IP Law Daily, PATENT—E.D. Va.: More focused set of antitrust issues left for trial in Stelara® class action following reconsideration, (Jan 16, 2026)

By Patricia K. Ruiz, J.D.

The class action alleges fraudulent misrepresentation during the method-of-use patent prosecution as well as anticompetitive conduct.

Ruling on a motion for reconsideration by Johnson & Johnson and Janssen Biotech, Inc., (J&J, collectively) in the Stelara® autoimmune drug class-action litigation, the U.S. District Court for the Eastern District of Virginia granted in part and denied in part J&J’s efforts to overturn portions of the court’s previous summary-judgment decision. The court ultimately removed monopolization theory advanced by CareFIrst of Maryland, Inc., Group Hospitalization and Medical Services, Inc., and CareFirst BlueChoice, Inc. (CareFirst, collectively) based on J&J’s acquisition of the Momenta patents, narrowed the Walker Process fraud claims, and allowed other allegations of fraud on the U.S. Patent and Trademark Office to proceed (Carefirst Of Maryland v. Johnson & Johnson, No. 2:23-cv-00629-JKW-LRL (E.D. Va. Jan. 14, 2026)).

Background. Ustekinumab is a biologic drug used to treat certain autoimmune diseases. J&J received a composition patent for ustekinumab in 2005 and began marketing it under the Stelara® brand name following FDA approval in 2009, with further approvals in 2013 and 2016; the composition patent expired on September 25, 2023. In July 2020, the U.S. Patent and Trademark Office (PTO) rejected J&J’s method-of-use patent application for ustekinumab, but after J&J submitted additional materials, the PTO allowed the patent on March 30, 2021, giving it an expiration date of September 24, 2039. In 2020, J&J acquired Momenta Pharmaceuticals, obtaining exclusive rights to four manufacturing patents covering biosimilars to ustekinumab. CareFirst, a group of third-party payers, filed a putative class action alleging fraudulent misrepresentation during the method-of-use patent prosecution and anticompetitive conduct through obtaining and enforcing both the method-of-use patent and the Momenta patents.

CareFirst moved for partial summary judgment, while J&J moved for summary judgment. Both parties also sought to exclude expert witnesses. The court ultimately denied J&J’s motions for summary judgment as to whether an antitrust injury had occurred and as to whether its acquisition of certain patents constituted a “willful” maintenance of monopoly. It also determined that issues of fact remained as to the definition of the product market, making the plaintiffs’ motion for summary judgment inappropriate. Finally, it delivered a mixed ruling on the extent on the existence of Walker Process fraud, permitting certain allegations of fraud on the PTO to continue, but dismissing others.

Reconsideration request. J&J sought reconsideration on five grounds: (1) it should have received summary judgment on the Momenta acquisition theory; (2) the court misapprehended the record regarding privilege-log issues, and allowing the Momenta theory to proceed would invite negative inferences about privileged communications; (3) the Jostins and Granlund studies were no longer part of the case; (4) the court misunderstood the record concerning whether Dr. Luis Ralat’s conduct could demonstrate intent to defraud the PTO; and (5) the court mistakenly concluded that a jury could find that a duty-bound employee knew about the Ochsenkühn reference.

Momenta patent acquisition theory. On reconsideration, the court vacated its earlier ruling and granted summary judgment for J&J on CareFirst’s monopolization claim based on J&J’s acquisition of the Momenta patents. The court held that CareFirst’s theory relied on impermissible negative inferences drawn from J&J’s privilege log and metadata—something the law does not permit. Without those inferences, CareFirst lacked admissible evidence that J&J acquired the Momenta patents with intent to “exclude rivals on some basis other than efficiency,” and therefore no reasonable jury could find anticompetitive intent under the Sherman Act.

Walker Process fraud. The court removed Walker Process theories based on the Jostins and Granlund studies, explaining that they were not part of the case because the court had denied leave to amend and because CareFirst had stated it would not rely on them as independent fraud theories. However, the court allowed two Walker Process theories to proceed: (1) the allegation that Dr. Ralat intended to deceive the PTO when he deleted references before stating that “no studies had been conducted with ustekinumab for [ulcerative colitis],” and (2) the allegation that a duty-bound employee knowingly withheld the Ochsenkühn study from the PTO. J&J’s reconsideration arguments on these issues merely repeated earlier ones and did not identify new evidence, new law, or clear error.

Privilege. In ruling on J&J’s motions in limine Nos. 3 and 9, the court granted in part J&J’s requests to exclude privilege-log and metadata evidence to the extent they would require the jury to infer the contents of privileged communications. Limited use of metadata—such as showing the fact or timing of communications—remained permissible if CareFirst established an appropriate foundation and avoided negative inferences.

The Case is No. 2:23-cv-00629-JKW-LRL.

Judge: Walker, J.

Attorneys: Marc Christian Greco (Glasser & Glasser PLC) for Carefirst of Maryland, Inc. Agnese Whitt (Dechert, LLP) for Johnson & Johnson.

Companies: Carefirst of Maryland, Inc.; Johnson & Johnson

Cases: Patent VirginiaNews