Regeneron Pharmaceuticals v. Sanofi Biotechnology SAS

Background

Regeneron Pharmaceuticals, Inc. sued Sanofi Biotechnology SAS, Sanofi S.A., Sanofi-Aventis LLC, and Genzyme Corporation. The parties, through counsel, jointly requested a protective order under Federal Rule of Civil Procedure 26(c) for nonpublic and competitively sensitive information that could be disclosed during discovery. The court found good cause for an appropriately limited confidentiality order covering the pretrial phase of the case.

Confidentiality designations

The order allows a producing party to label only material that it reasonably and in good faith believes contains specified types of previously undisclosed information, including financial information, ownership or control information, business plans, product-development or marketing information, information prepared for company operations, or information the court later determines deserves confidential treatment.

A producing party may use the higher-level “Highly Confidential” designation for confidential material that contains trade secrets or other confidential business information whose disclosure is likely to reveal or significantly affect specified business strategies, product plans, costs, pricing, customer-contract terms for products outside the license and collaboration agreement at issue, or proprietary commercial data belonging to third parties. The order states that this designation should be used only in those limited circumstances.

Who may receive protected information

Confidential material may be disclosed only to specified recipients, including the parties, insurers and their counsel, outside lawyers and their litigation staff, litigation vendors, mediators or arbitrators who sign a nondisclosure agreement, certain people identified in a document, potential witnesses who sign a nondisclosure agreement, experts or specialized advisers who sign a nondisclosure agreement, deposition transcription staff, and the court and its personnel.

Highly Confidential material may be disclosed to a narrower group. It may be given to outside counsel, certain vendors, mediators or arbitrators, people identified in documents, experts or specialized advisers, deposition transcription staff, and the court. It may also be given to up to three designated inside lawyers who need access for this case, provided they are not involved in specified competitive pricing, sales, marketing, research, development, or manufacturing decisions. Those inside lawyers may not share the information with the receiving party’s other employees, managers, executives, officers, directors, or board members, except other designated inside lawyers.

Other provisions

Before certain witnesses, experts, advisers, mediators, or arbitrators receive confidential information, they must receive the order and sign the required nondisclosure agreement. Parties may challenge confidentiality designations before trial, and unresolved disputes may be presented to the court.

A party that files protected discovery material with the court must publicly file a redacted version and file the unredacted version under seal. The order states that the court retains discretion over whether to keep material confidential when it is submitted in connection with a motion or other proceeding, and that material introduced at trial is unlikely to remain sealed.

A party that wants to use an artificial-intelligence tool with another party’s discovery materials must give written notice, request consent, and provide reasonable information about the tool, its use, and protective measures if requested. The parties agreed that any such tool should be a closed model used in a secure, access-restricted environment.

The order provides that accidental disclosure of information protected by attorney-client privilege or work-product protection does not waive that protection. After a claim of accidental disclosure, the receiving party generally must return or destroy the information within five business days, while the producing party must later provide a privilege log. The receiving party may ask the court to order production of the information, but the motion must be filed under seal.

Within 60 days after the final disposition of the case, including appeals, recipients generally must return or destroy confidential discovery material and certify that they retained no copies or summaries. Outside counsel may keep archival copies of specified case materials, which remain subject to the order. The order continues after the litigation ends, and the court retains jurisdiction to enforce it or impose contempt sanctions.

Disposition

Judge Philip M. Halpern entered the stipulated confidentiality agreement and protective order. The opinion does not decide the parties’ underlying claims or defenses.