Daubert in Patent Cases - 1
Carnegie Mellon, Sorkin, Pharmastem
Scientific Evidence and Expert Testimony - Patent Litigation
Fall 2006
Prof. Morris
DAUBERT for PATENT LIABILITY EXPERTS
Daubert motions against scientific experts are rare in patent
cases. (They are less rare against damages experts. Why?) But
they may be useful occasionally. Here are excerpts from three
recent cases involving Daubert motions.
As usual, I have edited these excerpts. Formatting and
emphasis in boldface is mine, deletions are marked by ... or ***
or [replacement text], quotations have been revised to be
continuous using square brackets for the later author's words,
and many record cites and footnotes have disappeared without a
trace.
CARNEGIE MELLON UNIVERSITY and THREE
RIVERS BIOLOGICALS, INC., Plaintiffs, v.
HOFFMANN-LaROCHE, INC., ROCHE
MOLECULARSYSTEMS, INC., THE PERKINELMER CORPORATION, CHIRON
CORPORATION, CETUS ONCOLOGY
CORPORATION, ROCHE DIAGNOSTIC SYSTEMS,
INC., and ROCHE BIOMEDICAL LABORATORIES,
INC.,Defendants.
Francisco, CA.
No. C 95-3524 SI
Plaintiffs Carnegie Mellon University and Three
Rivers Biologicals, Inc. (collectively "Carnegie
Mellon" [or POs]) contend that defendants HoffmannLa Roche Inc., Roche Molecular Systems, Inc., Roche
Diagnostic Systems, Inc., Roche Biomedical
Laboratories, Inc., Laboratory Corporation of America
Holdings, and the Perkin-Elmer Corporation
(collectively "the Roche defendants") and Chiron
Corporation and Cetus Oncology Corporation
(collectively "the Chiron defendants ") [together
"Defendants or AIs] have infringed [various] claims of
[two patents, both of which are] entitled
"Enzyme Amplification and Purification"
and involve recombinant DNA technology. Both the
Roche defendants and the Chiron defendants have
moved for summary judgment on the issue of
infringement of [one of the patents, US Patent No.
4,767,708, the "'708 Patent."] Also before the Court are
defendants' motions to exclude the testimony and
declarations of plaintiffs' experts.
For the reasons set forth below, the Court hereby
(1) GRANTS the Roche defendants' motion to
exclude the declaration of Dr. William E. Brown;
(2) GRANTS in part and DENIES in part the
Chiron defendants' motion to exclude the testimony of
plaintiffs' experts; and
(3) GRANTS the defendants' motions for summary
judgment of non-infringement of the '708 Patent both
UNITED STATES DISTRICT COURT FOR THE
NORTHERN DISTRICT OF CALIFORNIA
55 F. Supp. 2d 1024
May 12, 1999, Decided
For PO (all the named plaintiffs):
Daniel E. Alberti, Eugene J. Majeski, Ropers
Majeski Kohn & Bentley, Redwood City, CA.
Arland T. Stein, Reed Smith Shaw & McClay,
Pittsburgh, PA.
For PO Three Rivers ONLY:
Walter P. DeForest, DeForest & Koscelnik,
Pittsburgh, PA.
For AI (all the named defendants EXCEPT Chiron):
Vanessa Wells, Heller Ehrman White & McAuliffe,
Palo Alto, CA.
Gidon D. Stern, S. Leslie Misrock, Stephen S.
Rabinowitz, Pennie & Edmonds LLP, New York, NY.
For AI Chiron:
Tamu K. Sudduth, Harold J. McElhinny, Constance
T.Y. McComb, Morrison & Foerster LLP, San
SUSAN ILLSTON, United States District Judge.
ORDER GRANTING IN PART AND DENYING IN
PART DEFENDANTS' MOTIONS TO EXCLUDE
THE TESTIMONY OF PLAINTIFFS' EXPERTS;
AND GRANTING DEFENDANTS' MOTIONS FOR
SUMMARY JUDGMENT
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literally and under the doctrine of equivalents.
{I have deleted the discussion of the technology in
general and in the 708 patent in particular.
Interestingly, the technology overview is based on the
Federal Circuit's decision in In re O'Farrell, 853 F.2d
894, 895-97 (Fed. Cir. 1988). instead of the parties'
briefs. That's where I learned it, too. - RJM}
***
DISCUSSION
1. [AIs]' Motions to Exclude [POs]' Expert
Testimony Under Daubert
The Roche defendants move to exclude the
declaration of Dr. William E. Brown, one of [POs]'
scientific experts, because his testimony fails to meet
the standards for admissibility and reliability under
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579,
125 L. Ed. 2d 469, 113 S. Ct. 2786 (1993). The Chiron
defendants also move to exclude the testimony of Dr.
Brown, as well as [POs]' other scientific experts, Dr.
Edwin Minkley and Dr. Stephen Benkovic.
Federal Rule of Evidence 702 provides:
If scientific, technical, or other specialized
knowledge will assist the trier of fact to understand
the evidence or to determine a fact in issue, a
witness qualified as an expert by knowledge, skill,
experience, training, or education, may testify
thereto in the form of opinion or otherwise.
As a guide for assessing the scientific validity of
expert testimony, the Supreme Court provided a
nonexhaustive list of factors that courts may consider:
(1) whether the theory or technique is generally
accepted within a relevant scientific community,
(2) whether the theory or technique has been
subjected to peer review and publication,
(3) the known or potential rate of error and
(4) whether the theory or technique can be tested.
Daubert, 509 U.S. at 593-94; see also Kumho Tire Co.,
Ltd. v. Carmichael, 526 U.S. 137, 1999 WL 152455 at
*9, 143 L. Ed. 2d 238, 119 S. Ct. 1167 (U.S. 1999).
The Ninth Circuit also has indicated that independent
research, rather than research conducted for the
purposes of litigation, carries with it the indicia of
reliability. See Daubert v. Merrell Dow Pharms., Inc.,
43 F.3d 1311, 1317 (9th Cir. 1995) ( "Daubert II"). In
particular, using independent, pre-existing research
"provides objective proof that the research
comports with the dictates of good science [and is
less likely] to have been biased by the promise of
remuneration."
If the testimony is not based on "pre-litigation" research
or if the expert's research has not been subjected to peer
review, then the expert must explain precisely how he
went about reaching his conclusions and point to some
objective source -- a learned treatise, the policy
statement of a professional association, a published
article in a reputable scientific journal or the like -- to
show that he has followed the scientific method, as it is
practiced by (at least) a recognized minority of
scientists in his field. Id. at 1318-19 (citing United
States v. Rincon, 28 F.3d 921, 924 (9th Cir. 1994)); see
also Lust v. Merrell Dow Pharms., Inc., 89 F.3d 594,
597 (9th Cir. 1996). The proponent of the evidence
must prove its admissibility by a preponderance of
proof. See Daubert, 509 U.S. at 593 n.10.
A. DR. WILLIAM E. BROWN
[Roche and Chiron] argue that the testimony of Dr.
William E. Brown is inadmissible because it does not
constitute scientific knowledge and because it is not
based on accepted scientific principles and
methodologies ... :
1. Dr. Brown offers an opinion contrary to a
scientific fact -- the absence of 3'-5' exonuclease activity
in Taq DNA polymerase -- that is no longer subject to
debate in the scientific community;
2. Dr. Brown is not an expert on DNA polymerases
or assays to measure 3'-5' exonuclease activity;
3. Dr. Brown's testimony has none of the indicia of
reliability required by Daubert;
4. Dr. Brown purports to reinterpret the work of a
number of scientists using analyses that are not accepted
within the scientific community; and
5. Dr. Brown's conclusions do not fit the issues
presented.
All of these arguments, to some extent, address the
factors set forth in Daubert. Accordingly, the Court will
address these arguments in the framework provided by
Daubert.
(1) Is Dr. Brown's theory or technique generally
accepted within a relevant scientific community?
[POs] rely on Dr. Brown's expert opinion that Taq
DNA polymerase does exhibit 3'-5' exonuclease
activity. [AIs] offer substantial evidence, however, that
Dr. Brown stands alone in this contention. Defendants
point to two learned treatises and 16 published studies,
all of which indicate that Taq DNA polymerase has no
3'-5' exonuclease activity. {n8}
{n8} Chiron's Request for Judicial Notice, Exhibits 1-18,
[relying on] two treatises and 16 articles [dated from 1988 to
1997]
In addition, defendants' experts have testified on the
universal agreement among scientists to this fact, also
citing numerous publications in peer-reviewed journals.
Even [POs]' other expert witnesses, Dr. Minkley and
Dr. Benkovic, appear unwilling to reach the same
conclusion as Dr. Brown. {n10}
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{n10} When asked whether he knew to his own satisfaction
that Taq polymerase exhibited 3'-5' exonuclease activity, Dr.
Minkley stated that
"it would not be truthful for me to say yes or no."
Sudduth Decl., Exhibit C ("Minkley Depo.") at 100:16-101:5.
When asked if he was suggesting that Taq polymerase
possessed a 3 '-5' exonuclease activity, Dr. Benkovic responded,
"I don't make any statement about the 3'-5' exonuclease
activity, no statement."
Sudduth Decl., Exhibit D ( "Benkovic Depo.") at
158:19-159:3.
{Who is Sudduth? - RJM}
Dr. Minkley and Dr. Benkovic were also unable to
name any other scientist who shares Dr. Brown's belief
that Taq DNA polymerase has 3'-5' exonuclease
activity. {n11}
{n11} Minkley Depo. at 120:1-12.
{There is no cite in the opinion to any testimony of
Dr. Benkovic on this point. I didn't delete it. RJM}
Consequently, [AIs] take the position that Dr. Brown's
testimony attempts to dispute an established fact -- the
absence of 3'-5' exonuclease activity in Taq DNA
polymerase -- that is no longer subject to debate in the
scientific community.
In response, [POs] offer no evidence to refute this
contention. Instead, [POs] allege that [AIs]' criticism of
Dr. Brown's testimony is
"not a proper Daubert argument."
To support this statement, they rely on language in
Daubert II that requires the Court to focus its inquiry on
an experts' methodology rather than his conclusions.
See Daubert II, 43 F.3d at 1318
("the test under Daubert is not the correctness of
the expert's conclusions but the soundness of his
methodology").
According to the [POs], any disagreement between Dr.
Brown and the scientific community speaks solely to the
validity of his conclusions and therefore should not be
considered by the Court in assessing the admissibility of
his testimony.
The Court disagrees, and finds that the opinions of
the scientific community do bear on the admissibility of
Dr. Brown's testimony. While Daubert forbids the
exclusion of expert testimony on the basis of a rigid
"general acceptance" test, it does not wholly remove
this factor from consideration. Daubert, 509 U.S. at
594.
"A 'reliability assessment . . . does permit[] explicit
identification of a relevant scientific community
and an express determination of a particular degree
of acceptance within that community.'"
Indeed, in decisions after Daubert, the Ninth Circuit
routinely has considered the reliability of expert
testimony against the backdrop of other scientists'
opinions. See, e.g., Daubert II, 43 F.3d at 1319
(stating that experts must "show that they have
followed the scientific method, as it is practiced by
(at least) a recognized minority in their field");
Lust v. Merrell Dow Pharms., Inc., 89 F.3d 594, 597
(9th Cir. 1996) (finding expert testimony inadmissible
because expert's opinions were not accepted by a
recognized minority in his field).
Moreover, focusing on Dr. Brown's methodology
rather than the general acceptance of his conclusions
would not salvage his opinion. As the Ninth Circuit has
noted [in Lust],
"when a scientist claims to rely on a method practiced
by most scientists, yet presents conclusions that are
shared by no other scientist, the district court
should be wary that the method has not been
faithfully applied."
The fact that Dr. Brown's conclusions are at odds with
the scientific findings in two learned treatises and 16
published studies, and are not supported by [POs]' other
experts, calls Dr. Brown's opinion into question.
Accordingly, this Court finds that the singular and
uncorroborated nature of Dr. Brown's opinion on the
3'-5' exonuclease activity of Taq DNA polymerase
weighs heavily against its reliability. See General
Electric Co. v. Joiner, 522 U.S. 136, 118 S. Ct. 512,
139 L. Ed. 2d 508 (1997) (finding expert testimony
unreliable based on "analytical gap" between data and
conclusions); see also Cabrera v. Cordis Corp., 134
F.3d 1418 (9th Cir. 1997) (finding expert testimony
unreliable because it was specifically prepared for trial
and had no support in medical literature); Rutigliano v.
Valley Business Forms, 929 F. Supp. 779 (D.N.J. 1996)
(finding expert testimony unreliable because expert's
theory was unsupported by extensive publication
record).
The Court is also unpersuaded by [POs]' argument
that basing the reliability of expert testimony on its
general acceptance within the scientific community will
unduly favor scientific orthodoxy. Justice Blackmun
specifically addressed this issue in Daubert:
Petitioners and, to a greater extent, their amici
exhibit a different concern. They suggest that
recognition of a screening role for the judge that
allows for the exclusion of "invalid" evidence will
sanction a stifling and repressive scientific
orthodoxy and will be inimical to the search for
truth. . . . We recognize that, in practice, a
gatekeeping role for the judge, no matter how
flexible, inevitably on occasion will prevent the
jury from learning of authentic insights and
innovations. That, nevertheless, is the balance that
is struck by Rules of Evidence designed not for the
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exhaustive search for cosmic understanding but for
the particularized resolution
of legal disputes.
Daubert, 509 U.S. at 596-97. Consequently, this Court
remains convinced that the opinions of the scientific
community are a valid yardstick against which to
measure the reliability of Dr. Brown's testimony, and
that Dr. Brown's testimony comes up short.
(2) Has Dr. Brown's theory or technique been
subjected to peer review and publication?
[AIs] argue that Dr. Brown's testimony does not
represent the sort of published, independent research to
which courts ascribe inherent reliability. It is undisputed
that Dr. Brown has not collected any empirical data on
the 3'-5' exonuclease activity of Taq DNA polymerase
and has only reviewed, in response to the present
litigation, the findings of those who have collected such
data. {n14}
n14 [POs]' Opposition to Motion to Exclude at 11:21-22
(stating that "Dr. Brown's testimony is based on
Defendant's own documents").
In addition, there is no evidence that Dr. Brown has
ever published his opinions regarding the 3'-5'
exonuclease activity of Taq DNA polymerase in a peerreviewed journal or presented them in any public forum.
{n15}
n15 Chiron's Motion to Exclude at 7:21-27.
Thus, the absence of peer-reviewed publication is
another factor in favor of excluding the testimony of Dr.
Brown. See Daubert II, 43 F.3d at 1319 (finding that
peer reviewed publication is a principal way that the
proponent of expert testimony can show that it satisfies
the first prong of Rule 702).
{I have left in some footnotes to highlight which
information comes from experts and which
information comes from attorney argument. -RJM}
(3) What is the known or potential rate of error
and can the theory or technique be tested?
Application of these two factors is difficult given
the circumstances surrounding the present case. See
Daubert II, 43 F.3d at 1317 n.4 (discussing the
impossibility of applying certain Daubert factors).
"The last two factors --testing and rate of error -do not apply . . . when the expert has not done
original research, but rather has surveyed available
literature and drawn conclusions that differ from
those presented by the scientists who performed the
original work."
Lust, 89 F.3d at 597. Such is the case here, and none of
the parties contends otherwise. {n16}
n16 Chiron's Motion to Exclude at 8:5-6; [POs]' Opposition to
Motion to Exclude at 11:21-22.
Thus, the Court need not consider these indicia of
reliability.
(5) Has Dr. Brown explained his methodology and
followed the scientific method as it is practiced by
at least a recognized minority of scientists in his
field?
The Ninth Circuit has repeatedly stated that where
evidence of pre-litigation research or peer review is not
available, the experts must
(1) "explain precisely how they went about
reaching their conclusions" and
(2) "point to some objective source -- a learned
treatise, the policy statement of a professional
association, a published article in a reputable scientific
journal or the like -- to show that they have followed the
scientific method as it is practiced by (at least) a
recognized minority of the scientists in their field."
Daubert II, 43 F.3d at 1319 (citing Rincon, 28 F.3d 921
at 924); see also Lust, 89 F.3d at 597. Thus, the Court
must determine whether Dr. Brown's testimony meets
this two-part test.
In explaining precisely how he went about reaching
his conclusions, see Daubert II, 43 F.3d at 1319, Dr.
Brown claims to have relied on [AIs]' laboratory
notebooks and internal documents. Dr. Brown's
declarations also cite excerpts from various scientific
articles. Accordingly, the Court finds that Dr. Brown
has satisfied the first prong of the Daubert II test.
However, the Court concludes that Dr. Brown has
failed to satisfy the second prong of the Daubert II test.
In particular, the manner in which Dr. Brown reaches
his "explained interpretation" of the data is not
scientific, and there is no evidence that his method of
reinterpretation is practiced by even a minority of
scientists in this field. See Daubert II, 43 F.3d at 1319.
He consistently departs from scientific standards in a
number of ways, including:
(1) examining only subsets of the controls (the ones
that do not disprove his theory);
(2) failing to address and exclude alternative
explanations for the data on which he bases his findings
(including explanations adopted by the authors of
published studies based on those data);
(3) ignoring the presence of background signal in
studies that infer 3'-5' exonuclease activity from counts
of radioactive markers;
(4) selectively examining only portions of the data
from a number of studies;
(5) rejecting studies reporting contrary empirical
findings because they cite another study he criticizes;
(6) relying on data from a notebook based on a
contaminated sample that the researchers themselves
had examined, tested and rejected;
(7) relying on a mismatch primer extension assay to
show activity, as opposed to inferring activity, and
misstating the data regarding that assay; and
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Daubert in Patent Cases - 5
Carnegie Mellon, Sorkin, Pharmastem
(8) relying on sentences from scientific literature
taken out of context.
Certain of these problematic methodologies are
discussed here for illustrative purposes.
{Skim these examples. -RJM}
(a) Ms. Stoffel's thin layer chromatography experiment
In his declaration, Dr. Brown concludes that the upward
smearing in Ms. Stoffel's thin-layer chromatography {n19}
n19 In thin-layer chromatography, samples are spotted side by
side near the bottom of a plate. Abramson II Decl. P 11, at
4:20-27. The bottom of the plate is then dipped into a shallow
layer of solvent that moves up the plate through capillary
action. Compounds in the samples move up the plate at
different rates, depending in part on their size: very small
compounds move rapidly to the top of the plate while larger
compounds move slowly (if at all) and remain at or near the
point where they were applied (the origin). At the end of the
experiment, the position of radioactively labeled compounds is
detected by exposing the plate to X-ray film.
{Who is Abramson? This is the first mention of that name in
the reported decision. I did not delete anything. Abramson
appears again below. -RJM}
experiment indicates that Taq DNA polymerase possesses 3'-5'
exonuclease activity. Brown Decl. PP10-11, at 3:10-4:3. [AIs]' expert
states that streaking or smearing in this experiment is not evidence of
3'-5' exonuclease activity; instead, smearing
"is extremely common with this separation technique, and
frequently arises simply from the addition of protein or salts
(e.g. in buffer solutions) to a sample."
Klug Decl. P 15, at 6:17-24. {n20}
n20 [AIs]' expert, Professor Sir Aaron Klug, received the Nobel
Prize for chemistry in 1982 and has co-authored over 216
scientific articles, principally on the structure and interaction of
nucleic acids and proteins. Klug Decl. PP 4 and 7, at 2:7-8 and
3:7-8.
Thus,
"Dr. Brown's interpretation of upward smearing in thin-layer
chromatography . . . is quite incorrect and violates established
practice for interpreting this type of experiment."
In addition, [AIs] contend that Dr. Brown again departs from
valid scientific practices by failing to consider all the experimental
controls:
The "Co 1" control on page 103 shows precisely the same kind
of streaking -- in a sample that has no enzyme at all (and
therefore, of necessity, no 3'-5' exonuclease activity). Similar
streaking is seen with the bacterial alkaline phosphatase (BAP)
samples on page 105, and this enzyme is known not to possess
a 3'-5' exonuclease activity. . . . That streaking also occurred in
negative controls and with another enzyme that lacks 3'-5'
exonuclease activity shows that it is merely a background
phenomenon. By failing to consider all the controls in this
experiment, and by failing to rule out other interpretations of
the data, Dr. Brown has departed from accepted principles of
interpretation so that his conclusions are unsound and
unreliable.
Abramson II Decl. P 12, at 5:1-5:15. The Court finds that Dr.
Brown's reinterpretation of the data from Ms. Stoffel's thin layer
chromatography experiment ignores several controls and Dr. Brown
has failed to demonstrate that such an analysis constitutes a valid
scientific practice.
(b) Ms. Stoffel's perchloric acid precipitation experiment
Dr. Brown concludes that Taq DNA polymerase has 3'-5'
exonuclease activity from the fact that solubilized material was
obtained from the single stranded, non-annealed DNA primer in Ms.
Stoffel's perchloric acid precipitation experiment. Brown Dccl. P 12.
[AIs] point out that Dr. Brown failed to consider all the controls and
failed to determine whether the data was significantly above the
background signal. Abramson II Decl. P 13, at 5:17-28. Without
explanation, Dr. Brown ignored the counts for the 10 minute
incubation and considered only the counts for the 60 minute aliquots.
In doing so, he failed to consider all the controls. [AIs]' expert
explained that a 60 minute incubation with E.coli DNA polymerase I
yielded higher counts than after 10 minutes,
"as must necessarily result when an enzyme progressively
digests a substrate and releases soluble material."
Id. at P 14. In contrast, Taq DNA polymerase did not produce such a
pattern, but instead yielded random variation. {n21}
n21 The Court recognizes that Dr. Abramson inadvertently
transposed two numbers in his declaration regarding the Stoffel
data, but this error in no way affects the conclusion of Dr.
Abramson or this Court since the actual data still indicate
random variation for the samples containing Taq DNA
polymerase.
The Court finds that Dr. Brown's reinterpretation of the data from
Ms. Stoffel's perchloric acid precipitation experiment fails to
consider the experimental data as a whole and Dr. Brown's reanalysis departs from established scientific methods.
(c) Ms. Stoffel's incorporation assay
Dr. Brown concludes that Taq DNA polymerase has 3'-5'
exonuclease activity from the presence of radioactivity in an acid
insoluble fraction in Ms. Stoffel 's incorporation assay. {n22}
n22 For the incorporation assay, Ms. Stoffel ordered
oligonucleotides (DG69 and DG70) in which the hydroxyl
group normally present at the 3' end was replaced with a 3'
phosphate group to form a "blocked" oligonucleotide that could
not be extended by a DNA polymerase enzyme. Abramson II
Decl. P 15, at 6:28-7:3.
Brown Decl. P 13, at 4:17-5:21. Dr. Brown argues that radioactively
labeled nucleotides could only be incorporated into the DNA strand
(i.e. the acid insoluble fraction) if Taq DNA polymerase had removed
the phosphate blocker at the 3' end of the DG69 and DG70 primers.
[AIs]' expert states that Dr. Brown's analysis is incomplete because it
fails to consider the relevant scientific literature concerning the
specificity that 3'-5' exonucleases have for particular substrates.
Abramson II Decl. P 17, at 7:26-8:7. In particular, [AIs] provided
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testimony that the 3'-5' exonuclease activity in DNA polymerases
requires a 3' hydroxyl (-OH) end for binding and catalysis, and will
not remove a 3' phosphate (-PO[4]) blocker. Goodman Decl. P 16,
6:22-23.
It is well known that the 3'-5' exonuclease activity of DNA
polymerases cannot remove a 3' terminal nucleotide that
contains a "blocking" 3' phosphate group. Indeed, this is shown
by the excerpt from Kornberg's treatise that Dr. Brown attaches
as Tab B to his declaration. See A. Kornberg, DNA Replication
(1980) at p. 135, Table 4-7 (stating that the 3'-5' exonuclease
activity of DNA polymerase I has "very specific" requirements
for the substrate terminus and requires a "3'-hydroxyl" group in
a specific configuration). Thus, Dr. Brown's interpretation
departs from accepted scientific principles of interpretation by .
. . invoking an explanation that is impossible, in view of the
known substrate requirements of the 3'-5' exonuclease activity
of DNA polymerase I.
Abramson II Decl. P 17, at 7:26-8:7.
In addition, Dr. Brown infers that the removal of a phosphateblocked 3' nucleotide must necessarily result from the 3'-5'
exonuclease activity of Taq DNA polymerase. Brown Decl. P 13, at
4:17-5:21. [AIs], however, advance an alternative theory that the
removal of the phosphate- blocked nucleotide was the result of an
enzyme (a "kinase") purchased from New England Biolabs, a
chemical supply house. Abramson II Decl. P 15, at 6:26-7:9. They
support this argument with passages taken from a New England
Biolabs catalog provided to the [POs], suggesting that Dr. Brown's
analysis "failed to exclude alternative explanations and also failed to
consider published data that renders his conclusion untenable." Id.
The Court finds that Dr. Brown's interpretation departs from accepted
scientific principles of interpretation by failing to consider and
exclude likely explanations of the data and by invoking an
explanation that is highly improbable, in view of the known substrate
requirements of the 3'-5' exonuclease activity of DNA polymerase.
(d) Myers, Bost, and Dakis primer extension assays containing
a double mismatch
Dr. Brown argues that the double mismatch experiments {n23}
n23 The double mismatch experiment utilizes primer DG227
and template TSYC657. Brown Decl. P 15, at 6:15-20. This
primer/template combination has a double mismatch, A/A and
C/C, at the 3' end of the primer. The assay is performed by
mixing an enzyme with radioactively labeled nucleotides and a
primer that is either perfectly matched to a template, or
mismatched at the 3' end. Abramson II Decl. P 18, at 8:11-20,
P 19, at 8:22-9:17. After a defined period, the DNA from the
unincorporated nucleotides is removed by precipitating the
DNA with acid, and then the remaining radioactivity is
measured to determine how much new DNA the enzyme has
formed by adding radioactive nucleotides onto the 3' end of the
primer. Thus, the assay measures nucleotide incorporation by
primer extension. With a perfectly matched primer, extension is
efficient, showing a high level of radioactivity on analysis. But
a mismatched base at the 3' end of the primer presents an
obstacle to further extension. If the enzyme has 3'-5'
exonuclease activity, it can remove the mismatch and extend
the primer. Removing the mismatch slows the enzyme down
somewhat, and the final radioactive count is lower with the 3'
mismatched primer than with the matched primer. This is
usually expressed as a ratio and a mismatched:matched ratio of
50-80% is typical. If the enzyme lacks 3'-5' exonuclease
activity, then two outcomes are possible. Either the enzyme will
be unable to extend the mismatched primer thereby yielding
counts that are not significantly above background, or the
enzyme will inefficiently extend the mismatched primer thereby
yielding much lower radioactive counts with the 3' mismatched
primer than with the matched primer. A high
mismatched:matched ratio implies that the enzyme has 3'-5'
exonuclease activity whereas a low ratio implies that the
enzyme lacks 3'-5' exonuclease activity.
performed by Mr. Myers, Mr. Bost, and Mr. Dakis indicate that Taq
DNA polymerase has 3'-5' exonuclease activity. Brown Decl. P
15-23, at 6:15-10:16. In particular, Dr. Brown contends that a DNA
polymerase is highly unlikely to extend the DNA from a 3'
mismatched end with incorrect A/A and C/C basepairs. Brown Decl.
P 17, at 7:3-16. According to Dr. Brown, for extension to occur from
the 3' end of primer DG 227 at the level shown by the data, it would
be necessary for Taq DNA polymerase to remove the mismatched
bases through a 3'-5' exonuclease activity.
[AIs] contend that the 3% incorporation found by Myers, Bost,
and Dakis is
"merely a reflection of the polymerase function, which can
propagate (at a slower rate) through errors in the DNA chain."
Klug Decl. P 16, at 6:26-7:13. Therefore, this level of incorporation is
"perfectly consistent with the complete absence of any 3'-5'
exonuclease activity."
Id.; see also Abramson II P 19, at 8:22-9:17. [AIs] further argue that
the two peer reviewed publications which Brown cites, Huang et al.
([POs]' Exhibits in Support of [POs]' Opposition to [AIs]' Motions
for Summary Judgment ("PX") 140, Tab 8) and Kwok et al.
(Abramson II Decl., Exhibit G), actually refute his reasoning by
indicating that 3' mismatches can in fact be extended:
Kwok did not say that extension was "highly unlikely" . . . .
Kwok reported that she actually observed extension with A:A
and C:C mismatches, but at relatively lower efficiency (50%
and 16% respectively). . . . Huang et al. report that efficiency of
A:A mismatch extension varied with time: they detected no
extension (under the conditions of their assay) at 5 minutes, and
50% extension after 60 minutes.
Abramson II Decl. P 24, at 11:4-24.
The Court agrees that neither the Kwok nor the Huang article
supports Dr. Brown's conclusion that 3% relative incorporation
necessarily indicates the presence of a 3'-5' exonuclease. By not
pointing to any objective source indicating the scientific soundness
of Dr. Brown's argument with regard to the Myers, Bost, and Dakis
assays, the [POs] have failed to satisfy their burden under Daubert II.
160217.0032 rjm
Daubert in Patent Cases - 7
Carnegie Mellon, Sorkin, Pharmastem
Accordingly, the Court finds that Dr. Brown's re-analysis of these
assays departs from established scientific principles.
(e) Ms. Lawyer's mismatch correction assay
Dr. Brown argues that Ms. Lawyer's mismatch correction assay
{n24}
n24 In the primer correction assay, a polymerase is mixed with
a primer that is mismatched at its 3' end to a template.
Abramson II Decl. P 29, at 14:20-15:6. The primer-template
pair is extended and copied millions of times in a polymerase
chain reaction (PCR). If the polymerase has 3'-5' exonuclease
activity, then it will correct the mismatch prior to extension and
copying. If the polymerase lacks 3'-5' exonuclease activity, then
the mismatch will persist and PCR will yield amplified DNA
containing the uncorrected sequence. To determine whether the
mismatch is corrected, a restriction enzyme (Bam HI) is
incubated with the amplified DNA. Id. P 30, at 15:8-23. If the
mismatch has been corrected, then Bam HI will be able to cut
the amplified DNA. Id. If the mismatch persists, then Bam HI
will not be able to cut the DNA. Id. Thus, if the DNA is
shortened, then the polymerase has corrected the mismatch and
has 3'-5' exonuclease activity. The size of the DNA fragments is
measured by gel electrophoresis.
demonstrates 3'-5' exonuclease activity in Taq DNA polymerase.
Brown Decl. PP 24-25, at 10:19-11:21. Dr. Brown relies on a single
set of experiments conducted by Ms. Lawyer, in which the incubation
of Taq DNA polymerase with the FR 435 primer and a particular
template gave rise to amplified DNA that could be cut with Bam HI.
[AIs] contend that Ms. Lawyer's experiments as a whole do not
support Dr. Brown's conclusions because she later accumulated
evidence sufficient to convince her and her supervisors that a
contaminated reagent had rendered these particular results unreliable.
Abramson II Decl. PP 32-33, at 16:19-17:27.
The Court agrees that Dr. Brown's analysis of the Lawyer assay
is flawed. Not only does Dr. Brown rely on a single piece of
preliminary data and ignores multiple pieces of subsequent
contradictory data, he also explicitly rejects the reasoning of the
individual performing the experiments. [POs] have offered nothing to
indicate such a methodology is rooted in a recognized scientific
method. Accordingly, the Court finds that Dr. Brown's
reinterpretation of the Lawyer assay departs from established
scientific principles.
(f) Mr. Bost's radioactivity release assay
Dr. Brown argues that Mr. Bost's radioactivity release assay
{n25}
n25 In the radioactivity release assay, DNA is radioactivity
labeled at its 3 ' end and incubated with a polymerase.
Abramson II Decl. at P 36, at 18:27-19:27. The DNA is then
precipitated with an acid and the soluble radioactivity (i.e.
radioactivity released from the DNA) is counted. With
appropriate controls, the amount of soluble radioactivity can be
used to measure the 3'-5' exonuclease activity of the
polymerase.
demonstrates that Taq polymerase has a "low [but] measurable level
of 3'-5' exonuclease activity." Brown Decl. PP 26-27, at 11:24-12:16.
[AIs] contend that Dr. Brown's statements regarding the Bost assay
simply have no support in the data. Abramson II PP 36-37, at
18:27-20:14. Specifically, none of the values measured for Taq DNA
polymerase exceeds a control data point representing the release of
soluble radioactivity in the absence of enzyme. Id. P 36, at
18:27-19:27.
For this reason, the Court finds that Dr. Brown departs from
accepted scientific practice by failing to consider background
variations in the Bost assay. Additionally, the Court does not agree
with [POs] that the phrase "within the variability of the background,"
as used in the [AIs]' analysis of these results, is a euphemism for data
manipulation. Plaintiff's Opposition to Motion to Exclude 15:20-21.
On the contrary, it appears to reflect a healthy respect for statistical
variability that is essential to good science. Klug Decl. P 14, at
6:5-15.
(g) Tindall article and Aliotta article
Dr. Brown bases his opinion that Taq DNA polymerase
possesses a 3'-5' exonuclease activity on the reinterpretation of
several peer-reviewed scientific papers, including a 1988 article by
Tindall and Kunkel (PX 140, Tab 2) and an article by Aliotta et al.
(PX 140, Tab 11). Brown Decl. PP 28-30, at 12:19-14:18, P 34, at
16:19-17:17. Though he uses the data presented in these publications,
Dr. Brown manipulates the data to reach conclusions at odds with the
interpretations of the paper's authors. P 29, 13:13-14:8, P 34, at
16:19-17:17. According to the [AIs],
"Dr. Brown's armchair analysis does not . . . qualify as science."
Abramson II Decl. P 40, at 22:18-19. [AIs] argue that Dr. Brown's
recalculation of the Tindall and Kunkel data and the significance he
attributes to the negative numbers that he obtains are both invalid. P
38, at 20:18-21:6.
[AIs] argue that Dr. Brown's reinterpretation of the
scientific literature demonstrates
"a complete absence of the rigour that is essential
for good science."
Klug Decl. P 17, at 8:2. The Court agrees that the
reinterpretation of peer-reviewed literature does not
conform with the Supreme Court's reasoning that
"submission to the scrutiny of the scientific
community is a component of 'good science,' in part
because it increases the likelihood that substantive
flaws in methodology will be detected."
Daubert, 509 U.S. at 593. Not only do the [POs] ask the
Court to accept as reliable an expert opinion presented
without peer review, but they also seek to discredit
analyses of the very same data that have been subjected
to the scrutiny of the scientific community.
Accordingly, the Court finds that Dr. Brown's
methodology departs from accepted scientific practice
and falls below the standard for reliability enunciated in
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Daubert in Patent Cases - 8
Carnegie Mellon, Sorkin, Pharmastem
Daubert.
[POs] argue that, while [AIs] may take issue with
Dr. Brown's conclusions, his methodologies are sound.
[POs] claim that Dr. Brown's conclusions are based on
valid scientific techniques and procedures described in
[AIs]' own laboratory notebooks. [POs]' argument,
however, misses the point; Dr. Brown did not use any of
these laboratory techniques himself. It is undisputed that
Dr. Brown performed no scientific tests of his own.
Indeed, although [AIs] provided [POs] with samples for
testing, no results of tests on those samples have been
presented.
Instead, Dr. Brown relies on "reinterpretation" and
"reanalysis" of data and findings in studies performed
by others, all of whom reach conclusions contrary to
his. Dr. Brown points to no objective source that
indicates that this "reinterpretation" or "reanalysis" is an
accepted methodology in this field. In addition, even if
it were, Dr. Brown points to no objective source that
suggests that selective reliance on data, disregard and
lack of explanation for contrary findings, ignoring
alternative explanations for empirical results, and
relying on problematic data constitutes a methodology
adopted by at least a minority of scientists in this field.
The Ninth Circuit has upheld the exclusion of
expert testimony where the expert selectively chose his
support from the scientific landscape. Lust v. Merrell
Dow Pharmaceuticals, Inc., 89 F.3d 594, 598 (9th Cir.
1996). In addition, at least one other court has excluded
expert testimony where the experts based their opinions
on data in the published articles of others who reached
contrary conclusions. Jones v. United States, 933 F.
Supp. 894, 898 (N.D. Cal. 1996) (Williams, J.) ("This
tactic does not qualify as good science. "). Similarly, in
General Electric Co. v. Joiner, 522 U.S. 136, 118 S. Ct.
512, 139 L. Ed. 2d 508 (1997), the Supreme Court
upheld the exclusion of expert testimony based on
analysis of epidemiological studies performed by others
because the expert's conclusion contradicted the
conclusions of the authors of those studies.
The Supreme Court's opinion in Joiner is
particularly illustrative. That case involved the
testimony of plaintiff's expert that exposure to PCBs
caused plaintiff's lung cancer. 118 S. Ct. at 517-19. In
Joiner, although certain epidemiological studies relied
upon by the expert found that the incidence of lung
cancer death among PCB workers was somewhat higher
than ordinarily expected, those studies ultimately
concluded that the increase was not statistically
significant and did not suggest a link between the
increase in lung cancer deaths and exposure to PCBs.
Id. at 519. The Supreme Court held that
nothing in either Daubert or the Federal Rules of
Evidence requires a district court to admit opinion
evidence which is connected to existing data only
by the ipse dixit of the expert. A court may
conclude that there is simply too great an analytical
gap between the data and the opinion proffered.
Therefore, the district court had not abused its
discretion under Daubert by excluding the expert's
testimony.
In this case, like Joiner,
"there is simply too great an analytical gap between
the data and the opinion proffered."
Id. Like the expert in Joiner, Dr. Brown analyzed data
that was not his own and reinterpreted it in a manner
inconsistent with the conclusions of those who
originally generated it. Dr. Brown does not explain why
he considers only his selective reinterpretation of the
data and ignores the large body of scientific literature
finding that Taq DNA polymerase does not contain 3'-5'
exonuclease activity. Dr. Brown, like the expert in
Joiner, fails to connect the existing data to his
conclusions using a valid scientific method practiced by
a minority of scientists in his field.
[POs]' reliance on Ruiz-Troche v. Pepsi Cola of
Puerto Rico, 161 F.3d 77 (1st Cir. 1998), does not
change the Court's conclusion. Relying on Ruiz-Troche,
[POs] contend that Daubert does not require the party
proffering the expert testimony to prove the correctness
of the expert's opinion. In Ruiz-Troche, however, the
First Circuit found that the expert's testimony on the
amount of drugs consumed by the plaintiff was
premised on a methodology that was supported by the
scientific literature. Id. at 83-84. Here, Dr. Brown has
failed to convince this Court that the selective culling of
excerpts from [AIs]' laboratory notebooks while
ignoring the large body of scientific literature based on
reproducible results is a methodology accepted by at
least a minority of scientists in the relevant field.
Similarly, [POs]' reliance on Kennedy v. Collagen
Corp., 161 F.3d 1226 (9th Cir. 1998) is unpersuasive.
[POs] cite Kennedy for the proposition that disputes as
to the strength of an experts' qualifications go to the
weight of the testimony, not its exclusion. (Letter Brief
dated April 14, 1999, at page 2.) In Kennedy, the Ninth
Circuit determined that the testimony of [POs]' expert
was admissible under Daubert because the expert had
"relied upon a wide variety of objective, verifiable
evidence" to establish that defendant's medical product
caused autoimmune disorders. Id. at 1228. The Ninth
Circuit pointed to:
(1) a peer-reviewed article co-authored by the
expert that supported his opinion,
(2) other scientific publications and clinical studies
160217.0032 rjm
Daubert in Patent Cases - 9
Carnegie Mellon, Sorkin, Pharmastem
establishing a link between the defendant's product and
autoimmune diseases, and
(3) testimony from one of defendant's scientists
validating the expert's methodology. Id. Thus, Kennedy
is distinguishable from the case at bar because Dr.
Brown's expert opinion is devoid of any such factors.
For the foregoing reasons, the Court finds that the
studies upon which Dr. Brown relied were not
sufficient, individually or in combination, to support
~his conclusion that Taq DNA polymerase contains
3'-5' exonuclease activity. See Joiner, 118 S. Ct. at 519.
This, combined with the other Daubert factors discussed
above, renders Dr. Brown's testimony inadmissible.
{n27}
n27 [AIs] also argue that Dr. Brown's testimony does not satisfy
the "fit" requirement of Fed. R. Evid. 702. Rule 702 includes
both a reliability, or "scientific knowledge," requirement and a
relevance, or "fit," requirement. Daubert, 509 U.S. at 589-91.
Because the Court has already found Dr. Brown's testimony
inadmissible under the reliability prong, the Court sees no
reason to address [AIs]' claim that his testimony also fails to
satisfy the relevance prong of Rule 702.
Accordingly, the Court hereby GRANTS [AIs]' motions
to exclude the testimony of Dr. Brown.
B. Dr. Edwin Minkley
The Chiron [AIs] argue that Dr. Minkley is not
qualified to testify on the 3'-5' exonuclease activity of
Taq DNA polymerase, noting in particular that [POs]
have not offered any evidence of Dr. Minkley's
qualifications. In particular, the Chiron [AIs] take issue
with Dr. Minkley's statement that genetic
complementation is evidence of 3'-5' exonuclease
activity or its equivalent, on which [POs] rely to support
their claim of infringement under the doctrine of
equivalents. The Chiron [AIs] argue that Dr. Minkley's
testimony is contrary to accepted scientific principles
and is directly contradicted by the Suzuki et al. article
submitted by Dr. Benkovic in his declaration in support
of [POs]' opposition to defendant's motion for summary
judgement. n30 Additionally, the Chiron [AIs] allege
that Dr. Minkley's large financial stake in the outcome
of the litigation weighs against the admissibility of his
testimony.
[POs] contend that Dr. Minkley is
"a qualified expert under FRE 702"
by virtue of his position at Three Rivers Biologicals and
his Ph.D. in biochemistry from Harvard University.
Furthermore, Dr. Minkley is one of the named
inventors on the '708 Patent.
The Court finds that the Chiron [AIs] have failed to
establish that Dr. Minkley's testimony is inadmissible
under Daubert. While Dr. Minkley's testimony is
susceptible to some of the same criticism as Dr. Brown's
testimony, Dr. Minkley does not attempt to reinterpret
other scientists' data. Thus, the strongest argument for
excluding Dr. Brown's testimony -- that his
methodologies do not represent valid scientific practices
-- cannot be applied to Dr. Minkley. Accordingly, the
Court is unwilling to exclude the testimony of Dr.
Minkley under Daubert, and therefore DENIES the
Chiron [AIs] motion to exclude the testimony of Dr.
Minkley.
C. DR. STEPHEN J. BENKOVIC
The Chiron [AIs] argue the Dr. Benkovic's
testimony is inadmissible under the relevance
requirement of Daubert. n33 Specifically, the Chiron
[AIs] contend that a significant part of Dr. Benkovic's
testimony interprets the prosecution history of the '708
Patent, contradicting the Court's own claim
construction. The Chiron [AIs] also contend that the
rest of Dr. Benkovic's testimony is irrelevant and
inadmissible because it discusses genetic
complementation and proofreading in a manner
inconsistent with established scientific principles.
[POs] argue that Dr. Benkovic's testimony on the
prosecution history of the patent is relevant background
about the role of 3'-5' exonuclease activity in the
claimed invention. Furthermore, [POs] argue that the
rest of Dr. Benkovic's testimony
"bears on infringement under the Doctrine of
Equivalents"
and therefore satisfies Daubert's relevance requirement.
Testimony from a scientific expert must meet the
two prongs of Rule 702, i.e., both a reliability, or
"scientific knowledge," requirement and a relevance, or
"fit," requirement. Daubert, 509 U.S. at 589-91. Since
the Chiron [AIs] raise no objections to the reliability of
Dr. Benkovic's testimony, the Court need only consider
its relevance. On this matter, the Court agrees with
[POs] that Dr. Benkovic's testimony directly bears on
their claim of infringement under the doctrine of
equivalents. Consequently, Dr. Benkovic's testimony is
admissible under Daubert. The Court hereby DENIES
the Chiron [AIs]' motion to exclude the testimony of Dr.
Benkovic.
2. Motions for Summary Judgment on the Issue of
Non-infringement
***
A. Literal Infringement
***
Accordingly, the Court finds that pTma15, the plasmid
encoding Tma DNA polymerase, does not literally
infringe the '708 Patent since [AIs] have established that
Tma DNA polymerase lacks 5'-3' exonuclease activity.
{Are you surprised at the simplicity (and identity)
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Carnegie Mellon, Sorkin, Pharmastem
of the fact needed to defeated literal infringement?!
-RJM}
B. Doctrine of Equivalents
***
Lastly, the fact that the accused polymerase product
has a similar name to the patented invention is
insufficient to show that they are equivalents. [POs]'
argument regarding the use of the name "Taq DNA
Polymerase I" relies solely on semantics and fails to
establish that the accused polymerase products contain
each element of the relevant claims in the '708 Patent.
See Markman v. Westview Instr., Inc., 52 F.3d 967,
974, 983 (Fed. Cir. 1995) (affirming district court's
grant of judgment as a matter of law for noninfringement despite defendant's use of the claim term
"inventory" to describe defendant's product); see also
Phillips Petroleum Co. v. Huntsman Polymers Corp.,
157 F.3d 866, 877 (Fed. Cir. 1998) (finding that the use
of the term "block copolymer" in defendants' documents
internal documents and product formulation sheets did
not raise a genuine issue of fact even though the term
"block copolymer" appeared in plaintiff's claims).
Thus, the Court grants defendants' motions for
summary judgment that plasmids pLSG5, pLSG8,
pLSG32, pRDA3-2, pLK103 and pTma15, the
processes for constructing these plasmids, and the host
cell strains containing these plasmids do not infringe the
'708 Patent under the doctrine of equivalents.
CONCLUSION
[Motion disposition as at start of case.]
IT IS SO ORDERED.
Dated: May 12, 1999
SUSAN ILLSTON
United States District Judge
FELIX L. SORKIN, Plaintiff, VS.
AMSYSCO, INC., Defendant.
CIVIL ACTION NO. H-04-4182
UNITED STATES DISTRICT COURT FOR THE
SOUTHERN DISTRICT OF TEXAS, HOUSTON
DIVISION
2006 U.S. Dist. LEXIS 39399
June 12, 2006, Decided
For Norris Hayes, Defendant: Matthew D Murphey,
Dallas, TX.
For Felix L Sorkin, Plaintiff: John Karl Buche, Buche &
Associates PC, La Jolla, CA.
For Amsysco Inc, Defendant: Daniel David Kistler,
Gordon & Rees LLP, Houston, TX; Matthew D
Murphey, Dallas, TX.
For Amsysco Inc, Counter Claimant: Daniel David
Kistler, Gordon & Rees LLP, Houston, TX.
KEITH P. ELLISON, UNITED STATES DISTRICT
JUDGE.
MEMORANDUM AND ORDER
Pending before the Court in this patent
infringement case are Defendant [AI] Amsysco, Inc.'s
("Amsysco")
- motion for summary judgment and
- objections to the declaration and expert report of
David Trejo, which is offered in support of Plaintiff
Felix Sorkin's ("Sorkin") response to the motion.
After reviewing the parties' filings and the applicable
law, the Court finds that
- the objections are justified and, therefore, that
Dr. Trejo's report is inadmissible as summary judgment
evidence [and]
- the motion for summary judgment should be and
hereby is GRANTED.
I. BACKGROUND
{Skim or skip and come back if you need it. -RJM}
[AI] Amsysco is an Illinois corporation that sells posttensioning products to building contractors. Post-tensioning systems
strengthen concrete structures by incorporating tensioned metal
tendons into those structures. A cap containing grease, which acts as
a rust inhibitor, fits over the end of each tendon at the anchoring
point. In 1995, [PO] Sorkin was issued a patent -- U.S. Patent No.
5,440,842 (the "Sorkin patent") -- for a cap containing a membrane
holding the grease in place inside the cap, to prevent leakage during
shipment. Sorkin now contends that Amsysco has infringed the
patent by selling a product that meets each limitation of claims 1, 9,
and 12 of the patent, which read as follows:
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Daubert in Patent Cases - 11
Carnegie Mellon, Sorkin, Pharmastem
Claim 1
An apparatus for sealing an anchor retaining a tendon,
whereby an end of said tendon extends from said anchor,
comprising:
a vessel member having a void and an exterior outer edge
along the perimeter of said vessel member;
a rust inhibitor disposed within said void; and
a retaining member permanently affixed around said
exterior outer edge of said vessel member,
whereby said retaining member is punched by said
tendon end upon placing said vessel in sealed
communication with said anchor.
[Claims 9 and 12 deleted. See patent linked on coursewebpage if you
want to see these claims.]
The Court held a claim construction hearing on
February 24, 2006, to determine the correct definitions
of disputed terms contained in claims 1, 9, and 12 of the
Sorkin patent. On February 27, 2006, the Court issued a
Memorandum and Order (Docket No. 89), construing
those terms as follows:
Disputed Term -> Construction
"exterior outer edge" (claims 1 and 12) ->
"the portion of the sealing cap that is adjacent to
but outside of the vessel member"
"outermost exterior outer ridge (claim 9) ->
"the portion of the sealing cap that is adjacent to
but furthest outside of the void, or 'vessel member'"
"permanently affixed" (claims 1, 9, and 12) ->
"secured and remaining without essential change,
until the cap is inserted in place into an anchor"
Shorn of technical language, Sorkin's invention
consists of a hollow cap that contains grease, which is
held in place by a thin film attached to the top of the
cap. When the end of a metal tendon is inserted into the
hollow space in the cap, it punctures the film, allowing
the grease to coat the tendon and thereby prevent it
from rusting. Amsysco's product is a very similar cap;
the only discernible difference between the two is that
the void in the Amsysco cap widens abruptly but very
slightly just below the top, forming a small ledge to
which the retaining film is attached. Sorkin contends
that this difference between the two caps is insufficient
to defeat a finding of infringement, either literal or
under the doctrine of equivalents. Amsysco now moves
for summary judgment on all of Sorkin's claims.
II. ANALYSIS
***
B. Amsysco's Objections to Dr. Trejo's Report
In support of his response to Amsysco's motion for
summary judgment, Sorkin has submitted the
declaration of David Trejo, Ph.D., P.E. (Docket No.
103). Amsysco objects to the declaration on the grounds
that it contains legal conclusions and that it does not
satisfy the standards for scientific evidence established
by Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579,
113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993).
With regard to the former concern, the Court agrees
with Amsysco that the declaration is peppered
throughout with statements expressing Dr. Trejo's
opinion that the Amsysco cap infringes Sorkin's patent,
both literally and under the doctrine of equivalents.
While FED. R. EVID. 704(a) permits experts to express
otherwise admissible opinions concerning an ultimate
issue to be decided by a court, the rule
"does not allow a witness to give legal conclusions."
United States v. Izydore, 167 F.3d 213, 218 (5th Cir.
1999). Trejo's statements regarding infringement are,
therefore, inadmissible.
Amsysco is also correct in pointing out that Dr.
Trejo's declaration does not satisfy the Daubert standard
for expert opinion testimony. Daubert requires the
Court to consider, in deciding the admissibility of such
testimony, whether an expert's theory or technique
(1) has been tested in accordance with the scientific
method;
(2) has been subjected to peer review and
publication;
(3) has a reasonable known or potential rate of
error; and/or
(4) is generally accepted in the relevant field.
509 U.S. at 593-95. These four factors are not exclusive
but, rather, should guide the "flexible" inquiry
envisioned by FED. R. EVID. 702. Daubert, 509 U.S. at
594.
Dr. Trejo's declaration self-evidently fails the
Daubert test. Not once does it cite any source for the
theories and factual assertions that it contains. While the
Court does not doubt that Dr. Trejo is a highly skilled
engineer, Daubert simply does not permit the Court to
accept expert opinion testimony that is not supported by
evidence of scientific research and testing. Nowhere in
the declaration does Dr. Trejo specify what information
or literature, apart from the caps themselves, was used
in forming his opinions.
"Information also included general literature on
post-tensioning systems and other information
related to the issues in dispute here."
"Information also included general literature on
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Daubert in Patent Cases - 12
Carnegie Mellon, Sorkin, Pharmastem
post-tensioning systems and other pertinent
information."
[Trejo Decl. at 12 and 21]. Nor does he explain how he
developed his methods of analyzing the caps or the
patent claims.
Moreover, it is clear from his declaration that Dr.
Trejo did not, in fact, perform any scientific testing on
the caps that he examined.
"Inspection of the defendant's caps (provided by
the plaintiff's counsel) indicates that a rust inhibitor
is present in the cap void. It should be noted that no
testing or analysis was performed on this material."
"[I]f the Defendant's product contains polyethylene,
this is clearly a literal infringement of the patent.
However, testing is likely needed to determine this
and is recommended."
"The defendant's cap does contain a material that
apparently is a rust inhibitor (material was not
evaluated). If this is in fact the case, the defendant's
cap system literally infringes the second part of the
third term in Claim 12."
"As already noted, both cap systems contain a
grease-like material (believed to be a rust inhibitor)
in their voids with the purpose of preventing
corrosion of the tendon."
Dr. Trejo's credibility is further undermined by his
expression, despite his failure to determine what the
substance inside the caps actually is, of the opinion that
"the material in the void of the Defendant's cap
performs an equivalent function as described in the
'842 patent, here specifically in Claim 12."
Finally, Dr. Trejo makes many bald assumptions
regarding the caps' functions and purposes.
"Visual observations of the Defendant's cap and the
patented cap require careful examination to
distinguish any differences and use and
performance of the Defendant's cap system, based
on observations and connecting these caps, is
similar, if not exactly the same as the patented
cap."
C. Literal Infringement
***
Indeed, Sorkin has essentially conceded the literal
infringement issue by quibbling over depth. The prior
art contained a retaining member located eight
millimeters inside of the cap. Amsysco's retaining
member is one twentieth of an inch (that is, about one
and one-quarter millimeters) inside of the cap. The
Court cannot conceive of any non-arbitrary line that can
be drawn between the two, rendering the first membrane
"outside" and the second "inside" of their respective
caps. How would Sorkin characterize a retaining
member placed one and one-half millimeters inside of
the cap? Three millimeters? One suspects that Sorkin
would prefer to use a sliding scale that favors a finding
of infringement at any depth of fewer than eight
millimeters. This the Court cannot do. Accordingly,
summary judgment is hereby GRANTED for Amsysco
on Sorkin's claim of literal infringement of Claims 1, 9,
and 12 of the Sorkin patent.
D. Infringement Under the Doctrine of Equivalents
***
...As Sorkin so adamantly maintains, the only
difference between his cap and Amsysco's is the
location of the film. In other words, it is the same
difference that allowed Sorkin to patent his cap despite
the existence of the prior art.
Sorkin cannot defend his patent by pointing to this
difference and, at the same time, dismiss the importance
of the difference in the infringement context. He may
not, that is, use the claim terms, limited as they are by
the prosecution history, as both shield and sword.
Accordingly, summary judgment is hereby GRANTED
for Amsysco on Sorkin's infringement claim under the
doctrine of equivalents.
III. CONCLUSION
[Disposition of motions and objections as at start of
case.]
"Both cap systems contain a grease-like material in
their voids with the purpose of preventing
corrosion of the tendon. Clearly the material in the
voids of the cap systems is placed in the void to
perform equivalent functions."
"The Defendant's product is clearly for sealing the
opening of an anchor."
For all of the aforementioned reasons, Dr. Trejo's report
does not constitute adequate summary judgment
evidence, and the Court therefore declines to consider it
in deciding Amsysco's motion.
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Daubert in Patent Cases - 13
Carnegie Mellon, Sorkin, Pharmastem
PHARMASTEM THERAPEUTICS, INC., Plaintiff, v.
VIACELL INC., et al., Defendants.
C.A. No. 02-148 GMS
UNITED STATES DISTRICT COURT FOR THE
DISTRICT OF DELAWARE
2004 U.S. Dist. LEXIS 18638
September 15, 2004, Decided
Reconsideration granted by, in part, Injunction denied
by, Judgment entered by Pharmastem Therapeutics v.
Viacell, Inc., 2004 U.S. Dist. LEXIS 25176 (D. Del.,
Dec. 14, 2004)
Philip A. Rovner, Esquire of Potter Anderson &
Corroon LLP, Wilmington, Delaware. Counsel for
Plaintiff. Of Counsel: Paul J. Andre, Esquire, Lisa
Kobialka, Esquire of Perkins Coie LLP, Menlo Park,
California.
Jeffrey L. Moyer, Esquire of Richards Layton & Finger,
Wilmington, Delaware, Richard D. Kirk, Esquire of
Morris James Hitchens & Williams LLP, Wilmington,
Delaware, and Robert F. Stewart, Esquire of Dilworth
Paxson LLP, Wilmington, Delaware. Counsel for
Defendants. Of Counsel: Paul F. Ware, Esquire, John C.
Englander, Esquire, James C. Rehnquist, Esquire, James
W. McGarry, Esquire, and Elaine Herrmann Blais,
Esquire of Goodwin Procter LLP, Boston,
Massachussetts; William F. Abrams, Esquire, Thomas
F. Chaffin, Esquire and Randal Ivor-Smith, Esquire of
Pillsbury Winthrop LLP, Palo Alto, California; and
James L. Rodgers, Esquire, Evelyn H. McConathy,
Esquire, and Lisa Burgin Conte, Esquire of Dilworth
Paxson LLP, Philadelphia, Pennsylvania.
Gregory M. Sleet, UNITED STATES DISTRICT
JUDGE.
MEMORANDUM OPINION
I. INTRODUCTION
On February 22, 2002, PharmaStem Therapeutics,
Inc. ("PharmaStem") filed suit against [defendant AIs]
alleging infringement of [two] United States Patents. ...
The Patents-In-Suit are generally directed toward
cryopreserved therapeutic compositions containing
hematopoietic stem cells obtained from umbilical cord
or placental blood of a newborn, the '681 Patent, and
methods pertaining to the therapeutic use of such
compositions, the '553 Patent.
ViaCell asserted the defenses of invalidity for
anticipation, indefiniteness, inequitable conduct and
obviousness.
[ 01/13/03 Markman hearing
10/10/03 jury trial ]
During trial, both parties properly moved for judgment
as a matter of law ("JMOL") pursuant to Rule 50(a) of
the Federal Rules of Civil Procedure. The court
reserved ruling on all JMOL motions.
[ 10/29/03 The] jury returned a unanimous
verdict on all claims in favor of [PO] PharmaStem. The
jury
- found that each of the defendants infringed the
claims of the '681 and '553 Patents[;]
- found that each of the defendant's infringement of
those patents was willful[;]
- upheld [the patents'] validity and enforceability[;]
- found that PharmaStem did not commit any antitrust violation[;] and
awarded PharmaStem past damages in the amount
of $ 7,126,544.92.
[ 10/30/03 The court entered judgment on the
verdict.
Following the jury's verdict, [various defendants
filed various motions] and PharmaStem filed a motion
for enhanced damages, attorneys' fees, pre judgment
interest and post judgment interest, a motion for a
permanent injunction, as well as a motion to strike [one
of the AIs affidavits in support the affidavit of Chris
Adams submitted in support of a] motion to alter or
amend the judgment. Addressing these motions
collectively herein, the court will
- enter judgment as a matter of law that defendants
do not infringe the '553 patent and
- grant a partial new trial on the issue of
infringement of the '681 Patent.
***
III. DISCUSSION
***
B. Defendants' Motion for a New Trial
***
3. Infringement of the '681 Patent
a. Dr. Hendrix's Testimony
As one of the bases for their motion for a new trial
on infringement of the '681 Patent, the defendants
contend that Dr. Mary Hendrix, PharmaStem's
infringement expert, should not have been permitted to
testify. During the pretrial stage of proceedings, the
defendants objected to Dr. Hendrix's testimony in a
motion in limine and then again at the close of trial
moved to strike the doctor's testimony. The court denied
both of these motions, but will revisit its rulings in light
of the evidentiary record now before it.
Rule 702 has three requirements as to expert
opinions:
160217.0032 rjm
Daubert in Patent Cases - 14
Carnegie Mellon, Sorkin, Pharmastem
1) the witness must be an expert;
2) the witness must testify to scientific, technical,
or other specialized knowledge; and
3) the testimony must assist the trier of fact.
See United States v. Velasquez, 64 F.3d 844, 849, 33
V.I. 265 (3d Cir. 1995) (citations omitted). The U.S.
Supreme Court's decision in Daubert v. Merrell Dow
Pharmaceuticals, 509 U.S. 579, 125 L. Ed. 2d 469, 113
S. Ct. 2786 (1993), established a gatekeeping role for
trial court judges in determining the admissibility of
expert testimony on scientific evidence. When an expert
bases opinion testimony on scientific knowledge, the
testimony will not be admitted unless it is derived by
the scientific method and is supported by "appropriate
validation." Daubert, at 590. This standard of
evidentiary reliability focuses on the scientific validity
of the expert's methods rather than the soundness of his
specific conclusions. Id. at 589
("[the] inquiry into the reliability of, scientific
evidence . . .. requires a determination as to its
scientific validity.");
see also Oddi v. Ford Motor Co., 234 F.3d 136, 145 (3d
Cir. 2000); United States v. Shea, 957 F. Supp. 331 at
337. An expert's opinion is reliable if it is based on the
"methods and procedures of science" rather than on
"subjective belief or unsupported speculation"; the
expert must have "good grounds" for his or her belief.
See Daubert, 509 U.S. at 589.
samples in reaching her opinion. Hendrix Tr. at 1038.
Moreover, she explicitly testified that her opinion that
all of the defendants' cord blood units infringe the '681
Patent was based on the fact that the defendants
"promise stem cells for pediatric and adult
transplantation." Hendrix Tr. at 1021. In this regard, her
opinions are not based upon any methods or procedures
of science in general and certainly not upon her specific
expertise as a stem cell biologist, no matter how
knowledgeable she may have been in that field. The
court therefore determines that her opinion of
infringement is no more than a lay-person's
interpretation of the defendants' marketing materials.
The materials relied upon by Dr. Hendrix may be
persuasive on the issue of infringement, but permitting
PharmaStem to couch its presentation of this evidence
in the form of an expert opinion was an error.
IV. CONCLUSION
***
Dated: September 15, 2004
Gregory M. Sleet
UNITED STATES DISTRICT JUDGE
The defendants contend that the subject of Dr.
Hendrix's testimony was not one for which expertise
was necessary in that she based her infringement
opinion entirely on an analysis of the defendants'
marketing materials, without ever considering any data
regarding the composition of the defendants' cord blood
units. Dr. Hendrix is an accomplished stem cell
biologist, but is not qualified as an expert in marketing
or advertising. Moreover, her so-called analysis of the
defendants' marketing materials was well within the
jury's common knowledge, common sense and common
experience. See United States v. Stevens, 935 F.2d
1380, 1399-1400 (3d Cir. 1991) (upholding Federal
Rule of Evidence 403 exclusion of expert testimony
regarding eye witness identification where the evidence
was susceptible of elucidation without specialized
knowledge and jury could have ascertained through
common sense). In view of these considerations, the
court is persuaded that Dr. Hendrix's conclusion,
evidenced in her expert report and adduced through her
testimony, that 100 % of the defendants' cord blood
units infringe the '681 Patent was based upon a legally
improper methodology that was unreliable as a matter
of law under Daubert.
Significantly, Dr. Hendrix's admitted that she did
not review or analyze any of the defendants' cord blood
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