When is a replacement deposit not required for biological materials?

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.

A replacement deposit of biological materials is not required under certain conditions, even if the depository cannot furnish samples to requesters outside its jurisdiction. According to MPEP 2407.05, these conditions are:

• National security reasons
• Health reasons
• Environmental safety reasons

As stated in the MPEP: “The provisions of 37 CFR 1.805(h) indicate that a replacement deposit is not required even though the depository cannot furnish samples, under certain conditions, to those requesting a sample outside of the jurisdiction where the depository is located.” This exemption aligns with Article 5 of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.