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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J&J suffered another blow today as a key Remicade® (infliximab) patent was revoked by US Court of Appeals (Federal Circuit).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

CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

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