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LEO Pharma A/S v. Actavis Laboratories UT, Inc.

United States District Court, D. Delaware

February 26, 2018





         Presently before the court in this patent infringement action brought under the Hatch-Waxman Act is the motion to dismiss the inequitable conduct counterclaim of defendant Actavis Laboratories UT, Inc. ("Actavis"), filed by plaintiffs LEO Pharma A/S, LEO Laboratories Limited ("LEO Labs"), and LEO Pharma, Inc. ("LEO Pharma") (collectively, "LEO") pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. (D.I. 104) For the following reasons, I recommend that the court grant LEO's motion to dismiss without prejudice.


         On May 6, 2016, LEO filed a complaint for patent infringement under the Hatch-Waxman Act against Actavis. (D.I. 1) The action relates to Abbreviated New Drug Application ("ANDA") Nos. 208807 and 209086 (together, "the Actavis ANDAs"), which were filed by Actavis with the U.S. Food and Drug Administration ("FDA") seeking approval to market generic versions of LEO's Picato® pharmaceutical products. (D.I. 73 at ¶ 1) The Picato® products are gels containing ingenol mebutate as the active pharmaceutical ingredient ("API") at dosage strengths of 0.015% and 0.05%. (Id.) LEO Pharma is the holder of New Drug Application ("NDA") No. 202833 for ingenol mebutate gel at concentrations of 0.015% and 0.05%, which was approved by the FDA on January 23, 2012. (Id. at ¶ 13) LEO's Picato® products are approved for the topical treatment of actinic keratosis. (Id. at ¶ 16)

         The second amended complaint alleges infringement often patents: U.S. Patent Nos. 7, 410, 656 ("the '656 patent"), 8, 278, 292 ("the '292 patent"), 8, 372, 827 ("the '827 patent"), 8, 372, 828 ("the '828 patent"), 8, 377, 919 ("the '919 patent"), 8, 536, 163 ("the '163 patent"), 8, 716, 271 ("the '271 patent"), 8, 735, 375 ("the '375 patent"), 9, 416, 084 ("the '084 patent"), and 9, 676, 698 ("the '698 patent") (collectively, the "patents-in-suit"). (Id. at ¶ 8) The '084 patent and the '698 patent, identified as the "Process Patents, " cover methods of producing ingenol mebutate. (Id. at ¶20) The Process Patents are both entitled, "Method of Producing Ingenol-3-Angelate, " they share a common specification and common inventors, [1] and both claim priority to Provisional Application No. 61/366, 018, which was filed in 2010. (D.I. 106, Exs. 6-7) The '698 patent is a continuation of the '084 patent. (Id., Ex. 7)

         Actavis filed its answer and counterclaims to the second amended complaint on July 10, 2017, which included a counterclaim and an affirmative defense that the Process Patents are unenforceable for inequitable conduct. (D.I. 85 at 55, ¶¶ 159-196[2]) Actavis' allegations of inequitable conduct are based on LEO's purportedly deliberate failure to disclose as prior art U.S. Patent No. 7, 378, 445 ("the '445 patent") to the U.S. Patent and Trademark Office ("USPTO") during prosecution of the Process Patents. (Id. at 84-85) The '445 patent, entitled "Treatment of Prostate Cancer, " does not share a common inventor[3] with the Process Patents. (D.I. 106, Ex. 8) In 2011, the assignee of the '445 patent assigned its entire patent portfolio, including the '445 patent and U.S. Patent No. 7, 449, 492 ("the '492 patent") to LEO Labs. (D.I. 73 at ¶ 21; D.I. 85, Ex. 3; D.I. 85 at ¶¶ 188-89) During prosecution of the Process Patents, Actavis disclosed the '492 patent to the USPTO, but did not disclose the '445 patent as prior art. (D.I. 85 at ¶ 187) Presently pending before the court is LEO's motion to dismiss Actavis' counterclaim for inequitable conduct, which is based on LEO's alleged failure to disclose the '445 patent during prosecution of the Process Patents. (D.I. 104)


         A. Rule 12(b)(6)

         Rule 12(b)(6) permits a party to move to dismiss a complaint for failure to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). When considering a Rule 12(b)(6) motion to dismiss, the court must accept as true all factual allegations in the complaint and view them in the light most favorable to the plaintiff. Umland v. Planco Fin. Servs., 542 F.3d 59, 64 (3d Cir. 2008).

         To state a claim upon which relief can be granted pursuant to Rule 12(b)(6), a complaint must contain a "short and plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a)(2). Although detailed factual allegations are not required, the complaint must set forth sufficient factual matter, accepted as true, to "state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007); see also Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009). A claim is facially plausible when the factual allegations allow the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. Iqbal, 556 U.S. at 663; Twombly, 550 U.S. at 555-56.

         When determining whether dismissal is appropriate, the court must take three steps.[4] See Santiago v. Warminster Twp., 629 F.3d 121, 130 (3d Cir. 2010). First, the court must identify the elements of the claim. Iqbal, 556 U.S. at 675. Second, the court must identify and reject conclusory allegations. Id. at 678. Third, the court should assume the veracity of the well-pleaded factual allegations identified under the first prong of the analysis, and determine whether they are sufficiently alleged to state a claim for relief. Id.; see also Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011). The third prong presents a context-specific inquiry that "draw[s] on [the court's] experience and common sense." Id. at 663-64; see also Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009). As the Supreme Court instructed in Iqbal, "where the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged - but it has not 'show[n]' - 'that the pleader is entitled to relief" Iqbal, 556 U.S. at 679 (quoting Fed.R.Civ.P. 8(a)(2)).

         B. Rule 12(f)

         Rule 12(b)(6) does not offer a mechanism for dismissing affirmative defenses because it refers only to "claim[s]." See Wyeth Holdings Corp. v. Sandoz, Inc., C.A. No. 09-955-LPS-CJB, 2012 WL 600715, at *4 (D. Del. Feb. 3, 2012). However, Rule 12(f) 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). "When ruling on a motion to strike, the [c]ourt must construe all facts in favor of the nonmoving party and deny the motion if the defense is sufficient under the law. Further, a court should not grant a motion to strike a defense unless the insufficiency of the defense is clearly apparent." Symbol Techs., Inc. v. Aruba Networks, Inc., 609 F.Supp.2d 353, 356 (D. Del. 2009) (citations and internal quotation marks ...

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