Board of Regents, The University of Texas System et al v. Boston Scientific Corporation
Filing
368
MEMORANDUM OPINION RE: Post Trial Motions. Signed by Judge Gregory B. Williams on 6/5/2024. (lnb) (Main Document 368 replaced on 6/5/2024) (lnb).
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
BOARD OF REGENTS, THE UNIVERSITY
OF TEXAS SYSTEMS, and TISSUEGEN,
INC.,
C.A. No. 18-392
Plaintiffs,
v.
BOSTON SCIENTIFIC CORPORATION,
Defendant.
Stamatios Stamoulis, STAMOULIS & WEINBLATT LLC, Wilmington, DE; Michael W. Shore,
Chijioke E. Offor, Alex Q. Jacobs, THE SHORE FIRM, Dallas, Texas; Brian D. Melton, John P.
Lahad, Corey M. Lipschutz, SUSMAN GODFREY L.L.P, Houston, Texas
Counsel for Plaintiffs
Brian E. Farnan, Michael J. Farnan, FARNAN LLP, Wilmington, DE; Michael P. Kahn, AKIN
GUMP STRAUSS HAUER & FELD LLP, New York, NY; Rachel J. Elsby, AKIN GUMP
STRAUSS HAUER & FELD LLP, Washington D.C; Chad Drown, Timothy E. Grimsrud,
Katherine S. Razavi, Lauren J.F. Barta, Doowon R. Chung, N. Chethana Perera, FAEGRE
DRINKER BIDDLE & REATH LLP, Minneapolis, :MN; David J.F. Gross, FAEGRE DRINKER
BIDDLE & REATH LLP, East Palo Alto, CA; Evan J. Kline-Wedeen, FAEGRE DRINKER
BIDDLE & REATH LLP, Chicago, Illinois; Christopher J. Burrell, FAEGRE DRINKER
BIDDLE & REATH LLP, Washington, D.C.
Counsel for Defendant
MEMORANDUM OPINION
June 5, 2024
Wilmington, Delaware
polymer fiber to deliver drugs.
D.I. 124,
,r,r
65-66, 80.
Plaintiffs asserted claims against
Defendant for direct and induced infringement of claims 1, 11, 17, and 26 of the '296 patent
(hereinafter, the "Asserted Claims"). Id. at
,r 79.
In response, Defendant alleged that one or
more of the asserted claims of the '296 patent is invalid. D.I. 238 at 24-25.
On December 12, 2022, the Court issued an order to bifurcate trial into two phases. D.I.
260. Following the first phase of trial, the jury ruled in favor of Plaintiffs on infringement of the
'296 patent and denied Defendant's claims of invalidity. D.I. 331. After phase two, the jury
found for Plaintiffs on their claims that Defendants induced infringement of the '296 patent and
that Defendant's infringement of Plaintiffs' patented technology was willful. D.I. 333. Finally,
the jury found that Defendant's infringement entitled Plaintiffs to reasonable royalty damages
totaling $42 million. Id at 4. Judgment was entered on February 15, 2023. D.I. 342.
Defendant now moves for a new trial under Rule 59(a) on the grounds that Plaintiffs
engaged in improper conduct during their opening statements, introduced improper evidence and
argument throughout the trial, and invited the jury to render a verdict based on improper
considerations during closing. D.I. 345. Defendant also moves for judgment as a matter of law
under Rule 50(b) on the grounds that the Asserted Claims are anticipated and lack written
description as a matter of law; no reasonable jury could have found infringement based on the
Court's constructions of "fiber" and "immiscible;" Plaintiffs failed to present sufficient evidence
to support their damages theory; and no reasonable jury could have found willful infringement.
Id.
Given the jury's finding of willful infringement, Plaintiffs seek enhancement of the jury's
damages award under 35 U.S.C. § 284. D.I. 350. Additionally, Plaintiffs seek pre-judgment
interest pursuant to the "de facto rule" of federal courts and post-judgment interest under 28
3
U.S.C. § 1961. Id at 1. Defendant opposes Plaintiffs' motion for enhanced damages and
contends that Plaintiffs' request for pre-judgment interest should be denied as premature or,
alternatively, reduced. D.I. 355 at 2.
2. LEGAL STANDARD
a. Judgment as a Matter of Law
A court may enter JMOL against the non-moving party where it "finds that a reasonable
jury would not have a legally sufficient evidentiary basis to find for the party on [an] issue."
FED. R. CIV. P. 50(a)(l). However, JMOL is appropriate "only if, viewing the evidence in the
light most favorable to the nonmovant and giving it the advantage of every fair and reasonable
inference, there is insufficient evidence from which a jury reasonably could find liability."
Lightning Lube, Inc. v. Witco Corp., 4 F.3d 1153, 1166 (3d Cir. 1993). Entry of JMOL is a
remedy to be invoked only "sparingly." CGB Occupational Therapy, Inc. v. RHA Health Servs.
Inc., 357 F.3d 375, 383 (3d Cir. 2004).
Following a jury trial, a renewed motion for JMOL under Rule 50(b) may be granted only
if the movant demonstrates "that the jury's findings, presumed or express, are not supported by
substantial evidence or, if they were, that the legal conclusion(s) implied [by] the jury's verdict
cannot in law be supported by those findings." Pannu v. Iolab Corp., 155 F.3d 1344, 1348 (Fed.
Cir. 1998) (alteration in original) (internal quotation marks omitted).
Substantial evidence
requires such relevant evidence that a reasonable mind might accept it as adequate to support the
finding under review. See Enplas Display Device Corp. v. Seoul Semiconductor Co., 909 F.3d
/398, 407 (Fed. Cir. 2018). In determining whether substantial evidence supports the jury verdict,
the Court cannot make credibility determinations, weigh the evidence, or substitute its own
conclusions for that of the jury where the record evidence supports multiple inferences. See
4
Lightning Lube, 4 F.3d at 1166. The standards that govern a Rule 50(b) motion, however, "vary
according to whether the movant has the burden of proof."
Fireman's Fund Ins. Co. v.
Videfreeze Corp., 540 F.2d 1171, 1177 (3d Cir. 1976).
To grant JMOL in favor of a party with the burden of proof, the court "must be able to
say not only that there is sufficient evidence to support the finding [sought by the moving party]
... but additionally that there is insufficient evidence for permitting any different finding." Id.
(quoting 9 WIGMORE ON EVIDENCE§ 2495 at 306 (3d ed. 1940)); see also Amgen Inc. v.
• Hospira, Inc., 944 F.3d 1327, 1333 (Fed. Cir. 201'9) ("[W]here the movant b[ears] the burden of
proof on an issue, JMOL is only granted where 'there is insufficient evidence for permitting any
different finding."' (quoting Fireman's Fund, 540 F.2d at 1177)); Deere & Co. v. Agco Corp. et
al, C.A. No. 18-827-CFC, 659 F.Supp.3d 418 (D. Del. March 28, 2023).
b. Motion for New Trial
Under Fed. R. Civ. P. 59, "a new trial should only be granted when a 'miscarriage of
justice would result if the verdict were to stand,' the verdict 'cries out to be overturned,' or the
verdict 'shocks the conscience."' Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC, 503
F. Supp. 3d 156, 166 (D. Del. 2020); see also Intellectual Ventures I, LLC v. Canon Inc., 104 F.
Supp. 3d 629, 637 (D. Del. 2015) ("[T]he court should grant a new trial on the basis that the
verdict was against the weight of the evidence only where a miscarriage of justice would result if
the verdict were to stand.").
3. DISCUSSION
For the reasons stated below, the Court (1) grants Defendant's motion for judgment as a
matter of law as to willfulness and denies Defendant's motion for judgment as a matter of law as
5
to invalidity, infringement, and damages; (2) denies Defendant's motion for a new trial; (3)
denies Plaintiffs' motion for enhanced damages; and (4) grants Plaintiffs' motion for pre- and
post-judgment interest.
a. Judgment As a Matter of Law
i. Defendant is not entitled to JMOL on the issue ofwhether Song
anticipates the asserted claims.
Defendant contends that Song anticipates the asserted claims, and ''there is no record
evidence that supports the jury's finding otherwise." D.I. 364 at 12. For the following reasons,
the Court disagrees.
"A single prior art reference anticipates a patent claim if it expressly or inherently
describes each and every limitation set forth in the patent claim." Trintec Indus., Inc. v. Top-
U.S.A. Corp., 295 F.3d 1292, 1295 (Fed. Cir. 2002). While a single reference may expressly
anticipate a claim where the reference explicitly discloses each and every claim limitation, the
prior art need not be ipsissimis verbis (i.e., use identical words as those recited in the claims) to
be expressly anticipating. Structural Rubber Prods. Co. v. Park Rubber Co., 749 F.2d 707, 716
(Fed.Cir.1984).
"Instead, a reference may still anticipate if that reference teaches that the
disclosed components or functionalities may be combined and one of skill in the art would be
able to implement the combination." Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 13 31, 1344
(Fed. Cir. 2016) (finding that ''the reference anticipated the claims even without a particular
disclosure of the specific combination recited in the disputed claims.").
The '296 patent claims "biodegradable polymer fibers capable of controlled delivery of
I
therapeutic agents." '296 patent, Abstract. Claim 1 of the '296 patent, the only independent
claim asserted by Plaintiffs, discloses "[a] composition comprising at least one biodegradable
6
polymer fiber wherein said fiber is composed of a first phase and a second phase, the first and
second phases being immiscible, and wherein the second phase comprises one or more
therapeutic agents." '296 patent, claim 1. Song similarly describes "delivery systems for the
gradual release of active agents and processes for making such systems and is particularly
directed to delivery systems using heat sensitive active agents with biodegradable polymers and
melt spinning processes for making such systems." D.I. 347, Ex. 6 (hereinafter, "Song"),
Abstract.
According to Defendant, Song anticipates claim 1 of the '296 patent by "disclos[ing] that
its 'invention is a fiber having a support matrix'
O, 'made up of wall material' Dthat 'can be any
spinnable synthetic or natural polymer' [], including 'biodegradable polymers' □" and an "active
agent [that] is dispersed throughout the support matrix." D.I. 346 at 12-13 (internal citations
omitted). Defendant notes that, just like claim 1, Song also asserts that "[t]he active agent and
wall material ... must be immiscible with each other." Id (internal citations omitted).
Plaintiffs, on the other hand, argue that claim 1 is not anticipated because "Song fails to
disclose [the limitations of claim 1] together in an enabled embodiment where the second
phase is noncontiguous (i.e., is composed of discrete regions) as claimed in the '296 patent."
D.I. 354 at 6 (emphasis added). Specifically, Plaintiffs argue that "Song lacks any example of an
embodiment involving a biodegradable polymer with drug in a noncontiguous phase." Id.
Plaintiffs also contend that "biodegradability" has a different meaning in Song than it does in the
'296 patent. Each argument is considered in turn below.
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1. Plaintiffs' Enablement Claims:
According to Plaintiffs, the "'296 patent requires drug in a noncontiguous phase (i.e.
discrete drug-containing regions) within a biodegradable polymer fiber." D.t 354 at 6. During
trial, Plaintiffs' expert, Dr. Pitt, testified that the asserted claims of the '296 patent disclose a
fiber with discrete drug-containing regions dispersed throughout the fiber. See Tr. 900:2-901: 12.
Dr. Pitt explained that Song, on the other hand, does not disclose a fiber with discreate regions
but instead ''teaches that you have contiguous channels." Id at 898:13-899:3. According to Dr.
Pitt,
Contiguous means that you've got these regions that are touching each
other, stretching out the length of this fiber, and when there's contact with
the solution, which is water or saliva, this stuff just starts to dissolve and go
out the ends. So that's not a discrete region."
Id at 900:10-15. Because Song teaches a fiber with contiguous channels, Dr. Pitt noted that
Song and the '296 patent disclosed fibers that differ in the way each releases drug particles. Id at
901:3-8. Specifically, Dr. Pitt argued that Song delivers drugs from the fiber's "front end and
D
back end" whereas, in the '296 patent, ''you have a fiber, and it's biodegrading, and the drug is
coming out in the radial direction instead of going out the ends. Id. Thus, according to Dr. Pitt,
because Song does not disclose a biodegradable polymer with a non-contiguous drug phase,
Song cannot anticipate the asserted claims. Id at 901 :9-12. Plaintiffs raise the same argument in
response to Defendant's renewed motion for JMOL.
See D.I. 354 at 5-6 (arguing that
anticipation cannot be proven because "Song lacks any example of an embodiment involving a
biodegradable polymer with drug in a noncontiguous phase").
According to Defendant, Dr. Pitt's testimony regarding the noncontiguous drug phases in
the '296 patent cannot be used to distinguish the asserted claims from Song because the asserted
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claims do not require that the fiber include drug-containing channels that are noncontiguous or
discrete.
D.I. 363 at 1-2.
Thus, according to Defendant, Plaintiffs erred by introducing
testimony on a feature not required by the claims. D.I. 363 at 2. The Court agrees.
Anticipation challenges "focus only on the limitations actually recited in the claims."
DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1252-54 (Fed. Cir. 2014) (finding that
asserted patent where "[b]oth the district court and DOR introduced a limitation found neither in
the '572 patent's claims nor the parties' stipulated construction.") (emphasis added). "It is the
claim:s that define the claimed invention[,] [a]nd it •is claims, not specifications, that are
anticipated." Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1570-71 (Fed. Cir.
1988), cert. denied, 465 U.S. 1026, 104 S.Ct. 1284, 79 L.Ed.2d 687 (1984) ("A claim is
anticipated only if each and every element as set forth in the claim is found, either expressly or
inherently described, in a single prior art reference."). Accordingly, a patentee cannot "avoid
[an] anticipating disclosure" by "engage[ing] in a post hoc attempt to redefine the claimed
invention by impermissibly incorporating language appearing in the specification into the
claims." In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). While "it is entirely proper to use
the specification to interpret what the patentee meant by a word or phrase in the claim," the
patentee cannot rely on "extraneous limitation appearing in the specification ...." Id (internal
quotations omitted). "[B]y 'extraneous," the Federal Circuit meant "a limitation read into a
claim from the specification wholly apart from any need to interpret ... particular words or
phrases in the claim." Id. (internal quotations omitted).
In this matter, there is no dispute that claim 1 of the '296 patent does not explicitly recite
a fiber with "noncontiguous" phases and does not assert "dispersed discrete regions that release
the drug." Additionally, Plaintiffs did not allege that any terms in claim 1 of the '296 patent
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required a construction that would read the "noncontiguous" phase requirement into the claim,
and the Court never adopted a construction requiring such a limitation. Thus, to the extent that
Plaintiffs inject the "noncontiguous" phase limitation into the asserted claims from the
specification's description of the invention, the Court agrees with Defendant that the limitation
cannot be used to differentiate the asserted claims from the prior art.
D.I. 346, n. 2;
MobileMedia Ideas v. Apple, 780 F.3d 1159, 1172 (Fed. Cir. 2015).
Because, as explained in more detail below, Defendant cannot challenge Plaintiffs'
arguments differentiating• "biodegradable" polymers as asserted in the •'296 patent from
"biodegradable" polymers in Song, Defendant is not entitled to JMOL on the issue of
anticipation.
2. Plaintiffs' Arguments on "Biodegradability":
During his trial testimony, Dr. Pitt testified that Song also failed to anticipate the asserted
claims because Song did not cover "biodegradable" polymers as asserted in the '296 patent. Tr.
898: 5-11.
According to Dr. Pitt, "even though biodegradable polymers are mentioned in
passing [in Song]," Song is not "directed to biodegradability in the same manner as the '296
p~tent." Id at 898:13-899:3. In making this argument, Dr. Pitt construed "biodegradable," as
used in the '296 patent, to mean that the asserted fiber must "biodegrade [in order] to release the
[drug] agent." Id at 899:2. Defendant contends that this testimony should be disregarded
because: (1) Dr. Pitt "conceded that Song anticipates the asserted claims," and (2) Dr. Pitt's
testimony improperly construed the term "biodegradable." D.I. 346 at 13-14; D.I. 363 at n. 5.
For the following reasons, the Court finds neither argument persuasive.
First, while Dr. Pitt testified that "claim 1 talks about a biodegradable polymer ... [not]
taught in Song," Defendant argues that Dr. Pitt "later recanted that testimony after being
impeached by his prior deposition testimony." D.I. 346 at 13 (emphasis added). Specifically,
Defendant highlighted during trial Dr. Pitt's deposition testimony in which he explained that
"one of [Song's] examples is using a biodegradable polymer, and the second phase is solely and
only the therapeutic agent." Tr. 911:17-19. Defendant noted that Dr. Pitt also testified during
his deposition that the second phase disclosed by the Song example "is [an] active agent [and] is
immiscible with the [first] phase that is the wajl material" and noted that the first phase, in tum, .
"is the polymer, and in some cases that could be biodegradable." Id at 912:17-23, 913:24-914:9.
When faced with this deposition testimony during cross-examination, Dr. Pitt admitted to each
statement and confirmed that he had no "problem with the jury relying on [his] sworn
[deposition] answers."
Id at 914:19-22.
Thus, Defendant argues that Dr. Pitt "did not
contradict" Defendant's evidence of anticipation "on cross-examination or otherwise," but
instead admitted once more that Song discloses each limitation of the asserted claims. D.I. 346
at 13-14.
Dr. Pitt, however, did present testimony that countered Defendant's anticipation claims
by testifying during trial that, among other things, Song is not "directed to biodegradability in the
same manner as the '296 patent." Tr. 899:4-6; see also id at 897:24-899:3. While Defendant
argues that Dr. Pitt "later recanted th[is] testimony on cross-examination," Defendant cites an
exchange in which counsel for Defendant sought to impeach Dr. Pitt by confronting him with his
prior deposition testimony. D.I. 346 at 12 (citing Tr. 911:10-21, 912:16-23, 913:22-914:9). In
seeking to impeach Dr. Pitt, however, Defendant asked whether Dr. Pitt was "asked [certain]
question[s] and ... g[a]ve [certain] answer[s] at your deposition" and limited Dr. Pitt's response
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by noting that "it's really important right now that [Dr. Pitt] not inject anything new without
approval from people." Tr. 910:18-20, 911:10-11, 912:11-12, 912:16-17, 913:22-23. Thereafter,
Dr. Pitt merely admitted to making certain statements during his deposition. See, e.g., 911 :20-21
(Q: "Did you give that testimony" A: Yes.").
While Dr. Pitt also noted that the jury could rely on his deposition testimony, at no point
did Dr. Pitt retract his prior inconsistent trial testimony. See id at 914:19-22. For instance,
Defendant cannot identify any testimony in which Dr. Pitt adopted his deposition testimony or
alleged that his trial testimony was ina
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