Caselaw Digest
Caselaw Digest

Samsung Bioepis UK Limited v Janssen Biotech, Inc

30 July 2024
[2024] EWHC 1984 (Pat)
High Court
A company's patent for a drug to treat a bowel disease was declared invalid because earlier test results from a bigger trial already strongly suggested the drug would work. Other smaller studies weren't enough to prove the drug didn't work, but they didn't show it would work either.

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.

Similar Cases

Caselaw Digest Caselaw Digest

UK Case Law Digest provides comprehensive summaries of the latest judgments from the United Kingdom's courts. Our mission is to make case law more accessible and understandable for legal professionals and the public.

Stay Updated

Subscribe to our newsletter for the latest case law updates and legal insights.

© 2025 UK Case Law Digest. All rights reserved.

Information provided without warranty. Not intended as legal advice.