Regeneron Pharmaceuticals Inc. v. Novartis Pharma AG

Background

The parties submitted a joint letter under the court’s discovery-dispute procedures. Regeneron asked for a conference and, if necessary, permission to file a motion to compel production of two categories of materials:

1. Novartis’s Patent Prosecution Guide; and 2. Confidential versions of briefs and decisions from Patent Trial and Appeal Board proceeding IPR2021-00816, in which the Board invalidated the ’631 patent.

The letter identified the parties’ competing positions but did not decide the underlying patent, antitrust, or Walker Process claims.

Patent Prosecution Guide

Regeneron argued that Novartis had waived attorney-client privilege, which generally protects confidential communications made for the purpose of obtaining or providing legal advice. Regeneron pointed to Novartis’s production of a redacted version after withholding the entire Guide as privileged, arguing that Novartis had selectively disclosed material on the same subjects and therefore waived protection over the whole document. Regeneron also argued that Novartis first served a privilege log for the Guide on March 10, 2025, rather than in 2022, as Novartis claimed.

Novartis argued that the Guide contained both privileged and nonprivileged material. It said it had produced portions describing the law, common patent-examination practices, and nonlegal advice, while redacting legal advice about prosecution strategies and litigation or invalidation risks. Novartis asserted that the Guide was prepared by attorneys and patent agents for its Intellectual Property Practice Group and circulated only within that group, preserving confidentiality.

Patent-board materials

Regeneron argued that confidential versions of the IPR papers were responsive to several document requests and relevant to its claims. It identified material concerning prior art, Novartis’s relationship with Genentech, licensing of the ’631 patent, and the alleged market significance of prefilled syringes compared with vials. Regeneron contended that the public versions were inadequate because they redacted those statements.

Novartis argued that the redacted IPR papers were publicly available and that the redacted statements were not responsive to any timely document request. It relied on an agreed June 19, 2020 cutoff for much of document discovery and argued that the 2021 IPR materials fell outside that limit. Novartis also argued that one later request was untimely and that the parties had not met and conferred about it.

Court’s action

The court granted the application for a conference. It scheduled the discovery-dispute conference for May 7, 2025, at 3:30 p.m. in the White Plains courthouse. The Clerk was requested to terminate the pending letter motions, identified as Documents 168 and 169.

The order did not rule on the privilege dispute, compel production, determine whether the IPR papers were responsive, or decide the merits of Regeneron’s claims. Judge Philip M. Halpern signed the order on March 31, 2025.