Parties Dispute Intent Standard in STELARA® Antitrust Appeal

As we previously reported, portions of CareFirst’s antitrust claims concerning STELARA® (ustekinumab) survived summary judgment in December 2025.

On January 14, 2026, the U.S. District Court for the Eastern District of Virginia reconsidered that decision and granted summary judgment to Johnson & Johnson and Janssen Biotech, Inc. (collectively, “J&J”) on CareFirst’s theory that J&J’s acquisition of four Momenta Pharmaceuticals manufacturing patents violated Section 2 of the Sherman Act. The court found insufficient evidence that, at the time of the acquisition, J&J intended to use the patents to exclude competitors. On February 10, 2026, the court directed entry of final judgment for J&J. CareFirst appealed.

In its opening brief, CareFirst argues that “monopolization is not a specific-intent offense” and that the district court improperly required evidence that J&J specifically intended to exclude competitors when it acquired the Momenta patents. CareFirst contends that the district court misinterpreted the Fourth Circuit’s decision in 2311 Racing LLC v. National Association for Stock Car Auto Racing, LLC and that completed monopolization requires only general intent. It further argues that J&J’s acquisition, retention, and subsequent assertion of the patents against ustekinumab biosimilar manufacturers should be considered together as part of the alleged monopolization scheme.

In its response brief, J&J asks the Fourth Circuit to affirm and disputes CareFirst’s characterization of the district court’s ruling as imposing a specific-intent requirement. According to J&J, the decision “turned entirely upon J&J’s lack of knowledge” of the contents of the Momenta patents at the time of the acquisition, not on whether J&J subjectively intended to exclude competitors. J&J also argues that the acquisition had no actual or reasonably foreseeable anticompetitive effects when it occurred.

The Federal Trade Commission filed an amicus brief “in support of neither party for reversal.” The FTC argues that monopolization under Section 2 “does not require proof of specific intent to exclude rivals or harm competition.” It contends that the district court erred to the extent it required such proof but takes no position on whether CareFirst would survive summary judgment under the correct standard.

Under the Fourth Circuit’s briefing schedule, CareFirst’s reply brief is due October 8, 2026. The court has not yet scheduled oral argument.

Stay tuned to Goodwin’s Big Molecule Watch as we continue to monitor the STELARA® antitrust litigation.