Key Facts
- •Samsung sought revocation of Janssen's European Patent (UK) No. 3 883 606 for ustekinumab in treating ulcerative colitis (UC).
- •The patent claims ustekinumab for use in treating UC according to a specific dosing regimen.
- •The priority date was 20 November 2018.
- •Samsung argued invalidity based on anticipation and obviousness over prior art by Ochsenkühn and the 'Sands Slides'.
- •The prior art included retrospective analyses of a small number of UC patients treated with ustekinumab and results from the UNIFI Phase III clinical trial (induction phase).
Legal Principles
Claim interpretation should consider claim language, specification, and drawings.
Sycurio v PCI-PAL [2024] EWCA Civ 606
Anticipation requires clear and unmistakable directions; merely asserting a treatment effect is insufficient.
T239/16
Obviousness is a multifactorial question; expectation of success is a key factor but needs to be balanced against other factors.
Actavis v ICOS [2019] UKSC 15
Outcomes
Patent invalid for obviousness.
The Sands Slides, showing positive results from the UNIFI trial's induction phase, created a strong expectation of success in the maintenance phase, rendering the patent obvious. The Ochsenkühn prior art, while showing some positive results, lacked the necessary strength to demonstrate anticipation or obviousness.
Anticipation and obviousness attacks over Ochsenkühn's work failed.
The Ochsenkühn Abstract and Poster, while showing some improvement in UC patients, did not demonstrate efficacy to the required standard and did not create a reasonable expectation of success.