The District of Massachusetts Federal Court has determined that the patent for Johnson & Johnson’s Remicade (infliximab) is invalid—ruling in favor of Celltrion and Pfizer’s Hospira, who are seeking to bring a cheaper version of the drug onto the market.
With $6.6 billion in sales last year ($4.5 billion of which was in the U.S.)—and arguably Johnson & Johnson’s biggest product—the patent for Remicade will end in September of 2018, leaving the door wide open for competitors. Remicade is indicated for the treatment of numerous autoimmune disorders, including Crohn’s disease, ulcerative colitis, and rheumatoid arthritis.
According to the official company report on the ruling:
The court issued a ruling in favor of Celltrion and Hospira, holding that U.S. Patent No. 6,284,471 for REMICADE® (‘471 patent) is invalid. Janssen is disappointed with the court’s ruling and plans to appeal the decision to the Court of Appeals for the Federal Circuit. Janssen is also continuing the appeal process in the proceedings related to the ‘471 patent before the U.S. Patent & Trademark Office, and is awaiting a date to be set for an oral hearing in the appeal.
Reuters reports that “J&J, which is also defending other Remicade patents, said it plans to appeal the latest court decision.”
The FDA approved a biosimilar version of Remicade, Celltrion’s Inflectra (infliximab-dyyb), in April, which Pfizer will market in the U.S.
According to FirstWord Pharma, “[i]n response to court ruling, Pfizer said it was ‘committed to bringing biosimilars to patients in the U.S. as quickly as possible, and are continuing with the preparation of our launch plans for Inflectra for 2016.'”
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Filed Under: Drug Discovery
