United States District Court, D. Delaware
ALLERGAN USA, INC. and ALLERGAN INDUSTRIE SAS, Plaintiffs,
PROLLENIUM U.S. INC. and PROLLENIUM MEDICAL TECHNOLOGIES INC., Defendants.
REPORT AND RECOMMENDATION
R. Fallon, United States Magistrate Judge.
before the court in this patent infringement action is the
motion of plaintiffs Allergan USA, Inc. and Allergan
Industrie SAS ("Allergan") to dismiss the
inequitable conduct counterclaim and strike the inequitable
conduct affirmative defense of defendants Prollenium U.S.
Inc. and Prollenium Medical Technologies Inc.
("Prollenium"). (D.I. 34) For the following reasons, I
recommend that the court grant Allergan's motion to
dismiss and strike without prejudice.
develops, manufactures, and distributes a line of dermal
fillers under the JUVEDERM® mark that are injected into
facial tissue to smooth wrinkles and folds. (D.I. 5 at
¶¶ 36, 39) Allergan's JUVEDERM® products
are injectable hyaluronic acid ("HA") gels
crosslinked with 1, 4-butanediol diglycidyl ether
("BDDE"). (D.I. 29 at ¶¶ 8, 10) The
JUVEDERM® products contain a small amount of a local
anesthetic called lidocaine to mitigate the pain and
discomfort associated with the dermal filler injection.
(Id. at ¶¶ 8, 10-11)
maintains the rights to six patents (the
"patents-in-suit") directed to HA-based
compositions including lidocaine which are used as dermal and
subdermal fillers. (D.I. 5 at ¶¶ 12-37) The
patents-in-suit cover Allergan's JUVEDERM® products,
and they claim priority to Provisional Application No.
61/085, 956, which was filed by inventor Pierre Lebreton on
August 4, 2008. (Id. at ¶¶ 41, 59; D.I.
35, Ex. A at 1) The provisional application is directed to
HA-based dermal and subdermal fillers including lidocaine
gel. (D.I. 35, Ex. A at 1) In the specification, the
provisional application identifies several prior art
references, including U.S. Application No. 10/743, 557 by
Sadozai et al. ("Sadozai"). (Id.
at 2) Sadozai describes "a process for making an
HA-based composition including lidocaine which includes
hydrating dried HA particles with a phosphate buffer
containing lidocaine." (Id.)
six months after filing the provisional application, Dr.
Lebreton filed U.S. Application No. 12/393, 884 ("the
'884 application"), which claims priority to the
provisional application and is directed to HA-based dermal
and subdermal fillers including an anesthetic agent. (D.I. 29
at ¶ 13; D.I. 35, Ex. B) The '884 application is the
parent application of the patents-in-suit. (D.I. 29 at ¶
13) Unlike the provisional application, the specification of
the '884 application omits any reference to Sadozai.
(D.I. 35, Exs. B & C) However, the applicant disclosed
Sadozai in an August 2009 Information Disclosure Statement
("IDS") submitted to the U.S. Patent &
Trademark Office ("PTO"). (Id., Ex. H) The
examiner initialed the IDS to indicate that he had considered
the references listed on it, including the Sadozai reference.
(Id., Ex. D)
examiner rejected the claims of the '884 application as
obvious in view of prior art references teaching
BDDE-crosslinked HA dermal fillers combined with references
teaching the addition of lidocaine to other dermal fillers.
(D.I. 29 at ¶ 14; D.I. 26, Ex. A at 5-9) Specifically,
the examiner concluded that homogenously combining an HA
composition and lidocaine would be obvious to a person of
ordinary skill in the art at the time of the invention to
anesthetize the tissue at the surgery site. (D.I. 29 at
¶ 15; D.I. 26, Ex. A at 7-8)
response to the final rejection, Dr. Lebreton submitted a
declaration dated May 2, 2012 which alleged that the prior
art combinations were not obvious. (D.I. 26, Ex. B) According
to Dr. Lebreton, a person of ordinary skill in the art would
expect the addition of lidocaine to the HA composition to
result in degradation of the HA prior to administration of
the injection. (D.I. 29 at ¶¶ 17-18; D.I. 26, Ex. B
at ¶ 5) Dr. Lebreton also represented that it was not
known at the time whether HA compositions with lidocaine were
stable in storage after undergoing high temperature
sterilization. (D.I. 29 at ¶¶ 17, 19-20; D.I. 26,
Ex. B at ¶¶ 6-7) For these reasons, Dr. Lebreton
identified the combination of lidocaine with HA in a stable
dermal filler gel as an unexpected result of the '884
application. (D.I. 29 at ¶¶ 22-24; D.I. 26, Ex. B
at ¶¶ 9-10, 15) The examiner allowed the '884
application after concluding that Dr. Lebreton's
declaration adequately established the existence of
unexpected results. (D.I. 29 at ¶¶ 26-27; D.I. 26,
Ex. D at 3) The '884 application issued as U.S. Patent
No. 8, 357, 795 ("the '795 patent") on January
22, 2013. (D.I. 29 at ¶ 13, 16)
December 2018, Prollenium launched a dermal filler product
called Revanesse® Versa, which is an injectable HA gel
containing small quantities of lidocaine. (D.I. 5 at ¶
42; D.I. 29 at ¶ 42) Allergan filed suit on January 22,
2019, alleging that Prollenium's Revanesse® Versa
dermal filler products infringe the patents-in-suit. (D.I. 1;
D.I. 5 at ¶ 44) Prollenium filed its answer, affirmative
defenses, and counterclaims on May 6, 2019, alleging, among
other things, that the patents-in-suit are unenforceable
because they were obtained as a result of inequitable conduct
before the PTO. (D.I. 11 at ¶¶ 9-21, 58-64)
Allergan subsequently filed a motion to dismiss
Prollenium's inequitable conduct counterclaim and
affirmative defense, and Prollenium responded by amending its
answer and counterclaim. (D.I. 20; D.I. 29) Allergan now
moves to dismiss Prollenium's amended counterclaim and
affirmative defense for inequitable conduct. (D.I. 34)
12(f) permits "[t]he court [to] strike from a pleading
an insufficient defense or any redundant, immaterial,
impertinent, or scandalous matter." Fed.R.Civ.P. 12(f).
The court must construe all facts in favor of the nonmoving
party and deny the motion unless the defense is clearly
insufficient as a matter of law. Symbol Techs., Inc. v.
Aruba Networks, Inc., 609 F.Supp.2d 353, 356 (D. Del.
2009). "A decision to grant or deny a motion to strike a
pleading is vested in the trial court's discretion,"
but motions to strike under Rule 12(f) are generally
disfavored. Aoki v. Benihana, Inc., 839 F.Supp.2d
759, 764 (D. Del. 2012) (internal citations and quotation
marks omitted); Fesnak & Assocs., LLP v. U.S. Bank
Nat'l Ass 'n, 722 F.Supp.2d 496, 502 (D. Del.
case, Allergan moves to strike Prollenium's affirmative
defense of inequitable conduct. Affirmative defenses for
inequitable conduct are subject to the heightened pleading
standard of Rule 9(b). See Senju Pharm. Co., Ltd. v.
Apotex, Inc., 921 F.Supp.2d 297, 306 (D. Del. 2013)
("Just as a claim for inequitable conduct must meet the
heightened pleading requirements of Rule 9(b), a defendant is
also required to plead this affirmative defense with
particularity under Rule 9(b)."). Pursuant to the
heightened pleading requirement of Rule 9(b), sufficiently
pleading an affirmative defense of inequitable conduct
requires identification of the "specific who, what,
when, where, and how of the material misrepresentation or
omission committed before the PTO." Exergen Corp. v.
Wal-Mart Stores, Inc., 575 F.3d 1312, 1328-29 (Fed. Cir.
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. See Umland v. Planco Fin.
Servs., Inc., 542 F.3d 59, 64 (3d Cir. 2008).
"Courts use the same standard in ruling on a motion to
dismiss a counterclaim under Rule 12(b)(6) as they do in
assessing a claim in a complaint." Goddard Sys.,
Inc. v. Gondal, C. A. No. 17-1003-CJB, 2018 WL 1513018,
at *4 (D. Del. Mar. 27, 2018).
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.
court's determination is not whether the non-moving party
"will ultimately prevail," but whether that party
is "entitled to offer evidence to support the
claims." In re Burlington Coat Factory Sec.
Litig., 114 F.3d 1410, 1420 (3d Cir. 1997) (internal
citations and quotation marks omitted). This "does not
impose a probability requirement at the pleading stage,"
but instead "simply calls for enough facts to raise a
reasonable expectation that discovery will reveal evidence of
[the necessary element]." Phillips v. Cty. of
Allegheny, 515 F.3d 224, 234 (3d Cir. 2008) (quoting
Twombly, 550 U.S. at 556). The court's analysis
is a context-specific task requiring the court "to draw
on its judicial experience and common sense."
Iqbal, 556 U.S. 663-64.
of fraud are subject to the heightened pleading requirements
of Federal Rule of Civil Procedure 9(b). U.S. ex rel.
Whatley v. Eastwick Coll.,657 Fed.Appx. 89, 93 (3d Cir.
2016). Under Rule 9(b), a plaintiff must "state with
particularity the circumstances constituting fraud or
mistake." Fed.R.Civ.P. 9(b). This heightened pleading
standard was meant to "place the defendants on notice of
the precise misconduct with which they are charged, and to
safeguard defendants against spurious charges of...
fraudulent behavior." Seville Indus. Mach. Corp. v.
Southmost Mack Corp.,742 F.2d 786, 791 (3d Cir. 1984).
Accordingly, the complaint must provide "all of the
essential factual background that would accompany 'the
first paragraph of any newspaper story'-that is, the
'who, what, when, where, and how' of the events at
issue." Whatley, 657 Fed.Appx. at 93 (quoting
In re Rockefeller Ctr. Prop., Inc. Sec. Litig., 311
F.3d 198, 215 (3d Cir. 2002)). "The use of boiler plate
and conclusory allegations will not suffice."
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