Clinical Trial Medicine As Prior Art At The EPO

• Published date: 01 February 2023
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: aera
• Author: Aera Firm

Pharmaceutical innovator companies increasingly have to consider the potential prior art effect of clinical studies carried out in order to gain approval of their medicines. The prior art effect may arise either from the clinical trial protocol being published online at clinicaltrials.org, or it may arise because the trial patients took the medicine home with them and self-administered at home.

Decision T 7/07 found that in a phase 3 clinical trial, the patent proprietor had 'lost control' of the study medicine and that, as a consequence, the trial patients constituted members of the public. Since the skilled person had the means to analyse the contents of the trial medicine available, it was concluded that the invention in question lacked novelty over the clinical trial.

Recent decision T 670/20 refers back to T 7/07 and provides more insight into when a clinical trial medicine may be considered available to the public (and when not). In the Catchword, the Board states:

The clinical trials were carried out in accordance with the EMEA Guidelines for Good Clinical Practice. These guidelines explicitly require adherence to the prescribed protocol and assurance of drug accountability. This set-up of the trials implies that the patients who decided to participate in the trials agreed, following their informed consent, to use...