TAKEDA PHARMACEUTICAL COMPANY LIMITED et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al

Filing 317

OPINION filed. Signed by Judge Joel A. Pisano on 3/20/2013. (eaj)

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
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TAKEDA PHARMACEUTICAL CO,
:
LIMITED, et al.
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Plaintiffs,
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v.
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:
ZYDUS PHARMACEUTICALS
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USA INC., et al.
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Defendants.
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____________________________________:

Civil Action No. 10-1723 (JAP)
OPINION

PISANO, District Judge.
Plaintiffs Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals North
America, Inc., Takeda Pharmaceuticals LLC, Takeda Pharmaceuticals America, Inc.,
(collectively, “Takeda”) and Ethypharm, S.A. (“Ethypharm,” together with Takeda, “Plaintiffs”)
bring this Hatch-Waxman patent infringement action against defendants Zydus Pharmaceuticals
(USA) Inc. and Cadila Healthcare Limited (together, “Defendants”) claiming infringement of the
following patents alleged to cover Takeda’s Prevacid SoluTab product (“SoluTab”): U.S. Patent
Nos. 6,328,994 (the “ ‘994 patent”), 7,431,942 (the “ ‘942 patent”), 7,875,292 (the “ ‘292 patent)
and 5,464,632 (the “ ‘632 patent”). Trial is scheduled to begin on March 26, 2013. Presently
before the Court are the parties’ motions in limine.
1. Plaintiff’s Motion to Preclude Expert James Morrison
Plaintiffs move to preclude the testimony of Defendants’ expert witness James Morrison,
a former employee of the United States Food and Drug Administration (“FDA”) who was

employed with the agency for nearly 40 years. Federal Rule of Evidence 702 governs the
admissibility of expert testimony and states:
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.
Fed. R. Evid. 702. “Under the Federal Rules of Evidence, a trial judge acts as a ‘gatekeeper’ to
ensure that ‘any and all expert testimony or evidence is not only relevant, but also reliable.’”
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) (citing Daubert v. Merrell Dow Pharms., 509 U.S.
579, 589-92 (1993)). In making this determination, the Court undertakes a three-pronged
inquiry: (1) the witness is qualified as an expert in a particular field; (2) the methodology applied
by the witness is sufficiently reliable; and (3) the witness’s testimony “fits” the facts of the case
in dispute—that is, the proffered testimony would assist the trier of fact. Pineda, 520 F.3d at
244. The burden of meeting these elements, and of showing that “good grounds” exist for the
expert’s opinion, lies with the proponent. U.S. v. Mitchell, 365 F.3d 215, 244 (3d Cir. 2004).
Plaintiffs’ argument in support of its motion centers on its assertions that Morrison is not
qualified to testify because he is not one skilled in the relevant art and, therefore, cannot opine on
infringement and invalidity. However, as Defendants state, they are not proffering Morrison to
testify or opine “on the intricacies of the chemistry underlying the claims at issue, or even patent
invalidity.” Def. Br. at 10. Rather, Defendants state that they intend to proffer Morrison to
testify about the “expectations of the [FDA] vis-á-vis [certain] representations made by Zydus
…, and whether the FDA would accept certain conclusions reached by Plaintiffs’ infringement

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expert…” Def. Br. at 2. In this light, the Court has reviewed the materials submitted by
Defendants and finds that Defendants have shown that Morrison satisfies the three requirements
noted above. As such, the Court shall deny Plaintiffs’ motion.1
2. Plaintiffs’ Motion to Preclude Evidence of Prior Art References
Plaintiffs move pursuant to Federal Rule of Civil Procedure 37(c)(1) to preclude all
testimony and other evidence relating to six particular prior art references (the “New
References”) that Plaintiffs allege were improperly introduced for the first time at the September
24, 2012 deposition of Plaintiffs’ expert Dr. Fennerty and the February 20, 2013 deposition of
Plaintiffs’ expert Dr. Byrn. Plaintiffs claim that Zydus never cited any of the New References in
any of its required contentions or in any of its expert reports, and further state that Defendants
“[u]ndoubtedly … will try to use the New References accompanying new invalidity theories to
bolster its case that the asserted ‘632 patent is purportedly invalid.” Pl. Br. at 2.
Rule 37 provides that “[i]f a party fails to provide information or identify a witness as
required by Rule 26(a) or (e), the party is not allowed to use that information or witness to
supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially
justified or is harmless.” Fed. R. Civ. P. 37(c)(1). Under Rule 26(a), however, evidence that is
to be used solely for impeachment purposes is not required to be produced as the rule’s required
disclosures.
In response to Plaintiffs’ motion, Defendants state that their intent is only to offer the
New References at trial with Dr. Byrn for impeachment and/or to refresh recollection. In such a
situation, it is not required that the references be previously disclosed as part of Defendants’
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In permitting Morrison to testify, the Court makes no determination at this time regarding this
witnesses’ credibility. If the Court, as factfinder, does not find Morrison’s testimony to be
convincing, or if the basis for any of his conclusions is lacking, then his testimony can be found
to be not credible.
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earlier-served invalidity contentions. Being that it is not Defendants’ intent to offer the New
References as invalidating prior art, the Court finds Plaintiffs’ motion to be without basis and the
motion shall be denied.
3. Defendants’ Motion to Preclude Evidence of Particle Size Diameter
Defendants have moved in limine to preclude certain evidence of average particle
diameter. Defendants rely primarily upon Bayer AG v. Elan Pharmaceutical Research Corp.,
212 F.3d 1241 (Fed. Cir. 2000) in arguing that the Court need not look beyond the ANDA to
resolve the infringement issues in this case. Plaintiffs oppose the motion, and argue that
Defendants’ motion, although styled as one in limine, is actually more properly a motion for
summary judgment.
The focus of the infringement inquiry in this case, like a typical ANDA case, is on what
the ANDA applicant will likely market if the application is approved. See Bayer Schering
Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1330 (Fed. Cir. 2012). The question to be answered
is whether, if Defendants’ drug were put on the market, it would infringe the relevant patents.
See id. Such a question should not be resolved by way of a motion in limine, but rather, given
the stage of this litigation, should be determined at trial. The Court, therefore, denies
Defendants’ motion.
4. Defendants’ Motion to Preclude Evidence of Instrument Testing
During Markman proceedings in this case the parties sought construction of a number of
claim terms, including the following: “fine granules having an average particle diameter of 400
µm or less” ('994 Patent, Claim 1); “fine granules having an average particle diameter of 300 to
400 µm” ('942 Patent, Claim 1); and “wherein the average particle diameter of the fine granules
is 300 to 400 µm” ('994 Patent, Claim 2). Plaintiffs’ proposed constructions for these terms,

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ultimately adopted by the Court, incorporated a ± 10% deviation into the average particle
diameter measurement. This was based upon the accepted standard of error for a method of
measurement called laser diffraction.
Defendants are seeking to prevent Plaintiffs from introducing evidence of the
average particle diameter of the granular distribution of fine granules in Zydus’s exhibit batch
tablets measured by any method other than laser diffraction. Defendants now assert that the
Court’s claim constructions that incorporate the ± 10% deviation apply only to laser diffraction
and only to batch/bulk sample measurements. However, the Court did not construe the
abovementioned terms to include any such limitations. Indeed, Defendants did not even advance
such a position during the claim construction process. The Court having not previously
construed the above terms to include the limitations now advanced by Defendants, the Court will
not preclude Plaintiffs from introducing evidence of particle sized measured by a method other
than laser diffraction. Defendants’ motion is denied.
For the reasons above, the parties’ motions in limine are denied. An appropriate Order
accompanies this Opinion.
/s/ Joel A. Pisano
Joel A. Pisano, U.S.D.J.

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