Remicade™ Biosimilars US: Key Remicade™ patent revoked by Fed Cir

by | Jan 23, 2018

J&J suffered another blow today as a key Remicade® (infliximab) patent was revoked by US Court of Appeals (Federal Circuit).   Upholding the USPTO decision on reexamination of US 6,284,471, the Fed Cir held that the 35 USC §121 safe harbour does not apply, and the ‘471 patent was invalidated under the doctrine of obviousness-type double patenting (ODP).

The decision essentially makes redundant the pending appeal to the Fed Cir relating to the ‘471 patent in parallel proceedings initiated by Celltrion.  Janssen appealed the August 2016 decision of the District Court (Massachusetts CA No 1: 15-cv-10698) which also revoked the ‘471 patent for ODP.

There are several infliximab biosimilar products already available in the US, although uptake has been slow.  As previously reported, there is an ongoing dispute between Pfizer (Hospira) and J&J arising from Pfizer’s allegations that J&J’s anticompetitive conduct has improperly prevented biosimilar uptake.

Naomi Pearce

Naomi Pearce

Executive Lawyer, Patent Attorney & Trade Mark Attorney

Naomi is recognised as one of Australia’s leading patent lawyers in virtually every notable legal guide and directory.  Naomi is also Lawyers Weekly Women in Law Partner of the Year (SME Law) for 2021, and the Founding Principal of Pearce IP, which was recognised as the IP Team of the Year in the Australian Law Awards in December 2021.

Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from 25 years’ experience including as VP of IP in-house at global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.

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