Epic battle over Stelara continues with win for Janssen against Samsung Bioepis

Samsung Bioepis has failed to invalidate a second medical use patent for Janssen's blockbuster Stelara in the Netherlands. The District Court The Hague dismissed the revocation action, but the Korean company will not accept this outcome quietly.

In a long-awaited judgment, the District Court The Hague has upheld Janssen’s EP 3 883 606. The patent covers a second medical use of Janssen’s blockbuster drug Stelara, with claims to the antibody ustekinumab for treating ulcerative colitis.

Samsung Bioepis, which aims to enter the Dutch market with its own product, mounted a broad challenge against the Dutch parts of EP 606. The company attacked the patent for lack of novelty and inventive step whilst arguing against the grant due to prior art.

The 68-page judgment came from a panel led by presiding judge Marjolein Visser, who also sits as a judge at the Paris central division of the Unified Patent Court. The judges, including Bierling and Verrips, thoroughly examined both parties’ technical arguments.

Ultimately, they concluded that the patent was properly granted and dismissed Samsung Bioepis’s action (case ID: C/09/659616 / HA ZA 24-44).

Appeal swiftly lodged

Days after the judgment’s publication, Samsung Bioepis announced its appeal. This comes as no surprise, given the intense ongoing dispute between Samsung’s biosimilar division and Janssen over Stelara in the Netherlands and elsewhere.

Janssen, a wholly-owned subsidiary of Johnson & Johnson, produces ustekinumab as the active ingredient in Stelara, one of Johnson & Johnson’s highest-grossing drugs globally. Stelara also treats psoriasis, psoriatic arthritis and Crohn’s disease.

Originally, EP 1 309 692 B1 formed the basis for Stelara, covering “ANTI-IL-12 antibodies, compositions, methods and uses”. This patent also underpinned an SPC for Stelara in various European countries. While both the basic patent and SPC have expired, a case regarding the SPC remains pending at the Dutch Supreme Court. This dispute concerns an SPC waiver for producing a Stelara biosimilar for export to third countries.

In February 2025, the Dutch Court of Appeal upheld a District Court judgment in PI proceedings between the parties. The District Court judges had previously dismissed Janssen’s PI application in January 2024. A successful PI against Samsung Bioepis would only have had a brief retroactive effect until July 2024, when the SPC expired. Janssen’s subsequent appeal also failed. The Supreme Court hearing date remains unknown.

Although Samsung Bioepis does not manufacture in the Netherlands, the Dutch courts claimed jurisdiction as the company is based there.

UK proceedings

While biosimilar products of Stelara can now be sold in the EU following the SPC’s expiry, Janssen aims to prevent their sale for treating ulcerative colitis through the second medical use patent EP 606.

Challenges to EP 606’s validity are pending across Europe. In the UK, Samsung Bioepis prevailed in summer 2024 when the High Court revoked EP 606. Samsung Bioepis argued the patent was invalid over prior art, and judge Richard Meade declared it invalid for obviousness (case ID: HP-2023-000020). Janssen was denied leave to appeal.

An intensive battle over EP 606 continues at the EPO. Initially, five opponents challenged the patent but four withdrew, leaving only Samsung Bioepis. The EPO Opposition Division has scheduled oral proceedings for 20 January 2026.