Astellas Pharma Inc. et al v. Actavis Elizabeth LLC et al
MEMORANDUM ORDER re 59 MOTION for Teleconference to Resolve Discovery Dispute. The parties are ORDERED to submit a final proposed Protective Order by 7/27/2017. See Order for details. Signed by Judge Christopher J. Burke on 7/20/2017. (dlb)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ASTELLAS PHARMA INC., ASTELLAS
IRELAND CO., LTD., and ASTELLAS
PHARMA GLOBAL DEVELOPMENT,
ACTAVIS ELIZABETH LLC, et al.,
Civil Action No. 16-905-SLR-CJB
At Wilmington this 20th day of July, 2017 ..
WHEREAS, 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") 1;
NOW, THEREFORE, IT IS HEREBY ORDERED that:
As to the parties' first dispute, which relates to production of non-party
confidential information pursuant to the Protective Order, the Court will ADOPT Plaintiffs'
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.1) Windlas did not participate in the teleconference.
proposed language. (See D.I. 61, ex. 1 at if 3) 2 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 information.
The 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 if 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.
With regard to the parties' third dispute, which relates to the disclosure by
The parties shall change the phrase "the Court shall order production of' in
Plaintiffs' proposal to "the Producing Party shall produce[.]"
Plaintiffs of Defendants' confidential information between other Defendants, the Court will
ADOPT Defendants' proposed language. (See D.I. 61, ex.
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. 15-1000RGA (D. Del. Apr. 26, 2016) (D.I. 71at~16); Forest Labs., LLC v. Apotex Corp., Civil Action
No. 15-18-GMS (D. Del. Sept. 18, 2015) (D.I. 48
As 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~ IO(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.1; 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, ifthe 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 if 9).
The parties are ORDERED to submit a final proposed Protective Order,
incorporating the above decisions, by no later than July 27, 2017.
Christopher J. Burke
UNITED STATES MAGISTRATE JUDGE
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