Hagens Berman is co-interim lead counsel on behalf of a proposed direct purchaser class in an action currently pending against drug manufacturer Takeda. The allegations of the complaint center upon Takeda’s decision to allegedly knowingly misrepresent the scope of two patents it presented to the FDA for listing in the Orange Book.

Case Status
Interim Co-Lead Counsel
U.S. District Court Southern District of New York
Second Circuit Court of Appeals
Case Number
1:15-cv-03278 (RA)(SDA); 20-481
Takeda Pharmaceutical Company Limited
Takeda America Holdings Inc
Takeda Pharmaceuticals U.S.A. Inc.
Takeda Development Center Americas Inc.
File Date


According to the complaint, after wrongfully describing the patents as specifically claiming the drug Actos (when, in reality, the patents only claimed the use of Actos in certain combination therapies), Takeda used the listings to leverage settlements with various generic manufacturers that delayed generic competition. Plaintiffs allege that as a result of this wrongdoing, purchasers who needed to buy Actos were forced to pay monopoly prices for the medication for longer than they should have.

The direct purchasers’ lawsuit was originally filed in 2015 (after a related suit filed on behalf of a proposed end payor class was remanded back to the district court by the Second Circuit following an initial grant of a motion to dismiss). In 2019, the district court denied, in part, the defendants’ motion to dismiss, upholding claims against Takeda but dismissing claims asserted against various generic manufacturers. Takeda is currently challenging this order on appeal to the Second Circuit.

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