationof adenosine is the medically recognized standard of care when pharmacologic stress is required to perform myocardial perfusion imaging. Id. When adenosine is required for myocardial perfusion imaging, more than 90% of the adenosine is suppled by Astellas. Id. Further, 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 patent and the 5,731,296 patent. Id. at ¶¶ 17-18. The '877 Patent relates solely to the use of Astellas's adenosine product "Adenoscan®," for its vasodilative properties when used in conjunction with myocardial imaging. Id. at ¶ 18. The '877 Patent expired on May 18, 2009. Id. 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, because adenosine is unpatentable. Id. at ¶ 22.

Several other companies sell an adenosine product that is not meaningfully distinguishable from Astellas's adenosine product. Id. Astellas charges $8.05 per ml. of Adenoscan, compared with $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. Among other things, the letter stated:[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.

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. Stephens v. Dep't ofHealth & 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 Rule 12(d) of the Federal Rules of Civil Procedure. Without the benefit of discovery, it would be premature for the Court to conduct summary judgment analysis.

Furthermore, the Eleventh Circuit has cautioned that "Rule 12(b)(6) dismissals are particularly disfavored in fact-intensive antitrust cases." Spanish Broad. Sys. v. Clear Channel Commc'ns, 376 F.3d 1065, 1070 (11th Cir. 2004)(citations omitted). 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, and hostile witnesses thicken the plot.'" (quoting Norfolk Monument Co. v. Woodlawn 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.

1. Injury in...