Court Largely Grants Class Certification, But Narrows Walker Process Claims over Biologic Drug Stelara on Summary Judgment

Why It Matters

The decisions preserve a large antitrust class that could pressure J&J to accelerate biosimilar entry, while limiting plaintiffs’ claims narrows potential liability and signals courts’ scrutiny of patent‑related fraud allegations.

Key Takeaways

• Class certified for Sherman Act claims covering 90‑95% of TPPs.
• Court denied summary judgment on J&J’s market power evidence.
• Walker Process claim narrowed to single patent misrepresentation.
• Momenta patent acquisition claim dismissed after privilege‑log issue.
• Expert testimony on market power deemed jury question.

Pulse Analysis

Biologic drugs like Stelara dominate treatment for ulcerative colitis, and their market power has long drawn antitrust scrutiny. When a major insurer such as CareFirst sues on behalf of third‑party payers, the case tests how courts balance the need for broad class certification against the technical challenges of identifying injury across a fragmented payer landscape. By leveraging data from the six largest pharmacy‑benefit managers, the court affirmed that a data‑rich environment can satisfy ascertainability and predominance requirements, setting a precedent for future health‑care class actions that rely on big‑data analytics.

The court’s refusal to grant summary judgment on J&J’s alleged market power underscores the difficulty of proving monopoly in the biosimilar arena without concrete entry data. Plaintiffs’ reliance on cross‑elasticity models drawn from analog drugs like Humira and Remicade fell short of the evidentiary bar established in the Zetia case, where actual generic entry data were available. By deeming expert testimony a jury question rather than an admissibility issue, the decision reinforces the importance of robust, empirically grounded economic analyses in antitrust litigation involving high‑price biologics.

Finally, the narrowing of the Walker Process claim to a single alleged misstatement and the dismissal of the Momenta‑patent acquisition theory signal a judicial tightening of fraud‑based antitrust theories. Courts appear less willing to entertain speculative patent‑acquisition arguments, especially when privileged communications are invoked. This outcome may prompt pharmaceutical companies to reassess merger strategies and patent‑portfolio disclosures, while plaintiffs may need to focus on more concrete evidence of intent to deceive the Patent Office. The rulings together shape a more cautious legal environment for future biologic monopoly challenges.