United States District Court, D. New Jersey
November 1, 2005.
DAIICHI PHARMACEUTICAL CO., LTD. and DAIICHI PHARMACEUTICAL CORPORATION, Plaintiffs,
APOTEX, INC. and APOTEX CORP., Defendants.
The opinion of the court was delivered by: WILLIAM BASSLER, District Judge
Defendants Apotex, Inc. and Apotex Corp. (collectively as
"Apotex" or "Defendants") filed two motions in limine: (1) to
exclude the expert report and testimony of Richard Killworth; and
(2) to exclude the expert report and testimony of Dr. Phillip
Plaintiffs Daiichi Pharmaceutical Co. Ltd., and Daiichi
Pharmaceutical Corporation (collectively as "Daiichi" or
"Plaintiffs") filed a motion in limine to exclude or limit the
expert testimony of Joseph Robinson.
For the reasons set forth below, Defendants' motion is
denied, and Plaintiffs' motion is denied.
Rule 702 of the Federal Rules of Evidence, which governs expert
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.
Under the Federal Rules of Evidence, the judge has a
gatekeeping responsibility to "ensure that any and all scientific testimony or evidence admitted is not only relevant but
reliable." Daubert v. Merrell Dow Pharmaceuticals, Inc.,
509 U.S. 579, 589 (1993). The purpose of the gatekeeper function "is
to make certain that an expert, whether basing testimony upon
professional studies or personal experience, employs in the
courtroom the same level of intellectual rigor that characterizes
the practice of an expert in the relevant field." Kumho Tire
Co., Ltd. v. Carmichael, 526 U.S. 137
, 152 (1999). In Elcock v.
Kmart Corp., 233 F.3d 734 (3d Cir. 2000), the Third Circuit held
that "before an expert witness may offer an opinion pursuant to
Rule 702, he must first be qualified by virtue of specialized
expertise." 233 F.3d at 741. While the Circuit employs a liberal
standard of qualifying experts, an expert's testimony may,
nonetheless, be excluded if his specialized experience is in a
field or specialty that is not directly on point with the matter
before the court. Elcock, 233 F.3d at 742; see also Aloe
Coal Co. v. Clark Equip. Corp., 816 F.2d 110
(3d Cir. 1987). An
expert's conclusion may be drawn from a set of observations based
on extensive and specialized experience, but his opinion must be
more than mere speculation. See Daubert, 509 U.S. at 590;
Elcock, 233 F.3d 745. If it is determined that the expert's
opinion has a reliable basis in the knowledge and experience of
his discipline and is relevant to the matter before the court,
the expert is permitted wide latitude to offer opinions, including those that are not based on firsthand knowledge or
observation. Daubert, 509 U.S. at 592; Kumho Tire,
526 U.S. at 148.
A. Richard Killworth
Apotex requests that the Court exclude the expert testimony of
Richard Killworth, arguing that he does not qualify as an expert
witness under Fed.R.Evid. 702. Defendants contend that Mr.
Killworth has limited experience at the U.S. Patent and Trademark
Office ("PTO") and that he is unfamiliar with the regulations
enacted since his three years' employment at the PTO from 1967
through 1970. Additionally, Apotex argues that Mr. Killworth has
no "specialized knowledge" because he was not employed at the PTO
at the time of the prosecution of Daiichi's U.S. Patent No.
5,401,741 ("the '741 patent").
Apotex's arguments are not credible. It is not necessary that
Mr. Killworth have worked at the PTO during a specific time frame
to opine on PTO practice and procedure. The Court finds no
support for this contention. The plain language of Rule 702
clearly provides that work experience at a certain period in time
is not a determining factor in qualifying a witness as an expert.
Rule 702 requires that an expert witness have specialized
knowledge, the basis of which "can be practical experience as
well as academic training and credentials." Elcock v. Kmart
Corp., 233 F.3d 734, 741 (3d Cir. 2000). Mr. Killworth qualifies as an expert because of his experience with the PTO in
combination with the specialized skills and knowledge he has
gained from his extensive work experience in the field of patent
Mr. Killworth has over 35 years' experience in patent law as a
patent examiner, law clerk and technical advisor to Judge Almond
of the United States Court of Customs and Patent Appeals, and as
a registered patent attorney. Kidd Decl., Exhibit A. In addition,
he has taught patent law and procedure at numerous law schools
and as a CLE instructor, and he has extensively published
articles on patent law. Id.; Daiichi Opp. Br., p. 2. In his
teaching capacity, he has lectured on the requirements for
satisfying the duty of candor during the prosecution of patents.
Killworth Deposition on Dec. 8, 2004, at 29:22-25. Clearly, Mr.
Killworth has specialized knowledge and has kept informed of new
requirements and changes in patent law, which, in addition to his
work experience with the PTO, qualifies him as an expert on the
practice and procedures of the PTO.
"Under Rule 702, an expert can be employed if his testimony
will be helpful to the trier of fact in understanding evidence
that is simply difficult, though not beyond ordinary
understanding." United States v. Downing, 753 F.2d 1224, 1229
(3d Cir. 1985) (internal citations omitted). The trial judge has
broad discretion in admitting expert evidence. See Salem v. United States Lines Co., 370 U.S. 31, 35 (1962). The Court will
allow Mr. Killworth's testimony because it is relevant and it
will be beneficial to the Court's understanding of the technical
requirements of patent prosecution.
B. Doctor Phillip Beutel
Apotex also seeks to exclude the expert testimony of Doctor
Phillip Beutel since he does not qualify as an expert under
Fed.R.Evid. 702 on the subject of the commercial success of
Daiichi's patented product, FLOXIN® Otic ("Floxin").*fn1
Apotex contends that Dr. Beutel should be barred from testifying
because his report and opinion are primarily based on information
provided to him by Daiichi "with virtually no independent or
objective investigation or verification of the information
provided." Apotex Br., p. 6 (emphasis in original). Apotex argues
Dr. Beutel's opinions and testimony are not the product of
reliable principles and methods and, furthermore, he lacks the
experience necessary to form his conclusions.
Dr. Beutel is an economist and Vice President at National
Economic Research Associates, an economic consulting firm that
evaluates the market for patented inventions, calculations of
economic damages, and the valuation of intellectual property. Livaccari Decl., Exbt. B at 2. Dr. Beutel has also taught
undergraduate and graduate level economics at Miami University in
Oxford, Ohio. Id.
Apotex's arguments that Dr. Beutel's opinions are not reliable
because he has never been employed by a pharmaceutical company
and has limited experience in evaluating the issue of commercial
success are unavailing. An expert may be qualified to testify
even though the court, or the opposing party, feel he is not the
`best' qualified. Holbrook v. Lykes Bros. Steamship Co., Inc.,
80 F.3d 777, 782 (3d. Cir. 1996).
Whether Dr. Beutel's opinions are reliable depends upon whether
they are based in a valid scientific method or, alternatively,
his experience and knowledge. Consideration of a product's
commercial success is an acceptable method of determining whether
an invention was obvious at the time of its patent. The Supreme
Court held in Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966), that commercial success "might be utilized to give light
to the circumstances surrounding the origin of the subject matter
sought to be patented. As indicia of obviousness or
nonobviousness, [this inquiry] may have relevancy." Significant
sales in a relevant market often demonstrate the presence of a
commercially successful product and help rebut a challenge of
obviousness. J.T. Eaton & Co. v. Atlantic Paste & Glue Co.,
106 F.3d 1563, 1571 (Fed. Cir. 1997); Ecolochem, Inc. v. Southern Cal. Edison Co., 227 F.3d 1361, 1377 (Fed. Cir.
2000). Plaintiffs argue that Dr. Beutel used reliable market data
and other information to reach his conclusion that Floxin has
been commercially successful. Daiichi supports their claims by
citing several cases for approving as statistically sound the
data used by Dr. Beutel in his conclusions. See e.g., Purdue
Pharma L.P. v. Endo Pharms. Inc., 70 U.S.P.Q.2d 1185, 1199
(S.D.N.Y. 2004); In re Brand Name Prescription Drugs Antitrust
Litigation, No. 94-cv-897, 1999 WL 639173, *3 (N.D.Ill. Aug. 17,
1999). Defendants, on the other hand, provide nothing more than
conclusory allegations and out of context deposition statements
in support of their claims that Dr. Beutel's analysis is not
scientifically sound. The Court notes that Apotex's argument that
Dr. Beutel only used information provided by Daiichi is
disingenuous because his report clearly states that he and his
staff considered Apotex's own experts' reports. Livaccari Decl.,
Exbt. B at 2. Additionally, as noted by Plaintiffs, Dr. Beutel
relied on market data generally accepted in the pharmaceutical
industry and, in fact, by Apotex. Daiichi Opp. Br. at 7. Dr.
Beutel testified that he also took steps to independently
corroborate the data he used. 12-10-04 Deposition of Dr. Beutel,
at 24: 5-16.
The Court is satisfied that Dr. Beutel has extensive experience
in economics, used reliable methods in formulating his conclusions, and is qualified to opine on the issue of Floxin's
C. Professor Joseph Robinson
Daiichi seeks to exclude or limit the scope of Apotex's expert,
Professor Joseph Robinson, on the ground that he does not qualify
as a person of ordinary skill in the art or as an expert in the
method of treatment claimed in the '741 patent.
The Court conducted a Markman proceeding on the claims
contained in the '741 patent and in its Opinion made the
determination that a person of ordinary skill in the art is a
general practitioner or pediatrician. Daiichi now bases its
argument to exclude Professor Robinson on the Court's construct
of the ordinary person skilled in the art.
Daiichi argues that Professor Robinson's proposed testimony
regarding prior art falls outside his area of expertise because
he is not a general practitioner or pediatrician with experience
treating ear infections.
The Court is not persuaded by these arguments. The purpose of
defining the person of ordinary skill in art is not to set a
ceiling as to who qualifies as an expert. The ordinary person
skilled in the art is an objective test used to determine how
disputed terms in the claim language of a patent should be
defined. Markman v. Westview Instruments, Inc., 52 F.3d 967,
986 (Fed. Cir. 1995). Elaborating further, the Federal Circuit
held in Endress Hauser, Inc. v. Hawk Measurement Sys. Pty. Ltd.,
122 F.3d 1040, 1042 (Fed. Cir. 1997), that "[t]he `person of
ordinary skill in the art' is a theoretical construct used in
determining obviousness. . . . To suggest that the construct
applies to particular individuals could mean that a person of
exceptional skill in the art would be disqualified from
testifying as an expert because not ordinary enough." (Emphasis
in original). The fact that Professor Robinson does not fit
within the standard of the ordinary person skilled in the art as
defined in the Court's prior Opinion on claim construction, does
not render him unqualified to testify on the issue of prior art.
To the contrary, he is exceptionally qualified to opine on the
issue of prior art of otic products. Professor Robinson has an
extensive background in the design and development of products
used to treat ear infections as well as more than 40 years'
experience teaching pharmacy and medical students about drug
delivery systems and preparation of otic solutions. Livaccari
Decl., Exbt. A.
Professor Robinson's testimony will be useful to the Court's
understanding of the technical aspects in the development of otic
medicines. Plaintiffs bald conclusions are not enough to convince
the Court otherwise. To the extent that he may testify about
disputed facts, Professor Robinson's opinions are the proper
subjects of cross-examination. See United States v. Mitchell, 365 F.3d 215 (3d Cir. 2004); Walker v. Gordon,
46 Fed. Appx. 691 (3d Cir. 2002).
For the foregoing reasons, Apotex's motions in limine to
exclude the testimony of Richard Killworth and Phillip Beutel are
denied. Furthermore, Daiichi's motion in limine to exclude or
limit the testimony of Joseph Robinson is denied.
An appropriate Order follows.
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