Regeneron Pharmaceuticals Inc. v. Novartis Pharma AG

Application granted. The unredacted document (Doc.

179) shall remain under seal, and the redacted document

shall remain the publicly-filed version (Doc. 180).

April 24, 2025

SO @ARDERED.

VIA ELECTRONIC FILING

. Philip M. Halpern

Hon. Philip M. Halpern United States District Judge

Southern District of New York

300 Quarropas St., Courtroom 520 Dated: White Plains, New York

White Plains, NY 10601 April 24, 2025

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

(S.D.N.Y.) — Joint Letter Motion to Seal Exhibits 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 (the “Pre-Motion Letter,” or, “Letter’) respectfully

requesting a conference concerning Regeneron’s assertion that Novartis has waived privilege as

to all documents and communications concerning its investigation and analysis of Vetter’s

inventorship claim regarding U.S. Patent No. 9,220,631 (“the ’631 patent”). In accordance with

Rule 5(B) of Your Honor’s Individual Practice Rules, the Standing Order In Re: Electronic Filing

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

Sections 6 and 21, Regeneron and Novartis write to request permission to file the Pre-Motion

Letter and exhibits identified below under seal or in redacted form. Pursuant to Rule 5(B) of Your

Honor’s Individual Practice Rules, the Pre-Motion Letter and below-identified exhibits are

contemporaneously filed under seal.

A district court “has supervisory power over its own records and files,” and public access

to these records and files “has been denied where court files might have become a vehicle for

improper purposes.” Mixon v. Warner Commc’ns, Inc., 435 U.S. 589, 598 (1978). While “[t]here

is acommon law presumption in favor of permitting public access to judicial documents,” a “court

balances this common law presumption of access against competing comparisons, including the

privacy interests of those resisting disclosure.” GoSMiLE, Inc. v. Dr. Jonathan Levine, D.M.D.

P.C., 769 F. Supp. 2d 630, 649 (S.D.N.Y. 2011) (citing Lugosch v. Pyramid Co. of Onondaga, 435

F.3d 110, 119 (2d Cir. 2006)). Competitively sensitive information, for example, should be

protected against public disclosure if such disclosure would cause significant and irreparable

competitive injury. See, e.g., Standard Inv. Chartered, Inc. v. Fin. Indus. Reg. Auth., 347 F. App’x

615, 617 (2d Cir. 2009) (finding that presumption of public access was overcome when disclosure

would subject a party to financial harm and cause significant competitive disadvantage).

Among the exhibits attached to the joint letter is Exhibit 14, an excerpted version of the

ITC deposition transcript of Daniel Van Plew, Executive Vice President and General Manager of

Industrial Operations and Product Supply at Regeneron. Mr. Van Plew’s deposition transcript has

been produced in this case and designated as “CONFIDENTIAL BUSINESS INFORMATION”

pursuant to the Protective Order. See Dkt. 76. Regeneron seeks to seal Exhibit 14. The sealing of

Exhibit 14 is narrowly tailored to protect commercially sensitive and confidential information,

including testimony on non-public patent sublicense offers and corresponding strategic business

and commercial development decisions. Importantly, disclosure of this confidential business

information would likely result in competitive harm to Regeneron. For example, disclosure of the

economic terms of the parties’ various licensing and/or commercial agreements could

disadvantage them in future negotiations with third parties with respect to similar agreements. See,

e.g., Gracyzk v. Verizon Commc’ns, Inc., No. 18-6465, 2020 WL 1435031, at *8-9 (S.D.N.Y. Mar.

24, 2020) (granting party’s request to seal portions of contracts that contained “sensitive financial

information” that would cause them to suffer “competitive disadvantage in future

negotiations”). To protect parties from harm of this nature, courts in this Circuit have generally

exercised their discretion to seal judicial records. See, e.g., KeyBank Nat’l Ass’n v. Element Transp.

LLC, No. 16-8958, 2017 WL 384875, at *3 (S.D.N.Y. Jan. 26, 2017) (“KeyBank asserts that the

sensitive nonparty financial information it seeks to protect is all the data a competitor would need

to determine its valuation of the leases. This competitive injury is sufficiently serious to warrant

protection.”). In contrast, there is no benefit to the public from disclosure of the confidential

information sought to be sealed here. Thus, the competitive disadvantages that would flow to

Regeneron if such information was disclosed outweighs the interest of the public, including

competitors, of viewing those specific terms. See Lugosch, 435 F.3d at 120.

Fourth Lucentis Development Agreement and Related Documents. The Fourth

Lucentis Development Agreement (Exhibit 2) is a contract between Novartis and Vetter that

contains commercially sensitive terms, including the terms on which the parties agreed to resolve

Vetter’s claim that it had an ownership interest in the ’631 Patent. The confidential terms on which

the parties agreed would be valuable to Novartis’s current or future competitors and/or

counterparties in similar negotiations with Novartis and therefore should be sealed. See, e.g.,

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 . . . .”). The

Fourth Lucentis Development Agreement contains detailed and commercially sensitive provisions,

including provisions regarding royalty rates and specific licensing and sublicensing terms, that, if

disclosed, would harm Novartis by providing future counterparties with insights into how, and on

what terms, agreements could be reached, that those counterparties otherwise would not have.

This potential competitive harm to Novartis warrants sealing. See id.; Rubik’s Brand Ltd. v.

Flambeau, Inc., 2021 U.S. Dist. LEXIS 53529 at *2-3 (S.D.N.Y March 22, 2021) (granting motion

to seal documents containing the terms of confidential agreements and noting that “[d]isclosure of

these contractual terms could harm [the party’s] and/or its business partners by disadvantaging

them in negotiating future licensing agreements. Indeed, courts in this District have granted

motions to seal in order to protect these sorts of competitive interests.”) (citation omitted);

Fairstein v. Netflix Inc., 2024 U.S. Dist. LEXIS 93867, at *3 (S.D.N.Y. May 21, 2024) (“The

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.”).

Exhibits 1, 9, 10, and 11 are directly related to Novartis and Vetter’s agreements predating

the Fourth Lucentis Development Agreement and reflect confidential and commercially sensitive

negotiations between Novartis and Vetter leading up to the execution of the agreement.

Additionally, Exhibit 13 contains excerpts of Novartis’s response to interrogatories that seek

information about those negotiations, Novartis’s position in its dispute with Vetter, and Novartis’s

development of Lucentis PFS in conjunction with Vetter. All of these exhibits are properly filed

under seal in connection with the parties’ discovery dispute. See Rubik’s Brand, 2021 U.S. Dist.

LEXIS 53529, at *3-4 (granting motion to seal documents containing information about

“development . . . strategies”). For example, Exhibit 11 contains “Novartis Commentary on

Vetter’s mark-up and Novartis updated amendment.” This document thus speaks to Novartis’s

analysis and strategy as to a draft agreement that preceded the parties’ executed agreement, which

warrants sealing. See Vellali v. Yale Univ., 2021 U.S. Dist. LEXIS 192336, at *4-6 (D. Conn.

Sept. 30, 2021) (“business strategies” are properly filed under seal; granting motion to seal where

“disclosure of the information would interfere with [the party’s] present contracts with other clients

the terms of which were the product of private negotiations”).

Documents For Which Privileged Is Disputed. Regeneron argues in the pre-motion

letter that Novartis waived privilege through an interrogatory response (Exhibit 3) and deposition

testimony of David Spinner (Exhibits 4 and 12). While Novartis does not agree that these excerpts

contain privileged information, to the extent the Court ultimately disagrees with Novartis’s good-

faith analysis and determines they are privileged, there is an interest in maintaining them 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.”)).

Additionally, Exhibits 5, 6 and 7 are discovery letters exchanged by Regeneron and

Novartis prior to filing the Pre-Motion Letter. Each contains references to the material that

Regeneron claims revealed privileged information and is subject to sealing for the reasons stated

herein. Thus, for the same reasons that the Court should allow Novartis’s interrogatory response

and the Spinner testimony to be filed under seal, Novartis and Regeneron should also be permitted

to file redacted versions of the discovery letters that redact the portions of those letters that refer

to otherwise sealed exhibits. If the Court agrees with Novartis and holds that these materials are

not privileged, Novartis would not object to refiling Exhibits 3, 4, 5, 6, 7, and 12 in unredacted

form.1

1 Exhibit 12 contains, on page 189, confidential information concerning the development of Lucentis PFS, and sealing

is warranted to prevent disclosure of that information. See Rubik’s Brand Ltd., 2021 U.S. Dist. LEXIS 53529, at *2-

3. Novartis would thus propose to re-file Exhibit 12 with only this excerpt redacted.

Pre-Motion Letter. Finally, the Pre-Motion Letter itself quotes from certain of the

exhibits that Novartis requests to file under seal. Accordingly, the Court should permit Novartis

to file on the public docket a version of the Pre-Motion Letter that redacts references to materials

filed under seal, for the same reasons that the underlying exhibits should be filed under seal.

Accordingly, courts in this District routinely seal documents to prevent the disclosure of a

party’s confidential or competitively sensitive business information. See, e.g., PDV Sweeny, Inc.

v. ConocoPhillips Co., No. 14-5183 (AJN), 2014 WL 4979316, at *3 (S.D.N.Y. Oct. 6, 2014)

(granting motion to seal “with respect to those documents...containing sensitive commercial

information affecting the parties’ ongoing relationship”); Louis Vuitton Malletier S.A. v. Sunny

Merch. Corp., 97 F. Supp. 3d 485, 511 (S.D.N.Y. 2015) (granting motion to redact documents

containing advertising expenditures and plans, merchandising strategies, policies, and sales);

Playtex Prods., LLC v. Munchkin, Inc., No. 14- 1308, 2016 WL 1276450, at *11 (S.D.N.Y. Mar.

29, 2016) (granting request to seal documents concerning “Playtex’s (i) sales and revenue, (ii)

analytical testing of the Diaper Genie Refills, (iii) qualitative market research, and (iv) research

and development for new products”).

For the reasons stated above, Regeneron and Novartis respectfully requests that the Court

grant its motion and allow Regeneron and Novartis to file the Pre-Motion Letter and above-

identified exhibits to the Pre-Motion Letter under seal or in redacted form.

Respectfully Submitted,

/s/ Anish R. Desai /s/_Robert Milne

Anish R. Desai 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

rmilne@whitecase.com

adesai@paulweiss.com

Counsel for Novartis Pharma AG,

Counsel for Plaintiff Regeneron Novartis Pharmaceuticals Corp.,

Pharmaceuticals, Inc. and Novartis Technology LLP