Hagens Berman has filed a class-action lawsuit on behalf of health benefit providers who purchased Stelara since Sept. 26, 2023. The lawsuit alleges drugmakers delayed the entry of biosimilar drugs to market, thereby artificially increasing the cost of Stelara.

Case Status
Active
Court
U.S. District Court for the Eastern District of Virginia Norfolk Division
Case Number
2:23-cv-00629
Defendant(S)
Johnson & Johnson
Janssen Biotech, Inc.
File Date

WHAT’S THE ISSUE?

Hagens Berman has filed a class-action lawsuit against Johnson & Johnson (J&J), on behalf of health benefit providers, accusing the pharmaceutical giant of unlawfully delaying the release of biosimilar medications that could compete with its highly lucrative autoimmune medication, Stelara (ustekinumab). Johnson & Johnson has grossed well over $50 billion on sales of Stelara to date, and the drug, which is used to treat life-threatening conditions like Crohn’s disease, plaque psoriasis and ulcerative colitis, accounted for about 10% of J&J’s entire revenue in 2022. According to the lawsuit, it is estimated that purchasers of Stelara will overpay by more than $1 billion between September 2023 and early 2025 due to J&J’s alleged conduct.

DRUG-PRICING FRAUD ALLEGATIONS EXPLAINED

Since 2009, J&J has manufactured and sold ustekinumab under the brand name Stelara, and Stelara has been one of the best-selling drugs in the United States for nearly a decade. J&J was set to lose its exclusive right to sell Stelara in the United States in September 2023, but, according to the lawsuit, the drug company engaged in a series of illegal activities to prolong its exclusivity over Stelara and continue charging allegedly supracompetitive prices for the drug. The complaint alleges the following unlawful acts:

  • Defrauding the U.S. Patent and Trademark Office: According to the lawsuit, J&J intentionally misled a patent examiner about prior art and patentability to fraudulently obtain a patent for Ustekinumab. J&J then allegedly used this patent to stop other companies from launching biosimilar alternatives to Stelara.
  • Purchasing a biosimilar manufacturer to block the development of competitors to Stelara: In 2020, J&J purchased the biosimilar manufacturer Momenta, which held patents on manufacturing methods useful in developing biosimilar alternatives to Stelara. The lawsuit alleges that J&J did this specifically to block and stall the release of drugs that could compete with Stelara.
  • Suing companies that tried to bring biosimilar drugs to market: According to the lawsuit, J&J then used these allegedly fraudulently and unlawfully obtained patents to sue or threaten to sue companies that tried to introduce competitor products to Stelara. The complaint alleges that the goal of its lawsuit and threats was to delay the entry of biosimilar competition to the market.

According to the complaint, J&J’s alleged strategy was successful, and its lawsuit and threats against biosimilar competitors resulted in settlements that pushed the entry date for biosimilar alternatives to Stelara to 2025.

TOP PHARMA LAW FIRM

Hagens Berman is one of the most successful plaintiffs’ litigation law firms in the U.S. taking on pharmaceutical companies and has achieved total settlements valued at more than $320 billion, including settlements with some of Big Pharma’s largest sellers and manufacturers over antitrust schemes, pay-for-delay, IP shams and other forms of wrongdoing that drive up the costs of prescription drugs for people who need them. The firm achieved the two largest U.S. antitrust settlements in 2022, totaling nearly $800 million, both against pharmaceutical companies accused of conduct similar to that alleged in this case.

CASE TIMELINE

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