What makes a biological material deposit acceptable for patent purposes?

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.

For a biological material deposit to be acceptable for patent purposes, it must meet specific criteria as outlined in MPEP 2404. The key requirement is:

“Where a deposit is required to provide the necessary access, a deposit is acceptable for patent purposes only where it is made in accordance with these regulations.“

This means that the deposit must:

• Be made in a recognized depository institution
• Comply with the regulations set forth in 37 CFR 1.801-1.809
• Provide sufficient access to satisfy the statutory requirements for patentability under 35 U.S.C. 112

It’s important to note that even if access to biological material is required, a deposit may not be necessary if sufficient access can be provided through other means.