W.L. Gore & Associates Inc. et al v. C.R. Bard Inc.

Filing 491

MEMORANDUM ORDER re 442 MOTION to Strike is GRANTED in part and DENIED in part; 436 REPORT AND RECOMMENDATION is REJECTED; 241 MOTION for Summary Judgment of No Willful Infringement is GRANTED; 435 REPORT AND RECOMMENDATION is Adopted in all respects; 229 MOTION for Summary Judgment of No Invalidity Based on Non-Enablement or Insufficient Written Description is GRANTED. Signed by Judge Leonard P. Stark on 12/2/15. (ntl)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
W.L. GORE & ASSOCIATES, INC.,
Plaintiff,
C.A. No. 11-515-LPS

v.
C.R. BARD, INC., and BARD
PERIPHERAL VASCULAR, INC.,
Defendants.

/

MEMORANDUM ORDER

WHEREAS, on November 17, 2015, Defendants C.R. Bard, Inc., and Bard Peripheral
'\__.,

Vascular, Inc. ("Defendants" or "Bard") filed a Motion to Strike the Supplemental Expert Report
of Dr. Enrique Criado on Comparable Technologies ("Motion to Strike") (D.I. 442), arguing in
their opening brief (D.I. .443) that Dr. Criado's supplemental expert report "went outside the
i

'limited' and 'focused' scope that Judge Burke authorized in his October 23, 2015 MeJllorandum
Order [D.I. 411]" and additionally challenging the supplemental expert report under Rule 702 as
unreliable and not fitting this case (D.I. 443 at 1);
WHEREAS, on November 24, 2015, PlaintiffW.L. Gore & Associates, Inc. ("Plaintiff'
or "Gore") filed an answering brief in opposition to the Motion to Strike (D .I. 4 7 5), arguing that
"Criado's.supplemental report is not untimely, contains no new opinions, provides a reliable
opinion on the technical comparability of the Goldfarb patent [U.S.

~atent

No. 5,735,892 ('"892

patent")], and works no prejudice on Bard" (id. at l);
WHEREAS, the Court has considered the Motion to Strike in light of the Court's prior
ruling (D.I. 474), Federal Rule of Civil Procedure 702, and all of the pertinent filings;
1

1

WHEREAS, Judge Burke issued a 9-page Report and Recommendation ("Willful
InfringementReport") (D.I. 436), dated November 16, 2015, recommending that Defendants'
Motion for Summary Judgment of No Willful Infringement ("Willful Infringement Motion")
. (D.I. 241) be denied, stating that "[t]his is one of those circumstances where it seems most
prudent and appropriate to wait until the record is more fully developed at trial before coming to
a conclusion as to the objective reasonableness of Bard's defenses" (D.I. 436 at 7) (internal
quotation marks omitted);
~

WHEREAS, on November 23, 2015, Defendants objected to the Willful mfringement
Report ("Defendants' Willful Infringement Objections") (D.I. 464), arguing that "Bard has actual
products, microscopic photographs, and snap gauge measurements that show it does not infringe
the asserted claims" and that "[t]he reasonableness of Bard's prior art invalidity defenses is
illustrated by the recent report and recommendation denying-in-part Gore's motion for summary
judgment of no anticipation" (id. at 1);
· WHEREAS, on November 30, 2015, Plaintiff responded to Defendants' Willful
Infringement Objections (D.I. 483), arguing that "the reasonableness of Bard's defenses is best
decided after a presentation of the facts.at trial, exactly as Judge Burke held" (id. at 2);
WHEREAS, Judge Burke issued a 20-page Report and Recommendation ("Section 112
Report") (D.I. 435), dated November 16, 2015, recommending that Plaintiff's Motion for
Summary Judgment of No Invalidity Based on Non-Enablement or Insufficient Written
Description ("Section 112 Motion") (D.I. 229) be granted;
WHEREAS, on November 23, 2015, Defendants objected to the Section 112 Report
("Defendants' Section 112 Objections") (D.I. 463), and specifically objected to (1) the Section

2

:

112 Report's conclusion that a reasonable jury could not find that the "tubular covering"
limitation is not enabled (id. at 5-8), (2) the Section 112 Report's conclusionthat a reasonable
jury could not find that the tubular covering limitation does not comply with the written
description requirement (id. at 8-9), and (3) the Section 112 Report's determination that there
were no genuinely disputed factual issues regarding whether the "less than about 0 .10 mm"
limitation complies with both the enablement and written description requirements (id. at 9-1 O);
WHEREAS, on November 30, 2015, Plaintiff responded to Defendants' Section 112
Objections (D.I. 482), arguing that "Bard's objections to Judge Burke's [Section 112 Report]
either articulate new and unsupported arguments that have no merit or reiterate the same
arguments Judge Burke fully analyzed and rejected as being insufficient to create a material issue
of fact" (id. at 1);
WHEREAS, the Court has considered the Section 112 Motion and the Willful
Infringement Motion de novo, 1 seeMasimo Corp'. v. Philips Elec. N Am. Corp., 62 F. Supp. 3d
368, 379 (D. Del. 2014); 28 U.S.C. § 636(b)(l); Fed. R. Civ. P. 72(b)(3), and has further
reviewed all of the pertinent filings;
NOW THEREFORE, IT IS HEREBY ORDERED that:
1.

Defendants' Motion to Strike (D.I. 442) is GRANTED IN PART and DENIED IN

PART.2 Specifically, the motion is granted with respect to the following portions of Dr. Criado's

1

In doing so, the Court has applied the familiar legal standards of Federal Rule of Civil
Procedure 56, which include drawing all reasonable inferences in favor of the non-moving party.
2

In evaluating the Motion to Strike, the Court has considered several ,legal standards.
Under Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597 (1993), the Supreme Court
explained that Federal Rule of Evidence 702 creates "a gatekeeping role for the [trial] judge" in
order to "ensur[ e] that an expert's testimony both rests on a reliable foundation and is relevant to
3

Supplemental Expei;t Report on Comparable Technologies (D.I. 443-1) ("Supplemental Report"),
and the Court hereby STRIKES these portions: (1) Dr. Criado's incorporation by reference of his
previous expert reports (see id. at l); (2) the "additional materials reviewed" by Dr. Criado and
"attached as Exhibit B" to his Supplemental Report, and all references to such materials; (3) the
phrase "and of similar importance to Bard's accused peripheral stent graft products" in the last
sentence on page 2; (4) all of page 4 of the Supplemental Report below the chart; and (5) all of
page 5. The motion is denied with respect to all portions not listed above.
2.

In a Memorandum Order (D.I. 411) ("Stamm Daubert Order") addressing

Defendants' Daubert motion to exclude opinions of Plaintiffs damages expert, Laura B. Stamm,
Judge Burke permitted Plaintiffs technical expert, Dr. Enrique Criado, "one opportunity to offer

the task at hand." Rule 702 requires that expert testimony "help the trier of fact to understand the
evidence or to determine a fact in issue." Fed. R. Civ. P. 702(a). Expert testimony is admissible
only if "the testimony is based on sufficient facts or data," "the testimony is the product of
reliable principles and methods," and "the expert has reliably applied the principles and methods
to the facts of the case." Fed. R. Civ. P. 702(b)-(d).
Also implicated are Federal Rule of Civil Procedure 26(a)(2)(B)(i), which requires that an
expert's report contain "a complete statement of all opinions the witness will express and the
basis and reasons for them," as well as Rule 26(a)(2)(c), providing that "a party must make these
[expert] disclosures at the time and in the sequence that the court orders." In determining
whether a failure to disclose is harmless courts consider such factors as: (1) the importance of the
information withheld; (2) the prejudice or surprise to the party against whom the evidence is
offered; (3) the likelihood of disruption of the trial; (4) the possibility of curing the prejudice; (5)
the explanation for the failure to disclose; and (6) the presence of bad faith or willfulness in not
disclosing the evidence (the "Pennypack factors"). See Konstantopoulos v. Westvaco Corp., 112
F.3d 710, 719 (3d Cir.1997) (citing Meyers v. Pennypack Woods Home Ownership Ass'n, 559
·
F.2d 894, 904-905 (3d Cir.1977)).
Additionaly, pursuant to Rule 37(c)(l), the Court has the power to exclude evidence as a
sanction for a party's failure to comply with its obligations under the rules, including the specific
deadlines and obligations imposed by a scheduling order - and, here, including Plaintiffs failure
to keep Dr. Criado's Supplemental Report within the confines set out in Judge Burke's order.
4

a brief supplemental expert report limited to the issue of the technological comparability of the
Goldfarb patent and [the '892 patent]." (Id. at 15) (emphasis added) This Court determined that
Judge Burke did not abuse his discretion in providing Dr. Criado this opportunity, and the Court
adopted the Stamm Daubert Order in all respects. (D.I. 474 at 3-4) Inherent in the Court's
adoption of the Stamm Daubert Order is the Court's agreement with Judge Burke that, in order
for Ms. Stamm's challenged opinions to "pass muster under Daubert," there must be a showingdisclosed in one or more of Dr. Criado's expert reports -that the claimed technologies in the
Goldfarb and '892 patents are comparable. 3 (See D.I. 411 at 11)
3.

Defendants argue that Dr. Criado's Supplemental Report went beyond the

"limited" and "focused" scope that Judge Burke authorized in his Stamm Daubert Order. With
respect to the stricken portions of the Supplemental Report listed .above, the Court agrees. First, '.
i

the Supplemental Report improperly incorporated by reference all of Dr. Criado's past expert
reports. Dr. Criado was required to limit his Supplemental Report to articulating the precise
opinions on technological comparability of the Goldfarb and '892 patents that he purportedly
disclosed to Ms. Stamm before expert reports were served. (See D.I. 411 at 15-16) Dr. Criado's
wholesale incorporation by reference of every opinion he has ever given in this case into his
Supplemental Report does come within this limited scope.
4.

Second, Dr. Criado improperly considered "additional materials" attached as

Exhibit B to his report. Dr. Criado was not permitted to rely on these additional materials, which

3

The record indicates that Ms. Stamm had one or more conversations with Dr. Criado
regarding the technical comparability of the Goldfarb and '892 patents. (See D.I. 411 at 4)
Defendants argued, and Judge Burke and this Court agreed, that Dr. Criado had not disclosed
opinions regarding technical comparability of the Goldfarb and '892 patents in any of his expert
reports.
5

include the opinions of another expert, Dr. Leonard. Dr. Criado was permitted simply to "set out
in writing the very opinion that Ms. Stamm has been relying on all along." (Id.) Dr. Leonard's
opinions did not exist before Dr. Criado's conversations· with Ms. Stamm. (See D.I. 443 at 6)
5.

Finally, Dr. Criado was not permitted to opine on the "comparable importance" of

the Goldfarb and '892 patents by referring to (1) alleged incorporation of technology covered by
the Goldfarb and/or '892 patents into various products, (2) alleged difficulty of designing around
the '892 patent, or (3) licensing issues involving the Goldfarb patent. (See generally D.I. 443-1
at 4-5) These categories of Dr. Criado's opinions fall outside of the limited scope articulated by
Judge Burke in the Stamm Daubert Order, because they are unrelated to a comparison of the
technologies of the Goldfarb and '892 patents.

6.

Regarding the portion of the Supplemental Report that the Court has not stricken,

the Court determines that Defendants' arguments under Rule 702 go to the weight rather than the
admissibility of Dr. Criado's opinions. Defendants argue that Dr. Criado's Supplemental Report
is unreliable and does not fit this case because "he did not compare the claimed invention in
Goldfarb to the claimed invention of the '892 patent." (D.I. 443 at 1) The Court disagrees. Dr.
Criado explicitly discusses the claims of the Goldfarb patent in his Supplemental Report (see D.I.
443-1 at 3), and the admissibility of the surviving portions of his Supplemental Report does not
turn on inclusion of a claim-by-claim comparison of the two patents. The surviving portions of
Dr. Criado's Supplemental Report meet Rule 702's requirements for reliability and fit, because
they will "help the trier of fact to understand the evidence or to determine a fact in issue." Fed.
R. Civ. P. 702(a).
7.

Defendants' Willful Infringement Objections (D.I. 464) are SUSTAINED. The
6

Willful Infringement Report (D.I. 436) is REJECTED. Defendants' Motion for Summary
Judgment of No Willful Infringement (D.I. 241) is GRANTED.
8.

The Willful Infringement Report states that Defendants' invalidity and non-

infringement positions "are rather fact-specific" and that the "District Court will be in the best
position" to decide whether the objective prong of the willfulness inquiry is met, under In re
Seagate Tech., LLC, 497 F.3d 1360, 1371 (Fed. Cir. 2007), "after having seen any relevant
evidence presented at trial." (D.I. 436 at 6) The objective prong of the willfulness inquiry "is
not met when the infringer, whatever its state of mind at the time of its infringement, presents in
the litigation a defense, including an invalidity defense, that is objectively reasonable." Carnegie:
Mellon Univ. v. Marvell Tech. Grp., Ltd., 2015 WL 4639309, at *12 (Fed. Cir. Aug. 4, 2015).
Here, Defendants have asserted objectively reasonable non-infringement and invalidity defenses. ·
9.

In order to meet the objective prong.under Seagate, Plaintiff must show "by clear

and convincing evidence that the infringer acted despite an objectively high likelihood that its
actions constituted infringement of a valid patent." Id. at 1371. If the objective prong cannot be .
shown, then the Court should not put the issue of willfulness - including the second "subjective"
prong- before a jury. See Powell v. Home Depot U.S.A., Inc., 663 F.3d 1221, 1236 (Fed. Cir.
2011) ("Since Seagate, [the Federal Circuit] has required patentees to prove the objective prong
of the willful infringement inquiry by clear and convincing evidence as a predicate to the jury's .

consideration of the subjective prong. . . . Should the court determine that the infringer's
reliance on a defense was not objectively reckless, it cannot send the question of willfulness to

the jury, since proving the objective prong is a predicate to consideration of the subjective
prong.") (emphasis added).

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10.

Defendants' non-infringement.arguments with respect to the "affixed" limitations

("exterior" and "luminal") are objectively reasonable. Regarding the "affixed" limitations,
Defendants cite expert opinions analyzing scanning electron microscope photographs showing
"large gaps between the ePTFE layers and the outer and luminal stent surfaces." (See D.I. 464 at
5) (citing D.I. 260-1

if 139, App. I, J)

Although Plaintiff disputes this evidence (see D.I. 483 at 5-

7), the Court determines that Defendants' non-infringement arguments are supported by enough
evidence to be objectively reasonable, even if they were generated during litigation. See Halo
Elecs., Inc. v. Pulse Elecs., Inc., 769 F.3d 1371, 1382 (Fed. Cir. 2014) (holding District Court

properly considered defense developed during litigation in determining no willful infringement);
see also Fairchild Semiconductor Corp. v. Power Integrations, Irie., 2015 WL 1883937, at *2

(D. Del. Apr. 23, 2015) (concluding first prong of Seagate could not be satisfied in light of
credible, reasonable non-infringement theories).
11.

At least some of Defendants' invalidity arguments are also objectively reasonable.

In Carnegie Mellon, the Court reasoned that "there was enough uncertainty about what [a prior

art reference] discloses and what CMU' s claims require that we cannot say that the [invalidity]
defenses were objectively unreasonable." Id. at *14. In this case, there was enough uncertainty
about whether certain prior art references anticipated claims 32 and 33 of the '892 patent that
Judge Burke recommended denial of summary judgment of no anticipation as to the references.
(See, e.g., D.I. 428 at 28-31) (discussing "Palmaz" reference and holding that expert opinion

regarding Palmaz was "sufficiently grounded in the factual record and supported by a logical
process of reasoning") The Court adopted the recommended denial of summary judgment as
well as Judge Burke's reasoning with respect to the prior art referenc~s that survived the motion.
8

(See D.I. 474 at 4-6) Defendants' objectively reasonable invalidity defenses are an independent
reason why Plaintiffs willfulness allegations with respect to claims 32 and 33 of the '892 patent
must fail.
12.

Defendants' Section 112 Objections (D.I. 463) are OVERRULED. Judge Burke's

Section 112 Report (D.I. 435) is ADOPTED in all respects. Plaintiffs Motion for Summary
Judgment of No Invalidity Based on Non-Enablement or Insufficient Written Description (D.I.
229) is GRANTED.
13.

The Court agrees with the Section 112 Report's determination that "the method of

constructing the claimed covering using extruded tubes simply amounts to an improved mode of
achieving the claimed invention that need not be enabled by the patent." (D.I. 435 at 16-17)
(citing lnvitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1071 (Fed. Cir. 2005))
"Enablement does not require the inventor to foresee every means of implementing an invention
at pains oflosing his patent franchise." lnvitrogen, 429 F.3d at 1071. As such, the Court
disagrees with Defendants' objection regarding lack of enablement of the "tubular covering"
. limitation. For similar reasons, the Court also disagrees with Defendants' objection regarding the
tubular covering limitation's alleged failure to comply with the written description requirement.
"[T]he written description requirement does not demand that all methods of making the product
be described in the specification; instead, one way of making the product is sufficient." (D.I. 435
at 18) (citing case law supporting this proposition) Finally, the Court agrees with the Section 112
Report's statement, in footnote 11 (id. at 19), that the Court has "already considered and
rejected" Bard's arguments regarding enablement and adequate description of the "less than
about 0.10 mm thick" limitation. Therefore, the Court overrules Defendants' objection with

9

respect to this limitation and determines, as a matter of law, that the "less than about 0.10 mm
thick" limitation is enabled and adequately described in the patent's specification in compliance
with the requirements of§ 112.
14.

Given the detailed reasoning provided in the Section 112 Report, and given that

Defendants have not raised any arguments that are not adequately addressed therein, the Court
finds it unnecessary to address Defendants' Section 112 Objections any further.
15.

Further, having reviewed the parties' letter of November 30, 2015 (D.I. 484), IT

IS ORDERED that the asserted claims have already been found not to be invalid as indefinite and
Bard will not be permitted to present evidence or argument relating to indefiniteness at the jury
trial. In connection with summary judgment, the Court has already concluded that the asserted
claims are not indefinite. (See D.I. 405 at 6-8) The Court does not agree with Bard that there is a
factual dispute related to whether "the method of measurement is outcome determinative" and
that this dispute must be resolved before indefiniteness can be decided. (D.I. 484 at 4) Instead,
as a matter of law (i.e., as a matter of claim construction and based solely on intrinsic evidence as
well as Bard's admissions), the claims are not indefinite in light of the specification of the '892
patent, which (as Bard admits) discloses at least one method for measuring thickness. (See D.I.
405 at 8 ("[T]he specifications of the patents-in-suit provide guidance as to how to perform the
measurement at issue here."); D.I. 484 at 3 ("Bard's expert, for example, measured the thickness
using a snap gauge during manufacturing and before the stent graft is collapsed into the delivery
system - precisely as the patent describes."))
Bard's arguments regarding the alleged "outcome determinative" nature of the dueling
experts' methodologies for measuring thickness raise issues of infringement that may be heard

10

and decided by the jury. An accused product may infringe at one point in time and, after
manipulation of some kind, cease to infringe at another point in time. See In re Electro-Mech.

Indus., 359 F. App'x 160, 164 (Fed. Cir. 2009) (holding certain products infringed before "gaps"
in products were "filled" but not after). In this case, the "0.10 mm" limitation may be met by the
accused products at certain times post-affixation but not at others. While Bard may present
evidence and make arguments to this effect in the context of infringement, it may not do so in
relation to indefiniteness, as the Court has resolved indefiniteness in this case.
16.

In light of the Court's narrowing of the issues for trial, and having. considered the

parties' request for 13 hours per side, IT IS HEREBY ORDERED that the parties' trial
presentations shall not exceed twelve (12) hours per side. The Court finds that the remaining
issues that are the subject of the upcoming jury trial may be fairly and adequately presented in
this amount of time.
Specifically, trial will be held at some or all of the following times, subject to the parties'
time limits: (i) Monday, Dec. 7: 8:30 a.m. to 4:00 p.m. (no evidence will be presented this first
day); (ii) Tuesday, Dec. 8 through Friday, Dec. 11: 8:30 a.m. to 5:,00 p.m.; and (iii) Monday, Dec.
14: 8:30 a.m. to 5:00 p.m.
17.

Finally, the parties shall SUBMIT Revised Preliminary Jury Instructions to the

Court on or before Friday, December 4, taking into account the issues resolved in this Order.

December 2, 2015
Wilmington, Delaware

UNITED STATES DISTRICT JUDGE

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