OTSUKA PHARMACEUTICAL CO., LTD. v. MYLAN INC. et al

Filing 298

REDACTED VERSION OF OPINION OF SEPTEMBER 29, 2017. Signed by Judge Jerome B. Simandle on 11/7/2017. (dmr)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
MYLAN INC. and MYLAN
PHARMACEUTICALS INC., and MYLAN
LABORATORIES LIMITED,
Defendants.

HONORABLE JEROME B. SIMANDLE
Civil Action No.
14-4508 (JBS-KMW)
REDACTED VERSION OF
OPINION OF
SEPT. 29, 2017

SIMANDLE, District Judge:

INTRODUCTION
These related patent infringement actions under the HatchWaxman Act, 35 U.S.C. §§ 271, 281, generally concern Plaintiff
Otsuka Pharmaceutical Co, Ltd.’s (hereinafter, “Otsuka”)
position that Defendants’ submissions of abbreviated new drug
applications (hereinafter, “ANDAs”) infringe the various patents
covering Otsuka’s Abilify® aripiprazole product, U.S. Patent Nos.
8,017,615 (“the ’615 patent”), 8,580,796 (“the ’796 patent”) and
8,642,760 (“the ’760 patent”). and collectively, the “patentsin-suit”). Defendants Mylan Inc., Mylan Pharmaceuticals Inc.,
and Mylan Laboratories Limited (hereinafter “Mylan”) have filed
a motion for summary judgment of non-infringement [Docket Item
205]. Plaintiff Otsuka has filed a motion for discovery under
Rule 56(d), Fed. R. Civ. P., in response to Mylan’s motion

[Docket Item 232]. The Court has had the benefit of extensive
briefing and oral argument.
BACKGROUND
Factual and Procedural Background1
As this Court has summarized previously, Otsuka holds New
Drug Application (hereinafter, “NDA”) No. 21-436, approved by
the Food and Drug Administration (hereinafter, the “FDA”), for
aripiprazole tablets, which Otsuka markets for the treatment of
certain psychiatric conditions under the trade name Abilify®.

In

connection with Abilify’s® listing in the Orange Book, the FDA’s
book of drug products approved under the Food, Drug, and
Cosmetic Act (hereinafter, the “Orange Book”), 21 U.S.C. §
355(j), Otsuka identifies, in relevant part, the ’615, the ’796,
and the ’760 Patents.2
In simple terms, the ’615, the ’796, and the ’760 Patents
claim novel forms of anhydrous aripiprazole that have low
hygroscopicity.
The asserted claims of the ’615, the ’796, and the ’760
Patents, teach the process for preparing the low hygroscopic
aripiprazole (the ’615 Patent), as well as claiming two of its

1

For purposes of the pending submissions, the Court need not
retrace the detailed factual and procedural history of these
complex infringement actions, and writes primarily for the
parties.
2

Otsuka’s Orange Book listing also identifies the ’421 Patent.
2

forms: one in a pure crystal form (the ’796 Patent) and the
other in a finalized form (the ’760 Patent)3

The ’796 and ’760

Patents, each of which contain only two claims, then identify a
specific low hygroscopic form of “anhydrous aripiprazole
crystals B” and an “aripiprazole drug substance,” both of which
have a moisture content below either 0.40% or 0.10% even after
being placed in a dessicator maintained at a temperature of 60°
C and a humidity level of 100%.
’760 Patent at 44:23-32.)

(See ’796 Patent at 44:23-32;

Simply put, these forms do not take

on water, despite exposure to a high-moisture environment.
1. Otsuka’s Infringement Litigation in this District
the generic Defendants
involved in these related infringement actions began to file
ANDAs with the FDA, seeking approval to market generic
aripiprazole tablets and/or orally disintegrating aripiprazole
tablets, prior to the expiration of the ’615, ’796, and ’760,
Patents.4

Each Defendant’s ANDA, however, included a “paragraph

3

Claims 3 and 4 of the ’615 Patent differ only in specific
moisture content, with claim 3 teaching 0.40% or less, while
claim 4 teaches 0.10% or less. (Compare `615 Patent at 44:43-46
(claim 3), with ’615 Patent at 45:1-4 (claim 4).)
4

As the lengthy exclusivity period of the patent covering the
primary aripiprazole compound came to a close, Otsuka moved to
enjoin the defendants from launching competing generic
aripiprazole products, on the grounds that the package inserts
or labels for the proposed generic products in all of the
related infringement actions would induce infringement of claim
1 of the ’350 Patent.
3

iv” certification, advancing their positions that their ANDAs
would not infringe any of the valid patents-in-suit, and/or a
“section viii” statement, certifying that the applicant would
not seek approval for any indications or uses asserted to be
covered by the ’350 Patent. See Otsuka Pharm. Co., Ltd. v.
Torrent Pharmaceuticals Ltd., Inc., 99 F. Supp. 3d 461 (D.N.J.
2015)(“TRO Opinion”)

In other words, Mylan purports to seek

approval for a noninfringing aripiprazole product.

See

generally id.
Otsuka filed infringement actions in this District,
alleging that these Defendants’ proposed generic aripiprazole
products will infringe at least one claim of the ‘615, ‘796,
and/or the ‘760 patents, among the other patents covering
Otsuka’s Abilify® product.
“Low hygroscopicity” refers to a measurement of
hygroscopicity employing the “Hygroscopicity-Test Method,” (or
“HTM”) described as:
One g of the sample was accurately weighed in a weighing
bottle (diameter 5 cm), covered with kimwipes and left to rest
in a 60ºC/100% RH environment (water/dessicator). 24 hours
later, the weighing bottle was removed, transferred to an
environment of a room temperature and about 30% REH (magnesium
chloride hexahydrate saturated water solution/dessicator) and
left to rest for 24 hours and the water content of the sample
was measured by the Karl Fischer method.
(’760 Patent at 22:56-64.)

4

On

Mylan submitted ANDA No. 206-240 to

the FDA seeking approval to market generic aripiprazole tablets
in the United States (Mylan SMF at ¶ 9.) Specifically, Otsuka
originally asserted against Mylan, claims of infringement of
claims 1 and 2 of the ’760 patent, as well as claims 1 and 2 of
the ’796 patent and claims 3, 4, 15 and 16 of the ’615 patent.
(Id. at ¶ 32.) Otsuka is dismissing its claims under the ‘615
and ‘796 patents, and only the ‘760 patent is in dispute.
(Otsuka Opp. Br. at 2.) [Docket Item 236.]
Mylan first produced a sample of its aripiprazole API to
Otsuka on October 14, 2015 and produced additional API samples
on August 15, 2016, but both times, Otsuka objected because the
samples were provided in packaging that did not comply with
specifications. (Id. at ¶¶ 29-30; Otsuka
RSMF at ¶¶ 29-30.)

(Id. at ¶ 41.)
Dr. Myerson opined that Mylan’s samples had
specifications call for, and that
statements
support his
infringement opinion. (Mylan SMF at ¶ 35.)

5

2. Markman hearing and Claim Construction
The Court conducted a Markman hearing on October 19, 2015
and issued its Markman opinion on November 16, 2015. The Court
stated that “[i]n simple terms, [the patents-in-suit] claim
novel forms of anhydrous aripiprazole that have low
hygroscopicity.” See Otsuka Pharmaceutical Co., Ltd v. Torrent
Pharmaceuticals Limited, Inc, 151 F. Supp. 3d 525, 551 (D.N.J.
2015).

Additionally, the Court stated that “[t]he asserted

claims of the ’615, the ’796 and the ’760 patents, in turn,
teach the process for preparing the low hygroscopic aripiprazole
(the ‘615 patent), as well as claiming the two of its forms: one
in a pure crystal form (the ’796 patent) and the other in a
finalized form (the ’760 patent). Id. at 533-34. The Court
construed the term “Anhydrous Aripiprazole Crystals B,” as it
appears in asserted claims 3, 4, 15 and 16 of the ’615 patent,
and claims 1 and 2 of the ’796 parent, to mean “Anhydrous
aripiprazole Crystalline substance, having: 1) a proton nuclear
magnetic resonance spectrum (DMSO-d6, TMS) having characteristic
peaks at [specified levels]; 2) a powder x-ray diffraction
spectrum having characteristic peaks at [specified levels]; 3)
clear infrared absorption bands at [specified levels] on the IR
(KBr) spectrum; 4) an endothermic peak near about 141.5ºC in
thermogravimetric/differential thermal analysis (heating rate
5ºC./min); and 6) low hygroscopicity, all as specifically
6

defined in the specification of the ’615 patent at 9:37-63 [or
the ’796 patent at 9:34-60].” [Docket Item 104 at 4-5.]
The Court construed the term “aripiprazole drug substance,”
as it appears in asserted claims 1 and 2 of the ’760 patent, to
mean “a drug substance that consists of aripiprazole, either in
pure chemical form or as the active chemical ingredient in
finalized form.” [Id. at 5.]
The Court construed the term “wherein said low
hygroscopicity is defined as a moisture content of [0.40%/0.10%]
or less after placing said substance/Crystals for 24 hours in a
desiccator maintained at a temperature of 60ºC and a humidity
level of 100%,” as it appears in asserted claims 3, 4, 15 and 16
of the ’615 patentw, claims 1 and 2 of the ’796 patent, and
claims 1 and 2 of the ’760 patent, to mean “wherein said low
hygroscopicity is defined as a moisture content of 0.40% or less
[0.10% or less] after the “Hygroscopicity-Test Method” in the
specification of the ’615 patent at 22:56-63 [or the “796 patent
at 22:59-67; or the ‘760 patent at 22:56-64]”. [Id.]
The Hygroscopicity-Test method described in the patents is
as follows: “(7) Hygroscopicity Test Method – One g of the
sample was accurately weighed in a weighing bottle (diameter 5
cm), covered with kimwipes and left to rest in a 60ºC./100% RH
environment (water/dessicator). 24 hours later, the weighing
bottle was removed, transferred to an environment of a room
7

temperature and about 30% RH (magnesium chloride hexahydrate
saturated water solution/dessicator) and left to rest for 24
hours and the water content of the sample was measured by the
Karl Fischer method.” (’796 patent 22:59-67; ’760 patent 22:5664.)
STANDARDS OF REVIEW
A. Rule 56(d)
Fed. R. Civ. P. 56(d) allows district courts to defer
consideration of or deny a motion for summary judgment “[i]f a
non-movant shows by affidavit or declaration that, for specified
reasons, it cannot present facts essential to justify its
opposition.” Third Circuit case law makes clear that to prevail
under Rule 56(d) the non-movant “must identify with specificity
‘what particular information is sought; how, if uncovered, it
would preclude summary judgment; and why it has not been
previously obtained.’” Lunderstadt v. Colafella, 885 F.2d 66, 71
(3d Cir. 1989) (quoting Dowling v. City of Philadelphia, 855
F.2d 136, 140 (3d Cir. 1988)) (citations omitted); see also
Hancock Indus. v. Schaeffer, 811 F.2d 225, 230 (3d Cir. 1987)
(noting that nonmovant must show a need for discovery and
identify what material facts will be uncovered); Koplove v. Ford
Motor Co., 795 F.2d 15, 18 (3d Cir. 1986) (noting nonmovant must
specify what discovery is needed and why it had not previously
been obtained).
8

B. Infringement
Federal Rule of Civil Procedure 56(a) generally provides
that the “court shall grant summary judgment if the movant shows
that there is no genuine dispute as to any material fact” such
that the movant is “entitled to judgment as a matter of law.”
FED. R. CIV. P. 56(a). A “genuine” dispute of “material” fact
exists where a reasonable jury’s review of the evidence could
result in “a verdict for the non-moving party” or where such
fact might otherwise affect the disposition of the litigation.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
Disputes over irrelevant or unnecessary facts, however, fail to
preclude the entry of summary judgment. Id.

Conclusory, self-

serving submissions cannot alone withstand a motion for summary
judgment. Gonzalez v. Sec’y of Dept. of Homeland Sec., 678 F.3d
254, 263 (3d Cir. 2012) (internal citations omitted).
In evaluating a motion for summary judgment, the Court must
view the evidence in the light most favorable to the non-moving
party, and must provide that party the benefit of all reasonable
inferences.

Scott v. Harris, 550 U.S. 372, 378 (2007); Halsey

v. Pfeiffer, 750 F.3d 273, 287 (3d Cir. 2014).

However, any

such inferences “must flow directly from admissible evidence
[,]” because “‘an inference based upon [] speculation or
conjecture does not create a material factual dispute sufficient
to defeat summary judgment.’”

Halsey, 750 F.3d at 287 (quoting
9

Robertson v. Allied Signal, Inc., 914 F.2d 360, 382 n. 12 (3d
Cir. 1990); citing Anderson, 477 U.S. at 255).
Under the framework of the Hatch-Waxman Act, the
infringement inquiry focuses on a comparison of the asserted
patent claims against the ANDA product that is likely to be sold
following FDA approval. Warner-Lamber Co. v. Apotex Corp., 316
F.3d 1348, 1365-66 (Fed. Cir. 2003).

As relevant here, 35

U.S.C. § 271(a) governs direct infringement and provides that,
“whoever without authority makes, uses, offers to sell, or sells
any patented invention, within the United States ... during the
term of the patent therefor, infringes the patent.”

See also

Commil USA, LLC v. Cisco Sys., Inc., ___ U.S. ___, 135 S. Ct.
1920, 1926 (2015) (describing the “three forms” of statutory
liability for patent infringement).
Evaluation of summary judgment on the issue of infringement
(or, non-infringement) requires a two-part inquiry: claim
construction by the court of the asserted claim terms as a
matter of law, see, e.g., Akzo Nobel Coatings, Inc. v. Dow Chem.
Co., 811 F.3d 1334, 1339 (Fed. Cir. 2016); Purdue Pharma L.P. v.
Boehringer Ingelheim, GMBH, 237 F.3d 1359, 1363 (Fed. Cir.
2001); Cybor Corp. v. FAS Techs., 138 F.3d 1448, 1454 (Fed. Cir.
1998), and then a factual determination of whether the properly
construed claim terms “‘read on the accused product or method.’”
Clare v. Chrysler Grp. LLC, 819 F.3d 1323, 1326 (Fed. Cir. 2016)
10

(quoting Georgia-Pac. Corp. v. U.S. Gypsum Co., 195 F.3d 1322,
1330 (Fed. Cir. 1999)); see also Kustom Signals, Inc. v. Applied
Concepts, Inc., 264 F.3d 1326, 1332 (Fed. Cir. 2001) (describing
the patent infringement analysis as “a question of fact”).

In

other words, the second stage of the infringement inquiry
focuses upon a comparison of the asserted patent claims against
the accused invention.

See generally Spectrum Pharm., Inc. v.

Sandoz Inc., 802 F.3d 1326, 1336 (Fed. Cir. 2015) (citation
omitted).
More specifically, the patent holder must demonstrate, by a
preponderance of the evidence, that the accused device infringes
the patent either literally or under the doctrine of
equivalents.

See Akzo Nobel Coatings, Inc., 811 F.3d at 1339

(citation omitted); see also Envirotech Corp. v. Al George,
Inc., 730 F.2d 753, 758 (Fed. Cir. 1984) (citation omitted).
Literal infringement, in turn, requires that the accused product
include “‘every limitation’” in the “‘exact[]’” form described
by the asserted claims.

Microsoft Corp. v. GeoTag, Inc., 817

F.3d 1305, 1313 (Fed. Cir. 2016) (quoting Crown Packaging Tech.,
Inc. v. Rexam Beverage Can Co., 559 F.3d 1308, 1312 (Fed. Cir.
2009) (internal quotation marks and citation omitted)). Literal
infringement requires one-to-one correspondence between the
patented invention and the accused device (or, satisfaction of
the so-called “all-elements rule”).
11

See, e.g., Transocean

Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
699 F.3d 1340, 1356 (Fed. Cir. 2012) (citation omitted). If a
single claim limitation is not present in a proposed ANDA
product, that product cannot literally infringe the claim. Glaxo
Wellcome, Inc. v. Impax Labs., Inc., 356 F.3d 1348, 1351 (Fed.
Cir. 2004).
Doctrine of equivalents infringement occurs, by contrast,
in the favor of “‘equivalence between the elements of the
accused product ... and the claimed elements of the patented
invention.’”

Id. (quoting Duramed Pharm., Inc. v. Paddock

Labs., Inc., 644 F.3d 1376, 1380 (Fed. Cir. 2011) (internal
quotation marks and citation omitted)).

More succinctly, a

patentee may establish infringement under the doctrine of
equivalents if an element of the accused product “‘performs
substantially the same function in substantially the same way to
obtain the same result as the claim limitation.’”

Spectrum

Pharm., Inc. v. Sandoz Inc., 802 F.3d 1326, 1337 (Fed. Cir.
2015) (quoting Pozen Inc. v. Par Pharm., Inc., 696 F.3d 1151,
1167 (Fed. Cir. 2012) (citation omitted)).
Additionally, the doctrine of equivalents can be limited by
the public disclosure rule. Specifically, “when a patent drafter
discloses but declines to claim subject matter ... this action
dedicates that unclaimed subject matter to the public.” Johnson
& Johnson Assocs. Inc. v. RE Serv. Co., Inc., 285 F.3d 1046,
12

1054 (Fed. Cir. 2002). Therefore, “[a]pplication of the doctrine
of equivalents to recapture subject matter deliberately left
unclaimed would ‘conflict with the primacy of the claims in
defining the scope of the patentee's exclusive right.’” Id.
(quoting Sage Prods. Inc. v. Devon Indus., Inc., 126 F.3d 1420,
1424 (Fed. Cir. 1997)).
Under either theory, though, summary judgment may be
granted only if the undisputed factual evidence points to only
one reasonable conclusion regarding infringement.

See Chimie v.

PPG Indus., Inc., 402 F.3d 1371, 1376 (Fed. Cir. 2005);
TechSearch, LLC v. Intel Corp., 286 F.3d 1360, 1369 (Fed. Cir.
2002); Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d
1316, 1323 (Fed. Cir. 2001).

In other words, summary judgment

on the issue of infringement would be appropriate only “where no
reasonable factfinder could find that the accused product
contains every claim limitation or its equivalent.”

Spectrum

Pharm., Inc., 802 F.3d at 1337 (citation omitted); see also
Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 808 F.3d
1313, 1317 (Fed. Cir. 2015); Baxter Healthcare Corp. v. HQ
Specialty Pharma Corp., 133 F. Supp. 3d 692, 697-98 (D.N.J.
2015) (describing and applying the same analytical framework to
cross-motions for summary judgment on the issue of
infringement).

13

DISCUSSION
A.

Otsuka’s 56(d) motion

Otsuka argues that the two API samples that Mylan has
produced are not representative of the API Mylan intends to use
in manufacturing its tablet products.

Because Otsuka claims

that it has not received a representative sample of Mylan’s API,
Otsuka moves under Rule 56(d), Fed. R. Civ. P., requesting that
the Court deny Mylan’s motion for summary judgment, or in the
alternative, defer ruling on Mylan’s motion for summary judgment
until Mylan produces a representative API sample that Otsuka can
test to fairly evaluate infringement. [Docket Item 233 at 2-3]
Otsuka argues that (1) the produced samples contain

(2) the samples do not meet

specification
; and (3)

testing by Otsuka’s laboratory, SSCI, demonstrated that,

[Docket Item 233 at 3-4.]
Importantly,

, after oral argument on

the summary judgment motions, Mylan
(Ex. 1
14

to Docket Item 277.]

[Id. at 2.]

[Id.]

Mylan replies that it has “produced two separate samples

that meet

specifications, and neither of those samples

provided an infringing result,” so “there is no basis to produce
a third sample in this litigation.” The Court therefore finds
that Mylan shall produce a representative sample to Otsuka.
B.

Mylan’s motion to strike

Mylan moves to strike the entirety of (1) the Declaration
of Dr. Allan S. Myerson submitted in support of Otsuka’s summary
judgment opposition brief and its 56(d) motion, and (2) the
Expert Report of Karen S. Gushurst, as well as any discussion
of, reference to, or reliance upon Dr. Myerson’s declaration
and/or Ms. Gushurst’s expert report in connection with Mylan’s
pending Motion for Summary Judgment of Non-Infringement and/or
Otsuka’s Rule 56(d) motion. (Appendix A to Mylan Reply Br. at
23)

Mylan argues that Dr. Myerson relies on facts and opinions

that were not disclosed in his expert reports, during his
depositions, or otherwise during discovery, and that Otsuka
untimely disclosed Ms. Gushurst’s expert report and her testing
15

information for the first time in its opposition to Mylan’s
motion – over three months after the deadline for opening expert
reports and one month after the close of discovery. (Id.)5

In

response, Otsuka argues that the reports do not offer late
expert opinions on infringement, but instead report substantial
evidentiary problems with two API samples that Mylan has
produced over the course of the litigation; thus, Otsuka
appropriately requires discovery of a representative sample of
Mylan’s API. (Docket Item 253.)

The Court therefore denies

Mylan’s motion to strike, but will allow Mylan to opportunity
respond with its own and expert and to depose Dr. Myerson and
Ms. Gushurst on their opinions set forth in Otsuka’s opposition,
if it chooses to do so.
C.

Discussion of Rule 56(d) motion and Mylan’s motion to
strike

Ostuka’s argument that Mylan has not produced a sample of
aripiprazole API that is representative of the API Mylan intends
to use in its commercial products, though disputed by Mylan, is

5

Additionally, Mylan moves to strike Otsuka’s separate 56(d)
motion, or in the alternative, deem it incorporated into
Otsuka’s opposition to Mylan’s motion. (Docket Item 246.) Mylan
argues that Otsuka’s 56(d) motion is redundant of the arguments
presented in Otsuka’s opposition to Mylan’s motion for summary
judgment, but because it is filed as a separate motion, it
allows Otsuka additional briefing in its opposition. The Court
finds Otsuka’s Rule 56(d) motion to be proper in form; as the
Rule 56(d) movant, not knowing whether its request to defer
summary judgment practice would succeed, Otsuka appropriately
filed its opposition to Mylan’s motion for summary judgment.
16

well-taken. The samples Mylan produced in 2015 and 2016 were
tested by analytical testing laboratory SSCI

(Decl. of Andrew E. Renison at ¶¶ 811.) Each test indicated
(Id. at
¶¶ 6, 9-11, 13.)
Second, the Mylan API samples did not meet
specification
according to Otsuka’s expert Allan S. Myerson, Ph.D. (Id. at ¶
9.) Such API could not be used in the commercial manufacture of
Mylan’s API products and are not representative samples.
Third, the SSCI testing showed

(Id.)
Fourth,

17

See Letter of Otsuka’s
Counsel, Jan. 13, 2017 [Docket Item 277], and Exs. 1-3 attached
thereto.
Mylan’s counterargument, that Mylan previously produced
samples that met the

specification, and that Otsuka’s

position is a “red herring,” misses the essential point that
those samples were non-conforming in other relevant ways,

Otsuka has met its Rule 56(d) burden of showing that it
acted diligently during the discovery period to procure
conforming samples of Mylan’s aripiprazole API, and that it is
entitled to reopen discovery to obtain and analyze the Mylan API

Otsuka has demonstrated that it needs access to a
third sample of Mylan’s aripiprazole API before it can
18

meaningfully respond to Mylan’s summary judgment motion. Since
Otsuka has raised sufficient doubt about the representative
nature of the first two samples, which thus would not be
suitable for testing regarding hygroscopicity under the ‘760
patent, Mylan will be required to produce a representative
sample of its actual aripiprazole API.
The Court assumes that this sample

Sample Protocol. Because there has been so much dispute and
doubt about the manner of selection, production, storage,
shipment, and testing of samples in this case, the Court will
also require counsel for Otsuka and Mylan to agree, within
fourteen (14) days, to a suitable protocol (“Sample Protocol”)
for each aspect of selection and production of the sample, as
well as shipment, packaging, and testing methods to maximize
reliability of ultimate testing of hygroscopicity which is of
essential moment in this case. Mylan is encouraged to retain a
defined split sample of the same API and subject it to its own
testing under the agreed-upon procedures and methods.
When counsel have agreed to the Sample Protocol, Mylan will
produce the sample within fourteen (14) days thereafter. The
19

parties will mutually exchange reports of these test results,
including a confirmation of the methods used for storage, sample
preparation, and testing within fourteen (14) days thereafter.
By using an agreed-upon Sample Protocol, the Court hopes to
achieve definitive and reliable results that will make a renewal
of Mylan’s summary judgment motion of non-infringement
unnecessary, one way or the other.
Finally, in the alternative, counsel are encouraged, but
not required, to agree upon a neutral and independent testing
laboratory to carry out this scientific testing in accordance
with the Sample Protocol. The selected laboratory would furnish
its results to both parties and the parties would share the
selected laboratory’s costs and expenses. This will eliminate
the prospect of bias or self-serving conduct in the testing
process.
Accordingly, Otsuka’s motion under Rule 56(d) to reopen
discovery and require Mylan to produce this sample will be
granted. Mylan’s motion for summary judgment of non-infringement
will be dismissed without prejudice to renewal, if necessary,
after completion of the Rule 56(d) discovery. The accompanying
Order will be entered.

20

CONCLUSION
An accompanying Order will be entered.

September 29, 2017
Date

Redacted:

s/ Jerome B. Simandle
JEROME B. SIMANDLE
U.S. District Judge

November 7, 2017

21