US Patent and Trademark Office (PTO) issued a final rejection of Johnson & Johnson's Remicade patent (6,288,471)

With a biosimilar lurking, Johnson & Johnson faces patent setback on Remicade – what happens next?

Last week, the US Patent and Trademark Office (PTO) issued a final rejection of Johnson & Johnson's Remicade patent (6,288,471) following a re-examination. The patent was originally due to expire in September 2018. Johnson & Johnson indicated that will pursue "all available appeals" in a bid to defend the validity of patent '471, which the PTO has essentially ruled makes the same claims as earlier, expired patents. This process is particularly significant given pending FDA Advisory Committee assessment of Celltrion's biosimilar Remicade product – CT-P13 – next month (ViewPoints: Celltrion gets a date with the FDA for biosimilar Remicade – but will Hospira be on board?).

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