When is a deposit of biological material required for a patent application?

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 deposit of biological material is required for a patent application when:

• Access to the biological material is necessary to satisfy the statutory requirements for patentability under 35 U.S.C. 112, and
• Such access is not otherwise available in the absence of a deposit.

As stated in MPEP 2404:

“Biological material need not be deposited unless access to such material is necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112 and that access is not otherwise available in the absence of a deposit.“

It’s important to note that the mere reference to a deposit in an application disclosure does not necessarily imply that a deposit is required.