COPAN ITALIA SPA et al v. PURITAN MEDICAL PRODUCTS COMPANY LLC et al

Filing 54

ORDER denying 18 Motion to Dismiss for Failure to State a Claim By JUDGE JON D. LEVY. (akr)

UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
COPAN ITALIA S.P.A., et al.,

)
)
Plaintiffs,
)
)
v.
)
)
PURITAN MEDICAL PRODUCTS )
COMPANY LLC, et al.,
)
)
Defendants.
)

1:18-cv-00218-JDL

ORDER ON DEFENDANTS’ PARTIAL MOTION TO DISMISS
Defendants Puritan Medical Products Company LLC and Puritan Diagnostics
LLC (together, “Puritan”) have moved to dismiss the indirect patent infringement
claims asserted by Plaintiffs Copan Italia S.p.A. and Copan Diagnostics, Inc.
(together, “Copan”) for failure to state a claim upon which relief can be granted under
Fed. R. Civ. P. 12(b)(6). In the alternative, Puritan moves for “a more definite
statement” of the indirect infringement claims under Fed. R. Civ. P. 12(e). ECF No.
18 at 15. For the reasons explained below, I deny Puritan’s motion.
I. FACTUAL BACKGROUND
This case concerns “flocked” swabs that are used to collect and transport
biological specimen samples for analysis. The complaint (ECF No. 1) alleges the
following facts, which I treat as true for purposes of the motion to dismiss.
Before the early 2000s, the standard tool for collecting and transporting
biological specimen samples was a fiber swab similar in construction to a Q-tip: a

1

small rod with fibers wrapped around the tip. Copan claims that in 2003 it invented
and released the industry’s first “flocked” swabs. Flocked swabs consist of a rod
several inches long with a layer of short fibers deposited onto its tip so that the fibers
stand perpendicular to the rod. “Flocking” is the process of depositing the fibers
electrostatically. In the years since they were first released, flocked swabs have
grown in popularity as compared to traditional fiber swabs because of their
documented benefits in the absorption, transport, and elution (release) of biological
specimen samples.
Puritan began selling its own flocked swabs in 2011. The flocked swabs that
Puritan manufactures, like Copan’s, consist of rods with a layer of small fibers on the
tip of one end, which fibers are deposited on the tip by a process of electrostatic
flocking. In a blog post on its website, Puritan instructs customers to use its flocked
swabs to collect biological specimens. Puritan also advertises that its flocked swabs
have the “[h]ighest performing collection and elution[,]” ECF No. 1 at ¶ 100, and a
later blog post similarly claims “greater sample absorption, retention, and faster
release.” Id. at ¶ 107.

In addition, Puritan has funded several studies on the

effectiveness of its flocked swabs for collecting and transporting biological specimens
for analysis when compared to other flocked swabs.
When Puritan began selling its flocked swabs in 2011, Copan had at least one
patent application for its flocked swab technology pending in the United States. On
December 22, 2011, Puritan published a press release acknowledging that the U.S.
patent examiner had allowed certain claims in Copan’s Patent Application No.

2

10/543,873. The following day, Puritan’s outside counsel sent a letter to a general
manager at Copan that cited Patent Application No. 10/543,873 and stated that
Puritan had “reviewed all pending published patent applications assigned to Copan
Italia S.P.A. and Copan Innovation Limited.” ECF No. 1 at ¶¶ 14, 63.
Copan’s Patent Application No. 10/543,873 was ultimately approved and
issued as Patent No. 8,114,027 on February 14, 2012. Between November 2012 and
November 2015, four additional U.S. patents were issued to Copan for its flocked
swab design and the method for using a flocked swab to collect, transport, and release
a biological specimen sample for analysis. The patents-in-suit include Copan’s five
U.S. patents issued between 2012 and 2015: Patent No. 8,114,027 (“the ‘027 patent”),
Patent No. 8,317,728 (“the ‘728 patent”), Patent No. 8,979,784 (“the ‘784 patent”),
Patent No. 9,011,358 (“the ‘358 patent”), and Patent No. 9,173,779 (“the ‘779 patent”).
In 2016, after the five patents-in-suit had issued, Puritan sent a letter to one of its
distributors acknowledging that “Copan . . . has several U.S. Patents.” ECF No. 1 at
¶ 65.
Copan’s complaint contains eleven counts alleging three types of claims: false
advertising (Counts I and II), direct patent infringement (Counts III, V, VII, VIII, and
X), and indirect patent infringement (Counts IV, VI, IX, and XI). Shortly after Copan
filed its complaint, Puritan moved to dismiss the indirect patent infringement counts
for failure to state a claim under Fed. R. Civ. P. 12(b)(6). In the alternative, Puritan
requests “a more definite statement of a pleading” under Fed. R. Civ. P. 12(e) on the

3

basis that the indirect infringement claims in the complaint are “so vague or
ambiguous that [Puritan] cannot reasonably prepare a response.” ECF No. 18 at 15.
II. MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM
A.

Standard of Review
To survive Puritan’s Rule 12(b)(6) motion to dismiss, the indirect infringement

counts in the complaint must be supported by “sufficient factual matter, accepted as
true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S.
662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)). A
claim is plausible when the facts pled in the complaint “allow[] the court to draw the
reasonable inference that the defendant is liable for the misconduct alleged.” Id.
(citing Twombly, 550 U.S. at 556). Because “[a] motion to dismiss for failure to state
a claim upon which relief can be granted is a purely procedural question not
pertaining to patent law,” the law of the regional circuit applies. McZeal v. Sprint
Nextel Corp., 501 F.3d 1354, 1355-56 (Fed. Cir. 2007); accord In re Bill of Lading
Transmission & Processing Sys. Patent Litig., 681 F.3d 1323, 1331 (Fed. Cir. 2012).
The First Circuit has laid out a two-step process for evaluating a Rule 12(b)(6)
motion: first, “isolate and ignore statements in the complaint that simply offer legal
labels and conclusions or merely rehash cause-of-action elements[,]” and second,
“take the complaint’s well-pled . . . facts as true, drawing all reasonable inferences in
the pleader’s favor, and see if they plausibly narrate a claim for relief.” Schatz v.
Republican State Leadership Comm., 669 F.3d 50, 55 (1st Cir. 2012). “There need not
be a one-to-one relationship between any single allegation and a necessary element

4

of the cause of action. What counts is the ‘cumulative effect of the [complaint’s]
factual allegations.’” Rodríguez-Reyes v. Molina-Rodríguez, 711 F.3d 49, 55 (1st Cir.
2013) (quoting Ocasio-Hernández v. Fortuño-Burset, 640 F.3d 1, 14 (1st Cir. 2011)).
B.

Legal analysis
Indirect patent infringement can take two forms: induced infringement or

contributory infringement. See 35 U.S.C.A. § 271(b)-(c) (West 2018).

Copan’s

complaint alleges both induced and contributory infringement of four of the five
patents-in-suit: the ‘027 patent, the ‘728 patent, the ‘358 patent, and the ‘779 patent.
Copan does not allege indirect infringement of the ‘784 patent. Puritan’s motion
argues that the complaint asserts no more than rehashed elements of each cause of
action and legal conclusions as to both theories of recovery. I address each form of
indirect patent infringement asserted in the complaint.
1. Induced Infringement
“Whoever actively induces infringement of a patent shall be liable as an
infringer.” 35 U.S.C.A. § 271(b). To state a claim for induced infringement, a plaintiff
must allege (1) knowledge of the patent, (2) specific intent that another party infringe
the patent, and (3) knowledge that the induced acts constitute infringement. See
Commil USA, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920, 1926 (2015); Nalco Co. v. ChemMod, LLC, 883 F.3d 1337, 1355 (Fed. Cir. 2018). The language in each induced
infringement claim in Counts IV, VI, IX, and XI closely mirrors the statutory
language of § 271(b) and the other required elements for induced infringement.

5

Accordingly, these allegations state legal conclusions and must be disregarded for
purposes of determining the sufficiency of the complaint. See Schatz, 669 F.3d at 55.
Turning to the first element of induced infringement, the parties dispute
whether Puritan’s alleged knowledge of Copan’s patent applications gives rise to an
inference that Puritan had knowledge of the patents-in-suit. Puritan asserts that
there is a settled bright-line rule that pleading knowledge of a patent application is
insufficient. In its decision in State Industries, Inc. v. A.O. Smith Corporation, 751
F.2d 1226, 1236 (Fed. Cir. 1985), the Federal Circuit reasoned that knowledge of a
patent application was not sufficient to satisfy the knowledge element for willful
patent infringement:
A “patent pending” notice gives one no knowledge whatsoever. It is not
even a guarantee that an application has been filed. Filing an
application is no guarantee any patent will issue and a very substantial
percentage of applications never result in patents. What the scope of
claims in patents that do issue will be is something totally
unforeseeable.
Id. Subsequent cases have relied on the reasoning in State Industries to support a
rule that “plaintiffs [must] plead knowledge of the actual patents at issue and not
mere knowledge of the pendency of patent applications.” LML Holdings, Inc. v. Pac.
Coast Distrib. Inc., No. 11-CV-06173 YGR, 2012 WL 1965878, at *4 (N.D. Cal. May
30, 2012); see also Boundaries Sols., Inc. v. CoreLogic, Inc., No. 5:14-cv-00761-PSG,
2014 WL 7463708 at *3 (N.D. Cal. Dec. 30, 2014) (quoting LML Holdings rule); Verint
Sys. Inc. v. Red Box Recorders Ltd., No. 14-cv-5403 (KBF), 2016 WL 7177844 at *2
(S.D.N.Y. Dec. 7, 2016) (quoting State Industries to support rule that “[k]nowledge of
a patent application is not enough” for a finding of induced infringement).
6

The Federal Circuit, however, recently indicated that the concerns expressed
in State Industries “are no longer valid when patent applications and realtime
prosecution activity are published[,]” so that patent applications are no longer
“secret.” WCM Indus., Inc. v. IPS Corp., 721 F. App’x 959, 970 n.4 (Fed. Cir. 2018).
In 1999, Congress enacted 35 U.S.C. § 122(b)(1)(A), “which provides for the
publication of patent applications filed on or after November 29, 2000, eighteen
months after the effective filing date of the application,” and therefore gives the public
access to far more information than just a “patent pending” notice. Id. The Federal
Circuit also emphasized in WCM Industries that “State Industries does not establish
a per se rule . . . but rather, ‘is in harmony with our prior and subsequent case law,
which looks to the totality of the circumstances presented in the case.’” Id. at 970
(quoting Shiley, Inc. v. Bentley Labs, Inc., 794 F.2d 1561, 1568 (Fed. Cir. 1986)).
Here, the complaint does allege Puritan’s knowledge of at least one of Copan’s
patent applications and other facts that permit the reasonable inference that Puritan
had knowledge of Copan’s U.S. patents. The complaint alleges that in December
2011, Puritan identified Copan’s Patent Application No. 10/543,873 in both a press
release and a letter that it had sent to Copan. The letter allegedly states that Puritan
had “reviewed all pending published patent applications assigned to Copan Italia
S.P.A. and Copan Innovation Limited.” ECF No. 1 at ¶ 63. Puritan also sent a letter
to one of its distributors in 2016, after the five patents-in-suit had issued,
acknowledging that “Copan . . . has several U.S. Patents.” ECF No. 1 at ¶ 65. These
communications, coupled with the allegation that the parties are competitors in what

7

is a specialized market, reasonably permit an inference that Puritan was keeping up
to date on the status of Copan’s patent applications. Viewing the allegations in the
light most favorable to Copan as the non-moving party, the complaint plausibly
pleads knowledge of the patents-in-suit.
To satisfy the second element of induced infringement, the complaint must
allege facts demonstrating that the defendant specifically intended that a third-party
infringe the patent. “[T]he requisite intent to induce infringement may be inferred
from all of the circumstances.” Warsaw Orthopedic, Inc. v. NuVasive, Inc., 824 F.3d
1344, 1347 (Fed. Cir. 2016) (quoting Broadcom Corp. v. Qualcomm Inc., 543 F.3d 683,
699 (Fed. Cir. 2008)). Thus, “active steps taken to encourage direct infringement,
such as advertising an infringing use or instructing how to engage in an infringing
use, show an affirmative intent that the product be used to infringe . . . .” MetroGoldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936 (2005) (internal
alteration, citation, and quotation marks omitted).1

“For pleading purposes,

circumstantial evidence often suffices to clarify ‘a protean issue such as . . . intent.’”
Rodríguez-Reyes, 711 F.3d at 56 (quoting Anthony v. Sundlun, 952 F.2d 603, 605 (1st
Cir. 1991)).
The complaint alleges that Puritan advertised and instructed that its flocked
swabs are used to perform the method claimed in Copan’s patents: collecting,
transporting, and releasing biological specimens for analysis. See Grokster, 545 U.S.

Puritan argues that Grokster does not apply here because it is a copyright case. Although the issue
in Grokster was copyright infringement, the Court devoted part of its opinion to discussing patent law
principles and ultimately adopted a patent doctrine in the copyright infringement context. Id. at 93637.
1

8

at 936. Among the publicly available materials described in the complaint are two of
Puritan’s advertisements, which state that Puritan’s flocked swabs have the
“[h]ighest performing collection and elution,” and that “our flocked specimen
collection devices provide the most efficient collection and elution on the market.”
ECF No. 1 at ¶¶ 100, 128. Advertising an infringing use may constitute an “active
step[] taken to encourage direct infringement,” Grokster, 545 U.S. at 936, and suffices
to show, albeit indirectly, an intent that the product should be used to infringe.
Accordingly, the second element of induced infringement is adequately pleaded.
Finally, the complaint also sufficiently pleads the third element of induced
infringement: knowledge that the induced acts constitute patent infringement.
Copan’s complaint details long-standing communication and litigation between the
two parties surrounding their respective flocked swabs, beginning around 2011 and
spanning several countries. In 2013, after Copan and Puritan had become involved
in litigation in Germany, a Puritan customer service representative told a potential
customer in Italy that “[d]ue to Copan’s patent on flock swabs, we cannot sell our
products into Italy.” ECF No. 1 at ¶¶ 64, 67. Given Puritan’s familiarity with Copan
and Copan’s products, the alleged facts support an inference that Puritan knew that
selling their flocked swabs and encouraging others to use the swabs to collect
biological specimens for testing would constitute infringement of the claimed methods
in Copan’s patents.

9

For the reasons discussed above, I conclude that the complaint states a
plausible claim to relief for induced infringement. Puritan’s motion to dismiss is
therefore denied as to those claims.
2. Contributory Infringement
As relevant here, contributory infringement occurs when a party (1) “sells
within the United States . . . [an] apparatus for use in practicing a patented process,”2
(2) which “constitut[es] a material part of the invention,” (3) “knowing the same to be
especially made or especially adapted for use in an infringement of such patent,” and
(4) the apparatus is “not a staple article or commodity of commerce suitable for
substantial noninfringing use . . . .” 35 U.S.C.A. § 271(c). “Like induced infringement,
contributory infringement requires knowledge of the patent in suit and knowledge of
patent infringement.” Commil, 135 S. Ct. at 1926. It does not, however, require proof
of an intent that the activity would cause infringement. Lifetime Indus., Inc. v. TrimLok, Inc., 869 F.3d 1372, 1381 (Fed. Cir. 2017).

Puritan argues that the facts pled in the complaint do not satisfy the first element of contributory
infringement because a defendant must “sell, offer to sell, or import a ‘component’ used in a patented
machine, instead of the entire machine itself.” ECF No. 29 at 10. But § 271(c) covers either “a
component of a patented machine . . . or a material or apparatus for use in practicing a patented
process . . . .” 35 U.S.C.A. § 271(c); see also Arris Grp., Inc. v. British Telecommunications PLC, 639
F.3d 1368, 1376 (Fed. Cir. 2011) (noting that § 271(c) “covers both contributory infringement of system
claims and method claims.”).
2

Each of the four patents for which Copan alleges contributory infringement includes an
independent claim for the “method of collecting a biological specimen to be analyzed” using a flocked
swab. ECF No. 1-5 at 8; see also ECF No. 1-1 at 6-7; ECF No. 1-2 at 7; ECF No. 1-4 at 8. Thus, Copan
may plead contributory infringement by alleging that Puritan sells a material or apparatus for use in
practicing its patented process. See Artrip v. Ball Corp., No. 1:14CV00014, 2017 WL 3669518, at *9
(W.D. Va. Aug. 24, 2017) (“[C]laims that recite a ‘method’ are properly treated as process claims.”
(citing Arris Grp., 639 F.3d at 1376 n.9)).
10

The allegations in each contributory infringement claim stated in Counts IV,
VI, IX, and XI of the complaint closely mirror the statutory language of § 271(c).
Therefore, those allegations state legal conclusions and must be ignored in assessing
the sufficiency of the complaint. Schatz, 669 F.3d at 55. But the complaint does
allege facts that support each of the four required elements. First, Copan alleges that
Puritan sells its flocked swabs in the United States, a claim that is bolstered by an
alleged blog post on Puritan’s website that asserts that the company can meet market
needs more quickly than suppliers of flocked swabs located abroad because its
products are manufactured in the United States. ECF No. 1 at ¶ 120. Second, it is
apparent from Copan’s patents, copies of which are attached to the complaint, that
flocked swabs constitute a material part of the patented method. Third, as discussed
above, Copan plausibly pleads that Puritan had knowledge of Copan’s U.S. patents
and knowledge of patent infringement by third parties.

Therefore, the complaint

adequately pleads the first three elements of contributory infringement.
The complaint also pleads sufficient facts to support a reasonable inference
that Puritan’s flocked swabs have no “substantial noninfringing use,” as required by
the fourth element. 35 U.S.C.A. § 271(c). “A substantial noninfringing use is any use
that is ‘not unusual, far-fetched, illusory, impractical, occasional, aberrant, or
experimental.’” Nalco Co., 883 F.3d at 1357 (quoting Vita-Mix Corp. v. Basic Holding,
Inc., 581 F.3d 1317, 1327 (Fed. Cir. 2009)). “[T]he inquiry focuses on whether the
accused products can be used for purposes other than infringement.” Bill of Lading,
681 F.3d at 1338. Whether an apparatus is “suitable for substantial noninfringing

11

use” is a question of fact that “cannot be evaluated in a vacuum.” i4i Ltd. P’ship v.
Microsoft Corp., 598 F.3d 831, 851 (Fed. Cir. 2010), aff’d, 564 U.S. 91 (2011). Relevant
considerations may include “the use’s frequency, . . . the uses practicality, the
invention’s intended purpose, and the intended market.” Id.
Because of “the difficulty of alleging enough facts to demonstrate a negative at
th[e pleading] stage . . . numerous post-Iqbal cases have not required detailed factual
allegations in support of a plaintiff’s claim that a defendant’s product lacks
substantial noninfringing uses.” Conair Corp. v. Jarden Corp., No. 13-cv-6702 (AJN),
2014 WL 3955172, at *4 (S.D.N.Y. Aug. 12, 2014) (collecting cases). As long as that
claim is not undermined by “allegations of other substantial non-infringing uses
elsewhere in the [c]omplaint,” a court may “draw a plausible inference of contributory
infringement.” Driessen v. Sony Music Entm’t, No. 2:09-cv-0140-CW, 2013 WL
4501063, at *2 (D. Utah Aug. 22, 2013); see also, e.g., Puget Bioventures, LLC v.
Biomet Orthopedics LLC, 325 F. Supp. 3d 899, 908 (N.D. Ind. 2018) (noting “the
obvious difficulty plaintiffs would face in pleading a negative without the benefit of
discovery.”); cf. Bill of Lading, 681 F.3d at 1338 (concluding that plaintiff failed to
state a claim for contributory infringement where plaintiff’s own allegations made
clear that defendant’s products had multiple noninfringing uses).
Here, the complaint alleges that Puritan’s flocked swabs “are not staple
articles or commodities of commerce suitable for a substantial noninfringing use.”
ECF No. 1 at ¶¶ 155, 168, 187, 200. In addition, the complaint alleges that Puritan
advertises and instructs that its flocked swabs be used to collect, transport, and

12

release biological specimens for analysis, and that Puritan has funded several studies
on the effectiveness of its flocked swabs when used for that purpose. Viewing the
complaint in the light most favorable to Copan as the non-moving party, it is
reasonable to infer from these alleged facts that Puritan’s flocked swab is a specialty
item that is designed and sold for use in the collection, transport, and release of
biological specimen samples, and that it is not suited for a substantial noninfringing
use. Furthermore, Copan has not alleged any facts that undermine the assertion that
Puritan’s flocked swabs have no substantial noninfringing uses.
I therefore conclude that the complaint states a plausible claim to relief for
contributory infringement and deny Puritan’s motion to dismiss as to those claims.
III. MOTION FOR A MORE DEFINITE STATEMENT
As an alternative to dismissal for failure to state a claim, Puritan moves for a
more definite statement of the indirect infringement claims in the complaint under
Fed. R. Civ. P. 12(e). Based on the specific factual allegations discussed above that
support the indirect infringement claims, I conclude that those claims are not “vague
or ambiguous” such that Puritan “cannot reasonably prepare a response.” Fed. R.
Civ. P. 12(e); see also Haghkerdar v. Husson Coll., 226 F.R.D. 12, 14 (D. Me. 2005)
(“The motion is granted sparingly since it is not to be used as a substitute for
discovery in trial preparation . . . but is to be used only when a pleading is too general.
Rule 12(e) motions are designed to strike at unintelligibility, rather than at lack of
detail in the complaint.” (internal citations and quotation marks omitted)). Thus, I
deny Puritan’s alternative request for a more definite statement.

13

IV. CONCLUSION
For the above reasons, Puritan’s motion to dismiss the indirect infringement
claims and alternative request for a more definite statement of the indirect
infringement claims (ECF No. 18) are DENIED.
SO ORDERED.
Dated this 9th day of November, 2018.
/s/ JON D. LEVY
U.S. DISTRICT JUDGE

14