In re ACTOS Antitrust Litigation

Background

This antitrust class action concerns allegations that Takeda prevented competitors from timely marketing a generic version of the diabetes drug ACTOS by falsely describing two patents to the Food and Drug Administration. As part of its regulatory-compliance defense, Takeda expressly waived attorney-client privilege and related protections concerning the applicability of pre-2003 regulations governing the submission of patent information to the Food and Drug Administration and Takeda’s compliance with those regulations.

The dispute involved the “Inaba Memo,” a January 30, 2009 document authored by Atsuhiro Inaba. Takeda produced the memo in 2022 after its privilege waiver. Plaintiffs later filed it under seal. During a September 9, 2022 hearing, Takeda’s counsel stated that Takeda was not seeking to take back the documents attached to the plaintiffs’ filing and had intended to produce documents related to the waiver’s subject matter.

Plaintiffs and Takeda discussed the memo again during a November 2022 meeting. Takeda did not then say that the memo had been produced by mistake or that it would seek its return. In March 2023, Takeda reproduced the memo with fewer redactions. In April 2023, after plaintiffs filed the memo under seal again, Takeda sought to take it back under the protective order, claiming inadvertent production. Takeda withdrew that request the next day, citing its prior statements and the passage of time.

When preparing Inaba for a July 2023 deposition, Takeda’s counsel learned that the legal analysis in the memo recounted advice from a meeting attended by Takeda in-house counsel and outside patent litigation counsel. Takeda then again sought to take back the memo when plaintiffs marked it as a deposition exhibit.

Legal standard

The party asserting attorney-client privilege bears the burden of establishing the privilege and showing that it was not waived. Federal Rule of Evidence 502(b) generally protects an inadvertent disclosure if the disclosure was inadvertent, the privilege holder took reasonable steps to prevent it, and the holder promptly took reasonable steps to correct the error.

The court also considered the protective order’s standard. Under that standard, waiver may be appropriate only when the production was “completely reckless,” meaning the producing party showed no regard for preserving the document’s confidentiality.

Court’s analysis

The court held that, regardless of which waiver standard applied, Takeda failed to show that privilege had not been waived. The court stated that the initial production might not have been completely reckless, but found that Takeda’s conduct after production was completely reckless because Takeda showed no regard for preserving the memo’s confidentiality.

The court identified several opportunities when Takeda could have sought to take back the memo: the September 2022 hearing, the November 2022 meeting, the March 2023 reproduction, and the April 2023 request that Takeda later withdrew. The court rejected Takeda’s explanation that information learned in July 2023 resolved lingering questions about privilege and the scope of the waiver, noting that Takeda had opportunities to investigate and act earlier.

Disposition

The court found that Takeda waived privilege with respect to the Inaba Memo. It ordered that Plaintiffs’ letter motion filed at ECF No. 531 remain under seal, finding that the proposed redactions and sealing requests were narrowly tailored to prevent unauthorized dissemination of sensitive business information. The clerk was directed to terminate the gavels at ECF Nos. 531 and 532.