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ARTICLE · 01 FEBRUARY 2023

Clinical Trial Medicine As Prior Art At The EPO

Aera A/S
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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.

DenmarkIntellectual Property
Henrik Skodt
Henrik Skodt
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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.

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