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Teva Neuroscience, Inc., et al v. Watson Laboratories

February 22, 2011


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



This matter comes before the Court by way of Plaintiffs' motion to dismiss the Mylan Defendants'*fn1 Third and Sixth Counterclaims pursuant to Federal Rule of Civil Procedure 12(b)(6) and to strike the Mylan Defendants' Fifth Affirmative Defense pursuant to Federal Rule of Civil Procedure 12(f) [Docket entry no. 64]. The Court has considered the submissions made in support of and in opposition to the instant motion.*fn2 No oral argument was heard. Fed. R. Civ. P. 78. This motion is returnable today, February 22, 2011. Based on the reasons that follow, Plaintiffs' motion is granted. The Mylan Defendants are hereby granted thirty (30) days in which to file an amended pleading which cures the deficiencies discussed herein.


Rule 12(f) of the Federal Rules of Civil Procedure provides: "The court may strike from a pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter." Fed. R. Civ. P. 12(f). A motion to strike an affirmative defense pursuant to 12(f) is governed by the same standards as a motion to dismiss pursuant to 12(b)(6). See In re Gabapentin Patent Litig., 648 F.Supp.2d 641, 647-48 (D.N.J. 2009) ("Because a motion [to strike] challenges the legal sufficiency of the pleading, it is governed by the same standards as a motion to dismiss[.] ... An affirmative defense is insufficient as a matter of law if it cannot succeed under any circumstances."). "Courts recognize that a motion to strike can save time and litigation expense by eliminating the need for discovery with regard to legally insufficient defenses." F.D.I.C. v. White, 828 F. Supp. 304, 307 (D.N.J. 1993); see also United States v. Geppert Bros., Inc., 638 F. Supp. 996, 998 (E.D. Pa. 1986). Nevertheless, the Third Circuit has cautioned that courts "should not grant a motion to strike a defense unless the insufficiency of the defense is 'clearly apparent.' " Cipollone v. Liggett Group, Inc., 789 F.2d 181, 188 (3d Cir. 1986).

For a complaint to survive dismissal, it "must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.' " Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). In determining the sufficiency of a complaint, the Court must accept all well-pleaded factual allegations in the complaint as true and draw all reasonable inferences in favor of the non-moving party. See Phillips v. County of Allegheny, 515 F.3d 224, 234 (3d Cir. 2008). Additionally, in evaluating a plaintiff's claims, generally "a court looks only to the facts alleged in the complaint and its attachments without reference to other parts of the record." Jordan v. Fox, Rothschild, O'Brien & Frankel, 20 F.3d 1250, 1261 (3d Cir. 1994).


On October 1, 2010, Plaintiffs, Teva Neuroscience, Inc., et al. (collectively referred to as "Teva"), filed the Complaint in this matter against various defendants, including the Mylan Defendants, for infringement of United States Patent No. 5,453,446 (" the '446 patent") based on Mylan's submission of an Abbreviated New Drug Application ("ANDA") seeking approval by the United States Food and Drug Administration ("FDA") to sell a generic versions of Azilecte, Teva's oral treatment for idiopathic Parkinson's disease, prior to the expiration of the '446 patent. The Mylan Defendants filed an Answer and Counterclaims to Teva's Complaint on November 30, 2010.

Plaintiffs have now filed a motion to dismiss the Mylan Defendants' third and sixth counterclaims and to strike their fifth affirmative defense, all of which involve allegations of inequitable conduct. In particular, the fifth affirmative defense alleged by the Mylan Defendants claims that the '466 patent at issue in this matter is unenforceable. The third and sixth counterclaims go on to allege the following:

The '466 patent is unenforceable due to inequitable conduct because of intentionally misleading the Examiner during the prosecution of the '466 patent with the statement at '466 patent, col. 3, ll. 11-26 and the arguments made during the prosecution of parent U.S. patent application serial no. 07/632,184 in the amendment dated August 12, 1992, at p. 8, ll. 15-27 and p. 12, ll. 6-26. The applicants intentionally and repeatedly explained that since the structures of deprenyl and the R-enantiomer of rasagiline are structurally similar and (-) deprenyl is more pharmaceutically active than () deprenyl, one would have expected that only the (-) enantiomer of rasagiline would be the active MAO-type B inhibitor. Therefore, the applicants submitted that their invention using R-rasagiline was surprising and unexpected. This is clearly misleading as both (-) deprenyl and () PAI are R enantiomers. The activity of the R-enantiomer was not surprising or unexpected in light of this fact that was not disclosed to the Examiner.

(Docket Entry No. 31). Thus, the Mylan Defendants allege that the '466 patent is unenforceable due to inequitable conduct by the Plaintiffs in the form of a material false representation or omission before the United States Patent and Trademark Office ("PTO"). Plaintiffs now argue that all counterclaims and/or affirmative defenses based on such inequitable conduct should be dismissed and/or stricken because the allegations upon which they are based fail to meet the pleading standard of Federal Rule of Civil Procedure 9(b), as interpreted by the Federal Circuit in Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1328 (Fed. Cir. 2009).

Generally speaking, "a patent may be rendered unenforceable for inequitable conduct if an applicant, with intent to mislead or deceive the examiner, fails to disclose material information or submits materially false information to the PTO during prosecution." Digital Control, Inc. v. Charles Mach. Works , 437 F.3d 1309, 1313 (Fed. Cir. 2006). In this regard, the party asserting inequitable conduct must ultimately "prove a threshold level of materiality and intent by clear and convincing evidence." Id. Although such a showing is clearly not required at the pleading stage, the Federal Circuit has held that inequitable conduct is analogous to fraud, which, under Federal Rule of Civil Procedure 9(b), must be pled with particularity. See Exergen, 575 F.3d at 1326. The Exergen court summarized the applicable pleading standard for inequitable conduct as follows:

In sum, to plead the "circumstances" of inequitable conduct with the requisite "particularity" under Rule 9(b), the pleading must identify the specific who, what, when, where, and how of the material misrepresentation or omission committed before the PTO. Moreover, although "knowledge" and "intent" may be averred generally, a pleading of inequitable conduct under Rule 9(b) must include sufficient allegations of underlying facts from which a court may reasonably infer that a specific individual (1) knew of the withheld material information or of ...

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