Lupin Ltd. v. Salix Pharmaceuticals, Inc. et al

Filing 123

ORDER granting 120 Letter Motion to Seal. Granted. SO ORDERED. (Signed by Magistrate Judge Robert W. Lehrburger on 5/9/2024) (tg)

May 8, 2024
BY ECF
5/9/2024
The Hon. Robert W. Lehrburger
Daniel Patrick Moynihan U.S. Courthouse
500 Pearl Street
New York, New York 10007
Re:

Norton Rose Fulbright US LLP
1301 Avenue of the Americas
New York, New York 10019-6022
United States of America
Direct line [phone]
[e-mail]
Tel [phone]
Fax [phone]

Lupin Ltd. v. Salix Pharma., Inc., et al., No. 1:22-cv-07656-JHR-RWL

Dear Judge Lehrburger:
We represent Defendant and Counterclaim-Plaintiff Salix Pharmaceuticals, Inc. and Defendant
Bausch Health US, LLC (“Defendants”) in the above-referenced action and submit this lettermotion pursuant to Rule III(G) and the Appendix of Your Honor’s Individual Practices in Civil
Cases to request that the Court permit Defendants to maintain the confidentiality of Defendants’
trade secret information within the document filed at Dkt. 82-1. Consistent with Your Honor’s
Individual Practices, and contemporaneously with this letter-motion, Defendants are (1) publicly
filing a copy of Dkt. 82-1 in redacted form; and (2) filing under seal a copy of Dkt. 82-1 with their
proposed redactions highlighted in yellow.
Plaintiff Lupin Ltd. does not object to Defendants’ proposed redactions of Dkt. 82-1.
The Proposed Redactions Protect Confidential, Trade Secret Information.
Defendants seek to maintain confidential trade secret information, which is “broadly defined” as
“any formula, pattern, device or compilation of information which is used in one’s business, and
which gives the owner an opportunity to obtain an advantage over competitors who do not know
or use it.” Town & Country Linen Corp. v. Ingenious Designs LLC, No. 18-CV-5075 (LJL), 2022
WL 2757643, at *14 (S.D.N.Y. July 14, 2022). Dkt. 82-1, Exhibit 1 to the Declaration of Benjamin
Bloodstein (the “Exhibit”), is a proposed Letter of Request seeking international judicial assistance
from Italy under the Hague Evidence Convention. Two Zach Zambon Chemicals reports (the
“Zach Reports”) are attached to the proposed Letter of Request to help orient the Italian authorities
and the foreign corporate recipient of the document request to the documents sought by
Defendants.1 The Exhibit reveals Defendants’ confidential, trade secret information relating to
manufacturing specifications for rifaximin active pharmaceutical ingredient (“API”) and flow
sheets that identify the proprietary process for production of purified rifaximin. The U.S. Food
and Drug Administration considers such information trade secrets and has protected it from
disclosure under a Freedom of Information Act request. See Appleton v. Food & Drug Admin.,
451 F. Supp. 2d 129, 141 (D.D.C. 2006) (drug specifications and manufacturing processes
1

Defendants understand that the documents sought by the Letters of Request are located at a processing plant that
was sold in 2017 by Zach Zambon Chemicals to a new owner. Defendants attached the Zach Reports to aid the new
owner in determining the location of the requested files. See Dkt. 82, ¶ 2. The Exhibit is maintained in confidence
by the Italian authorities.

Norton Rose Fulbright US LLP is a limited liability partnership registered under the laws of Texas.
Norton Rose Fulbright US LLP, Norton Rose Fulbright LLP, Norton Rose Fulbright Australia, Norton Rose Fulbright Canada LLP and Norton Rose Fulbright
South Africa Inc are separate legal entities and all of them are members of Norton Rose Fulbright Verein, a Swiss verein. Norton Rose Fulbright Verein helps
coordinate the activities of the members but does not itself provide legal services to clients. Details of each entity, with certain regulatory information, are
available at nortonrosefulbright.com.

The Honorable Robert W. Lehrburger
May 8, 2024
Page 2
comprise trade secrets exempt from FOIA disclosure).
Further, Defendants have safeguarded these trade secrets. The Zach Reports and other documents
that contain rifaximin API specifications were produced in discovery by Defendants and properly
designated to maintain their confidentiality pursuant to the terms of the Protective Order (Dkt.
114).
The Confidential, Trade Secret Information Should Be Protected From Disclosure.
The Second Circuit has set out a three-part test to determine whether to protect the confidentiality
of documents submitted to a court: (1) determine whether the documents are “judicial documents”
entitled to the presumption of public access; (2) determine the applicable weight of the
presumption that may apply; and (3) balance “countervailing factors” against such weight of the
presumption, including the “privacy interests” of the interested parties. See Lugosch v. Pyramid
Co. of Onondaga, 435 F.3d 110, 119-20, 124 (2d Cir. 2006) (holding that documents may be kept
under seal if “countervailing factors” warrant confidentiality). Under this test, Defendants are
appropriately seeking to seal only those portions of the Exhibit that comprise trade secret
information.
First, the Exhibit is not a “judicial document” entitled to a presumption of public access. The
Exhibit is discovery material produced to aid the Italian authorities and foreign corporate recipient
of the document request. See United States v. Smith, 985 F. Supp. 2d 506, 520 (S.D.N.Y. 2013)
(“discovery materials filed with the court in connection with discovery-related disputes are not
covered by the qualified right of access”). Further, the content of the redacted trade secret
information is not necessary to the Court’s review of Defendants’ Letters of Request. The Court
in Lugosch explained that “the mere filing” of a document does not afford it the presumption of
access and that it “must be relevant to the performance of the judicial function and useful in the
judicial process” to constitute a “judicial document.” Lugosch, 435 F.3d at 115, 119. Given the
nature of the Exhibit, it is not a “judicial document” and therefore the presumption of public access
should not apply.
Second, even if the presumption of access were to apply, it should be afforded little weight because
the documents at issue are discovery documents submitted only to assist in determining the
location of relevant information. See Alexander Interactive, Inc. v. Adorama, Inc., No. 12 CIV.
6608 PKC JCF, 2014 WL 4346174, at *2 (S.D.N.Y. Sept. 2, 2014) (“the weight of the presumption
is not particularly great” in connection with “a motion to compel further discovery from a party”).
Here, the Exhibit was filed in furtherance of foreign discovery and not a dispositive motion;
accordingly, “the presumption in favor of public access is weak.” Id.
Third, Defendants’ interest in protecting their confidential, trade secret information strongly
outweighs the public’s right to access the trade secrets contained within the documents. See Fed.
R. Civ. P. 26(c)(1)(G) (permitting protective orders for “trade secret or other confidential
information”); see also W.J. Deutsch & Sons Ltd. v. Diego Zamora, S.A., No. 1:21-CV-11003LTS, 2022 WL 890184, at *3 (S.D.N.Y. Mar. 25, 2022) (granting motion to redact “categories of
confidential business information that . . . have been previously recognized by courts in this circuit