Adams Respiratory Therapeutics, Inc. v. Perrigo Co.

255 F.R.D. 443, 2009 U.S. Dist. LEXIS 5145, 2009 WL 198524
District Court, W.D. Michigan·Decided January 26, 2009·No. No. 1:07-CV-993·Published·Cited by 3 cases

Opinion

OPINION

GORDON J. QUIST, District Judge.

Plaintiffs (collectively, “Adams”) have filed a Motion to Strike Defendants’ Fifth and Sixth Defenses and to Dismiss Counterclaims V and V (sic, VI), or in the Alternative for a More Definite Statement. (Docket no. 86.) Defendants’ (collectively, “Perrigo’s”) fifth defense alleges that Adams’s patent, U.S. Patent No. 6,372,252 (the “'252 patent”), is unenforceable by virtue of Adams’s reputed inequitable conduct before the Patent Office and subsequent purported patent misuse. The basis for Perrigo’s inequitable conduct allegation is its averment that Adams intentionally withheld relevant prior art during the '252 patent prosecution. This prior art includes “[Mutual’s] 600 mg extended-release guaifenesin tablets,” and the “extended-release, single-ingredient guaifenesin products” sold more than a year before Adams’s '252 patent application and manufactured or distributed by the recipients of a letter the FDA posted after it approved Adams’s New Drug Application (NDA). The letter warned each recipient it must cease manufacturing its “unapproved single ingredient guaifenesin extended release products no later than May 21, 2003.” Adams contends Perrigo’s First Amended Answer (docket no. 68) does not identify the alleged prior art or its materiality with the particularity required of fraud allegations by Fed.R.Civ.P. 9(b).

The basis for Perrigo’s patent misuse allegation is its averment that Adams knew the '252 patent was invalid when it filed suit. Perrigo claims Adams knew this because of its inequitable conduct, the “information in Perrigo R & D’s paragraph IV certification^] and facts made known to Adams during the Mutual Litigation.” Adams counters that Perrigo’s charge of patent misuse fails to satisfy Rule 9(b)’s particularity requirement because it relies in part on Perrigo’s purportedly insufficient allegation of inequitable conduct and it avers no facts suggesting Adams actually knew the '252 patent was invalid. Adams also contends that even if Perrigo has alleged sufficient facts, Perrigo relies upon extrinsic evidence to supply them, contrary to Rule 9(b)’s requirement that particularity be satisfied by the pleading itself.

I. Analysis

Inequitable conduct, while a broader concept than fraud, must be pled with particularity. Fed.R.Civ.P. 9(b), Ferguson Beauregard/Logic Controls, Inc. v. Mega Sys. LLC, 350 F.3d 1327, 1344 (Fed.Cir.2003).

[446] A. Reliance Upon Extrinsic Evidence

The first question is whether the Court may look to extrinsic matters to determine whether a party has met the particularity requirement.

A documentary exhibit to a pleading is part of the pleading for all purposes. Fed.R.Civ.P. 10(c) (emphasis added). “All purposes” includes the satisfaction of Rule 9(b)’s particularity requirement. Furthermore, the extrinsic evidence the Court may consider is not limited to exhibits to the pleadings. “[D]ocuments incorporated into the complaint by reference, and matters of which a court may take judicial notice” are also considered part of the pleading. Tel-labs, Inc., v. Makor Issues & Rights, Ltd., 551 U.S. 308, 127 S.Ct. 2499, 2509, 168 L.Ed.2d 179 (2007) 1 This includes public records as well. Amini v. Oberlin Coll., 259 F.3d 493, 502-03 (6th Cir.2001) (holding that the district court’s failure to consider information contained in EEOC filing was error because “[i]n determining whether to grant a Rule 12(b)(6) motion, ... matters of public record, orders, items appearing in the record of the case, and exhibits attached to the complaint” may be considered). Tellabs and Amini make clear that exhibits to the complaint are not the only external sources regarded as part of the pleading.

That numerous sources extrinsic to the pleadings may be regarded as part of the pleadings, not only for consideration of a Rule 12(b) (6) motion, but also for consideration of the particularity requirement of Rule 9(b), is demonstrated by Tellabs in discussing the interplay between Rules 9(b) and the Public Securities Litigation Reform Act pleading requirements. 15 U.S.C. § 78u-4(b)(1), (2). Among other things, Tellabs addressed whether the Court could consider extrinsic sources to determine whether the plaintiffs’ amended complaint satisfied Rule 9(b)’s particularity requirement. The Court held that extrinsic sources must be considered:

... courts must consider the complaint in its entirety, as well as other sources courts ordinarily examine when ruling on Rule 12(b)(6) motions to dismiss, in particular, documents incorporated into the complaint by reference, and matters of which a court may take judicial notice. The inquiry, as several Courts of Appeals have recognized, is whether all of the facts alleged, taken collectively, give rise to a strong inference of scienter, not whether any individual allegation, scrutinized in isolation, meets that standard.

Tellabs, 551 U.S. 308, 127 S.Ct. at 2509, 168 L.Ed.2d 179 (citations omitted).

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Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 255 F.R.D. 443, 2009 U.S. Dist. LEXIS 5145, 2009 WL 198524 (W.D. Mich. 2009).

255 F.R.D. 443 (Adams Respiratory Therapeutics, Inc. v. Perrigo Co.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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