Clinical Trials And Prior Disclosure – A Difficult Balancing Act For Patentees

The European Patent Office (EPO) has recently ruled that patients in a clinical trial were not members of the public such that the trial did not constitute prior public use of a pharmaceutical formulation (Board of Appeal decision T 0670/20). This decision adds to the growing body of EPO case law surrounding the topic of disclosures relating to clinical trials and provides more legal certainty for patentees with drug formulation patents.

Background

The patent at issue (EP 2140867) concerned a tablet formulation of an anti-blood clot drug edoxaban. Prior to the filing of the patent, phase IIa and IIb clinical trials had already started assessing the safety and effectiveness of edoxaban tablets (as claimed) in the prevention of blood clots following hip replacement surgery. The studies involved the administration of the drug for up to ten days, during which time a proportion of patients were discharged from hospital and were allowed to continue the treatment at