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ARTICLE · 16 JULY 2024

Clinical Trial Proposals As Prior Art

Marks & Clerk
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Clinical trial proposals, often published, may be cited as prior art against patent applications for medical products. Recent case law indicates that while such proposals rarely destroy novelty, they can challenge inventive step, depending on specific case details and expected outcomes.

United KingdomIntellectual Property
Sophie Topham
Sophie Topham
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There has been a spattering of case law over the last few years concerned with clinical trial proposals as prior art for patent applications. The status of clinical trial proposals as prior art is particularly relevant to patent applications relating to medical products and medical uses, and this issue has recently been of relevance to one of our clients' patents.

A clinical trial proposal sets out key details of the purpose of the clinical trial and how it will be conducted. A proposal usually includes details of the background and context for the trial, the primary and secondary outcomes, the design and methodology of the trial, and statistical considerations. Clinical trial proposals are used to monitor the quality of clinical trials, and help to ensure the safety of participants, the integrity of the data and to obtain ethical approval for the clinical trial. A clinical trial proposal is usually published following the relevant approval, although it may be

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