What are the specific conditions for exemption from replacement deposits?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

According to MPEP 2407.05, there are specific conditions under which a depository may be exempted from providing replacement deposits of biological materials. The MPEP states:

“The conditions are specified in this paragraph as being limited to national security, health or environmental safety reasons.”

These conditions can be broken down as follows:

• National security concerns
• Health-related issues
• Environmental safety considerations

If any of these conditions apply, the depository may be exempt from the requirement to furnish samples to requesters outside its jurisdiction without needing to provide a replacement deposit. This provision balances the need for access to biological materials for patent purposes with important safety and security considerations.