United States District Court, D. Delaware
LEO PHARMA A/S, LEO LABORATORIES LIMITED, and LEO PHARMA, INC., Plaintiffs,
ACTAVIS LABORATORIES UT, INC., Defendant.
REPORT AND RECOMMENDATION
R. FALLON, UNITED STATES MAGISTRATE JUDGE
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.
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)
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,  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)
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) 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 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.
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).
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.
determining whether dismissal is appropriate, the court must
take three steps. 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
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
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