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Litigation Update: Court Dismisses Janssen’s Ustekinumab Patent Infringement Counterclaim against Samsung Bioepis

Oct 29, 2024

On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings.  Samsung Bioepis commenced proceedings against Janssen seeking to impeach (invalidate) Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023.  

Samsung commenced the impeachment proceedings as an interested person, on the basis that it had filed a submission for a notice of compliance (NOC) for Pyzchiva®, biosimilar to Stelara® (ustekinumab).  Samsung received an NOC for Pyzchiva® in August 2024.  At that time, Health Canada published a product monograph for Pyzchiva®, which listed Sandoz as a distributor of Pyzchiva®. 

The Federal Court dismissed Janssen’s motion to add an infringement counterclaim because it was not satisfied that the proposed pleading was adequately particularised, and considered that it did not disclose a reasonable cause of action.  The Court stated that, “considering the allegations of direct and induced infringement, both individually and collectively, it is apparent that Janssen does not know what Samsung and Sandoz are presently doing with Pyzchiva beyond obtaining regulatory approval, but is hoping to use the discovery process to find out.  This is not a proper pleading”. 

Ahead of Samsung Bioepis and Sandoz in Canada with ustekinumab biosimilars are: JAMP who launched the Alvotech developed first biosimilar Jameteki™ on 1 March 2024, Amgen who launched Wezlana™ on 4 March 2024 and Celltrion who reported on 31 July 2024 its Canadian approval for Steqeyma (CT-P43)Biocon has also submitted a Canadian regulatory application, following a signed patent settlement and licence agreement with Janssen which enables Biocon to commercialise its ustekinumab biosimilar “Bmab 1200” in Europe, the United Kingdom, Canada and Japan.