Samsung Bioepsis v Janssen Biotech [2024] EWHC 1984 (Pat)
This was a patent revocation claim concerning a method of treating ulcerative colitis using an anti-IL12/IL23 antibody to achieve corticosteroid free clinical remission. The patent disclosed that the antibody in question (ustekinumab) was an effective maintenance treatment.
Janssen, the patentee, had developed a blockbuster antibody product called Stelara® which was an anti-IL12/IL23 antibody and which was authorised for the treatment of ulcerative colitis. Samsung wished to market its own biosimilar.
Samsung relied upon several pieces of prior art in support of its invalidity attack. It succeeded on one – the Sands Slides – a presentation of initial induction results obtained during Phase III clinical trials.
The case is notable because of the discussion of the correct approach to claim construction in light of Sycurio v PCI-PAL [2024] EWCA Civ 606 and the need for a claimed therapeutic effect to be a “real one” i.e. effective to treat a statistically significant proportion of patients compared to placebo.
Kathryn Pickard was instructed on behalf of Janssen, with Seaghan Davey assisting as a secondee at the instructing solicitors.