United States District Court, D. Delaware
ASTELLAS PHARMA INC., ASTELLAS IRELAND CO., LTD., and ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC., Plaintiffs,
ACTAVIS ELIZABETH LLC, et al., Defendants.
CHRISTOPHER J. BURKE UNITED STATES MAGISTRATE JUDGE.
Wilmington this 20th day of July, 2017:
on July 19, 2017 the Court held a teleconference regarding
protective order disputes between Plaintiffs Astellas Pharma
Inc., Astellas Ireland Co., Ltd., and Astellas Pharma Global
Development, Inc. (collectively, "Plaintiffs"), and
Defendants Actavis Elizabeth LLC, Lupin Ltd., Lupin
Pharmaceuticals, Inc., Zydus Pharmaceuticals (USA), Inc.,
Cadila Healthcare Ltd. (d/b/a Zydus Cadila), Aurobindo Pharma
Ltd., Aurobindo Pharma USA, Inc., Aurolife Pharma LLC,
Prinston Pharamaceutical Inc., Sawai Pharmaceutical Co.,
Ltd., Sawai USA, Inc., Sandoz, Inc., Apotex Inc. and Apotex
Corp. (collectively, "Defendants");
THEREFORE, IT IS HEREBY ORDERED that:
to the parties' first dispute, which relates to
production of non-party confidential information pursuant to
the Protective Order, the Court will ADOPT Plaintiffs'
proposed language. (See D.I. 61, ex. 1 at ¶
This dispute is really about the process by which
confidential third-party information that is in
Defendants' possession will be disclosed or withheld, and
the burdens associated with the process for producing or
withholding such information. The Court finds that
Plaintiffs' proposal best accomplishes the goals of
facilitating the efficient flow of discovery, while also
providing a full and fair mechanism for non-parties to
intervene and object to the disclosure of their confidential
parties' second dispute relates to the disclosure of
Plaintiffs' confidential information between Defendants.
As to this dispute, the Court will again ADOPT
Plaintiffs' proposed language. (See Id. at
¶ 10) That language specifies that the proposed
restrictions shall apply only to confidential information
"that relates solely to the validity,
enforceability or infringement of [United States] Patent No.
6, 346, 532 (the '532 patent)[.]" (Id.
(emphasis added)) It is not disputed that if Plaintiffs
possess records that do in fact relate solely to the
validity, enforceability or infringement of the '532
patent, then the Defendant Groups that are not asserting that
the '532 patent is invalid, unenforceable, and/or not
infringed would have no right to such documents under Federal
Rule of Civil Procedure 26, since the records would not be
"relevant to any [of those Defendant Group's]
claim[s] or defense[s.]" Fed.R.Civ.P. 26(b). And the
Court finds that Plaintiffs' proposal provides the best
way for the parties to identify and tee up with the Court any
disputes about whether a record falls into this category, and
whether it may be shared with certain other Defendants.
regard to the parties' third dispute, which relates to
the disclosure by Plaintiffs of Defendants' confidential
information between other Defendants, the Court will ADOPT
Defendants' proposed language. (See D.I. 61, ex.
1 at ¶ 10) In balancing here between the competing
interests of (1) litigation-related efficiency and (2)
protecting the parties' confidential information, the
Court errs on the side of the latter. The Court notes that
Defendants' proposed language is consistent with other
Protective Orders in ANDA cases within this District.
See, e.g., AstraZeneca LP v. Sigmapharm Labs., LLC,
Civil Action No. 15-1000-RGA (D. Del. Apr. 26, 2016) (D.I. 71
at ¶ 16); Forest Labs., LLC v. Apotex Corp.,
Civil Action No. 15-18-GMS (D. Del. Sept. 18, 2015) (D.I. 48
at ¶ 19).
to the parties' final dispute, which concerns
participation in post-grant proceedings by those with access
to confidential information, the Court will ADOPT
Plaintiffs' proposed language, and DENY Defendants'
request to preclude Plaintiffs' trial counsel from
"providing recommendations regarding drafting, crafting,
or amending of patent claims" in any post-grant
proceedings with respect to patents involving mirabegron.
(D.I. 61, ex. 1 at ¶ 10(A)) In adjudicating disputes
over what kind of prosecution bar should be entered, the
Court must balance (1) any unacceptable risk of inadvertent
disclosure or competitive use of confidential information
against (2) the potential harm the party affected by the
portion of the bar at issue would face were that portion
adopted, and were it denied its counsel of choice. See
Toshiba Samsung Storage Tech. Korea Corp. v. LG Elecs.,
Inc., Civil Action No. 15-691-LPS-CJB, 2016 WL 447794,
at *1 (D. Del. Feb. 4, 2016) (hereinafter,
"TSST-K") (citing In re Deutsche Bank
Trust Co. Ams., 605 F.3d 1373, 1379-80 (Fed. Cir.
2010)). It is Defendants' burden to show good cause for
its proposed provision effecting a prosecution bar. See,
e.g., Id. at 1 n.l; Xerox Corp. v. Google,
Inc., 270 F.R.D. 182, 183-84 (D. Del. 2010). And here,
there is very little concrete evidence in the record
regarding either (1) the risk of inadvertent disclosure or
competitive use of confidential information, or (2) the
potential harm that Plaintiffs would suffer were they to be
denied the counsel of their choice. The Court is also
cognizant that "it is hard to dispute that the magnitude
of [the risk of inadvertent disclosure of or competitive use
of confidential information] is far less pronounced with
respect to an IPR proceeding (in which [the patentee's]
claims may be only narrowed, not enlarged) as compared to the
prosecution of a new patent[.]" TSST-K, 2016 WL
447794, at *2 (citations omitted). In light of this, and the
lack of record evidence on the issue, the Court finds that
Defendants have not met their burden here. However, the Court
will consider a request to modify the Protective Order in the
future as to this issue, if the evidence warrants it. Cf.
Boston Scientific Corp. v. Cook Group Inc., Civil Action
No. 15-980-LPS-CJB (D. Del. Apr. 18, 2016) (D.I. 36 at ¶
parties are ORDERED to submit a final proposed Protective
Order, incorporating the above decisions, by no later than
July 27, 2017.
 Plaintiffs and Defendant Windlas
Healthcare Pvt. Ltd. ("Windlas") are bound by the
Stipulation and Order to Stay Claims and Be Bound By Result
in Litigation, dated July 11, 2017. (D.I. 60; see
also D.I. 61 at 1 n.l) Windlas did not participate in
 The parties shall change the phrase
"the Court shall order production of in Plaintiffs'
proposal to "the Producing Party shall