Takeda Faces Partial Privilege Waiver in Actos Antitrust Case

In In re Actos Antitrust Litigation, the U.S. District Court for the Southern District of New York addressed the scope of privilege in an antitrust case concerning the diabetes drug ACTOS. Plaintiffs alleged that Takeda Pharmaceuticals delayed generic competition by listing two patents in a way that misrepresented their coverage. The company raised a regulatory compliance defense and partially waived privilege over its communications with legal counsel. The court determined that the waiver was too limited and ordered a broader production of documents.

Legal Dispute Over Patent Listings and FDA Filings

The plaintiffs challenged Takeda’s submission of the ‘584 and ‘404 patents to the FDA, arguing that Takeda improperly listed them as drug product patents rather than method-of-use patents. This designation required generic manufacturers to file Paragraph IV certifications, which delayed their ability to enter the market. Plaintiffs claimed this tactic extended Takeda’s market control beyond the expiration of its earlier patent, the ‘777 patent.

Takeda responded by asserting that its decisions complied with pre-2003 FDA regulations and were based on legal advice. It waived privilege over certain communications related to those regulations but withheld others. Plaintiffs requested a court order requiring the disclosure of additional materials that could reflect Takeda’s intent and state of mind.

Ruling on Fairness and Privilege

The court held that Takeda’s use of legal advice as part of its defense created a need for greater transparency. Because Takeda claimed it acted in good faith under regulatory rules, the court found that fairness required access to more of the underlying legal communications. The decision emphasized that parties cannot selectively disclose favorable documents while withholding others on the same subject.

The judge ordered Takeda to review its privilege logs and produce any additional documents that involved communications about its decision to list and later reaffirm the ‘584 and ‘404 patents. Materials unrelated to the core issue, such as settlement drafts and discovery responses, were excluded.

Standards Governing Waiver of Privilege

The court applied Rule 502 of the Federal Rules of Evidence and other federal precedent to define the limits of privilege once a waiver occurs. The opinion highlighted the importance of avoiding selective disclosures that could mislead the opposing party or the court. In this case, the documents that contributed to Takeda’s regulatory decisions became discoverable because they were central to its defense.

Regulatory Compliance Evaluation

Companies involved in FDA filings or facing inquiries about their regulatory practices should be aware of how privilege waivers can impact litigation. When regulatory compliance is used as a defense, internal legal communications may become subject to review. If your business is reviewing compliance protocols or disclosure procedures, our team at Whitcomb, Selinsky, PC can assist with evaluating regulatory exposure and documentation policies.