CareFirst BlueCross BlueShield has filed a proposed class-action lawsuit accusing Johnson & Johnson and Janssen Biotech subsidiary of unlawfully delaying the introduction of biosimilar competition for ustekinumab.
J&J has sold ustekinumab under the brand name Stelara since 2009, according to the lawsuit, filed Dec. 7 in Virginia federal court. The drug treats a range of autoimmune diseases, including Crohn's disease, plaque psoriasis, active psoriatic arthritis and ulcerative colitis.
CareFirst said in its lawsuit that Stelara has been one of the best-selling drugs in the U.S. over the past decade, and in 2022 it brought in $6.4 billion in the U.S. and nearly $10 billion worldwide, accounting for about 10% of J&J's revenue. The payer alleges that in recent years it was widely accepted by J&J and the pharmaceutical industry that J&J "would lose exclusivity for sales of Stelara on Sept. 25, 2023 — the date its composition patent for ustekinumab would expire and biosimilar products would then enter the U.S. marketplace," the lawsuit said.
The payer alleges that J&J has "implemented a scheme to unlawfully prolong patent protection for Stelara well beyond September 2023." The alleged scheme included J&J filing fraudulent claims with the U.S. Patent Office between 2019 and 2021 that allowed it to gain an exclusive patent to treat ulcerative colitis, which it later used against companies seeking to launch biosimilar versions of Stelara in the U.S.
Another part of the alleged scheme involved J&J's purchase of biosimilar research company Momenta in 2020. Momenta held patents on "manufacturing methods ostensibly helpful in developing biosimilar versions of compounds like ustekinumab," but J&J instead used the patents to block and delay entry of biosimilar products and restrain U.S. biosimilar competition, the lawsuit said.
The final part of the alleged scheme involved J&J suing or threatening to sue the companies planning to bring biosimilars to the market to delay their entry.
"J&J's scheme worked," the lawsuit said. "J&J used its fraudulently acquired method-of-use patent and its unlawfully procured biosimilar manufacturing patents to extract settlements from each of the would-be biosimilar entrants. These settlements pushed out biosimilar entry for ustekinumab until 2025."
CareFirst alleges violation of federal and state antitrust and related laws, according to the lawsuit. It is seeking to halt J&J's use of the method-of-use patent, the Momenta technologies — including the Momenta patents — as well as monetary relief for overcharges caused by the wrongdoing.
A J&J spokesperson told Becker's: "We will be moving to dismiss this meritless complaint, which wrongly challenges our valid patent rights with conclusory and baseless allegations.We continue to defend the intellectual property associated with our medicines to protect our ability to innovate and develop life-changing therapies for patients."