United States District Court, E.D. Louisiana
THE UNITED STATES and THE ADMINISTRATORS OF THE TULANE EDUCATIONAL FUND, Plaintiffs
CYTOGEL PHARMA, LLC, Defendant
ORDER AND REASONS
MORGAN UNITED STATES DISTRICT JUDGE
the Court is a Motion in Limine on the Admissibility of the
Expert Testimony of Defendant Cytogel Pharma, LLC's
(“Cytogel”) Expert Dr. Stephen G. Davies, filed
by Plaintiff the Administrators of the Tulane Educational
Fund (“Tulane”) and Counterclaim-Defendant Dr.
James E. Zadina. Cytogel opposes. For the reasons that follow,
the motion is GRANTED IN PART and
DENIED IN PART.
1990s, Dr. Zadina and his colleagues at Tulane University
researched and developed opioid compounds related to
endomorphins, which are opioid peptides found naturally in
the human body. Based on their research, Tulane obtained
two patents, U.S. Patent Nos. 5, 885, 958 (“the
'958 Patent”) and 6, 303, 578 (“the '578
Patent”), claiming these compounds. On December 1,
2003, Tulane licensed the patents to Cytogel.
Tulane and Cytogel signed a Licensing Agreement, Dr. Zadina,
who was an employee of Tulane and the Department of Veterans
Affairs (“VA”), began performing consulting work
for Cytogel pursuant to a Consulting Agreement. Dr. Zadina
advised Cytogel on the development of Cyt-1010, a synthetic
opioid peptide covered by the '958 and '587 Patents,
for commercial use as an analgesic. Cytogel alleges Dr. Zadina
accessed confidential data and information relating to
Cyt-1010 and used this information to further his own secret
work on the development of compounds that would compete
directly with Cyt-1010.
September 8, 2010 onward, Cytogel “disengaged
from” Dr. Zadina. On August 22, 2012, Dr. Zadina and his
colleague at Tulane Dr. Laszlo Hackler formally assigned to
Tulane and the VA their ownership rights to a patent
application they filed for a group of synthetic opioid
compounds. On May 6, 2014, the resulting patent,
U.S. Patent No. 8, 716, 436 B2 (“the '436
Patent”), issued. Cytogel alleges the compound claimed
in the '436 Patent is a “modified version of
Cyt-1010 and plainly designed to compete with [Cyt-1010] as a
potential pharmaceutical treatment.”
August 19, 2016, the United States and Tulane filed suit
against Cytogel for declaratory judgments of ownership and
inventorship of the '436 Patent. On September 7, 2016,
Cytogel filed thirteen counterclaims against Plaintiffs
Tulane and the United States, joining Dr. Zadina as
Counterclaim-Defendant. On July 23, 2018, Cytogel filed its
Second Amended and Restated Counterclaims, which included a
fourteenth counterclaim to correct the inventorship of the
Davies prepared two expert reports for Cytogel. One report
addresses ownership and inventorship of the '436 Patent
and infringement of the '958 and '578
Patents. The other report is a rebuttal report to
the report of Cytogel's expert Dr. Jane V. Aldrich, who
prepared a report on the relationship between Cyt-1010 and
the '436 Patent compounds.
and Dr. Zadina filed the instant motion on September 10,
2018. They seeks to prevent Dr. Davies from
testifying at trial on the following five issues: (1) the
inventorship of the '436 Patent, (2) Dr. Zadina's
motivation (3) the infringement of the '958 and '578
Patents, (4) Cyt-1010's status as a “lead compound,
” and (5) the date of inventorship of the '436
Patent. Cytogel opposes.
September 20, 2018, the Court, on its own motion, ordered
that there be a separate trial for Count 2 of the Complaint
and Count 14 of Cytogel's Second Amended and Restated
Counterclaims, which involve inventorship of the '436
702 of the Federal Rules of Evidence permits an expert
witness with “scientific, technical or other
specialized knowledge” to testify if such testimony
“will help the trier of fact to understand the evidence
or to determine a fact in issue, ” so long as (1)
“the testimony is based upon sufficient facts or data,
” (2) “the testimony is the product of reliable
principles and methods, ” and (3) “the expert has
reliably applied the principles and methods to the facts of
the case.” Furthermore, Rule 703 provides:
“An expert may base an opinion on facts or data in the
case that the expert has been made aware of or personally
observed.” Rule 703 continues:
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. But if the facts or data would otherwise be
inadmissible, the proponent of the opinion may disclose them
to the jury only if their probative value in helping the jury
evaluate the opinion substantially outweighs their
general rule, questions relating to the bases and sources of
an expert's opinion affect the weight of the evidence
rather than its admissibility, and should be left for the
finder of fact. “Unless wholly unreliable, the
data on which the expert relies goes to the weight and not
the admissibility of the expert opinion.” Thus,
“[v]igorous 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.” The Court is not concerned
with whether the opinion is correct, but whether the
preponderance of the evidence establishes that the opinion is
reliable. “It is the role of the adversarial
system, not the court, to highlight weak
Court notes Tulane and Dr. Zadina do not argue Dr.
Davies' testimony should be excluded based on his
qualifications. The Court has reviewed Dr. Davies'
qualifications as outlined in his expert
reports and finds he has the scientific,
technical or other specialized knowledge to testify to the
technical questions at issue in the instant matter.
Because the first trial in this case does not deal with
issues of inventorship of the '436 Patent, Dr.
Davies' testimony on inventorship is not
and Dr. Zadina argue the Court should exclude Dr. Davies'
testimony on inventorship of the '436 Patent because Dr.
Davies' testimony is not based on firsthand knowledge of
the factual issues relevant to inventorship. Cytogel
argues Dr. Davies' analysis would be helpful to a
factfinder. The Court notes this issue is relevant
only to Count 2 of the Complaint and Count 14 of
Cytogel's Second Amended and Restated Counterclaims,
which are the only claims involving inventorship of the
'436 Patent. The Court has ordered a separate trial for
those counts. As a result, the Court grants Tulane and
Dr. Zadina's motion to exclude Dr. Davies' testimony
on inventorship at the first trial in this case. To the
extent the motion relates to Dr. Davies' testimony at the
second trial, the Court denies Tulane and Dr. Zadina's
motion without prejudice, to be refiled, if appropriate, at
the time of that trial.
Dr. Davies' testimony on whether the '436 Patent
resulted or emerged from information provided by Cytogel is
relevant, reliable, and helpful to a factfinder.
Davies' expert report includes a comment that “Dr.
Zadina was influenced to produce the ['436 Patent
compound], and was further motivated to test [the compounds]
by his consultation with Cytogel.” Cytogel
argues this supports his opinion that the “'436
Patent compounds “resulted and emerged from information
obtained from Cytogel.”Tulane and Dr. Zadina argue the
Court should exclude Dr. Davies' testimony on Dr.
Zadina's mental processes in finding he was
“motivated” to invent the '436 Patent
compounds by information he obtained from
Cytogel. Expert opinions may not be based on
“subjective belief or unsupported
speculation.” “Inferences about the intent or
motive of parties or others lie outside the bounds of expert
testimony.” Dr. Davies is not allowed to testify
about Dr. Zadina's motivation.
majority of Dr. Davies' opinions parallel the language of
the Consulting Agreement. The Court denies Tulane and
Dr. Zadina's motion in limine on this issue. Dr. Davies
will be permitted to give his opinion that the '436
Patent compounds resulted and emerged from information
obtained from Cytogel. At trial, Dr. Davies should couch his
testimony in the language of the Consulting Agreement rather
than speculate about Dr. Zadina's motivation.
Dr. Davies' testimony on whether Tulane and Dr. Zadina
infringed the '958 and '578 Patents is relevant,
reliable, and helpful to a factfinder.
Davies' expert report includes a section that concludes
Dr. Zadina, Tulane, and the VA infringed the '958 and
'578 Patents. He bases his conclusion on his review of
the '958 and '578 Patents, his review of the '436
Patent, his being informed Cytogel held an exclusive license
to the '958 and '578 Patents, deposition transcripts,
and correspondence between Dr. Zadina and researchers in his
laboratory. Tulane and Dr. Zadina argue the Court
should exclude Dr. Davies' testimony on infringement
because they allege the patent license was not exclusive, and
Cytogel does not have the right to enforce the '958 and
'578 Patents against Tulane.
relating to the bases and sources of an expert's opinion
affect the weight of the evidence rather than its
admissibility and should be left for the finder of
fact. The Court finds the issues Tulane and
Dr. Zadina raise go to the weight and not the admissibility
of his testimony. Tulane and Dr. Zadina may raise these
issues on cross-examination. The Court also finds Dr.
Davies' testimony on the alleged infringement will help
the factfinder understand the similarities between and among
Cyt-1010, EM-1, and the '436 Patent compounds and how
Cyt-1010 and EM-1 were used in developing the '436 Patent
compounds. As a result, the Court denies Tulane and Dr.
Zadina's motion on this issue. Dr. Davies' testimony
on alleged patent infringement will be allowed.
Dr. Davies' testimony on whether Cyt-1010 is a
“lead compound” is relevant, reliable, and
helpful to a factfinder.
Davies' expert report includes a section describing the
process for identifying a “lead compound” in
medicinal chemistry. As the report explains, when researchers
study potential pharmaceutical compounds, they conduct
testing to identify leading candidates for further research,
which they label “lead compounds.” The report
states Cytogel identified Cyt-1010 as a lead compound through
preclinical testing. Dr. Davies concludes Dr. Zadina, when
developing the '436 Patent, relied on the testing Cytogel
conducted to identify Cyt-1010 as a lead compound and thereby
“avoided costly trial and error.” Tulane and
Dr. Zadina assert, based on Dr. Davies' deposition
testimony, that the data that establish Cyt-1010 as a lead
compound is contained in the '958 Patent,  which was
developed by Dr. Zadina for Tulane before Tulane and Cytogel
signed the Licensing Agreement. Tulane and Dr. Zadina
argue this shows Dr. Davies' testimony is
self-contradictory and unreliable.
and Dr. Zadina do not challenge Dr. Davies' explanation
of how lead compounds are identified. The Court finds Dr.
Davies' testimony on this subject, along with Dr.
Davies' conclusion that Cytogel identified Cyt-1010 as a
lead compound, will help the jury determine the extent to
which Dr. Zadina's work with Cytogel may have contributed
to his development of the '436 Patent
compounds. Tulane and Dr. Zadina's arguments
regarding alleged contradictions in Dr. Davies' testimony
are best raised on cross-examination. As a result, the Court
denies Tulane and Dr. Zadina's motion to exclude Dr.
Davies' testimony on Cyt-1010's identification as a
lead compound through preclinical testing and Dr.
Zadina's alleged reliance on this testing.
Dr. Davies' testimony regarding the date of inventorship
of the '436 Patent is relevant, reliable, and helpful to
Davies' expert report includes a chart on the timing of
Dr. Zadina's research.The chart lists 2005 as the
date for Dr. Zadina's first conceived the idea for the
'436 Patent compounds. The chart proceeds to list the
approximate dates of several of Cytogel's tests on
Cyt-1010 between 2006 and 2009 and the approximate dates of
Dr. Zadina's synthesizing or testing '436 Patent
Compounds between 2007 and 2010. Based on the timeline,
Dr. Davies concludes Dr. Zadina's consulting work for
Cytogel informed his development of the '436
Patent. When asked about ...