# Aquestive Therapeutics, Inc. v. Biodelivery Sciences International, Inc.

> District Court, E.D. North Carolina · August 6, 2019

URL: https://www.frixlaw.com/law-library/cases/10250638

## Case

- **Court:** District Court, E.D. North Carolina
- **Decided:** August 6, 2019
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

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## Opinion text

_IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NORTH CAROLINA
WESTERN DIVISION
No. 5:18-CV-514-D

AQUESTIVE THERAPEUTICS, INC., )
Plaintiff,
v. ) ORDER
BIODELIVERY SCIENCES
INTERNATIONAL, INC., )
Defendant. )

On 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 IDE. 88] . On January 22, 2019,
BioDelivery replied [D.E. 90]. On April 9, 2019, Aquestive filed a sur-teply [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.

Aquestive 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 □□□
1-3; [D.E. 1-2]; [D.E. 1-3].
On July 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] 7 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.
717. See id. Aquestive alleges that it owns all rights, title, and interest in the 167 patent. See
id. 718.
BioDelivery 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 BUNAVAIL, 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 BUNAVAIL 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. W 5; 32-33.
Aquestive 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. J] 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 9-1 0.

A 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), afPd, 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 aclaim to relief
that is plausible on its face.” Iqbal, 556 U.S. at 678. (quotation omitted); see Twombly, 550 US. at
570; Giarratano, 521 F.3d at 302. In considering the motion, the court must éonstrue the facts and

1 The court rejects BioDelivery’s argument that Aquestive lacks standing to sue for patent
infringement. See, e.g., Alfred E. Mann Found. for Sci. Res. v. Cochlear Corp., 604 F.3d 1354,
1359-63 (Fed. Cir. 2010); Aspex Eyewear, Inc. v Miracle Optics, Inc., 434 F.3d 1336, 1340-44
(Fed. Cir. 2006); Jasco Prods. Co. v. Prime Wire & Cable, Inc., No. 5:18-CV-44-RJC-DSC, 2018
WL 4576780, at *2 (W.D.N.C. Sept. 6, 2018) (unpublished); [D.E. 80-9].

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 Co.
v. Spansion Inc., 4 F. Supp. 3d 797, 803 (E.D. Va. 2014); cf. Disc Disease Sols. Ine. 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
2017).
When 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.w. Kolon Indus., Inc.,
637 F.3d 435, 448 (4th Cir. 2011); see Fed. R. Civ. P. 10(c); Goines v. Valley City, 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 dociment’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 amotion for summary judgment. See, eB, F ed. R. Evid. 201;
Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007); Philips v. Pitt Cty . Mem’]
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 USC. § 271(2). 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, Ine, 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 1 89817, at 3.5 EDN. Jan, 14, 2019)
(unpublished).
Although 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 GD. 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’], 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 buprenorphine hydrochloride,” Compl.. [D.E. J] 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 infringement claim.
As for 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. Ct. 1920, 1926 (2015); Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 766 (2011).
Although Aquestive alleges that BioDelivery knew of the ‘167 patent and, before J annary 6, 20 17,
had licensed production and sale of BELBUCA to a third-party, see Compl. DE 1] 7 4-5, 19,
Aquestive does not plausibly allege either direct infringement or that BioDelivery specifically
intended to infringe the “167 patent. Thus, the court rants BioDelivery’s ‘motion to dismiss

_ Aquestive’s indirect infringement claim

As for Aquestive’s contributory infringement claim, 35 U.S.C. § 271(c) concerns
contributory infringement. It states:
Whoever offers to sell or sells within the United States or imports into the United
States a component of a patented machine, manufacture, combination or
composition, or a material or apparatus for use in practicing a patented process,
constituting a material part of the invention, knowing the same to be especially made
or especially adapted for use in an infringement of such patent, and not a staple
article or commodity of commerce suitable for substantial noninfringing use, shall
be liable as a contributory infringer. oe
35 U.S.C. § 271(c). “Like induced infringement, contributory inftingement requires knowledge of
the patent in suit and knowledge of patent infringement.” Commil USA, LLC, 135 S. Ct. at 1926.
As with Aquestive’s direct and indirect patent infringement claims, Aquestive’s contributory
infringement claim is factually insufficient to state a plausible claim for relief. See Compl. [D.E.

1] (37. Accordingly, the court grants BioDelivery’s motion to dismiss Aquestive’s contributory
infringement claim. oe

_ As for BioDelivery’s motion to stay [D.E. 83], the motion is moot because the court grants
BioDelivery’s motion to dismiss [D.E. 79]. ‘Accordingly, the court denies as moot BioDelivery’s
motion to stay. oo

In sum, the court GRANTS BioDelivery’s motion to dismiss for failure to state a claim [DE.
79], DISMISSES without prejudice Aquestive’s complaint, and DENIES AS MOOT BioDelivery’s
motion to stay [DE. 83].
ORDERED. This (o day of August 2019.

a 4 Novos:
J S C. DEVER I
United States District Judge .

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10250638. Public record. Not legal advice.