Niazi Licensing Corporation v. St. Jude Medical S.C., Inc.

Filing 300

ORDER. IT IS HEREBY ORDERED: Plaintiff Niazi Licensing Corporation's motion to exclude the expert testimony of Dr. Arthur Erdman 196 is DENIED. Defendant St. Jude Medical S.C., Inc.'s motion to exclude the expert testimony of Dr. Martin Burke and Brad Carlson 164 is GRANTED IN PART AND DENIED IN PART. (See order for details). (Written Opinion). Signed by Judge Wilhelmina M. Wright on 9/14/2020. (RJE)

UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA

Niazi Licensing Corporation,

Case No. 17-cv-5096 (WMW/BRT)

Plaintiff,
ORDER
v.
St. Jude Medical S.C., Inc.,
Defendant.

Plaintiff Niazi Licensing Corporation (NLC) and Defendant St. Jude Medical S.C.,
Inc. (St. Jude), cross-move to exclude expert testimony. (Dkts. 164, 196.) For the
reasons addressed below, NLC’s motion to exclude Dr. Arthur Erdman is denied,
St. Jude’s motion to exclude Dr. Martin Burke is denied, St. Jude’s motion exclude Brad
Carlson is granted in part and denied in part, and St. Jude’s improper request for
reconsideration is denied.
BACKGROUND
NLC owns United States Patent No. 6,638,268 (the ’268 Patent), which issued on
October 28, 2003. The ’268 Patent is directed to a catheter system that can be inserted
into the coronary sinus of the heart. This catheter system allows medical professionals to
administer fluids and introduce pacing leads to the coronary sinus. Although the use of
catheters in general was well established by 2003, the ’268 Patent describes an invention
that, based on its structure and shape, purportedly is better suited for “use in the coronary
sinus, especially in patients suffering from congestive heart failure.” The ’268 Patent

claims a double catheter system with an “outer, resilient catheter having shape memory
and a hook-shaped distal end” and an “inner, pliable catheter slidably disposed in the
outer catheter.” The ’268 Patent also claims methods of using the catheter system.
NLC initiated this patent infringement lawsuit against St. Jude on November 13,
2017. NLC alleges that St. Jude infringed the ’268 Patent either literally or through the
doctrine of equivalents. According to NLC, St. Jude directly infringes the ’268 Patent by
using, manufacturing, selling, or offering to sell infringing catheter systems. NLC also
alleges that St. Jude indirectly infringes the ’268 Patent by inducing its customers—
namely, medical professionals—to infringe the ’268 Patent.
The  ’268 Patent includes 27 claims, some of which are directed to configurations
of the catheter and some of which are directed to the method of using the catheter system.
NLC alleges that St. Jude infringes independent Claims 1, 11, 13, 18 and 24 and
dependent Claims 10, 14, 15, 19, 23, 25, 26, and 27. The Court determined that Claims
1, 13, 18, and 24 are invalid as indefinite and that because Claims 10, 14, 15, 19, 23, 25,
26, and 27 depend on Claims 1, 13, 18, and 24, they also are indefinite. Only a single
method claim remains: Claim 11, which relates to a series of steps for “using a double
catheter.” On October 21, 2019, the Court issued a claim construction order as to Claim
11, construing “the catheter” to mean “the double catheter” and concluding that “Claim
11 is infringed only when the steps are performed in the order listed.”
On November 4, 2019, St. Jude moved to strike facts disclosed in the expert
reports of NLC’s technical expert, Dr. Martin Burke, and NLC’s damages expert, Brad
Carlson, because those facts were not disclosed before the fact-discovery deadline. On

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December 2, 2019, United States Magistrate Judge Becky R. Thorson granted St. Jude’s
motion to strike. NLC appealed, and the Court affirmed the magistrate judge’s December
2, 2019 Order. Currently pending before the Court are NLC’s motion to exclude the
expert testimony of St. Jude’s technical expert Dr. Arthur Erdman and St. Jude’s motion
to exclude the expert testimony of NLC’s experts Dr. Burke and Carlson.
ANALYSIS
The admissibility of expert testimony is a question of law for the district court that
is governed by Federal Rule of Evidence 702 and Daubert v. Merrell Dow
Pharmaceuticals, Inc., 509 U.S. 579 (1993). Rule 702 provides:
A witness who is qualified as an expert by knowledge, skill,
experience, training, or education may testify in the form of
an opinion or otherwise if:
(a)

(b)
(c)
(d)

the expert’s scientific, technical, or other specialized
knowledge will help the trier of fact to understand the
evidence or to determine a fact in issue;
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. Evid. 702. “An expert may base an opinion on facts or data in the case that the
expert has been made aware of or personally observed. If experts in the particular field
would reasonably rely on those kinds of facts or data in forming an opinion on the
subject, they need not be admissible for the opinion to be admitted.” Fed. R. Evid. 703.
The proponent of expert testimony must prove its admissibility by a
preponderance of the evidence. Lauzon v. Senco Prods., Inc., 270 F.3d 681, 686 (8th Cir.

3

2001). “Rule 702 reflects an attempt to liberalize the rules governing the admission of
expert testimony” and favors admissibility over exclusion. Id. (internal quotation marks
omitted). Determinations as to the admissibility of expert testimony are within the
district court’s discretion. See Arkwright Mut. Ins. Co. v. Gwinner Oil, Inc., 125 F.3d
1176, 1182 (8th Cir. 1997) (reviewing for an abuse of discretion).
It is a district court’s obligation to ensure that testimony admitted under Rule 702
“is not only relevant, but [also] reliable.” Daubert, 509 U.S. at 589. When determining
reliability, a district court evaluates the expert’s method as to (1) whether the method can
be (and has been) tested, (2) whether the theory or technique has been subjected to peer
review and publication, (3) the method’s known or potential rate of error, and (4) the
method’s general acceptance. Presley v. Lakewood Eng’g & Mfg. Co., 553 F.3d 638, 643
(8th Cir. 2009) (citing Daubert, 509 U.S. at 593–94). These factors are not exhaustive,
and the district court must evaluate the reliability of expert testimony based on the facts
of the case. Id. A district court also may consider “whether the expertise was developed
for litigation or naturally flowed from the expert’s research; whether the proposed expert
ruled out other alternative explanations; and whether the proposed expert sufficiently
connected the proposed testimony with the facts of the case.” Sappington v. Skyjack,
Inc., 512 F.3d 440, 449 (8th Cir. 2008) (internal quotation marks omitted).

When

weighing these factors, the district court functions as a gatekeeper to separate “expert
opinion evidence based on ‘good grounds’ from subjective speculation that masquerades
as scientific knowledge.” Glastetter v. Novartis Pharm. Corp., 252 F.3d 986, 989 (8th
Cir. 2001).

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Questions regarding the factual basis of an expert’s testimony ordinarily, however,
are issues of credibility of the expert’s testimony, not issues of admissibility. Sappington,
512 F.3d at 450; see also Minn. Supply Co. v Raymond Corp., 472 F.3d 524, 544 (8th Cir.
2006).

“Vigorous cross-examination, presentation of contrary evidence, and careful

instruction on the burden of proof are the traditional and appropriate means of attacking
shaky but admissible evidence.” Daubert, 509 U.S. at 596.
I.

NLC’s Motion to Exclude Expert Testimony of Dr. Erdman

NLC moves to exclude the testimony of St. Jude’s technical expert, Dr. Erdman.
NLC argues that Dr. Erdman does not qualify as an expert under Rule 702 because he is
not a medical doctor or electrophysiologist and, therefore, he is unable to testify
regarding the medical procedure of implanting permanent pacing leads in a lateral branch
of a coronary sinus. NLC also contends that permitting Dr. Erdman to present testimony
on the issues of invalidity and non-infringement will unfairly prejudice NLC. St. Jude
counters that Dr. Erdman will testify regarding the engineering aspects of noninfringement and invalidity, Dr. Erdman has skill in the art, and his testimony is offered
in conjunction with Dr. David Benditt, an electrophysiologist.

Moreover, St. Jude

contends, NLC fails to challenge any aspect of Dr. Erdman’s experience or any specific
qualification or opinion of Dr. Erdman.
Rule 702 requires an expert to possess “knowledge, skill, experience, training or
education sufficient to assist the trier of fact.” Robinson v. GEICO Gen. Ins. Co., 447
F.3d 1096, 1100 (8th Cir. 2006) (internal quotation marks omitted); accord Fed. R. Evid.
702. And such knowledge, skill, experience, training, or education must match “the

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subject matter of the witness’s testimony.” Robinson, 447 F.3d at 1101. When issues of
infringement and invalidity are disputed, courts analyze them from the perspective of a
person having ordinary skill in the art. Sundance, Inc. v. DeMonte Fabricating Ltd., 550
F.3d 1356, 1361 (Fed. Cir. 2008). To opine on those issues that require the examination
of evidence from the perspective of one of ordinary skill in the art, a witness must qualify
as an expert in the pertinent art.

Id. at 1363.

There also must be an “adequate

relationship between [the expert’s] experience and the claimed invention.” SEB S.A. v.
Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010) (distinguishing
Sundance and holding that the proffered expert had the “knowledge, skill, experience,
training, [and] education” of a “specialized” nature that was likely to “assist the trier of
fact to understand the evidence or to determine” infringement for the purposes of Rule
702 (internal quotation marks omitted)).1 Any gap in an expert witness’s qualifications
or knowledge generally pertains to the weight of the testimony, not its admissibility.
Robinson, 447 F.3d at 1100.
St. Jude offers Dr. Erdman as a technical expert who will opine on the engineering
aspects of non-infringement, invalidity, and the “specific aspects of the properties of the
materials required to perform claim 11” of the ’268 Patent. The parties agree that the
disputed technology at issue, a catheter delivery system, involves design principals that
are driven by the expertise of an engineer. Dr. Erdman’s qualifications include a Ph.D. in
1

See also Birchwood Labs., Inc. v. Battenfeld Techs., Inc., No. 09-3555, 2012 WL
2045757, at *8 (D. Minn. May 21, 2012) (concluding that printing expert’s testimony
was relevant to the field of art when the patent-in-suit claimed firearm shooting targets
because “[t]he general field of printing is not the whole field of relevant prior art, but
printing is an important aspect of the relevant field of printed shooting targets”).

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mechanical engineering. He is the Director of the University of Minnesota’s Medical
Devices Center, serves as the Richard C. Jordan Professor and is a Morse Alumni
Distinguished Teaching Professor of mechanical engineering at the University of
Minnesota. Dr. Erdman has 45 years of experience in mechanical design, bioengineering,
and medical device and product design, including catheter design.

His credentials

demonstrate that he possesses knowledge, skill, experience, training, and education
sufficient to assist the trier of fact. Moreover, Dr. Erdman’s education, experience, and
training match the subject matter of his testimony.
NLC argues that Dr. Erdman is not qualified in the pertinent art. This argument,
however, contradicts NLC’s position as to who, in this instance, would be a person of
ordinary skill in the art (POSITA). Even when parties attempt to narrowly construe who
constitutes a POSITA, courts construe a POSITA broadly to account for a wide variety of
expertise, experiences, and avenues of relevant knowledge acquired. See, e.g., Merck
Sharp & Dohme Pharm. v. Teva Pharm. USA, Inc., No. 07-1596 (GEB)(DEA), 2009 WL
3153316, at *46 (D.N.J. Aug. 19, 2009) (defining POSITA as “one with substantial
training in the chemical and biological sciences with an advanced degree in chemistry,
training in the areas of synthetic organic chemistry and medicinal chemistry, and who has
substantial experience working in the research and development of leukotriene
antagonists or who understands the prior art references and [has] the capacity to draw
inferences from them, individually and overall, in designing LTD4 antagonists”).
NLC has defined a POSITA in this case as “an electrophysiologist or an engineer
familiar with the anatomy of the coronary sinus in a normal heart, and familiar with the

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procedures and existing equipment used to conduct those procedures.” To be considered
a POSITA, according to NLC, an “engineer would have to have been familiar with the
anatomy of the coronary sinus of a normal heart, as understood at the time, as well as
with the then existing procedures conducted within the coronary sinus by
electrophysiologists.”

But NLC attacks Dr. Erdman’s qualifications based on his

inability to implant or direct a physician to implant a permanent pacing lead into the
coronary sinus and based on the fact that he is not a medical doctor. In doing so, NLC
fails to demonstrate how Dr. Erdman’s qualifications do not permit him to serve as a
POSITA in this instance. Contrary to NLC’s position, Dr. Erdman’s credentials qualify
him as a technical expert who can opine on factual matters that require the perspective of
one of ordinary skill in the art under NLC’s POSITA definition—which includes
expertise as “an engineer”—and as generally defined. Moreover, there is an adequate
relationship between the claimed invention, a catheter delivery system, and Dr. Erdman’s
experience, which includes catheter design.

NLC identifies no evidence that, as a

biomedical engineer, Dr. Erdman is not qualified in the relevant art.
Equally unpersuasive are NLC’s arguments that Dr. Erdman’s testimony must be
excluded because he is not a medical doctor, that he has never implanted a permanent
pacing lead, and that he has never personally witnessed an electrophysiologist implant a
permanent pacing lead in the coronary sinus. The record demonstrates that St. Jude does
not rely on Dr. Erdman’s experience with the placement procedure to establish him as an
expert. Instead, Dr. Erdman’s testimony relates to “specific aspects of the properties of
the materials required to perform claim 11” of the ’268 Patent. (Emphasis added.) These

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material properties include the “physical strength and support capabilities of various
components of the dual catheter system at issue relative to the specific sequence of steps
recited in claim 11.” Based on Dr. Erdman’s education and experience in the fields of
mechanical and biomedical engineering and his specific experiences related to catheter
design, there is an adequate relationship between Dr. Erdman’s experience and the
claimed invention.

Dr. Erdman applies that expertise to the facts of this case by

examining the method described in Claim 11.

NLC identifies no evidence to the

contrary, nor does NLC argue that Dr. Erdman’s background is unrelated to catheter
delivery design.
NLC’s attack on Dr. Erdman’s experience with the catheters and leads involved in
the procedure offers insufficient grounds to exclude Dr. Erdman, especially when
Dr. Erdman’s credentials, knowledge, skill, and training are considered. See Robinson,
447 F.3d at 1100 (an expert must merely possess “knowledge, skill, experience training
or education sufficient to assist the trier of fact” that matches his or her proffered
opinions (internal quotation marks omitted)). NLC identifies no other basis on which to
exclude Dr. Erdman’s testimony as NLC does not challenge the substance of
Dr. Erdman’s opinions. Dr. Erdman’s testimony must be useful to the factfinder, based
on sufficient facts or data, the product of reliable principles, and the result of reliable
application of those principals and methods to the facts of the case. Fed. R. Evid. 702.
NLC has not challenged Dr. Erdman on any of these grounds. To the extent NLC seeks
to challenge the factual basis for Dr. Erdman’s opinions or any purported gaps between

9

Dr. Erdman’s expertise and the proffered testimony, NLC may do so on crossexamination.
In summary, because NLC’s challenge to Dr. Erdman’s qualifications lacks merit,
NLC’s motion to exclude Dr. Erdman’s opinions and testimony is denied.
II.

St. Jude’s Motion to Exclude Expert Testimony of Dr. Burke

St. Jude moves to exclude the opinions of NLC’s technical expert Dr. Burke as
unsupported by sufficient facts and counter to the law and the facts of the case because
Dr. Burke’s opinions do not comport with this Court’s October 21, 2019 claim
construction order. NLC argues that Dr. Burke’s misunderstanding of the difference
between direct and indirect infringement is not a basis on which Dr. Burke can be
disqualified. The fact that Dr. Burke did not read the Court’s claim construction order is
not a basis for disqualification, NLC contends. Moreover, NLC maintains, Dr. Burke
applied the Court’s claim construction as to the order in which Claim 11 must be
performed as well as the claim construction of “the catheter.” The Court addresses each
proffered basis for exclusion in turn.
A.

Dr. Burke’s Understanding of Direct and Indirect Infringement

The opinions of Dr. Burke should be excluded, St. Jude argues, because Dr. Burke
demonstrated that he does not understand the difference between direct and indirect
infringement.

Testimony proffered by a witness who lacks the relevant technical

expertise does not meet the standard of admissibility under Rule 702. Sundance, Inc.,
550 F.3d at 1363. But a challenge to an infringement expert’s expertise in patent law
may not undermine the expert’s qualifications and testimony in the area of expertise in

10

which the expert is offered. See, e.g., WNS Holdings, LLC v. United Parcel Serv., Inc.,
No. 08-CV-275-bbc, 2009 WL 2136961, at *4 (W.D. Wis. July 14, 2009) (“Plaintiff’s
challenges to Cotton’s lack of expertise in patent law do not undermine Cotton’s
qualifications and testimony as an avionics expert.”), aff’d, 368 F. App’x 144 (Fed. Cir.
2010). “Experts routinely rely upon other experts hired by the party they represent for
expertise outside their field.” Carnegie Mellon Univ. v. Marvell Tech. Grp., Ltd., 807
F.3d 1283, 1303 (Fed. Cir. 2015) (internal quotation marks omitted).
NLC offers Dr. Burke as an expert in electrophysiology to opine on the medical
procedure for implanting permanent pacing leads into the coronary sinus. The parties do
not dispute Dr. Burke’s technical qualifications as St. Jude does not challenge
Dr. Burke’s knowledge, skill, or expertise as they relate to the method and devices at
issue. Instead, St. Jude challenges Dr. Burke’s ability to explain and understand the
difference between direct and indirect infringement. But NLC does not offer Dr. Burke
as an expert on patent law. And such a challenge is meritless when an expert witness’s
relevant expertise lies outside of the law. See, e.g., WNS Holdings, LLC, 2009 WL
2136961, at *4. St. Jude cites no case law, nor has the Court’s research produced any,
that suggests that a technical expert must be capable of reciting the difference between
direct and indirect infringement or that such an inability is an appropriate basis for
exclusion.
Therefore, the Court denies St. Jude’s motion to exclude Dr. Burke’s opinions and
testimony on this basis.

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B.

Dr. Burke’s Review of the Court’s Claim Construction Order

St. Jude also argues that the opinions of Dr. Burke should be excluded because
Dr. Burke did not read the Court’s claim construction order.
“An expert may base an opinion on facts or data in the case that the expert has
been made aware of or personally observed.”

Fed. R. Evid. 703.

In the patent-

infringement context, an expert’s opinion has sufficient foundation when the expert has
examined the accused method, the patented method, and the court’s claim construction
order, which are “the items most germane to forming an infringement opinion.” LTJ
Enters. v. Custom Mktg. Co., 168 F. Supp. 3d 1202, 1209 (D. Minn. 2016). An expert
may use the Court’s definitions in its claim construction order, as relayed by counsel,
when forming an expert opinion. Arason Enters., Inc. v. CabinetBed Inc., No. 16-cv03001-PAB-NRN, 2019 WL 4597863, at *4. (D. Colo. Sept. 23, 2019) (refusing to
disqualify an expert because the expert did not read the court’s claim construction in full
and instead relied on the court’s constructions as provided by counsel).
In this instance, St. Jude attacks Dr. Burke’s expert opinion based on Dr. Burke’s
failure to personally read the Court’s claim construction order. NLC represents that Dr.
Burke “understood from counsel that the Court had interpreted Claim 11 to require that
the steps be performed in order,” and Dr. Burke affirms as much in his declaration and in
his rebuttal opinion on validity. Although Dr. Burke did not read the Court’s claim
construction order, the claim construction was communicated to him through counsel. At
worst, Dr. Burke may have lacked the context provided by preforming an independent
reading of the Court’s claim construction order. But St. Jude fails to offer any argument

12

or legal authority as to the adverse effect of this manner of preparation on the
admissibility of Dr. Burke’s opinions.
Accordingly, the Court declines to exclude Dr. Burke’s opinions and testimony on
this basis.
C.

Dr. Burke’s Application of the Court’s Claim Construction Order

St. Jude next challenges the admissibility of Dr. Burke’s opinions on the ground
that he did not apply the Court’s construction of Claim 11.
Expert testimony that is unsupported by sufficient facts or contrary to the facts of a
case is inadmissible. Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 757 (8th Cir.
2006). “Once a district court has construed the relevant claim terms” in a patent, “that
legal determination governs.” Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312,
1321 (Fed. Cir. 2009). Expert testimony that conflicts with a district court’s claim
construction is inadmissible. See Finjan, Inc. v. Secure Computing Corp., 626 F.3d 1197,
1207 (Fed. Cir. 2010) (discussing with approval the district court’s decision to exclude
expert testimony that “attempted to resurrect a claim construction that the district court
already rejected”). Likewise, expert testimony that ignores or fails to consider a district
court’s claim construction is inadmissible.

See, e.g., MarcTec, LLC v. Johnson &

Johnson, 664 F.3d 907, 913 (Fed. Cir. 2012) (discussing exclusion of expert testimony
that “ignored the court’s claim construction” as “inadmissible under Daubert”). But
expert testimony that merely is contradictory to prior testimony may be subject to crossexamination, not exclusion under Daubert or Rule 702. In re AndroGel Antitrust Litig.
(No. II), 888 F. Supp. 2d 1336, 1356 (N.D. Ga. 2012) (concluding that any inconsistency

13

between expert’s deposition testimony and expert report “may be the subject of cross
examination, but does not justify exclusion”).
Dr. Burke’s disputed opinion relates to the order in which Claim 11 must be
performed. The Court’s October 21, 2019 claim construction order concluded that the
steps of Claim 11 must be performed in the order listed and that “Claim 11 is infringed
only when the steps are performed in the order listed.” (Emphasis added.) St. Jude
points to several admissions made by Dr. Burke during his deposition regarding his
application of the claim construction order. For example, Dr. Burke admitted that he
applied the steps out of the sequence detailed in Claim 11 and that such an application
may give rise to infringement. In addition, Dr. Burke marked an illustration during his
deposition in a manner that suggests he applied the steps of Claim 11 out of sequence
when rendering his infringement opinion.
Although testimony based on Dr. Burke’s decision to apply the steps of Claim 11
out of order would be of little use to the jury because the question of infringement relates
to completion of the steps of Claim 11 in order, a fulsome view of Dr. Burke’s expert
report and deposition testimony provides no grounds for his exclusion. Contradictory
expert testimony is grounds for cross-examination, not exclusion. Janopoulos v. Harvey
L. Walner & Assocs., Ltd., 866 F. Supp. 1086, 1096 (N.D. Ill. 1994) (“[D]iscrepancies in
[an expert’s] testimony and declaration go to the weight rather than the admissibility of
his opinions.”). And deposition testimony that contradicts an expert report bears on the
weight afforded the expert report, not on whether the expert should be precluded from
testifying. See, e.g., i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 852 (Fed. Cir.

14

2010) (“When the methodology is sound, and the evidence relied upon [is] sufficiently
related to the case at hand, disputes about the degree of relevance or accuracy (above this
minimum threshold) may go to the testimony’s weight, but not its admissibility.”).
St. Jude identifies numerous instances in which Dr. Burke contradicts himself,
arguing that, because these internal inconsistences contradict this Court’s claim
construction order, Dr. Burke should be excluded. But Dr. Burke applied the Court’s
claim construction.

Contrary to St. Jude’s representations, during his deposition,

Dr. Burke testified as follows:
Q.

And so what I’d like to know on behalf of St. Jude
then is when you were assessing whether they
infringed or not, would the presence of additional steps
within claim 11, meaning you performed all of the
steps listed in claim 11, but there were other steps done
in between, would fall within the scope of
infringement or noninfringement, as you applied the
standard in this case?
...

A.

Yea, I generally, as I understand it, relate it to the
scope of my testimony as it relates to St. Jude
infringing, that they have to follow these steps.

(Emphasis added). This exchange suggests that Dr. Burke was aware that the steps in
Claim 11 must be followed in the order listed to give rise to infringement. And at other
points in his deposition and expert reports, Dr. Burke acknowledges that the steps in
Claim 11 must be completed in the order listed.
For example, St. Jude contends that Dr. Burke was presented with the St. Jude
Instructions for Use (IFU) at his deposition and asked to identify the presence of each

15

step in Claim 11 in the sequence each step appeared in the IFU. In response, Dr. Burke
identified and marked the steps out of sequential order as 4, 3, 2, and 1, in a manner that
is contrary to the Court’s claim construction order. Dr. Burke’s testimony is inconsistent
with his expert report in which he tracks each claim element in sequential order alongside
St. Jude’s product literature instructions in sequential order, as is required by the Court’s
claim construction order. Such inconsistencies between an expert report and deposition
testimony are not a basis for exclusion. See, e.g., i4i Ltd. P’ship, 598 F.3d at 852.
The evidence identified by St. Jude does not constitute grounds to exclude
Dr. Burke.

At best, St. Jude has identified inconsistent or contradictory positions

between Dr. Burke’s expert reports and Dr. Burke’s deposition testimony.

Such

inconsistences are matters for cross-examination, not grounds for exclusion.
Accordingly, the Court denies St. Jude’s motion to exclude Dr. Burke’s opinions and
testimony on this basis.
D.

Dr. Burke’s Application of the Court’s Construction of “the catheter”

St. Jude also argues that Dr. Burke’s opinions should be excluded because he did
not apply the Court’s construction of “the catheter.”
When a district court has construed the relevant claim terms, that legal
determination governs. Exergen Corp., 575 F.3d at 1321. A party may not contradict a
district court’s claim construction. Id. And an expert witness may not present testimony
that conflicts with the district court’s claim construction. See Finjan, 626 F.3d at 1207.
Expert testimony that ignores or fails to consider the district court’s claim construction is
inadmissible. See, e.g., MarcTec, LLC, 664 F.3d at 913.

16

In the Court’s October 21, 2019 claim construction order, the Court construed
“the catheter” to mean “the double catheter.” Claim 11 defines “double catheter” to
include an “outer catheter and an inner catheter.” St. Jude relies on several admissions by
Dr. Burke during his deposition pertaining to his application of the Court’s construction
of “the catheter.” Dr. Burke was questioned during his deposition about the definition of
“the catheter” and whether, in his application of Claim 11, “the catheter” referred to a
“single catheter, the inner and the outer catheter, or any version.” In response, Dr. Burke
testified that in his application of Claim 11, “the catheter” pertained to “any version.”
St. Jude now argues that this testimony renders Dr. Burke’s opinion unreliable because he
did not apply the Court’s construction of “the catheter.”
Although it is true that failure to apply the Court’s claim construction of “the
catheter” is impermissible, a fulsome view of Dr. Burke’s expert report and deposition
testimony suggests that exclusion of his opinions and testimony is unwarranted on this
basis. Dr. Burke was questioned about whether following the steps of Claim 11 with the
use of an electrophysiology catheter before completion of the final step of Claim 11
would constitute infringement. In response, Dr. Burke testified that he “would stick to
the concept that claim 11 is a method for placing an electrical lead in a lateral branch of a
coronary sinus vein using a catheter, including an outer and inner cath[eter].”
(Emphasis added). Dr. Burke also was questioned about whether use of the stylet method
would result in infringement. Dr. Burke responded that “with . . . a dual outer and inner
sheath system that has engaged the branch using a guidewire, you can infringe using the
stylet method.” In each response, Dr. Burke explicitly refers to the double catheter

17

whether by referring to the component parts comprising the double catheter or by
referring to the catheter and the component parts.
Moreover, it appears from Dr. Burke’s expert report that he applied the Court’s
construction of “the catheter.”

Notably, in addressing steps 1 and 2 of Claim 11,

Dr. Burke opines that “[t]he instructions for the CPS inner catheters . . . direct the
electrophysiologist to insert the inner and other catheter into the coronary sinus” and that
“St. Jude’s instructions for the inner [catheter] direct an electrophysiologist to advance a
guide wire through the inner and outer catheters.” In addressing step 3 of Claim 11,
Dr. Burke opines that “[t]his step describes using the double catheter in a telescoping
manner,” and that “St. Jude’s instructions for the inner catheter explicitly direct
electrophysiologists to use the inner and outer catheters . . . , which an
electrophysiologists would understand as advancing the inner catheter out of the front of
the outer catheter along the guide wire.” Dr. Burke refers to the double catheter by
identifying the double catheter’s component parts, namely, an inner and outer catheter.
This aspect of Dr. Burke’s report is consistent with the Court’s claim construction.
Accordingly, because Dr. Burke’s expert report is consistent with this Court’s
claim construction order, his opinions and testimony will not be excluded.2
III.

St. Jude’s Motion to Exclude Expert Testimony of Carlson

St. Jude also moves to exclude the opinions of Carlson, NLC’s damages expert, as
unreliable and speculative. In particular, St. Jude challenges Carlson’s damages opinions
2

Should Dr. Burke attempt to testify at trial in a manner that is contrary to the
Court’s claim construction, the Court will address any objection. That is not the Court’s
expectation, however.

18

that pertain to the appropriate royalty base, arguing that Carlson fails to apportion
damages to the value attributable to the claimed method and improperly assumes that all
of St. Jude’s inner catheters are used in an infringing manner.3
Reasonable royalty damages are, by statute, “the minimum amount of
infringement damages ‘adequate to compensate for the infringement.’ ” LaserDynamics,
Inc. v. Quanta Comput., Inc., 694 F.3d 51, 66 (Fed. Cir. 2012) (quoting 35 U.S.C. § 284).
Generally, reasonable royalties must “be based not on the entire product, but instead on
the smallest salable patent-practicing unit.” Id. at 67 (internal quotation marks omitted).
As a “narrow exception” to this general rule, the “entire market value rule” permits a
patentee to recover a royalty based on the revenue for an entire multi-component product
if the patentee can show that “the patented feature drives the demand for [the] entire
multi-component product.” Id.
NLC concedes in its brief that “[t]his is not an entire market value rule case.”
Indeed, Carlson does not purport to invoke the entire-market-value rule in his report, nor
does he attempt to establish a relationship between the claimed method and customer
demand for any combination of St. Jude’s products. To the contrary, Carlson observes in

3

St. Jude seeks exclusion of Carlson’s opinions and testimony in their entirety, but
St. Jude’s arguments are directed solely at Carlson’s opinions as to the royalty base. For
instance, although St. Jude’s reply brief repeatedly refers to Carlson’s calculation of the
royalty rate as “inflated,” St. Jude offers no substantive factual or legal argument that
specifically challenges Carlson’s calculation of the royalty rate. As such, the Court limits
its analysis to whether Carlson’s royalty base opinions and testimony should be excluded.
See, e.g., VirnetX, Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1328–31 (Fed. Cir. 2014)
(separately evaluating admissibility of expert opinions pertaining to royalty base and
royalty rate, and concluding that the former were inadmissible whereas the latter were
admissible).

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his report that Claim 11 of the ’268 Patent requires “an outer catheter, an inner catheter, a
guide wire, and a lead,” and that “these components comprise the smallest saleable
component that is used by an electrophysiologist to practice the claimed methods.” As
such, Carlson derives a royalty base from this purported “smallest saleable” patentpracticing unit based on St. Jude’s revenues for these four components.
When, as here, the entire-market-value rule is not implicated, “principles of
apportionment apply.” VirnetX, Inc. v. Cisco Sys., Inc., 767 F.3d 1308, 1326 (Fed. Cir.
2014).

Because damages awarded for patent infringement “must reflect the value

attributable to the infringing features of the product, and no more,” apportionment
requires a damages expert to “separate the value of the allegedly infringing features from
the value of all other features.” Commonwealth Sci. & Indus. Rsch. Organisation v.
Cisco Sys., Inc., 809 F.3d 1295, 1301 (Fed. Cir. 2015) (internal quotation marks omitted).
Apportionment may be addressed in numerous ways, including “by careful selection of
the royalty base to reflect the value added by the patented feature [or] . . . by adjustment
of the royalty rate so as to discount the value of a product’s non-patented features; or by a
combination thereof.” Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1226 (Fed. Cir.
2014). The parties do not dispute that apportionment is required in this case. Instead, the
parties dispute whether Carlson reliably applied apportionment when calculating the
royalty base.
NLC contends that “Carlson has appropriately apportioned the royalty base by
limiting the royalty base to sales of the components recited in the claim.”

These

components, according to Carlson’s report, comprise the smallest salable patent-

20

practicing unit. But “the requirement that a patentee identify damages associated with the
smallest salable patent-practicing unit is simply a step toward meeting the requirement of
apportionment.” VirnetX, 767 F.3d at 1327. When “the smallest salable unit is, in fact, a
multi-component product containing several non-infringing features with no relation to
the patented feature . . . , the patentee must do more to estimate what portion of the value
of that product is attributable to the patented technology.” Id. Although “this process
may involve some degree of approximation” as “absolute precision” is not required, a
district court must “exercise[ ] its gatekeeping authority to ensure that only theories
comporting with settled principles of apportionment [are] allowed to reach the jury.” Id.
at 1328. Accordingly, “a patentee must be reasonable (though may be approximate)
when seeking to identify a patent-practicing unit, tangible or intangible, with a close
relation to the patented feature.” Id. at 1329. The record reflects that Carlson has not
done so here.
In his report, Carlson concludes that the “smallest saleable” patent-practicing unit
comprises “an outer catheter, an inner catheter, a guide wire, and a lead,” because these
four components are recited in Claim 11 of the ’268 Patent. But NLC has identified no
legal authority for satisfying the apportionment requirement in this way. Indeed, courts
have rejected such an approach. See, e.g., Lucent Techs., Inc. v. Gateway, Inc., 580 F.3d
1301, 1310, 1338 (Fed. Cir. 2009) (observing that expert’s use of “the price of the entire
computer as a royalty base” for a method claim was improper, even though a computer
was recited in the claim language); Cornell Univ. v. Hewlett-Packard Co., 609 F. Supp.
2d 279, 283–85 (N.D.N.Y. 2009) (same). Even if a component is “valuable, important,

21

or even essential” to practicing a patented method, “the patented feature must be
separated” from the unpatented elements of the component. VirnetX, 767 F.3d at 1329
(quoting LaserDynamics, 694 F.3d at 68). An expert’s testimony as to a royalty base is
inadmissible if the expert “fail[s] to apportion value between the patented features and
the vast number of non-patented features contained in the accused products” because
such an approach does not “carefully tie proof of damages to the claimed invention’s
footprint in the marketplace.” Id. at 1329 (internal quotation marks omitted).
Claim 11 of the ’268 Patent pertains to a “method for placing an electrical lead in
a lateral branch of a coronary sinus vein using a double catheter.” Claim 11 covers a
method, not the components involved in practicing the method. Carlson did not even
attempt to identify, let alone subtract, the value of any unpatented aspects of the four
components that comprise his definition of the royalty base. For instance, although leads
are recited in Claim 11, the ’268 Patent does not teach or disclose leads. The parties’
experts do not dispute this fact. Dr. Burke, NLC’s technical expert, testified that the
’268 Patent provides no discussion of how to accomplish the electrical features of a lead
and that the leads “weren’t part and parcel to the ’268 Patent.” The entirety of the ’268
Patent’s scope is limited to a “double catheter” for use in the “coronary sinus.” This
scope does not include leads. As such, Carlson’s royalty base accounts for more than the
method claimed. See Cornell Univ., 609 F. Supp. 2d at 283–84 (excluding damages
expert because the damages assessment was “in excess of the contribution of the claimed
invention to this market”); see also LaserDynamics, 694 F.3d at 68 (rejecting damages
award because the patent only covered a method practiced using an optical disc drive, but

22

damages were based on the entire computer). As in VirnetX, in this case, Carlson failed
to apportion value between the claimed method and any other valuable features contained
in the accused products. See 767 F.3d at 1329. In doing so, Carlson essentially opines
that St. Jude’s inner catheter, outer catheter, guide wire, and leads have no value other
than to perform the claimed method. But the record does not support such a conclusion.
Even NLC’s technical expert, Dr. Burke, has testified that a lead is a “very complex”
component with features that are not part of the claimed invention.
NLC contends that Carlson properly excluded “other devices involved in the
medical procedure, such as pacemakers and defibrillators.” But this fact does not excuse
NLC from its obligation to apportion value with respect to the four components that
comprise Carlson’s royalty base. See id. at 1327 (explaining that when “the smallest
salable unit is, in fact, a multi-component product containing several non-infringing
features with no relation to the patented feature . . . , the patentee must do more to
estimate what portion of the value of that product is attributable to the patented
technology”). Even assuming that the four components Carlson used to calculate the
royalty base represent the smallest salable patent-practicing unit, identifying the damages
associated with these components “is simply a step toward meeting the requirement of
apportionment,” and is not sufficient on its own. Id.
NLC also contends that “Carlson used the inner catheter sales as a limiter to
apportion the unit sales of outer catheters and leads.” Carlson opines that, in a given
year, St. Jude’s gross profit margin for inner catheters has ranged from approximately 60
percent to 70 percent, St. Jude’s gross profit margin for outer catheters has ranged from

23

approximately 83 percent to 86 percent, and St. Jude’s gross profit margin for leads has
ranged from approximately 82 percent to 89 percent. To calculate the royalty base,
Carlson limits the number of outer catheters and leads by using the number of inner
catheter sales for the same year because, according to Carlson, St. Jude’s inner catheters
had the lowest number of per-unit sales. But although this methodology reduces the
overall royalty base, this reduction has no logical connection to the proportionate value of
these components that is attributable to the claimed method of the ’268 Patent. The
purpose of apportionment is to ensure that a reasonable royalty damages award is “based
on the incremental value that the patented invention adds to the end product.” Exmark
Mfg. Co. v. Briggs & Stratton Power Prods. Grp, LLC, 879 F.3d 1332, 1348 (Fed. Cir.
2018) (explaining that when a patent claim “recite[s] both conventional elements and
unconventional elements, the court must determine how to account for the relative value
of the patentee’s invention in comparison to the value of the conventional elements
recited in the claim, standing alone” (internal quotation marks omitted)). Carlson’s
reduction of the royalty base fails to do so here. Because Carlson’s method arbitrarily
reduces the royalty base for outer catheters and leads to match the per-unit sales of inner
catheters, his method does not “carefully tie proof of damages to the claimed invention’s
footprint in the market place.” VirnetX, 767 F.3d at 1329 (internal quotation marks
omitted).
It is true that, rather than addressing apportionment when calculating the royalty
base, an expert may instead address apportionment by adjusting of the royalty rate “so as
to discount the value of the product’s non-patented features.” Exmark, 879 F.3d at 1348

24

(internal quotation marks omitted). But NLC does not argue, and the record does not
reflect, that Carlson used such an approach here. To the contrary, when addressing the
royalty rate calculation in his report, Carlson opines that the “portion of the realizable
profit that should be credited to the invention supports a higher royalty rate.” According
to Carlson, this is because “the claimed invention is not divorceable from St. Jude’s
catheters” and “the patent encompasses the entire product, not merely some component
of the product.” As such, Carlson’s calculation of the royalty rate expressly does not
discount the value of the non-patented features of an inner catheter, outer catheter, guide
wire, or lead—instead, Carlson concludes that no such value exists.
For these reasons, Carlson’s calculation of the royalty base does not comport with
settled principles of apportionment and, therefore, must be excluded. VirnetX, 767 F.3d
at 1328. Accordingly, St. Jude’s motion to exclude Carlson’s opinions and testimony is
granted in part. Carlson’s opinions and testimony as to the royalty base are inadmissible.
IV.

St. Jude’s Request for Reconsideration

St. Jude requests that the Court reconsider its ruling on its construction of “the
catheter” because of “the clear confusion expressed by NLC’s own expert even after this
Court’s claim construction ruling.” In support of its motion, St. Jude explains that “the
ambiguity caused by the claim’s failure to provide an antecedent basis for ‘the catheter’
injects confusion and allows gamesmanship as to which catheter is referenced, and where
infringement begins and ends.”
“Except with the court’s prior permission, a party must not file a motion to
reconsider. . . . A party who seeks permission to file a motion to reconsider must first file

25

and serve a letter of no more than two pages requesting such permission.” LR 7.1(j). To
the extent that St. Jude requests that the Court reconsider its prior ruling, that motion is
not properly before the Court because St. Jude neither sought nor received permission
from this Court before requesting reconsideration. Accordingly, St. Jude’s request for
reconsideration is denied.
ORDER
Based on the foregoing analysis and all the files, records and proceedings herein,
IT IS HEREBY ORDERED:
1.

Plaintiff Niazi Licensing Corporation’s motion to exclude the expert

testimony of Dr. Arthur Erdman, (Dkt. 196), is DENIED.
2.

Defendant St. Jude Medical S.C., Inc.’s motion to exclude the expert

testimony of Dr. Martin Burke and Brad Carlson, (Dkt. 164), is GRANTED IN PART
AND DENIED IN PART as follows:
a. St. Jude’s motion is GRANTED as to the opinions and testimony of
Carlson that pertain to the royalty base, which are excluded as
addressed in Part III of this Order.
b. St. Jude’s motion is DENIED in all other respects.

Dated: September 14, 2020

s/Wilhelmina M. Wright
Wilhelmina M. Wright
United States District Judge

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