United States District Court, E.D. North Carolina, Western Division
C. DEVER, III UNITED STATES DISTRICT JUDGE.
January 13, 2017, Aquestive Therapeutics, Inc., f/k/a MonoSol
Rx, LLC ("Aquestive" or "plaintiff), filed a
complaint in the United States District Court for the
District of New Jersey against BioDelivery Sciences
International, Inc. ("BioDelivery" or
"defendant") alleging patent infringement [D.E. 1].
On October 30, 2018, that court transferred the case to this
court [D.E. 70, 71]. On November 20, 2018, BioDelivery moved
to dismiss Aquestive's complaint [D.E. 79] and filed a
memorandum in support [D.E. 80]. On January 2, 2019,
Aquestive responded in opposition [D.E. 87]. On January 16,
2019, BioDelivery replied [D.E. 89]. On November 26, 2018,
BioDelivery moved to stay the action pending the United
States Patent and Trademark Office's ("PTO")
inter partes review of the patent at issue [D.E. 83]
and filed a memorandum in support [D.E. 84]. On January 7,
2019, Aquestive responded in opposition [D.E. 88]. On January
22, 2019, BioDelivery replied [D.E. 90]. On April 9, 2019,
Aquestive filed a sur-reply [D.E. 98]. As explained below,
the court grants BioDelivery's motion to dismiss, denies
as moot BioDelivery's motion to stay, and dismisses the
complaint for failure to state a claim.
is a pharmaceutical company based in New Jersey that
specializes in developing and commercializing
"film pharmaceutical and over-the-counter drug
products." Compl. [D.E. 1] ¶¶ 6, 14. Aquestive
has obtained over 150 patents. See Id. ¶ 14.
BioDelivery, which is based in North Carolina, sells various
film pharmaceutical products used to deliver drugs, including
the allegedly infringing BELBUCA (buprenorphine) buccal film
("BELBUCA") product. See Id. ¶¶
1-3; [D.E. 1-2]; [D.E. 1-3].
1, 2014, Garry L. Myers, Pradeep Sanghvi, Andrew Philip
Verrall, Vimala Francis, and Laura Moss obtained United
States Patent No. 8, 765, 167 (the '"167
patent"), entitled "Uniform Films for
Rapid-Dissolve Dosage Form Incorporating Anti-Tacking
Compositions." See Compl. [D.E. 1] ¶ 15; [D.E.
1-1]. The '167 patent concerns "rapidly dissolving
films that incorporate anti-tacking agents and/or
that contain an active component-such as a drug-that is
evenly distributed throughout the film." Compl. [D.E. 1]
¶ 16; see [D.E. 1-1]. Aquestive alleges that the'
167 patent discloses "pioneering improvements" that
"enable uniform distribution of components" in the
film and that "prevent undesired aggregations
of components in the final film product." Compl. [D.E.
1] ¶ 17. See Id. Aquestive alleges that it owns
all rights, title, and interest in the '167 patent.
See id. ¶ 18.
markets and sells BELBUCA, a pharmaceutical drug product used
to deliver buprenorphine hydrochloride, which is an opioid
prescribed to treat acute and chronic pain. See Id.
¶¶ 1-3, 21-22; [D.E. 1-2]; [D.E. 1-3]. BioDelivery
also sells BUNAVATL, a pharmaceutical drug product similar to
BELBUCA. See Compl. [D.E. 1] ¶ 4. On September 22, 2014,
Aquestive sued BioDelivery for patent infringement based on
BioDelivery's BUNAVATL product. See Id. On
October 28, 2014, BioDelivery filed four petitions for
inter partes review of the '167 patent with the
Patent Trial and Appeal Board ("PTAB"). See
Id. Despite the pending patent infringement suit
concerning BUNAVAIL, BioDelivery began to sell BELBUCA. See
id. ¶¶ 5, 32-33.
alleges that BELBUCA infringes the '167 patent. See
Id. ¶ 25. Specifically, Aquestive alleges that
BELBUCA infringes claims 13, 33, 39, 45, 52, 66, 73,
83, 89, 95-98, 100-03, 105, 107-08, and 117-18 of the
'167 patent. See id ¶ 28. Aquestive also alleges
that it has not granted to any party, including BioDelivery,
a license to make, use, sell, or offer for sale BELBUCA.
See Id. ¶ 29. Moreover, Aquestive
alleges that BioDelivery has induced direct infringement of
the '167 patent by actively encouraging others to make,
use, sell, or offer for sale BELBUCA in violation of the
claims of the '167 patent See Id. ¶¶
36-37. Aquestive seeks damages, enhanced damages for willful
infringement, attorneys' fees, and a permanent injunction
prohibiting BioDelivery from engaging in future infringement
of the '167 patent. See Id. at 9-10.
motion to dismiss under Rule 12(b)(6) tests the
complaint's legal and factual sufficiency. See
Ashcroft v. Iqbal, 556 U.S. 662, 677-80 (2009); Bell
Atl. Corp. v. Twombly, 550 U.S. 544, 554-63 (2007);
Coleman v. Md. Court of Appeals, 626 F.3d 187, 190
(4th Cir. 2010), aff'd. 566 U.S. 30 (2012);
Giarratano v. Johnson, 521 F.3d 298, 302 (4th Cir.
2008). To withstand a Rule 12(b)(6) motion, a
pleading "must contain sufficient factual matter,
accepted as true, to state a claim to relief that is
plausible on its face." Iqbal, 556 U.S. at 678
(quotation omitted); see Twombly, 550 U.S. at 570;
Giarratano, 521 F.3d at 302. In considering the
motion, the court must construe the facts and reasonable
inferences "in the light most favorable to the
[nonmoving party]." Massey v. Ojaniit 759 F.3d
343, 352 (4th Cir. 2014) (quotation omitted); see
Clatterbuck v. City of Charlottesville, 708 F.3d
549, 557 (4th Cir. 2013), abrogated on other
grounds by. Reed v. Town of Gilbert. 135 S.Ct.
2218 (2015). A court need not accept as true a
complaint's legal conclusions, "unwarranted
inferences, unreasonable conclusions, or arguments."
Giarratano, 521 F.3d at 302 (quotation omitted); see
Iqbal, 556 U.S. at 678-79. Rather, a plaintiffs
factual allegations must "nudge[ ] [its] claims,"
Twombly, 550 U.S. at 570, beyond the realm of
"mere possibility" into "plausibility."
Iqbal, 556 U.S. at 678-79. Moreover, Iqbal
and Twombly apply to patent infringement claims.
See Lifetime Indus., Inc. v. Trim-Lok, Inc., 869
F.3d 1372, 1379 (Fed. Cir. 2017); Macronix Int'l Co.
v. Spansion Inc., 4 F.Supp.3d 797, 803 (E.D. Va. 2014);
cf. Disc Disease Sols. Inc. v. VGH Sols., Inc., 888
F.3d 1256, 1259 n.3 (Fed. Cir. 2018: Woods v. City of
Greensboro, 855 F.3d 639.647 (4th Cir. 2017).
evaluating a motion to dismiss, a court considers the
pleadings and any materials "attached or incorporated
into the complaint." E.I. du Pont de Nemours &
Co. v. Kolon Indus., Inc., 637 F.3d 435, 448 (4th Cir.
2011); see Fed.R.Civ.P. 10(c); Goines v. Valley Cmty.
Servs. Bd., 822 F.3d 159, 165-66 (4th Cir. 2016). A
court may also consider a document submitted by a moving
party if it is "integral to the complaint and there is
no dispute about the document's authenticity."
Goines, 822 F.3d at 166. Additionally, a court may
take judicial notice of public records without converting the
motion to dismiss into a motion for summary judgment.
See, e.g.. Fed.R.Evid. 201; Tellabs,
Inc. v. Makor Issues & Rights. Ltd., 551 U.S. 308,
322 (2007); Philips v Pitt Cty. Mem'l Hosp., 572
F.3d 176, 180 (4th Cir. 2009).
Aquestive's direct infringement claim, whoever
"without authority makes, uses, offers to sell, or sells
any patented invention . . . infringes the patent" 35
U.S.C. § 271(a). When analyzing a direct infringement
claim, a court makes two inquiries. First, the court
determines the scope and meaning of the patent claims
asserted. Second, the court compares those claims to the
allegedly infringing product. See N. Am. Container. Inc.
v. Plastipak Packaging, Inc., 415 F.3d 1335, 1344 (Fed.
Cir. 2005). When analyzing the second issue, the court must
determine that every claim limitation or its equivalent is in
the accused device. See id.; Carroll Touch. Inc.
v. Electro Mech. Sys., Inc., 15 F.3d 1573, 1576 (Fed.
Cir. 1993). A complaint that alleges patent infringement must
place the "alleged infringer on notice of what activity
is being accused of infringement." Lifetime Indus.,
Inc., 869 F.3d at 1379 (alteration and quotation
omitted); see, e.g., Panduit Corp. v. Corning Inc.,
No. 5:18-CV-229-FL, 2019 WL 189817, at *3-5 (E.D. N.C. Jan.
14, 2019) (unpublished).
Aquestive identifies the specific claims that it alleges that
BELBUCA infringes, see Compl. [D.E. 1] ¶¶
2, 28, Aquestive "does not identify with any
particularity how each allegedly infringing feature
of the accused product infringes any of the" claims at
issue. Jenkins v. LogicMark. LLC, No.
3:16-CV-751-HEH, 2017 WL 376154, at *3 (E.D. Va. Jan. 25,
2017) (unpublished); see, e, g,, Artrip v. Ball
Corp., No. 1:14CV14, 2017 WL 5037470, at *3 (W.D. Va.
Nov. 3, 2017) (unpublished): Macronix Int'l.
Co., 4 F.Supp.3d at 804-05. For example, while Aquestive
alleges that BELBUCA is sold in different dosage strengths
and is a "buccal film providing transmucosal
delivery of buprenorpbine hydrochloride," Compl. [D.E.
1] ¶¶ 20-23, Aquestive does not allege how these
features of BELBUCA infringe the '167 patent. Thus, even
viewing the facts and reasonable inferences in the light most
favorable to Aquestive, Aquestive's direct patent
infringement is not factually sufficient to state a claim
upon which relief can be granted, and the court grants
BioDelivery's motion to dismiss Aquestive's direct
Aquestive's indirect infringement claim, whoever
"actively induces infringement of a patent shall be
liable as an infringer." 35 U.S.C. § 271(b). A
patentee alleging such a claim "has the burden to show
direct infringement for each instance of indirect
infringement." DSU Med. Corp. v. JMS Co., 471
F.3d 1293, 1303 (Fed. Cir. 2006); see Limelight Networks.
Inc. v Akamai Techs Inc., 572 U.S. 915, 917, 922 (2014).
Moreover, an indirect infringement claim requires proof of
specific intent and action to induce infringement. See
Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348,
1364 (Fed. Cir. 2003). The defendant must also have known of
the patent and that the induced acts constitute direct patent
infringement See Commil USA. LLC v. Cisco Sys.,
Inc., 135 S. Q. 1920, 1926 (2015); Global-Tech
Appliances. Inc. v. SEB S.A., 563 U.S. 754, 766 (2011).
Aquestive alleges that BioDelivery knew of the '167
patent and, before January 6, 2017, had licensed production
and sale of BELBUCA to a third-party, see Compl. [D.E. 1]
¶¶ 4-5, 19, Aquestive does not plausibly allege
either direct infringement or that BioDelivery specifically
intended to infringe the '167 patent. Thus, ...