Regeneron Pharmaceuticals Inc. v. Novartis Pharma AG

PAVBIUGAGUGIT YAO. PIE GQOCUTTICTI COMMAINNTIY WIG (Lue,

169) shall remain under seal, and the document containing the

placeholder for that exhibit shall remain the publicly-filed version

March 28, 2025 (Doc. 168).

SO ORDERED.

VIA ELECTRONIC FILING (Diy,

Hon. Philip M. Halpern Philip M. Halpern

Southern District of New York United States District Judge

300 Quarropas St., Courtroom 520

White Plains, NY 10601 Dated: White Plains, New York

March 31, 2025

Re: Regeneron Pharmaceuticals, Inc v. Novartis Pharma AG et al., Case No. 7:20-cv-05502-

PMH-AEK - Letter Motion to Seal Exhibit to Joint Pre-Motion Letter

Dear Judge Halpern:

Plaintiff Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Defendants Novartis Pharma

AG, Novartis Technology LLC, and Novartis Pharmaceutical Corp. (collectively, “Novartis”) are

prepared to submit a joint pre-motion letter (“Pre-Motion Letter’) respectfully requesting a

conference to resolve a discovery dispute concerning, among other issues, the production of

Novartis’s Patent Prosecution Guide (the “Guide”). Among the exhibits attached to the joint letter

is a copy of the Guide itself (Regeneron Ex. 2), which was produced by Novartis on an “Outside

Counsel’s Eyes Only” basis pursuant to the Stipulated Amended Protective Order (ECF No. 103).

Pursuant to Your Honor’s Individual Rule of Practice 5(B), the Standing Order for Electronic

Filing Under Seal in Civil and Miscellaneous Cases (1:19-mc-00583), and ECF Rules &

Instructions, Regeneron and Novartis write to request permission to file the Guide under seal for

the reasons set forth by Novartis below.' Novartis has conferred with counsel for Regeneron, and

Defendant Vetter Pharma International GmbH, and neither party opposes filing the Guide under

seal.

' Consistent with the Court’s Individual Rule of Practice 5(B), the parties have contemporaneously

filed under seal an unredacted copy of the Guide. Please note, Novartis is seeking to file the Guide

under seal in its entirety. While there are highlights in the exhibit, these highlights do not represent

Novartis’s proposed redactions, but rather were applied by Regeneron.

Under Lugosch v. Pyramid Co. of Onondaga, courts weigh the “common law presumption

of access” to judicial documents against “countervailing factors” like the privacy interests of the

parties. 435 F.3d 110, 119–20 (2d Cir. 2006). Notably, “[t]he presumption of public access in

filings submitted in connection with discovery disputes or motions in limine is generally somewhat

lower than the presumption applied to material introduced at trial, or in connection with dispositive

motions such as motions for dismissal or summary judgment.” Fairstein v. Netflix Inc., 2024 U.S.

Dist. LEXIS 93867, at *3 (S.D.N.Y. May 21, 2024) (quoting Brown v. Maxwell, 929 F.3d 41, 50

(2d Cir. 2019)). Any presumption of public access can be rebutted, for instance, by the interest in

protecting a company’s business secrets, or where the public disclosure of a company’s

confidential business information has the potential to cause competitive injury. See Lexington

Furniture Indus., Inc. v. Lexington Co., AB, 2021 U.S. Dist. LEXIS 55907, at *5–6 (S.D.N.Y. Mar.

24, 2021) (“[A] valid need to protect the confidentiality of such sensitive business information

may be a legitimate basis to rebut the public’s presumption of access to judicial documents.”); Sam

Dyer & Smr Dyer Farms LLC, v. Agri-Mark, Inc., 2022 U.S. Dist. LEXIS 13838, at *6 (N.D.N.Y.

Jan. 21, 2022) (“[C]onfidential business internal policies and procedures are appropriately sealed

because the public disclosure of such policies has the potential to cause competitive injury.”).

As the Guide is being filed in relation to a discovery dispute, the public interest in access

to this document is “lower” (Fairstein, 2024 U.S. Dist. LEXIS 93867, at *3) and any interest in

public access is outweighed by Novartis’s interest in protecting its confidential business

information. The Guide was prepared by Novartis’s Patent Prosecution Practice and Pharma

Patent Prosecution Efficiency Champions Teams as an internal tool for Novartis’s Intellectual

Property Practice Group. See Novartis Ex. A to the Pre-Motion Letter ¶¶ 1–2. It contains the

proprietary guidance of Novartis’s intellectual property professionals regarding cost-saving

strategies in patent prosecution, approaches to assessing the commercial relevance of Novartis

patents, unique record keeping processes, and other confidential business information. Such

sensitive business information is appropriately sealed. See Kidd v. Thomson Reuters Corp., 299

F. Supp. 3d 400, 408 (S.D.N.Y. 2017) (maintaining under seal “proprietary, confidential, and

commercially sensitive internal training materials” (citation omitted)). Indeed, the Guide should

not be publicized to Novartis’s competitors, who may use it as a tool to their own advantage.

United States v. Amodeo, 71 F.3d 1044, 1051 (2d Cir. 1995) (“Commercial competitors seeking

an advantage over rivals need not be indulged in the name of monitoring the courts . . . .”);

Encyclopedia Brown Prods., Ltd. v. Home Box Off., 26 F. Supp. 2d 606, 614 (S.D.N.Y. 1998)

(“Confidential business information dating back even a decade or more may provide valuable

insights into a company’s current business practices that a competitor would seek to exploit.”).

Moreover, Regeneron argues in the pre-motion letter that Novartis has waived privilege by

producing certain unredacted sections of the Guide. While Novartis does not agree that the

unredacted sections of the Guide are privileged, to the extent the Court ultimately disagrees with

Novartis’s good-faith analysis and determines those sections are privileged, there is an interest in

maintaining the Guide under seal to prevent the disclosure of privileged information. See Novartis

Int’l Pharm. AG v. Incyte Corp., 2024 U.S. Dist. LEXIS 135547, at *3 (S.D.N.Y.) (recognizing

that the “countervailing interest of preserving the privilege outweighs the presumption of public

access” (citing In re Agent Orange Prod. Liab. Litig., 98 F.R.D. 539, 545 (E.D.N.Y. 1983)

(“Where unsealing of documents might reveal material governed by the work product privilege or

the contents of communications between an attorney and client might be disclosed, the public

interest in protecting those privileges would take precedence over its interest in inspecting and

copying court records.”)).

For the reasons set forth above, Novartis respectfully requests that the Court grant its

unopposed motion to seal and allow Novartis and Regeneron to file Exhibit 2 to the joint pre-

motion letter under seal.

Respectfully submitted,

/s/ Christopher M. Pepe /s/ Robert Milne

Christopher M. Pepe Robert Milne

Paul, Weiss, Rifkind, Wharton & White & Case LLP

Garrison LLP 1221 Avenue of the Americas

1285 Avenue of the Americas New York, New York 10020-1095

New York, New York 10019-6064

Counsel for Plaintiff Regeneron Counsel for Novartis Pharma AG,

Pharmaceuticals, Inc. Novartis Pharmaceuticals Corp.,

and Novartis Technology LLP