JANSSEN APPEALS TO SUPREME COURT AFTER SAMSUNG BIOEPIS WIN IN SPC WAIVER CASE

“At the heart of the case was the interpretation of the EU regulation regarding the exemption for manufacturing pharmaceuticals for export to third countries, known as the SPC waiver. To date, European courts have seen little case law on this matter.”

In February, the Dutch Court of Appeal under presiding judge J.I. de Vreese-Rood upheld a District Court judgment in PI proceedings between Janssen and Samsung Bioepis (case ID: 200.337.844/01).

At the heart of the case was the interpretation of the EU regulation regarding the exemption for manufacturing pharmaceuticals for export to third countries, known as the SPC waiver. To date, European courts have seen little case law on this matter.

Specifically, the dispute concerns Janssen’s basic patent EP 1 309 692 B1, which covers “ANTI-IL-12 antibodies, compositions, methods and uses”. It forms the basis for Janssen’s drug Stelara, containing the active ingredient ustekinumab. It is used to treat conditions such as Crohn’s disease, psoriasis and ulcerative colitis. EP 892 formed the basis of an SPC for Stelara in the UK, Italy and Denmark. All expired in July 2024.

Janssen, a wholly-owned subsidiary of Johnson & Johnson, claimed its SPC rights were infringed in Italy and Denmark after Samsung Bioepis announced in October 2023 that it would manufacture its biosimilar product there for “export and storing”. Samsung Bioepis cited the SPC waiver and stated it would sell its product in Canada, South Korea and the UK.

Janssen argued that the defendant must produce a relevant marketing authorisation before beginning distribution of its Stelara biosimilar upon patent expiry. However, the court dismissed all arguments, ruling that Samsung Bioepis could continue distributing the biosimilar to third countries.

No production in the Netherlands

The District Court judges dismissed Janssen’s PI application in January 2024. A successful PI against Samsung Bioepis would only have had a short and retroactive effect until July 2024. Although Samsung Bioepis does not manufacture the product in the Netherlands, the Dutch judges claimed jurisdiction because Samsung Bioepis is based there.

Janssen’s subsequent appeal also failed. The Court of Appeal published its judgment in early April. The case appears fundamental to Janssen. JUVE Patent has learned that the US pharmaceutical manufacturer filed an appeal with the Dutch Supreme Court on 8 April.

The sale of biosimilar products from Stelara is now possible in the EU following the expiry of the SPC.

SPC waiver in play

Under the SPC waiver, companies may produce imitation products within the EU before patent protection expires under certain conditions. This follows regulation EC 2019/933, which has supplemented the previous SPC regulation (EC/469/2009) since 2019.

The manufacturing waiver applies when, for example, a generic or biosimilar drug is destined for export to third countries outside the EU where SPC protection does not exist.

Parallel proceedings

In the Netherlands, the two companies are also fighting over another Stelara patent. Janssen’s EP 3 883 606 has claims to the antibody ustekinumab for treating ulcerative colitis. Samsung Bioepis has challenged the validity of the Dutch part of the patent. The District Court The Hague has heard the case and parties await judgment.

In the UK, Samsung Bioepis obtained the revocation of Janssen’s EP 606 in summer 2024. The court refused permission to appeal against the High Court judgment.

Janssen took action against biosimilar suppliers of Stelara in 27 European countries. While Janssen reached settlement agreements with some, others like Samsung Bioepis continue to litigate vigorously.

Simmons for Samsung Bioepis

Samsung Bioepis turned to its regular advisors Simmons & Simmons in the Netherlands and UK. Bas Berghuis van Woortman and Machteld Hiemstra lead the cases in the Netherlands. European patent attorney Sebastien Versaevel and lawyer Bouke Algie are also part of the team.

A London team around partner Scott Parker coordinates the European disputes and led the trial in the UK.

Information taken from: Juve Patent. https://www.juve-patent.com/cases/janssen-appeals-to-supreme-court-after-samsung-bioepis-win-in-spc-waiver-case/