WATCH: The new EU Clinical Trials Regulation – IP Considerations

As part of a lifecycle IP strategy for a therapeutic product, it can be important to protect inventions arising during the clinical development of the product.  Disclosures made during the clinical trial process can have a significant impact on whether it is possible to protect these inventions, so it is important to understand what will be disclosed during the clinical development process and when that disclosure will occur.  

In Europe, the clinical trials landscape is evolving with the implementation of a relatively new EU Clinical Trials Regulation (EU-CTR).  One impact of the EU-CTR is that there is drive for increased public transparency and the overall impact of this is that more information will become publicly available at an earlier stage from trials conducted in the EU.  This is having an impact on lifecycle IP strategies.

This talk will summarise the key disclosure requirements under the in the EU-CTR and strategies to minimize the impact of the disclosures.