Samsung Bioepis destroys Stelara patent

Janssen is fighting Samsung Bioepis in Europe over its blockbuster drug Stelara. In the UK revocation claim the High Court has now declared a patent invalid. 

Samsung Bioepsis has successfully challenged Janssen’s EP 3 883 606. The patent has claims to the antibody ustekinumab for use in the treatment of ulcerative colitis.

Janssen is a wholly-owned subsidiary of Johnson & Johnson. The active ingredient ustekinumab forms the basis of Stelara, one of Johnson & Johnson’s global top-selling drugs. Stelara also treats psoriasis, psoriatic arthritis and Crohn’s disease. An SPC for ustekinumab expired on 19 July 2024.

Success for Samsung Bioepsis

Samsung Bioepis claimed the patent is invalid over the prior art. By destroying EP 606 the biotech company could sell a ustekinumab biosimilar under a “skinny label”, not covering ulcerative colitis.

Judge Richard Meade has now declared the patent invalid for obviousness (case ID: HP-2023-000020). It is not yet known if Janssen will appeal the decision.

Originally there were several other companies attacking the patent in the UK, among them Amgen, Celltrion and Accord. However, according to the High Court’s recent judgment, all apart from Samsung have settled with Janssen.

Fight in the Netherlands

Parallel proceedings between Samsung Bioepis and Janssen concerning the same patent are pending in the Netherlands.

In Germany, the dispute between Janssen and Formycon over Stelara focused on an SPC of EP 1 309 692 B1. A settlement between the three companies Formycon, Fresenius Kabi and Johnson & Johnson earlier this year ended all pending patent litigation over the disputed FYB202 biosimilar, which was also ongoing in the UK and Germany.