Samsung Bioepis UK Ltd v Janssen Biotech, Inc.

Permission to appeal should be refused where the proposed ground has no reasonable prospect of success or raises an argument that could and should have been advanced at trial. In assessing obviousness, a court may combine findings concerning distinct patient cohorts where the evidence establishes the relevant therapeutic expectation for each cohort. No separate evidential or scientific requirement arises merely because the cohorts are considered together, particularly where the claim requires a real treatment effect but no particular measure of statistical significance.

This was the first instalment of the form of order hearing following an earlier judgment in which the patent was held invalid for obviousness over the Sands Slides. The claimant sought permission to appeal findings concerning the interpretation of claim 1, specifically the corticosteroid-free clinical remission feature.

The proposed appeal concerned whether ustekinumab had to be capable of treating both patients who began treatment on corticosteroids and those who did not, and whether the court was entitled to combine its findings concerning those two cohorts when assessing expectation of success. The court had already held that the therapeutic effect had to be real and caused by the treatment, but that no particular measure of statistical significance was required.

1. Permission to appeal refused. The proposed challenge to the finding that claim 1 was an easier target for the prior-art attacks because some patients might not have been taking steroids at the outset was arguable only to a limited extent.

2. The court was entitled to combine its findings concerning patients who were not taking steroids at the beginning of treatment with its findings concerning patients who were taking steroids. For the first cohort, successful treatment would be expected to result in more patients being in corticosteroid-free clinical remission at the end of the maintenance phase. For the second cohort, successful treatment would be expected to enable some material number of patients to stop taking steroids.

3. There was no additional evidential or scientific difficulty in combining those conclusions. The combined finding was consistent with the earlier construction that the therapeutic effect had to be a real effect caused by the treatment. The absence of any requirement for statistical significance was material.

4. The proposed argument had not been advanced at trial. It was not put in evidence, cross-examination or argument that combining the cohorts involved any special difficulty. The issue therefore had no reasonable prospect of success and was not legitimate to raise for the first time on appeal.

5. The court refused permission to appeal. Costs and other consequential matters were reserved for the second instalment of the form of order hearing.

The judgment followed an earlier first-instance judgment delivered on 30 July 2024, in which the patent was held invalid for obviousness over the Sands Slides. The citation of that judgment was not stated.