What happens if a deposited biological material loses viability during the patent term?

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.

If a deposited biological material loses viability during the patent term, it can have serious implications for the patent. According to MPEP 2409, “When the original deposit or any replacement deposit becomes nonviable, it must be replaced by the applicant, patent owner, or assignee.” This requirement ensures that the enablement condition of the patent is maintained throughout its term. If the material cannot be replaced, it may affect the enforceability of the patent, as the invention may no longer be considered fully enabled.

The MPEP further states, “Failure to replace a nonviable deposit will cause the patent involved to be treated in any Office proceeding as if no deposit were made.” This underscores the critical importance of maintaining viable deposits throughout the patent term.