Miller Shah Secures Partial Summary Judgment in ACTOS Antitrust Litigation While the Trial is Delayed as the Case Awaits a Decision from the Second Circuit on the Class Certification Order

The case was originally filed in 2013 and has already taken two trips to the Second Circuit Court of Appeals. 

The certified class of End-Payors accuse Takeda of violating the law by “misdescribing” its patent rights to the FDA.  Plaintiffs allege that Takeda unlawfully engaged in anticompetitive and monopolistic conduct which inflated the price of its diabetes treatment, Actos (pioglitazone), by delaying the entry of generic alternatives and causing inflated prices.

On March 31, 2025, New York federal court District Judge Ronnie Abrams granted Plaintiffs’ motion for partial summary judgment with respect to willful acquisition or maintenance of its monopoly power, finding that there was no genuine dispute over whether the company misdescribed its patents. In addition, the Court refused to grant Takeda Pharmaceuticals Co.’s (“Takeda”) motion for summary judgment.  

Plaintiffs allege that Takeda made two improper statements to the FDA – its statement in its January 2010 Submission that the patents were “drug product” patents, and its statement in its May 2010 Letter that they “claimed the drug ACTOS” – which forced generics to file Paragraph IV certifications.  The District Court found that there was no genuine dispute as to whether Takeda’s statements to the FDA were incorrect or that the statements did, or were likely to, lead to price control or exclusion of competition.  As such, the Court found that Plaintiffs are entitled to partial summary judgment as “willful acquisition or maintenance of [monopoly] power as distinguished from growth or development as a consequence of a superior product, business acumen, or historic accident,” in part constitutes the offense of monopoly under Section 2 of the Sherman Act. 

Both sides also had sought a ruling that Takeda’s defense that contended that the misstatements were a reasonable mistake made in good faith, which according to the Court, allows companies to avoid liability if they are able to make a showing that they believed that the conduct was required by regulatory law.  The Judge reviewed Takeda’s argument that it believed a “drug product” patent involved any drug product, not just a brand drug product and that the patents covered the use of Actos in combination with other drugs but found that this interpretation may be counter to the plain language of the listing regulations.

However, the Court noted that it was not persuaded that the interpretation was unreasonable.  As such, issues of the objective reasonableness of Takeda’s misstatements and Takeda’s subjective good faith, as well as Takeda’s possession of monopoly power in the relevant market, precluded summary judgment at this time and remain to be established at trial. 

Trial was originally set to begin on July 21, 2025, but has since been suspended pending the Second Circuit’s review of Defendants’ appeal from the Court’s order granting class certification. 

Miller Shah LLP is a part of the End-Payor Plaintiffs’ litigation team.  The caption for this action is In re: Actos Antitrust Litigation, Case No. 1:13-cv-09244, in the United States District Court for the Southern District of New York.

The legal team at Miller Shah LLP has significant experience in class action matters.  If you have any questions regarding this subject or this post, please contact Natalie Finkelman Bennett (nfinkelman@millershah.com) or Madison Gregg (magregg@millershah.com).  The firm can also be reached toll-free at (866) 540-5505.