Page limits and deadlines are precious things, especially during federal litigation over lucrative drug patents. Johnson & Johnson is learning that lesson the hard way.
After the company's "failure to comply" with court rules on page limits, a Delaware federal judge threw out the company's initial motion seeking to keep Amgen from making and selling its proposed Stelara copycat.
As J&J’s top-selling drug, Stelara brought home $6.39 billion in U.S. sales last year. But the antibody’s days are numbered: Aside from Amgen’s would-be copycat, biosimilars from Biocon Biologics and Alvotech could hit the U.S. market sometime in the second half of 2023.
In the Amgen patent case, District Judge Maryellen Noreika noted that J&J's lawyers requested lenience on the court's page limit only seven minutes before submitting an over-the-limit brief.
"The effect of this was that Plaintiff granted itself an extension without leave of Court and without respect for the Court and its rules," a docket entry states.
The company can refile the motion with a brief that “complies” with the court’s rules, which it will almost certainly will do, meaning the loss this week may ultimately be a blip on the radar.
J&J sued Amgen back in November, alleging the latter company's plan to sell its biosimilar infringes two existing Stelara patents related to the drug’s active ingredient, plus methods of treatment in ulcerative colitis.
Amgen’s Stelara biosim has yet to win approval. J&J contends Amgen filed its biosimilar application with the FDA on or before Nov. 3, teeing up a potential decision date sometime in 2023’s second or third quarter.
J&J has been bracing for Stelara’s tumble off the patent cliff for several years now. As it stands, though, none of the copycat rivals in development have won an official FDA endorsement.
With the timeline for copycat encroachers still looking slightly murky, J&J’s chief financial officer Joe Wolk recently told investors he expected Stelara’s loss of exclusivity to set in by “late 2023.”