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Orexo AB v. Actavis Elizabeth LLC

United States District Court, D. Delaware

November 9, 2018

OREXO AB and OREXO US, INC., Plaintiffs,
v.
ACTAVIS ELIZABETH LLC, ACTAVIS PHARMA, INC., TEVA PHARMACEUTICALS USA, INC., and TEVA PHARMACEUTICAL INDUSTRIES, LTD., Defendants.

          Jack 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

          John 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

          MEMORANDUM OPINION

          CONNOLLY, UNITED STATES DISTRICT JUDGE

         Presently 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.

         I. BACKGROUND

         Orexo 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.[1]

         Shortly 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 appeal." Id.

         Judge 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 action?
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.

         The 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.

         After 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 recommended ...


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