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, MILBANK, TWEED, HADLEY & MCCLOY LLP, New York, New
York Counsel for Plaintiffs
C. Phillips, Jr., David A. Bilson, PHILLIPS, GOLDMAN,
MCLAUGHLIN, & HALL, P.A., Wilmington, DE, George C.
Lombardi, Michael K. Nutter, Ivan M. Poullaos, Laura B.
Greenspan, WINSTON & STRAWN LLP, Chicago, Illinois
Counsel for Defendants
CONNOLLY, UNITED STATES DISTRICT JUDGE
before me are competing filings regarding the Amended
Recommendation and Report (D.I. 108) (the
"Recommendation and Report") issued by the Special
Master appointed by the previously assigned judge to this
case, the now retired Honorable Gregory M. Sleet. Defendants
Actavis Elizabeth LLC, Actavis Pharma, Inc., Teva
Pharmaceuticals USA, Inc., and Teva Pharmaceutical
Industries, Ltd. (collectively, "Actavis") have
filed objections to the Recommendation and Report. D.I. 113.
Plaintiffs Orexo AB and Orexo US, Inc. (collectively,
"Orexo") have filed a motion to adopt the
Recommendation and Report. D.I. 115. I have studied the
Recommendation and Report (D.I. 108), the parties'
briefing submitted to Judge Sleet (D.I. 14, 22, 24, 113, 115,
130, 131, 134, 135), the parties' submissions to the
Special Master (D.I. 113 Ex. C, D.I. 131 Ex. B, D.I. 155), a
transcript of the February 7, 2018 hearing before the Special
Master (Tr. of Feb. 7, 2018 Hr'g), and 29 privileged
documents submitted by Orexo for the Special Master's
in camera review (D.I. 155). For the reasons
discussed below, I will overrule Actavis's objections and
adopt the Recommendation and Report.
alleged in its complaint that Actavis's generic versions
of Suboxone® and Subutex® infringe United States
Patent No. 8, 454, 996 ("the #996 patent"). In an
earlier case filed in this court, Orexo had alleged that
Actavis Elizabeth LLC's generic version of Zubsolv®
infringed the #996 patent. Orexo AB v. Actavis Elizabeth
LLC, 217 F.Supp.3d 756 (D. Del. 2016) (the "Zubsolv
litigation"). After a bench trial in the Zubsolv
litigation, the now retired Honorable Sue L. Robinson ruled
among other things that the #996 patent was valid and
infringed by Actavis Elizabeth LLC's generic version of
Zubsolv®. See Id. at 776-81. Actavis Elizabeth
LLC did not appeal Judge Robinson's rulings with respect
to the #996 patent.
after Orexo filed its complaint in this matter, Actavis filed
a motion to strike and dismiss. D.I. 13. In its brief filed
in support of the motion, Actavis argued that Orexo's
allegations in its complaint about Actavis's generic
versions of Suboxone® and Subutex® were
"derived" from confidential information Actavis
Elizabeth LLC had produced in the Zubsolv litigation pursuant
to a protective order which provided that Orexo could
"use [such confidential information] solely for purposes
of assisting Outside Counsel in connection with" the
Zubsolv litigation. D.I. 14 at 2 (quoting protective order).
In Actavis's words, "Orexo appears to have
'use[d]' that confidential information in this case
in violation of the Protective Order." Id. at 5
(alteration in original). Actavis based its conclusion that
"Orexo appears to have" violated the Zubsolv
litigation protective order on the fact that Orexo filed its
complaint in this action in February 2017 - four years after
the launch of Actavis's generic Suboxone® and two
years after the launch of its generic Subutex®. Actavis
further argued that "[c]ritically, Orexo waited until
after the [#]996 patent was held valid in the Zubsolv®
[l]itigation, and Actavis [Elizabeth LLC] had chosen not to
Sleet appointed the Special Master "for the purpose of
resolving" Actavis's "allegation that Orexo
improperly used confidential information produced under a
protective order in [the Zubsolv litigation] in connection
with the allegations in the complaint in this action."
D.I. 38 at 1. In the five-page appointment order, Judge Sleet
directed the Special Master to issue a report to the Court
addressing the following questions:
1. Did Orexo impermissibly "use" Actavis
confidential information to support the complaint in this
2. Did [Actavis] meet [its] burden of proof to show that the
protective order in the [Zubsolv] litigation was violated?
3. If there was a violation, identify the violation.
4. Such other questions that may arise that the Special
Master deems pertinent to the dispute to be addressed.
Id. at 2.
Special Master reviewed the parties' extensive briefing
on Actavis's motion to strike and dismiss and, consistent
with Judge Sleet's appointment order, offered the parties
the opportunity to "provide any submissions and/or
declarations [they] deemed helpful." D.I. 108 at 7. Also
consistent with Judge Sleet's appointment order, Orexo
submitted and the Special Master reviewed declarations from
Orexo's Head of Pharmaceutical Development and
Intellectual Property and from Orexo's lead outside
counsel in the Zubsolv litigation; privileged emails and
correspondence regarding the acquisition, testing, and
analyses of Actavis's generic versions Suboxone® and
Subutex®; and documents in which Orexo and its lawyers
evaluated potential litigation and analyzed patent
infringement claims and potential legal defenses to such
claims. Id. at 8.
reviewing these materials and hearing oral argument from the
parties, the Special Master issued his Recommendation and
Report. The Special Master found that "[t]here is no
basis to conclude there was any violation" of the
protective order issued in the Zubsolv litigation and