Samsung Bioepis UK Limited v Janssen Biotech, Inc

For anticipation of a medical-use claim, the prior art must give clear and unmistakable directions and demonstrate the claimed therapeutic effect. A treatment assertion or clinical-trial protocol is insufficient by itself.

Obviousness is a multifactorial assessment. A clinical trial does not create an automatic presumption of reasonable expectation of success. Concrete evidence is generally more important than assumptions about why regulators or sponsors approved a trial. Here, retrospective small-scale data created only a hope of success, whereas statistically significant phase III induction results from a reliable source gave the skilled person a high degree of confidence that efficacy would continue through maintenance and would improve corticosteroid-free remission.

Samsung sought revocation of Janssen’s European Patent (UK) No 3 883 606, concerning ustekinumab for treating moderately to severely active ulcerative colitis according to an induction and maintenance regimen, including corticosteroid-free clinical remission.

The validity challenges concerned claim construction, anticipation by an Ochsenkühn poster, and obviousness over the Ochsenkühn abstract and poster, the UNIFI protocol and the Sands Slides reporting phase III induction results from the UNIFI trial.

The central issues were whether the Ochsenkühn material demonstrated the claimed therapeutic effect and whether the available evidence gave the skilled person a reasonable expectation of success.

1. Claim construction. The claims had to be interpreted in the light of the specification and drawings, not in isolation. “For use in a method of treating” required a real therapeutic effect caused by the treatment, but no particular statistical-significance threshold was implied. Corticosteroid-free clinical remission did not require prior steroid use. “Remission” and disease activity were not confined to the Mayo score. The reference to 44 weeks required assessment of maintained long-term success at the relevant endpoint, understood in the context of the Patent’s induction and maintenance protocol.
2. Anticipation. The Ochsenkühn poster was made available to the public at DDW 2018. However, its retrospective, unblinded, single-centre analysis, small patient population, absence of placebo control and methodological limitations did not demonstrate that ustekinumab was effective in treating UC. Improvement in an individual patient could result from chance or placebo effect. The anticipation attack therefore failed.
3. Obviousness over Ochsenkühn. The same material generated only a modest increase in hope, not a reasonable expectation of success. The evidence relied impermissibly on mosaicking the Ochsenkühn material with the Sands Slides. The obviousness attack based on the Ochsenkühn work failed.
4. Obviousness over the Sands Slides. The Slides came from a highly reliable source and disclosed statistically significant induction results in a difficult-to-treat population. The skilled person would regard the results as demonstrating a real treatment effect. There was no positive reason to expect failure during maintenance, and no known example of a biologic succeeding in induction but failing in maintenance. The skilled person would therefore have a high degree of confidence, though not certainty, that efficacy would continue. The results also supported an expectation of increased corticosteroid-free clinical remission, because some patients were steroid-free at baseline and successful treatment would enable others to discontinue steroids.
5. Disposition. The Patent was invalid for obviousness over the Sands Slides. The anticipation and obviousness attacks based on the Ochsenkühn abstract and poster failed. The form of order was reserved.