What information must be included in a viability statement for non-Budapest Treaty 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.

For biological material deposits not made under the Budapest Treaty, a viability statement must be filed with the patent application. According to MPEP 2409 and 37 CFR 1.807(b), this statement must contain:

• The name and address of the depository
• The name and address of the depositor
• The date of deposit
• The identity of the deposit and the accession number given by the depository
• The date of the viability test
• The procedures used to obtain a sample if the test is not done by the depository
• A statement that the deposit is capable of reproduction

This information is crucial for establishing the viability and accessibility of the deposited biological material for patent purposes.