What are the consequences of not making a required biological material deposit 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.

Failing to make a required biological material deposit for a patent application can have serious consequences:

• Rejection of the application for lack of enablement under 35 U.S.C. 112
• Inability to overcome rejections based on prior art
• Potential invalidation of an issued patent

MPEP 2404 emphasizes the importance of deposits: “Where an invention depends on the use of a biological material, and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112.”

If a deposit is required but not made, the applicant may not be able to demonstrate that the invention is fully enabled, potentially leading to a denial of the patent or vulnerability to future challenges.