United States District Court, S.D. New York
September 13, 2005.
IRA SANDERS, M.D. and CHRISTOPHER M. SHAARI, M.D., Plaintiffs,
THE MOUNT SINAI SCHOOL OF MEDICINE, THE MOUNT SINAI HOSPITAL and THE MOUNT SINAI MEDICAL CENTER, Defendants.
The opinion of the court was delivered by: KEVIN FOX, Magistrate Judge
MEMORANDUM and ORDER
Plaintiffs Ira Sanders, M.D., and Christopher M. Shaari, M.D.,
allege, inter alia, breach of contract against The Mount Sinai
School of Medicine, The Mount Sinai Hospital and The Mount Sinai
Medical Center ("Mount Sinai" or "defendants").*fn1 Before
the Court is the defendants' motion to strike the expert report
of Maurice B. Stiefel ("Stiefel"), an attorney employed at the
law firm Bryan Cave LLP. The plaintiffs oppose the motion. It is
In 1998, Drs. Sanders and Shaari were awarded a patent (the
"Botulinum Use Patent") for their development of a method for treating the symptoms of
eight medical conditions, including hyperhydrosis (excessive
sweating) and rhinorrhea (runny-nose and post-nasal drip), using
the neurotoxin, botulinum toxin (the "Invention").*fn2
Previously, pursuant to an institutional policy governing the
development and patenting of scientific inventions by its
faculty, Mount Sinai had elected to exercise its option to accept
an assignment by the plaintiffs of their rights in the Invention.
Accordingly, on April 13, 1994, Drs. Sanders and Shaari assigned
their right, title and interest in the Invention to Mount Sinai,
together with all patent rights thereto, and agreed to cooperate
with Mount Sinai in submitting a patent application to the United
States Patent and Trademark Office ("PTO"). According to the
plaintiffs, pursuant to the Mount Sinai Faculty Handbook that
governed the terms of employment of faculty during the period
1989 through 1996, in return for their assignment of their rights
in the Invention, Mount Sinai agreed to pay them a specified
percentage of any net revenues derived from its development.
Furthermore, plaintiffs contend, under New York law, the
defendants had an implied obligation to use reasonable efforts to
commercialize the Invention so as to generate such revenues.
On March 29, 2001, the PTO declared Interference No. 104,688,
between the Botulinum Use Patent assigned to Mount Sinai by the
plaintiffs and a patent that had been filed by "Aoki et al." and
assigned to the Allergan Pharmaceutical Corporation ("Allergan").
During the interference proceeding that followed, the PTO sought
to determine which party had priority to the patented uses of the
botulinum toxin in the treatment of hyperhydrosis and rhinorrhea.
The priority of the uses of the botulinum toxin for other medical
conditions covered by the Botulinum Use Patent was not challenged by Allergan and, therefore, was not
considered in the interference proceeding.
On July 1, 2001, Mount Sinai entered into a licensing agreement
with Allergan, pursuant to which Mount Sinai licensed to Allergan
its rights under the Botulinum Use Patent to use botulinum toxin
for the treatment of hyperhydrosis. Allergan subsequently
developed and commercialized the botulinum toxin under the
product name, "Botox."
On November 9, 2001, Mount Sinai and Allergan presented to the
PTO, inter alia, provisional concessions of priority with
respect to the treatment of hyperhydrosis and rhinorrhea,
respectively. Thereafter, on February 26, 2002, the PTO issued a
decision that, among other things, accepted Mount Sinai's
concession of priority with respect to the treatment of
hyperhydrosis and, as a consequence, struck seven claims from the
Botulinum Use Patent. The plaintiffs contend that this aspect of
the PTO's decision constituted the loss of substantial patent
coverage by Mount Sinai. The plaintiffs contend further that
Mount Sinai's failure to police and enforce the rights contained
in the Botulinum Use Patent, so as to avoid such a loss of patent
coverage, constituted a breach of its implied obligation, as set
forth in the parties' patent assignment agreement, to use
reasonable efforts to commercialize the patent.
Stiefel's expert report speaks to these claims. In Stiefel's
view, Mount Sinai's failure to adopt any of three possible
courses of action by which it might have avoided the loss of
substantial patent coverage constituted a "failure to exercise
reasonable steps to maintain all, or as much as possible, of the
original patented subject matter" contained in the Botulinum Use
Patent. Thus, according to Stiefel, before settling the
interference proceeding, Mount Sinai should have sought a
"reissue" of the Botulinum Use Patent such that claims which were
likely to be stricken by the PTO would be retained in modified form. In
addition, or alternatively, in Stiefel's view, Mount Sinai should
have investigated evidence of early invention activity by Drs.
Sanders and Shaari, which would have allowed Mount Sinai to
contest priority with respect to the treatment of hyperhydrosis
and thus maintain its entire patent coverage intact. Finally,
according to Stiefel, Mount Sinai should have investigated
evidence that Drs. Sanders and Shaari may have been the first to
conceive the Invention and "commence diligence," that is, before
"Aoki et al." entered the field, again, in an effort to preserve
the "essential breadth of the patent coverage."
Mount Sinai contends that Stiefel's report is improper because
it invades the province of the court by offering legal
conclusions concerning the scope of the claims in the Botulinum
Use Patent. The defendants also contend that Stiefel's report
questions improperly decisions made by Mount Sinai, which, as the
owner of the Botulinum Use Patent, has exclusive control over its
use and disposal. Mount Sinai, therefore, seeks an order striking
Stiefel's report or, in the alternative, a reasonable amount of
time in which to submit a rebuttal.
For their part, the plaintiffs argue that the opinions
expressed by Stiefel in his report relate to the reasonableness
of certain courses of action open to Mount Sinai at the time of
the PTO's interference proceeding and, thus, are not legal
conclusions concerning patent protection. According to the
plaintiffs, Stiefel's discussion of the legal options available
to Mount Sinai "forms the premise for his opinions, in the same
manner as an expert assumes and discusses certain factual
predicates upon which an opinion is premised." Moreover,
plaintiffs argue, although they assigned their rights in the
Botulinum Use Patent to the defendants, nevertheless they are
entitled to challenge the reasonableness of the defendants'
actions where, as the plaintiffs allege, the defendants have "forfeited significant
Fed.R.Evid. 702 provides the following:
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 an opinion or otherwise, if
(1) the testimony is based upon sufficient facts or
data, (2) the testimony is the product of reliable
principles and methods, and (3) the witness has
applied the principles and methods reliably to the
facts of the case.
In Daubert v. Merrill Dow Pharmaceuticals, Inc.,
509 U.S. 579, 113 S. Ct. 2786 (1993), the Supreme Court explained that a
federal trial court has a gatekeeping responsibility when opinion
evidence is sought to be presented to a jury. The court must
ensure that the testimony to be presented to the jury is based
upon methods and procedures that are reliable, that is, "more
than subjective belief or unsupported speculation." Daubert,
509 U.S. at 590, 113 S. Ct. at 2795.
"Experts may testify on questions of fact as well as mixed
questions of fact and law." Fiataruolo v. United States,
8 F.3d 930, 941 (2d Cir. 1993). However, "[i]t is a well-established
rule in this Circuit that experts are not permitted to present
testimony in the form of legal conclusions." Densberger v.
United Technologies Corp., 297 F.3d 66, 74 (2d Cir. 2002)
(quoting United States v. Articles of Banned Hazardous
Substances, 34 F.3d 91, 96 [2d Cir. 1994]); see also Hygh
v. Jacobs, 961 F.2d 359, 363 (2d Cir. 1992) ("This circuit is in
accord with other circuits in requiring exclusion of expert
testimony that expresses a legal conclusion.") (citing cases).
Testimony in the form of legal conclusions is improper because it
"usurp[s] the roles of judge and jury." United States v. Russo,
74 F.3d 1383, 1395 (2d Cir. 1996). Furthermore, "the Supreme
Court has repeatedly held that the construction of a patent claim
is a matter of law exclusively for the court." Markman v. Westview Instruments,
Inc., 52 F.3d 967, 977 (Fed. Cir. 1995).
The Court has reviewed the parties' written submissions and has
determined that the expert report prepared by Stiefel is
admissible. In his report, Stiefel describes each of the eighteen
claims included in the original Botulinum Use Patent and
identifies the elements of the patent claims that were lost as a
result of the 2002 judgment of the PTO. For example, with respect
to claim 1 of the Botulinum Use Patent, Stiefel explains that
"one of the disease symptoms referred to for treatment is COPD
(Chronic Obstructive Pulmonary Disease), e.g., emphysema and
chronic bronchitis. Because Mt. Sinai lost claim 1 in the
Interference, it lost all patent coverage for treatment of that
Defendants argue that this and similar passages construe or
interpret the claims of the Botulinum Use Patent in a way that
involves claim construction, which is a question of law for the
court. However, it appears that the purpose of these passages is
not to engage in claim construction, but, rather, to lay a
foundation for the opinion, expressed by Stiefel, that Mount
Sinai failed to take reasonable measures to commercialize the
Botulinum Use Patent. As noted above, Stiefel proposes three ways
in which Mount Sinai might have taken reasonable steps to avoid a
loss of patent coverage at the time of the interference
proceeding. In the absence of a discussion of the content of the
claims contained in the original patent, Stiefel's proposal in
this regard would lack both context and factual support.
Therefore, when examined in the proper light, Stiefel's
discussion of the claims included in the Botulinum Use Patent is
"not a simple bald assertion of the law and [is] not designed to
invade the province of the trial court." Fiataruolo,
8 F.3d at 942. Defendants argue that Stiefel's report questions improperly
decisions made by Mount Sinai concerning the use and disposal of
the Botulinum Use Patent. As noted above, the plaintiffs allege
that Mount Sinai's failure to avoid the loss of patent coverage
constituted a breach of its implied obligation, as set forth in
the parties' patent assignment agreement, to use reasonable
efforts to commercialize the patent. Stiefel's report assumes
that such an implied obligation exists. Under the circumstances,
given that the plaintiffs were permitted to amend the complaint
to add this claim and that a decision on the merits of the
complaint has not been reached, Stiefel's decision to proceed on
such an assumption was not inappropriate.
The defendants have requested, in the event that Stiefel's
report is determined to be admissible, an order permitting them a
reasonable amount of time in which to submit a rebuttal. However,
as the plaintiffs point out, the defendants have already offered
the expert report of Ashley J. Stevens, the Director of the
Office of Technology Transfer at Boston University, which
addresses the issues raised in Stiefel's report directly.
Consequently, there does not appear to be any need for an
additional expert report on this subject.
For the reasons set forth above, the defendants' motion to
strike Stiefel's expert report is denied.
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