What are the requirements for describing biological material in 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.

According to MPEP 2406.01, there are specific requirements for describing biological material in a patent application:

• The biological material must be specifically identified in the application as filed.
• The description must be consistent with the requirements of 35 U.S.C. 112.
• The description should provide an antecedent basis for the biological material that will be or has been deposited.

The MPEP states: “The requirement for a specific identification is consistent with the description requirement of 35 U.S.C. 112 and provides an antecedent basis for the biological material which either has been or will be deposited before the patent is granted.” This means that the application must clearly describe the biological material in a way that links it to the deposit that will be made.