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CareFirst Brings Class Action Against J&J Alleging Unlawful Delay Tactics to Prevent Stelara® (ustekinumab) Biosimilar Competition

Dec 7, 2023

Carefirst and another Blue Cross/Blue Shield licensee have brought class action proceedings against Johnson & Johnson (J&J) and Janssen alleging that the companies unlawfully delayed the introduction of biosimilar competition for its Stelara® ustekinumab product onto the US market.  The complaint alleges that J&J would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and that J&J delayed biosimilar competition through a series of unlawful acts to unlawfully prolong patent protection for Stelara® well beyond September 2023.

The acts alleged in the Class Action include defrauding the US Patent and Trademark Office into incorrectly issue a patent to the use of ustekinumab to treat ulcerative colitis, acquiring the company Momenta, which held patents to manufacturing methods for ustekinumab, and suing or threatening suit of would-be biosimilar entrants for patent infringement.