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Takeda Pharmaceutical Co, Limited, et al. v. Zydus Pharmaceuticals Usa Inc.

May 25, 2011


The opinion of the court was delivered by: Pisano, District Judge.


Plaintiffs Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals North America, Inc., Takeda Pharmaceuticals LLC, Takeda Pharmaceuticals America, Inc., (collectively, "Takeda") and Ethypharm, S.A. ("Ethypharm," together with Takeda, "Plaintiffs") bring this patent infringement action under the Hatch-Waxman Act against defendants Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited (together, "Defendants") claiming infringement of three patents alleged to cover Takeda's Prevacid SoluTab product ("SoluTab"). These patents are U.S. Patent Nos. 6,328,994 (the " '994 patent"), 7,431,942 the " '942 patent"), and 5,464,632 (the " '632 patent"). Presently before the Court is a motion by Plaintiffs to dismiss Defendants' Seventh Counterclaim pursuant to Federal Rule of Civil Procedure 12(b)(6) and to strike certain allegations in the counterclaims of patent misuse pursuant to Rule 12(f). The Court considers the matter without oral argument pursuant to Rule 78. For the reasons below, Plaintiffs' motion is granted. A. Defendants' Counterclaims

Defendants Second Amended Answer and Counterclaims contain seven counterclaims. The Seventh Counterclaim, challenged in its entirety by Plaintiffs, alleges that the '632 patent is unenforceable due to patent misuse. Two types of misuse are alleged. First, Defendants allege that Takeda, "at the urging of" Ethypharm, "intentionally mislisted [the'632 patent] in the Orange Book*fn1 with respect to" SoluTab. Counterclaim ¶ 43. Defendants assert that Plaintiffs listed the '632 patent in the Orange Book even though "they were well aware that [the'632 patent] does not cover in any of its claims the actual composition of the product [SoluTab]. Id. ¶ 45. See also id. ¶ 47 ("At the time of the listing, and at the time of the commencement of this suit, [Plaintiffs] were aware that none of the claims of [the '632 patent] covered the actual composition of [SoluTab]." ). Defendants' assert that as a result of the alleged mislisting, under the Hatch-Waxman statutory scheme Plaintiffs were able to obtain a 30-month stay from the FDA's final approval of Defendants' ANDA by filing a timely infringement suit.

Second, Defendants allege that Plaintiffs, being aware that the '632 patent did not cover SoluTab, falsely marked SoluTab's packaging with the '632 patent. It is asserted that Plaintiffs "purposely undertook deceitful marking of the patent number on its labeling affixed to each and every bulk product package," and understood that by doing so "they were deceitfully indicating to the public that the product contained therein was protected by such patent." Id. ¶ 51. Defendants also bring a qui tam action pursuant to 35 U.S.C. § 292.

Three other counterclaims contain allegations of patent misuse. In the Fourth, Fifth and Sixth Counterclaims, which seek declarations of invalidity as to the '994 patent, the '942 patent and the '632 patent, respectively, Defendants allege that the claims in each of the patents are "invalid for failure to satisfy the provisions of the patent laws of the United States." Id. ¶¶ 31, 35, 39. Immediately thereafter, Defendants further allege that "the filing of an objectively baseless lawsuit based on a patent that is understood to be invalid for obviousness and continuing the prosecution of such case . constitutes patent misuse.". Id. ¶¶ 32, 36, 40.

Plaintiffs move to dismiss the Seventh Counterclaim and to strike the patent misuse allegations of the invalidity counterclaims (specifically paragraphs 32, 36 and 40). First, they allege that the Hatch-Waxman Act does not permit Defendants' patent misuse counterclaim based on mislisting. Second, they contend that Defendants do not adequately plead mislisting or false marking under the heightened pleading standard of Federal Rule of Civil Procedure 9(b) or under Rule 8's notice pleading requirements. As to the Seventh Counterclaim, Plaintiffs allege that Defendants do not set forth any supportive facts as to: (a) how SoluTab falls outside the scope of the '632 Patent; (b) Plaintiffs' knowledge of the same; (c) Plaintiffs' deceptive intent with respect to either the purported mislisting or the false marking; and (d) how Ethypharm played any role in the purported mislisting or false marking of Takeda's SoluTab. Similarly, with respect to the allegations of patent misuse within the invalidity counterclaims, Plaintiffs contend that Defendants do not set forth any supportive facts as to (a) the specific prior art rendering each of the three patents-in-suit obvious; (b) Plaintiffs' knowledge of the same; and (c) the "objectively baseless" nature of this lawsuit as to each of the three patents-in-suit.

B. Legal Standard

Under Federal Rule of Civil Procedure 12(b)(6), a court may grant a motion to dismiss if the complaint fails to state a claim upon which relief can be granted. The Supreme Court set forth the standard for addressing a motion to dismiss under Rule 12(b)(6) in Bell Atl. Corp. v. Twombly, 550 U.S. 544, 562, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). The Twombly Court stated that, "[w]hile 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 entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do[.]" Id. at 555 (internal citations omitted); see also Baraka v. McGreevey, 481 F.3d 187, 195 (3d Cir. 2007) (stating that standard of review for motion to dismiss does not require courts to accept as true "unsupported conclusions and unwarranted inferences" or "legal conclusion[s] couched as factual allegation[s]." (internal quotation marks omitted)). Therefore, for a complaint to withstand a motion to dismiss under Rule 12(b)(6), the "[f]actual allegations must be enough to raise a right to relief above the speculative level, ... on the assumption that all the allegations in the complaint are true (even if doubtful in fact) ..." Twombly, 550 U.S. at 555 (internal citations and footnote omitted).

The Supreme Court has emphasized that, when assessing the sufficiency of a civil complaint, a court must distinguish factual contentions and "[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements." Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009). When evaluating a motion to dismiss for failure to state a claim, district courts conduct a two-part analysis.

First, the factual and legal elements of a claim should be separated. The District Court must accept all of the complaint's well-pleaded facts as true, but may disregard any legal conclusions. Second, a District Court must then determine whether the facts alleged in the complaint are sufficient to show that the plaintiff has a "plausible claim for relief." In other words, a complaint must do more than allege the plaintiff's entitlement to relief. A complaint has to "show" such an entitlement with its facts.

Fowler v. UPMC Shadyside, 578 F.3d 203, 210-11 (3d Cir.2009) (quoting Iqbal, 129 S.Ct. at 1949-50). A complaint will be dismissed unless it "contain[s] sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.'" Id. at 1949 (quoting Twombly, 550 U.S. at 570). This "plausibility" determination will be "a context-specific task that requires the reviewing court to draw on its judicial experience and common sense." Fowler, 578 F.3d at 211 (citations omitted).

C. Analysis

1. Whether Defendants' Misuse Claim is Precluded

The Court first addresses Plaintiffs' argument that the Hatch-Waxman Act does not permit Defendants to assert a patent misuse counterclaim based on the allegedly improper listing of the '632 patent in the Orange Book. Patent misuse is one of the equitable defense to patent infringement. See U.S. Philips Corp. v. International Trade Com'n, 424 F.3d 1179, 1184 (Fed. Cir. 2005). "The patent misuse doctrine, born from the ...

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