Johnson & Johnson (J&J) has announced that the District of Massachusetts Federal Court has overturned its patent claims for Remicade (infliximab).
The court ruled that Pfizer’s biosimilar of J&J’s Remicade does not infringe patent, paving the way for the sale of Inflectra in October, reported the Wall Street Journal.
Inflectra is manufactured by South Korean biopharmaceutical company Celltrion for Pfizer-owned Hospira. The ruling holds the US patent for Remicade invalid, J&J said in a statement.
J&J's subsidiary Janssen Biotech markets Remicade, a prescription medication used to treat Crohn's Disease, Pediatric Crohn's Disease, Ulcerative Colitis, Pediatric Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Plaque Psoriasis.
The company said that it will appeal the latest decision to the Court of Appeals for the Federal Circuit.
Janssen will continue to defend its intellectual property rights relating to its innovative medicines.
Additionally, a commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch, according to a statement posted on J&J's website.
In April this year, Celltrion and Hospira's biosimilar, Inflectra, received US Food and Drug Administration approval.
The approval was based on review of evidence that included structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data.
J&J generated nearly $6.56bn in Remicade's sales last year.