Samsung Bioepis UK Limited v Janssen Biotech, Inc

Samsung Bioepis UK Limited v Janssen Biotech, Inc

The patent is invalid for obviousness over the Sands Slides, which disclosed statistically significant efficacy of ustekinumab in ulcerative colitis at the induction phase, providing the skilled person with a strong expectation of success at the end of the maintenance phase, including corticosteroid-free clinical remission. The Ochsenkühn Poster and Abstract did not anticipate or render the patent obvious, as they did not demonstrate efficacy to the required standard. The claim construction adopted required CSFCR at 44 weeks after the start of treatment, and the Sands Slides rendered this obvious. The skilled person would have sufficient knowledge of immunology and clinical trial design...

Parties
Claimant: Samsung Bioepis UK Limited; Defendant: Janssen Biotech, Inc.
Jurisdiction
England and Wales
Judgment Date
31 July 2024
Procedural Posture
Patent Revocation / Judgment After Expedited Trial
Outcome
Patent revoked for obviousness over the Sands Slides; anticipation and obviousness attacks over the Ochsenkühn Abstract and Poster fail.
Legal Topics
Patent Validity, Obviousness, Anticipation, Second Medical Use Claims, Clinical Trial Disclosure
Intellectual Property Patents Patent Validity Obviousness Anticipation Second Medical Use Claims Clinical Trial Disclosure

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Parties

Samsung Bioepis UK Limited

Claimant

Janssen Biotech, Inc.

Defendant

Procedural Posture

Patent Revocation / Judgment After Expedited Trial

Legal Issues

  1. 1 Whether European Patent (UK) No. 3 883 606 is invalid for anticipation or obviousness over prior art including the Ochsenkühn Poster, Ochsenkühn Abstract, and Sands Slides; construction of claim 1, specifically the meaning of 'at least 44 weeks after week 0' and 'corticosteroid-free clinical remission'; the identity and knowledge of the skilled person; the scope of common general knowledge (CGK) in the field.

Ratio Decidendi

The patent is invalid for obviousness over the Sands Slides, which disclosed statistically significant efficacy of ustekinumab in ulcerative colitis at the induction phase, providing the skilled person with a strong expectation of success at the end of the maintenance phase, including corticosteroid-free clinical remission. The Ochsenkühn Poster and Abstract did not anticipate or render the patent obvious, as they did not demonstrate efficacy to the required standard. The claim construction adopted required CSFCR at 44 weeks after the start of treatment, and the Sands Slides rendered this obvious. The skilled person would have sufficient knowledge of immunology and clinical trial design...

Court Disposition

Patent revoked for obviousness over the Sands Slides; anticipation and obviousness attacks over the Ochsenkühn Abstract and Poster fail.