In Re: Actos Direct Purchaser Antitrust Litigation

Background

Takeda Pharmaceutical Company Limited, Takeda America Holdings, Inc., Takeda Pharmaceuticals U.S.A., Inc., and Takeda Development Center Americas, Inc., collectively called “Takeda,” sought permission to pursue an interlocutory appeal. An interlocutory appeal is an appeal of a significant order before the district court case has reached final judgment.

Takeda sought review of two earlier orders: one in the related End-Payor case and one in the Direct Purchaser case. In those orders, the court denied Takeda’s motions to dismiss monopolization claims. The court had held that the plaintiffs plausibly alleged that Takeda acted anticompetitively by falsely representing to the Food and Drug Administration that two patents connected with the ACTOS drug application were properly described in the Orange Book as drug-product patents.

Issue

The proposed appeal concerned the interpretation of Section 355(b)(1), particularly the meaning of the word “claims.” The court had interpreted “claims” according to its ordinary meaning in the phrase “claims the drug,” but according to its patent-infringement meaning in the phrase “claims a method of using such drug.” The court stated that it continued to hold that interpretation, but found that the issue qualified for immediate appellate review.

Section 1292(b) standard

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

Court’s analysis

First, the court found a controlling legal question. The meaning of “claims” in Section 355(b)(1) was a pure statutory-interpretation issue that an appellate court could decide without reviewing the entire factual record. The court also found that adopting Takeda’s interpretation could end the litigation, satisfying the controlling-question requirement.

Second, the court found substantial ground for disagreement. It noted the lack of controlling authority, the novelty and complexity of the issue, and the strength of the parties’ competing arguments. The court also stated that the issue was one of first impression and could have important effects on other pharmaceutical companies.

Third, the court found that an immediate 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 litigation would end. The court concluded that this potential benefit outweighed the possibility of a short-term delay.

Disposition

The court granted Takeda’s motion to certify the End-Payor and Direct Purchaser orders for interlocutory appeal. It denied Takeda’s request for oral argument as moot. The order certified the issue for possible appellate review; it did not itself grant Takeda’s underlying motions to dismiss or decide the ultimate antitrust claims.