United States District Court, D. Delaware
M. Lennon and Pilar G. Kraman, YOUNG CONAWAY STARGATT &
TAYLOR, LLP, Wilmington, DE John T. Gutkoski, Douglas J.
Nash, Bella S. Satra, and F. Paul Vellano, EI, BARCLAY DAMON,
LLP, Boston, MA, Attorneys for Plaintiff.
B. Matterer and Richard K. Herrmann, MORRIS JAMES LLP,
Wilmington, DE Timothy H. Kratz, George J. Barry III, and
Meghan M. Rachford, MCGUIREWOODS LLP, Atlanta, GA Attorneys
U.S. DISTRICT JUDGE
Reckitt Benckiser ("Reckitt") brought this patent
infringement action under the Hatch-Waxman Act. Reckitt filed
suit against Defendants Aurobindo Pharma Limited and
Aurobindo Pharma USA, Inc. (collectively,
"Aurobindo"), which had submitted an Abbreviated
New Drug Application to market a generic version of
Mucinex® DM, an extended-release tablet that contains
dextromethorphan hydrobromide and guaifenesin. (See
D.I. 1 at ¶ 23) Reckitt asserts claims 1, 2, 6-12, 14,
17, 29, 30, 41, and 42 of U.S. Patent No. 6, 955, 821 and
claim 1 of U.S. Patent No. 7, 838, 032. (See D.I.
148 at 3 n.l) The patents claim controlled-release
formulations of the drug guaifenesin, which contain both
immediate-release and sustained-release portions or
Court issued a claim construction opinion on November 3,
2016. (See D.I. 134) In light of that claim
construction, the Court granted Aurobindo's motion for
leave to file a motion for summary judgment of
non-infringement. (SeeD.l. 138) The parties briefed
Aurobindo's summary judgment motion, as well as
Aurobindo's motion to exclude certain expert testimony.
The Court heard oral argument on the pending motions on
February 23, 2017. A five-day bench trial is scheduled to
begin on April 17, 2017.
reasons stated below, the Court will deny Aurobindo's
motion to exclude expert testimony and grant its motion for
summary judgment of non-infringement.
Motion to Exclude
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509
U.S. 579, 597 (1993), 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." Rule 702(a)
requires that expert testimony "help the trier of fact
to understand the evidence or to determine a fact in
issue." 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."
are three distinct requirements for proper expert testimony:
(1) the expert must be qualified; (2) the opinion must be
reliable; and (3) the expert's opinion must relate to the
facts. See Elcock v. Kmart Corp., 233 F.3d 734, 741
(3d Cir. 2000).
Rule 56(a) of the Federal Rules of Civil Procedure,
"[t]he court shall grant summary judgment if the movant
shows that there is no genuine dispute as to any material
fact and the movant is entitled to judgment as a matter of
law." The moving party bears the burden of demonstrating
the absence of a genuine issue of material fact. See
Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp.,
475 U.S. 574, 585-86 (1986). An assertion that a fact cannot
be - or, alternatively, is - genuinely disputed must be
supported either by "citing to particular parts of
materials in the record, including depositions, documents,
electronically stored information, affidavits or
declarations, stipulations (including those made for purposes
of the motion only), admissions, interrogatory answers, or
other materials, " or by "showing that the
materials cited do not establish the absence or presence of a
genuine dispute, or that an adverse party cannot produce
admissible evidence to support the fact." Fed.R.Civ.P.
56(c)(1)(A) & (B). If the moving party has carried its
burden, the nonmovant must then "come forward with
specific facts showing that there is a genuine issue for
trial." Matsushita, 475 U.S. at 587 (internal
quotation marks omitted). The Court will "draw all
reasonable inferences in favor of the nonmoving party, and it
may not make credibility determinations or weigh the
evidence." Reeves v. Sanderson Plumbing Prods.,
Inc., 530 U.S. 133, 150 (2000).
defeat a motion for summary judgment, the nonmoving party
must "do more than simply show that there is some
metaphysical doubt as to the material facts."
Matsushita, 475 U.S. at 586; see also Podobnik
v. U.S. Postal Serv., 409 F.3d 584, 594 (3d Cir. 2005)
(stating party opposing summary judgment "must present
more than just bare assertions, conclusory allegations or
suspicions to show the existence of a genuine issue")
(internal quotation marks omitted). The "mere existence
of some alleged factual dispute between the parties will not
defeat an otherwise properly supported motion for summary
judgment;" a factual dispute is genuine only where
"the evidence is such that a reasonable jury could
return a verdict for the nonmoving party." Anderson
v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986).
"If the evidence is merely colorable, or is not
significantly probative, summary judgment may be
granted." Id. at 249-50 (internal citations
omitted); see also Celotex Corp. v. Catrett, 477
U.S. 317, 322 (1986) (stating entry of summary judgment is
mandated "against a party who fails to make a showing
sufficient to establish the existence of an element essential
to that party's case, and on which that party will bear
the burden of proof at trial"). Thus, the "mere
existence of a scintilla of evidence" in support of the
nonmoving party's position is insufficient to defeat a
motion for summary judgment; there must be "evidence on
which the jury could reasonably find" for the nonmoving
party. Anderson, 477 U.S. at 252.
Aurobindo's Motion to Exclude Testimony of Mario A.
moves to exclude the expert opinions of Mario A. Gonzalez,
Ph.D., FCP, regarding infringement and invalidity,
specifically with respect to (1) the structure or physical
make-up of Aurobindo's product and (2) the obviousness of
the patents in suit. (See D.I. 148 at
Aurobindo contends that Dr. Gonzalez is not qualified to
opine on drug formulation science and that his opinions are
neither reliable nor fit the issues in the case. The Court
disagrees and will deny Aurobindo's motion.
Gonzalez is qualified to offer opinions here. Although there
is some disagreement as to the identity of a person of skill
in the art, Dr. Gonzalez undisputedly meets both sides'
definitions. (See D.I. 149 Ex. C at ¶¶
131-32) Dr. Gonzalez has a Ph.D. in pharmacokinetics, with
over 50 years of experience in the fields of pharmacy,
pharmacology, and pharmacokinetics. (See D.I. 152 at
¶ 1) Dr. Gonzalez is not himself a formulator, but he
has experience working in research and development of
specialized drug-delivery systems, including
immediate-release and modified-release dosage forms.
(See D.I. 141 Ex. F at ¶ 10) Dr. Gonzalez's
work includes collaborating with formulators to determine how
drug products perform and how they release active
ingredients. (See D.I. 141 Ex. D at 34-37)
respect to fit and reliability, Aurobindo contends that Dr.
Gonzalez has failed "to particularize his opinions and
to link Aurobindo's formulations to each limitation,
" specifically the requirement for two distinct
formulations. (D.I. 148 at 15) In particular, Aurobindo
suggests that the in vitro and pharmacokinetic data Dr.
Gonzalez discusses are not relevant to the structure of
Aurobindo's product and cannot show that Aurpbindo's
product has two distinct formulations. (See id.) But
Aurobindo does not argue that the data Dr. Gonzalez relies on
was collected using an unreliable methodology, and Dr.
Gonzalez articulates his reasoning supporting the conclusions
that he draws from the data. "The test of admissibility
is not whether a particular scientific opinion ... is
demonstrably correct. Rather, the test is whether the
'particular opinion is based on valid reasoning and
reliable methodology.'" Oddi v. Ford Motor
Co., 234 F.3d 136, 145-46 (3d Cir. 2000) (quoting
Kannankeril v. Terminix Int'l Inc., 128 F.3d
802, 806 (3d Cir. 1997)). That Aurobindo disagrees with Dr.
Gonzalez's conclusions is not reason to exclude his
opinions. Dr. Gonzalez's testimony is sufficiently
reliable and will assist the trier of fact. Accordingly, the
Court will deny Aurobindo's motion.
suggests that in deciding the motion for summary judgment,
the Court should not consider any evidence other than the AND
A. (See D.I. 140 at 11-12) The Court disagrees.
"[S]ection 271(e)(2) 'requires an infringement
inquiry focused on what is likely to be sold following FDA
approval, ' an inquiry that 'must be based on all of
the relevant evidence including the ANDA.'"
Tyco Healthcare Grp. LP v. Mut. Pharm. Co., 762 F.3d
1338, 1344 (Fed. Cir. 2014) (quoting Glaxo, Inc. v.
Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed. Cir. 1997)).
Thus, for example, biobatch test data submitted with an ANDA
- based on testing which falls into the safe harbor provision
of 35 U.S.C. § 271(e)(1) and, therefore, cannot be a
basis for infringement - may be irrelevant and, perhaps,
should not be considered. See Bayer AG v. Elan Pharm.
Research Corp., 212 F.3d 1241, 1249 (Fed. Cir. 2000).
But where additional evidence supplements the record with
respect to characteristics of the proposed commercial product
made pursuant to the specifications of the AND A, courts may
consider that evidence. See Bayer AG. v. Biovail
Corp., 279 F.3d 1340, 1346-47 (Fed. Cir. 2002). The
additional evidence that Reckitt provides here - a
dissolution study conducted by a commercial laboratory on
Aurobindo's ANDA drug product - falls into this latter
category. This testing provides relevant evidence about
characteristics of the product Aurobindo will likely sell,
and is appropriate to consider.
also requests that the Court disregard statements in Dr.
Gonzalez's expert report that contradict his deposition
testimony. (See D.I. 158 at 8) Although Aurobindo
identifies inconsistencies between Dr. Gonzalez's reports
and testimony, the Court is not persuaded that Dr.
Gonzalez's reports are shams - intended simply to
generate a dispute of material fact and defeat summary
judgment - ...