What are the requirements for testing biological deposit viability?
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.
The MPEP provides guidance on testing the viability of biological deposits. According to MPEP 2409:
“The depository must be able to furnish samples of the deposit to those who are entitled to receive samples under patent law and the Budapest Treaty. The depository must also agree to test the deposit for viability.”
While specific testing methods are not detailed in the MPEP, it is understood that the depository institution must employ appropriate scientific methods to ensure the deposit remains viable and capable of performing its intended function. The frequency and nature of these tests may vary depending on the type of biological material deposited.