United States District Court, D. Delaware
B. Blumenfeld, Derek J. Fahnestock, MORRIS, NICHOLS, ARSHT
& TUNNELL LLP, Wilmington, Delaware; Errol B. Taylor,
Fredrick M. Zullow, Anna Brook, Jordan P. Markham, Kyanna
Lewis, Nathaniel T. Browand, Venus Allahyarzadeh, MILBANK,
TWEED, HADLEY & MCCLOY LLP, New York, New York Counsel
C. Phillips, Jr., David A. Bilson, PHILLIPS, GOLDMAN,
MCLAUGHLIN, & HALL, P.A., Wilmington, Delaware; George C.
Lombardi, Michael K. Nutter, Ivan M. Poullaos, John R.
McNair, WINSTON & STRAWN LLP, Chicago, Illinois; Nimalka
R. Wickramasekera, WINSTON & STRAWN LLP, Los Angeles,
California Counsel for Defendants
CONNOLLY, UNITED STATES DISTRICT JUDGE
patent suit was filed by Plaintiffs Orexo AB and Orexo US,
Inc. (collectively, "Orexo") against Defendants
Actavis Elizabeth LLC, Actavis Pharma, Inc., Teva
Pharmaceuticals USA, Inc., and Teva Pharmaceutical
Industries, Ltd. (collectively, "Defendants").
Presently before me is Orexo's motion for summary
judgment that issue preclusion bars Defendants from
relitigating the validity of U.S. Patent No. 8, 454, 996 (the
"#996 patent"). D.I. 172. The matter is fully briefed.
D.I. 173, 174, 203, 205, 210, 216, 218. Forthe reasons
discussed below, I will deny Orexo's motion.
alleges in its complaint that Actavis Elizabeth LLC's
generic versions of Suboxone® and Subutex® infringe
the #996 patent. D.I. 1. In an earlier case filed in this
court, Orexo sued Actavis Elizabeth and its parent company,
Actavis, Inc., alleging, among other things, that Actavis
Elizabeth's generic versions of Zubsolv® infringe the
#996 patent. Orexo AB v. Actavis Elizabeth LLC, 217
F.Supp.3d 756 (D. Del. 2016) [the "Zubsolv
litigation"], rev'd on other grounds, 903
F.3d 1265 (Fed. Cir. 2018). In response to Orexo's
complaint in the Zubsolv litigation, Actavis Elizabeth and
Actavis, Inc. asserted as an affirmative defense and in a
counterclaim that claims of the #996 patent are "invalid
under one or more provisions of 35 U.S.C. §§ 101,
102, 103, and/or 112." D.I. 173, Ex. A at 16; see
also Id. at 11, 17.
September 2014, the parties in the Zubsolv litigation filed,
and the court approved, a stipulation to dismiss Actavis,
Inc. from the Zubsolv litigation. D.I. 203 at ¶ 12.
Under the terms of the stipulation, "Actavis, Inc.
including all affiliates and subsidiaries thereof... agree[d]
to be bound by any judgment... rendered as to Actavis
Elizabeth LLC in the Action (including appeals) as if they
were named defendants." Id. (quoting D.I. 173,
Ex. C at ¶¶ 1, 5). At the time the stipulation was
entered by the court, Defendant Actavis Pharma, Inc., like
Actavis Elizabeth, was a wholly-owned subsidiary of Actavis,
Inc. Id. at ¶ 13. It is undisputed that Actavis
Elizabeth and Actavis Pharma (collectively,
"Actavis" or the "Actavis entities") are
bound by the stipulation and the judgment ultimately issued
in the Zubsolv litigation. Id. at ¶¶
2015, Defendants Teva Pharmaceuticals USA, Inc. and Teva
Pharmaceutical Industries, Ltd. (collectively
"Teva") announced that Teva had agreed to purchase
certain Actavis, Inc. assets, including Actavis Elizabeth and
Actavis Pharma (the "Actavis transaction"). D.I.
203 at ¶¶ 19, 21.
2016, before the Actavis transaction was consummated, the
Zubsolv litigation proceeded to a bench trial before the now
retired Honorable Sue L. Robinson. Orexo AB, 217
F.Supp.3d at 759. In the proposed pre-trial order filed
jointly by the parties in the Zubsolv litigation, Actavis
Elizabeth identified as one of three "substantive issues
remaining to be litigated ... whether the Asserted Claims [of
the #996 patent] are invalid as obvious under 35 U.S.C.
§ 103." Joint Proposed Pretrial Order, Orexo AB
v. Actavis Elizabeth LLC, No. 14-cv-829-SLR (D. Del. May
4, 2016), D.I. 164-1, Ex. 5 at 1. Actavis Elizabeth did not
identify any other theories of invalidity in the pre-trial
order that remained to be litigated, and the only theory of
invalidity it presented at trial was obviousness. See
Orexo AB, 217 F.Supp.3d at 762-69.
August 2, 2016-after trial but before entry of a judgment in
the Zubsolv litigation-the Actavis transaction closed and
Teva acquired Actavis Elizabeth and Actavis Pharma. D.I. 203
at ¶¶ 19, 21. The terms of the transaction were set
forth in a "Master Purchase Agreement." Pursuant to
that agreement, Teva assumed Actavis's "Liabilities
and Claims." See D.I. 173, Ex. E at 35; Tr. of
Feb. 28, 2019 Hr'g at 36:8-39:3.
opinion issued on November 15, 2016, Judge Robinson held that
the asserted claims of the #996 patent "are not invalid
as obvious" and that Actavis Elizabeth infringed the
asserted claims. Orexo AB, 217 F.Supp.3d at 781;
see also D.I. 203 at ¶ 27. Actavis Elizabeth
did not appeal Judge Robinson's rulings with respect to
the #996 patent.
February 2017, Orexo filed this action. Orexo alleges in its
complaint that Actavis Elizabeth's manufacturing and
Actavis Pharma's distribution of generic versions of
Suboxone® and Subutex® infringe the #996 patent. D.I.
1 at ¶¶ 47-48, 74-75. Orexo alleges that Teva
infringes the #996 patent by manufacturing, selling, offering
for sale and/or importing into the United States generic
Suboxone® and Subutex® products "either
indirectly through [its] subsidiaries or affiliates or
directly." Id. at ¶¶ 49, 76.
their answer to the complaint, Defendants asserted as an
affirmative defense and counterclaim that "one or more
claims of the [#]996 patent are invalid under one or more
provisions of 35 U.S.C. §§101, 102, 103, and/or
112." D.I. 50 at 51; see also Id. at 22.
Defendants, however, now seek only to assert that the #996
patent is invalid under §§ 103 and 112. D.I. 205,
Ex. 2 at 23, 41.
LEGAL STANDARDS FOR SUMMARY JUDGMENT
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."
Fed.R.Civ.P. 56(a). "[T]he party moving for summary
judgment... bears the burden of demonstrating the absence of
any genuine issues of material fact." Celotex Corp.
v. Catrett, 477 U.S. 317, 323 (1986). If the moving
party has carried its burden, the non-moving party must then
"come forward with 'specific facts showing that
there is a genuine issue for trial."' Matsushita
Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574,
587 (1986) (quoting Fed.R.Civ.P. 56(e)).
facts are those "that could affect the outcome" of
the proceeding. Lamont v. New Jersey, 637 F.3d 177,
181 (3d Cir. 2011). "[A] dispute about a material fact
is 'genuine' if the evidence is sufficient to permit
a reasonable jury to return a verdict for the nonmoving
party." Id. A non-moving party asserting that a
fact is genuinely disputed must support such an assertion by:
"(A) citing to particular parts of materials in the
record, including depositions, documents, electronically
stored information, affidavits or declarations, stipulations
..., admissions, interrogatory answers, or other materials;
or (B) showing that the materials cited [by the opposing
party] do not establish the absence ... of a genuine dispute
...." Fed.R.Civ.P. 56(c)(1). The non-moving party's
evidence "must amount to more than a scintilla, but may
amount to less (in the evaluation of the court) than a
preponderance." Williams v. Borough of W.
Chester, 891 F.2d 458, 461 (3d Cir. 1989).
court must view the evidence in the light most favorable to
the non-moving party and draw all reasonable inferences in
that party's favor. Wishkin v. Potter, 476 F.3d
180, 184 (3d Cir. 2007). "[T]he facts asserted by the
nonmoving party, if supported by affidavits or other
evidentiary material, must be regarded as true" Aman
v. Cort Furniture Rental Corp., 85 F.3d 1074, 1080 (3d
Cir. 1996). If "there is any evidence in the record from
any source from which a reasonable inference in the
[nonmoving party's] favor may be drawn, the moving party
simply cannot obtain a summary judgment...."
argues in its summary judgment motion that "validity is
a single issue" as a matter of law and that, therefore,
the doctrine of issue preclusion bars Defendants from
challenging the validity of the #996 patent in this action.
D.I. 172. Defendants disagree that validity is a single
issue, but they do not dispute that if validity is deemed to
be a single issue then the Actavis entities are precluded
from challenging the #996 patent's validity in this
action. D.I. 203 at ¶ 11. Defendants contend that Teva
is not bound by any judgment or rulings issued in the Zubsolv
litigation regardless of whether validity is a single issue.
See D.I. 210 at 3-9.
their papers filed in opposition to Orexo's motion,
Defendants asserted as a factual matter that "[t]he
identical issue of the [#]996 patent's validity was not
previously litigated" in the Zubsolv litigation. D.I.
203 at 12; see also Id. at 12-14; D.I. 210 at 9-11.
In support of this assertion, Defendants stated that §
112 defenses they intend to assert in this action and certain
prior art references they intend to offer as part of an
obviousness defense under § 103 in this action were not
presented in the Zubsolv litigation. D.I. 203 at 12-14. Orexo
does not dispute that § 112 and the prior art references
cited by Defendants were not presented or adjudicated in the
Zubsolv litigation. Orexo simply contends that Defendants are
precluded from asserting these invalidity defenses ...