Clinical Trials as Prior Art: Confidentiality, Experimental Use, and Reasonable Expectation of Success

Patentees typically face invalidity challenges during litigation. Life sciences companies face a unique challenge when clinical trials, often their own, are asserted as prior art against their own patents. In this discussion, the presenters will review applicable case law elucidating when clinical trials constitute prior art, the impact, if any, that confidentiality agreements have on this finding, the "experimental use" exception to § 102 prior art, and the impact clinical trials may have on obviousness under § 103 in view of the "reasonable expectation of success" analysis. Although each decision is fact specific, the presenters will attempt to provide guidance on monitoring clinical trials and, more importantly, overseeing any publication of related protocols and resulting data.

Learning Objectives: 

1. Identify the legal standards under which clinical trial activity may be deemed prior art under 35 U.S.C. § 102 and § 103

2. Analyze key case law addressing the treatment of clinical trials as prior art in patent litigation

3. Evaluate the effect of confidentiality agreements on whether clinical trial disclosures are considered public and thus prior art

4. Assess how clinical trial data and protocols may influence obviousness determinations, particularly in light of the "reasonable expectation of success" standard

5. Apply best practices to oversee trial design, data sharing, and publication to support patent robustness in the life sciences sector