United States District Court, D. Delaware
INTEGRA LIFESCIENCES CORP., INTEGRA LIFESCIENCES SALES LLC, CONFLUENT SURGICAL, INC., and INCEPT LLC, Plaintiffs,
HYPERBRANCH MEDICAL TECHNOLOGY, INC., Defendant.
REPORT AND RECOMMENDATION
CHRISTOPHER J. BURKE UNITED STATES MAGISTRATE JUDGE
action filed by Plaintiffs Integra LifeSciences Corp.
("Integra"), Integra LifeSciences Sales LLC
("Integra Sales"), Confluent Surgical, Inc.
("Confluent") and Incept LLC ("Incept, "
and collectively with Integra, Integra Sales and Confluent,
"Plaintiffs") against Defendant HyperBranch Medical
Technology, Inc. ("Defendant" or
"HyperBranch"), Plaintiffs allege infringement of
United States Patent Nos. 7, 009, 034 (the '"034
patent"), 7, 332, 566 (the '"566 patent"),
7, 592, 418 (the '"418 patent"), 8, 003, 705
(the '"3705 patent") and 8, 535, 705 (the
'"5705 patent") (collectively, the
"patents-in-suit" or "asserted
patents"). Presently before the Court is
HyperBranch's motion for summary judgment of
non-infringement of claims 1, 6, 12 and 17 of the '5705
patent (the "Motion"). (D.I. 393) The Court
recommends that HyperBranch's Motion be GRANTED.
is involved in the design, development and manufacturing of
medical devices for orthopedics, tissue technologies and
speciality surgical solutions, with an emphasis on products
that help heal and/or regenerate tissue. (D.I. 1 at ¶ 7)
Integra Sales sells and distributes Integra's medical
technology products, including Integra's dural sealant
products. (Id. at ¶¶ 8, 25) Integra and
Integra Sales are affiliates of Confluent, which is a medical
device company that has developed in-situ polymerized
biomaterials with applications as synthetic sealants and
hemostats in minimally invasive surgery, adhesion prevention
and interventional procedures. (Id. at ¶¶
5, 9) Incept is a medical technology company that promotes
and advances technological innovation and entrepreneur ship.
(Id. at ¶ 10) The asserted patents "relate
to Integra's and Integra Sales' dural sealant
products and technology, particularly those used by
neurosurgeons and orthopedic spine surgeons."
(Id. at ¶ 25) Integra, Integra Sales and
Confluent are the exclusive licensees of the asserted
patents, and Incept owns them by assignment. (Id. at
¶¶ 11-16; D.I. 35, ex. 1 at ¶ 5)
HyperBranch is a medical device company that is involved in
the business of designing, developing, manufacturing and
selling surgical sealants. (D.I. 1 at ¶ 19; D.I. 25 at
¶ 2; D.I. 37 at ¶ 19) In this action, Plaintiffs
allege that HyperBranch directly and indirectly infringes the
asserted patents by, inter alia, the manufacture,
use, sale, and offers to sell of HyperBranch's Adherus
Dural Sealant, Adherus Spinal Sealant, Adherus AutoSpray
Dural Sealant, and Adherus AutoSpray Extended Tip (ET) Dural
Sealant (the "Accused Products"). (D.I. 1 at
¶¶ 28, 35, 42, 49, 56; D.I. 402 at vii-viii)
The '5705 Patent
'5705 patent, entitled "Biocompatible Polymers and
Hydrogels and Methods of Use" was issued on September
17, 2013, with the application having been filed on November
16, 2007. (D.I. 246, ex. F) The patent contains 18 claims
directed to methods of making a biocompatible degradable
hydrogel. ('5705 patent, cols. 30:34-32:19) Plaintiffs
assert claims 1, 6, 12 and 17 of the '5705 patent.
(See D.I. 402 at ix)
of the '5705 patent, the only independent claim, is
representative, and it recites:
1. A method of making a biocompatible degradable hydrogel to
treat a medical condition of a patient comprising:
identifying a medical condition for treatment by use of a
hydrogel formed in situ in a patient and fully degradable in
a patient in less than about 180 days; and mixing a first
precursor with a second precursor in situ in the patient to
form the hydro gel for treatment of the medical condition,
with the first biocompatible synthetic hydrophilic polymer
precursor having a water solubility of at least 1 gram per
100 milliliters and comprising at least two electrophilic
functional groups; and the second biocompatible synthetic
hydrophilic polymer precursor comprising at least two
nucleophilic amine functional groups; and wherein
(i) the first precursor is selected to have only one or two
chemically hydrolytically degradable ester bonds per every
electrophilic functional group on the first precursor; and
(ii) the second precursor comprises at least three
nucleophilic functional groups; wherein the biodegradable
groups of the hydrogel consist of the esters and the
hydrogel as placed in situ in the patient is essentially
fixlly degradable in a patient in less than about 180 days,
and wherein mixing the first and the second synthetic
hydrophilic polymer precursors forms crosslinking covalent
bonds that are reaction products of the electrophilic and the
nucleophilic groups, wherein essentially every ester bond in
the hydrogel is separated from other ester bonds in the
hydrogel by at least three covalent bonds when the hydrogel
('5705 patent, col. 30:34-65 (emphasis added))
filed the instant case on September 15, 2015. (D.I. 1) On
September 25, 2015, Chief Judge Leonard P. Stark referred
this case to the Court to hear and resolve all pretrial
matters, up to and including the resolution of
case-dispositive motions. (D.I. 15)
on the instant Motion was completed on December 21, 2017,
(D.I. 463), and the Court heard oral argument on the Motion
(and various other summary judgment and Daubert
motions filed in the case) on January 5, 2018, (D.I. 482
(hereinafter, "Tr.")). A 7-day trial is set to
begin on April 16, 2018. (D.I. 173)
STANDARD OF REVIEW
of summary judgment is appropriate where "the movant
shows that there is no genuine dispute as to any material
fact and the movant is entitled to judgment as a matter of
law." Fed.R.Civ.P. 56(a). The moving party bears the
burden of demonstrating the absence of a genuine issue of
material fact. See Matsushita Elec. Indus. Co., Ltd. v.
Zenith Radio Corp., 475 U.S. 574, 585-86 n.10 (1986). If
the moving party meets this burden, the nonmovant must then
"come forward with specific facts showing that there is
a genuine issue for trial." Id. at 587
(emphasis in original) (internal quotation marks and citation
omitted). If the nonmoving party fails to make a sufficient
showing on an essential element of its case with respect to
which it has the burden of proof, the moving party is
entitled to judgment as a matter of law. Celotex Corp. v.
Catrett, 477 U.S. 317, 322-23 (1986). During this
process, the Court will "draw all reasonable inferences
in favor of the nonmoving party, and it may not make
credibility determinations or weigh the evidence."
Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S.
133, 150 (2000).
in order to defeat a motion for summary judgment, the
nonmoving party must "do more than simply show that
there is some metaphysical doubt as to the material
facts." Matsushita, 475 U.S. at 586-87; see
also Podobnik v. U.S. Postal Serv., 409 F.3d 584, 594
(3d Cir. 2005) (party opposing summary judgment "must
present more than just bare assertions, conclusory
allegations or suspicions to show the existence of a genuine
issue") (internal quotation marks and citation omitted).
The "mere existence of some alleged factual
dispute between the parties will not defeat an otherwise
properly supported motion for summary judgment; the
requirement is that there be no genuine issue of
material fact." Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 247-48 (1986) (emphasis in
original): Facts that could alter the outcome are
"material, " and a factual dispute is genuine only
where "the evidence is such that a reasonable jury could
return a verdict for the nonmoving party." Id.
at 248. "If the evidence is merely colorable ... or is
not significantly probative ... summary judgment may be
granted." Id. at 249-50 (internal citations
omitted). A party asserting that a fact cannot be-or,
alternatively, is-genuinely disputed must support the
assertion either by citing to "particular parts of
materials in the record, including depositions, documents,
electronically stored information, affidavits or
declarations, stipulations (including those made for purposes
of the motion only), admissions, interrogatory answers, or
other materials"; or by "showing that the materials
cited do not establish the absence or presence of a genuine
dispute, or that an adverse party cannot produce admissible
evidence to support the fact." Fed.R.Civ.P. 56(c)(1)(A)
patent infringement analysis consists of two steps.
Markman v. Westview Instruments, Inc., 52 F.3d 967,
976 (Fed. Cir. 1995). First, the court must determine the
meaning and scope of the patent claims asserted to be
infringed. Id. Claim construction is generally a
question of law, although subsidiary fact finding is
sometimes necessary. Teva Pharms. USA, Inc. v. Sandoz,
Inc., 135 S.Ct. 831, 837-38 (2015). Second, the trier of
fact must compare the properly construed claims to the
allegedly infringing device. Markman, 52 F.3d at
976. This second step is a question of fact. ActiveVideo
Networks, Inc. v. Verizon Commc'ns, Inc., 694 F.3d
1312, 1319 (Fed. Cir. 2012).
infringement of a claim exists when every limitation recited
in the claim is found in the accused device." Kahn
v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir.
1998). If any claim limitation is absent from the accused
product, there is no literal infringement as a matter of law.
Amgen Inc. v. F. Hoffinan-La Roche Ltd, 580 F.3d
1340, 1374 (Fed. Cir. 2009). A product that does not
literally infringe a patent claim may still infringe under
the doctrine of equivalents if the differences between the
claimed invention and the accused product are insubstantial.
See Warner-Jenkinson Co., Inc. v. Hilton Davis Chem.
Co., 520 U.S. 17, 24, 40 (1997); Virnetx, Inc. v.
Cisco Sys., Inc., 767 F.3d 1308, 1322 (Fed. Cir. 2014).
patent owner has the burden of proving infringement, and must
do so by a preponderance of the evidence. SmithKline
Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878,
889 (Fed. Cir. 1988). When an accused infringer moves for
summary judgment of noninfringement, such relief is only
appropriate if, viewing the facts in the light most favorable
to the patentee, no reasonable jury could find that every
limitation recited in the properly construed claim is found
in the accused device, either literally or under the doctrine
of equivalents. See Chimie v. PPG Indus., Inc., 402
F.3d 1371, 1376 (Fed. Cir. 2005); see also Bell Atl.
Network Servs., Inc. v. CovadCommc'ns Grp., Inc.,
262 F.3d 1258, 1267 (Fed. Cir. 2001) ("[S]ummary
judgment is proper only if no reasonable jury could return a
verdict for the nonmoving party.") (internal quotation
marks and citation omitted).
asserted claims of the '5705 patent, which recite methods
of making a biocompatible degradable hydrogel formed "in
situ in a patient" to treat a medical condition, require
that "the biodegradable groups of the hydrogel consist
of the esters" (the "esters limitation").
HyperBranch argues that its Accused Products do not infringe
the asserted claims of the '5705 patent, either literally
or under the doctrine of equivalents, because the Accused
Products form hydrogels that have biodegradable amide
linkages, and they therefore do not read on the esters
limitation. (D.I. 402 at 2)
Court will first provide background information regarding
claim construction of the esters limitation. Then, the Court
will assess the ...