In re ACTOS Antitrust Litigation

Background

The opinion concerns two related antitrust cases: one brought by indirect purchasers, called the End-Payor Plaintiffs, and one brought by direct purchasers, called the Direct-Purchaser Plaintiffs. The opinion does not describe the underlying facts in detail and instead refers to the court’s earlier orders.

Takeda Pharmaceutical Company Limited, Takeda America Holdings, Inc., Takeda Pharmaceuticals U.S.A., Inc., and Takeda Development Center Americas, Inc., collectively called Takeda, asked the court to certify the court’s September 30, 2019 and October 8, 2019 orders for an interlocutory appeal under 28 U.S.C. § 1292(b). An interlocutory appeal is an appeal before the district court has entered a final judgment.

Earlier rulings and proposed appeal

In the earlier orders, the court denied Takeda’s motions to dismiss the plaintiffs’ monopolization claims. The court held that the plaintiffs had plausibly alleged that Takeda acted anticompetitively by falsely representing to the Food and Drug Administration that its ’584 and ’404 patents, in connection with the ACTOS new drug application, were properly described in the Orange Book as drug-product patents.

Takeda sought review of the court’s interpretation of Section 355(b)(1), particularly the meaning of the word “claims.” The court continued to believe that the ordinary meaning of “claims” applied to the phrase “claims the drug,” while the patent-infringement meaning applied to the phrase “claims a method of using such drug.” Even so, the court concluded that the requirements for certification were met.

Section 1292(b) analysis

Section 1292(b) permits a district court to certify an otherwise nonappealable order when three requirements are satisfied: the order involves a controlling legal question, there is substantial disagreement about that question, and an immediate appeal may materially advance the end of the litigation. The court described this as a limited exception to the usual rule delaying appellate review until final judgment.

Controlling legal question. The court found that the meaning of “claims” in Section 355(b)(1) was a pure legal question that an appellate court could decide without studying the factual record. It also found the question controlling because, if the Court of Appeals adopted Takeda’s interpretation, that interpretation would end the litigation.

Substantial ground for disagreement. Although the district court’s own interpretation had not changed, it recognized strong arguments on both sides, a lack of controlling authority, and the novelty and complexity of the issue. The court therefore found a substantial ground for disagreement about the meaning of “claims.” It also noted that the issue could have important effects on other pharmaceutical companies.

Advancing the litigation. The court found that an intermediate appeal could materially advance the litigation. If the Court of Appeals adopted Takeda’s interpretation, Takeda’s motions to dismiss would be granted and the cases would end. The court concluded that this potential benefit outweighed the risk of short-term delay.

Disposition

Judge Ronnie Abrams granted Takeda’s motion to certify the End-Payor and Direct-Purchaser orders for interlocutory appeal. The court denied Takeda’s request for oral argument as moot. The order did not decide the correctness of Takeda’s interpretation or the ultimate antitrust claims.