United States District Court, D. Delaware
PAR PHARMACEUTICAL, INC., PAR STERILE PRODUCTS, LLC, and ENDO PAR INNOVATION COMPANY, LLC, Plaintiffs,
HOSPIRA, INC., Defendant.
MEMORANDUM AND ORDER
F. BATAILLON SENIOR UNITED STATES DISTRICT JUDGE.
matter is before the Court on the defendant's Motion to
exclude the testimony of Karen M. Becker, Ph.D., under
Federal Rule of Evidence 702 and the principles set forth in
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579,
597 (1993) (D.I. 149). This is a patent infringement case arising
under the Hatch-Waxman Act, 21 U.S.C. § 355 and 35
U.S.C. § 271(e).
Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo
Par Innovation Company, LLC (collectively,
“Plaintiffs” or “Par”) manufactures
and sells Adrenalin® brand epinephrine injection, which
is used for emergency treatment of allergic reactions,
including anaphylaxis. Hospira, Inc., is seeking FDA approval
to market a generic version of Par's Adrenalin®
product (“Hospira's ANDA Product”) prior to
the expiration of Par's patents covering Adrenalin®,
U.S. Patent Nos. 9, 119, 876 (“the '876
patent”) and 9, 295, 657 (“the '657
patent”) (together, “the Patents-in-Suit”)
(D.I. 1, Exs. 1-2). Par alleges that Hospira's ANDA
Product infringes the Patents-in-Suit under 35 U.S.C. §
271(e)(2), and that the manufacture, use, offer for sale,
sale, or importation of Hospira's ANDA Product will
infringe the Patents-in-Suit under 35 U.S.C. §§
271(a), (b), and/or (c). D.I. 1. A four-day bench trial is
scheduled to begin on June 28, 2019 (D.I. 153).
of background, in 2012, the Food and Drug Administration
("FDA") approved the Adrenalin® epinephrine
injection formulation of Par's predecessor, JHP
Pharmaceuticals ("JHP"). However, the FDA asked JHP
to investigate improvements to the formulation and process to
reduce the levels of impurities in the Adrenalin®
product. Subsequent testing revealed the presence of Impurity
A, Impurity B, and Unknown C. The inventors developed a
procedure using gradient Hydrophobic Interaction Liquid
Chromatography ("HILIC")2 to isolate Impurity A,
Impurity B, and Unknown C ('876 patent, col. 16:38-20:61,
moves to preclude the testimony of Dr. Karen Becker,
Par's regulatory expert. She is expected to testify
concerning the regulatory framework in the context of
Hospira's statements and actions before FDA. Hospira
contends her testimony is speculative and irrelevant. It also
challenges Dr. Becker's qualifications, contending she is
unqualified as an expert in the case because she has never
been employed by the FDA or a pharmaceutical company, and
because she has advised on medical devices or combination
drug/device products rather than drug products. In response,
Par argues that Dr. Becker's testimony will assist the
Court in evaluating the weight, credibility, and meaning that
should be accorded to Hospira's statements and actions
Becker has a Bachelor of Science degree in Biological
Chemistry with High Honors from the University of Maryland; a
National Institutes of Health Graduate Research Fellowship;
and a Ph.D. in Pharmacology from the University of North
Carolina School of Medicine. Dr. Becker is an FDA regulatory
consultant. Her clients have included pharmaceutical, medical
device, and multi-national healthcare companies, Dr. Becker
has held positions in a series of successful scientific and
FDA regulatory consulting firms over the course of 25 years.
Daubert, the Supreme Court explained that Federal
Rule of Evidence 702 creates “a gatekeeping role for
the [trial] judge” in order to “ensur[e] that an
expert's testimony both rests on a reliable foundation
and is relevant to the task at hand.” Daubert,
509 U.S. at 597. The rule requires that expert testimony
“help the trier of fact to understand the evidence or
to determine a fact in issue.” Fed.R.Evid. 702(a).
Expert testimony is admissible only if “the testimony
is based on sufficient facts or data, ” “the
testimony is the product of reliable principles and methods,
” and “the expert has reliably applied the
principles and methods to the facts of the case.”
Fed.R.Evid. 702(b)-(d); see generally Elcock v.
Kmart Corp., 233 F.3d 734, 741-46 (3d Cir. 2000) (noting
the requirements of Rule 702 embody “three distinct
substantive restrictions on the admission of expert
testimony: qualifications, reliability and fit”).
language of Rule 702 requiring the expert to testify to
scientific knowledge means that the expert's opinion must
be based on the ‘methods and procedures of science'
rather than on ‘subjective belief or unsupported
speculation.'” In re Paoli R.R. Yard PCB
Litig., 35 F.3d 717, 742 (3rd Cir. 1994) (quoting
Daubert, 509 U.S. at 590). The proponent of the
expert testimony has the burden of establishing its
admissibility by a preponderance of the evidence.
Padillas v. Stork-Gamco, Inc., 186 F.3d 412, 418 (3d
Third Circuit recognizes a “liberal policy of
admissibility” regarding Rule 702. Pineda v. Ford
Motor Co., 520 F.3d 237, 243 (3d Cir. 2008) (quoting
Kannankeril v. Terminix Int'l, Inc., 128 F.3d
802, 806 (3d Cir. 1997); see also United States
v. Schiff, 602 F.3d 152, 173 (3d Cir. 2010).
“Vigorous cross-examination, presentation of contrary
evidence, and careful instruction on the burden of proof are
the traditional and appropriate means of attacking shaky but
admissible evidence.” Daubert, 509 U.S. at
596. “Rule 702 and Daubert put their faith in an
adversary system designed to expose flawed expertise.”
U.S. v. Mitchell, 365 F.3d 215, 244-45 (3d Cir.
2004) (citations omitted).
expert's opinion on a legal conclusion “'is
neither necessary nor controlling.'” See
High Point Design LLC v. Buyers Direct, Inc., 730
F.3d 1301, 1313 (Fed. Cir. 2013) (quoting Avia Grp.
Int'l, Inc. v. L.A. Gear Cal., Inc., 853 F.2d 1557,
1564 (Fed. Cir. 1988), abrogated on other grounds by
Egyptian Goddess, Inc. v. Swisa, Inc., 543 F.3d 665
(Fed. Cir. 2008) (en banc)). An expert cannot usurp
the role of the judge or jury. Berckeley Inv. Grp., Ltd.
v. Colkitt, 455 F.3d 195, 217 (3d Cir. 2006). That said,
an expert's opinion may be relevant to the factual
aspects of the analysis leading to that legal conclusion.
Id. When an expert's methodology is sound, and
the evidence relied upon is sufficiently related to the case
at hand, disputes about the degree of relevance or accuracy
(above this minimum threshold) may go to the testimony's
weight, but not its admissibility.” i4i Ltd.
P'ship v. Microsoft Corp., 598 F.3d 831, 852 (Fed.
Cir. 2010), aff'd, 564 U.S. 91 (2011).
trial courts should be more reluctant to exclude evidence in
a bench trial than a jury trial. See First Am.
State Bank v. Cont'l Ins. Co., 897 F.2d 319, 328
(8th Cir. 1990); Builders Steel Co. v. Comm'r,
179 F.2d 377, 379 (8th Cir. 1950). In bench trials, evidence
should be admitted and then sifted when the district court
makes its findings of fact and conclusions of law. Fields
Eng'g & Equip., Inc. v. Cargill, Inc., 651 F.2d
589, 594 (8th Cir. 1981). In a nonjury case, the trial court
is presumed to consider only the competent evidence.
First Am. State Bank, 897 F.2d at 328. Where the
court has assumed the role of fact-finder in a bench trial,
“the better course ‘is to hear the testimony, and
continue to sustain objections when appropriate.'”
Easley v. Anheuser-Busch, Inc., 758 F.2d 251, 258
(8th Cir. 1985).
Court finds Hospira's motion should be denied.
Hospira's contentions that the opinions are speculative
and/or irrelevant lose force because this is a bench trial.
The Court ...