On December 7, 2023, a group of health insurers and health insurance administrators filed a class action complaint against Johnson & Johnson and Janssen Biotech, Inc. (collectively “J&J”) in the Eastern District of Virginia alleging that J&J “is unlawfully delaying the introduction of biosimilar competition for ustekinumab.” The class action complaint alleges multiple violations of the Sherman Act and various state analogs, as well as violations of state consumer protection laws and unjust enrichment claims.
The are currently six patents listed in the Purple Book for J&J’s STELARA (ustekinumab). U.S. Patent No. 6,902,734, which expired on September 25, 2023, claimed the composition of ustekinumab. U.S. Patent No. 10,961,307 (“the ’307 patent”) is directed to methods of treating colitis with ustekinumab, and according to the Purple Book, expires on September 24, 2039. The four other patents listed in the Purple Book for ustekinumab are directed to methods of manufacturing.
Plaintiffs allege that J&C “defrauded the United States Patent and Trademark Office (PTO) into incorrectly issuing [the ’307] patent covering use of ustekinumab to treat ulcerative colitis.” Plaintiffs also allege that J&J acquired several manufacturing patents from Momenta in an effort to “delay competition from would-be ustekinumab biosimilar competitors and to further entrench its ustekinumab monopoly.”
As we have previously reported, J&J has entered into settlement agreements with Samsung Bioepis, Alvotech and Teva, Fresenius Kabi and Formycon AG, and Celltrion in relation to their respective ustekinumab biosimilar products. Plaintiffs allege that “J&J used its fraudulently obtained ’307 patent and unlawfully acquired Momenta patents to extract further delays from other would-be biosimilar competitors.”
The plaintiffs are represented by Glasser and Glasser, P.L.C., Lowey Dannenberg, P.C., and Hagens Berman Sobol Shapiro LLP. The defendants are represented by Dechert LLP. The civil action number is 2:23-cv-00629. The case is before U.S. District Judge Jamar K. Walker and Magistrate Judge Lawrence R. Leonard. The defendants’ response to the class action complaint is due on February 20, 2024.
Stay tuned to Big Molecule Watch for more updates on this litigation.
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