When is a deposit of biological material not necessary for patent applications?

A deposit of biological material is not necessary for patent applications when the required biological materials can be made or isolated without undue experimentation. This is explicitly stated in MPEP 2404.02:

“Applicant may show that a deposit is not necessary even though specific biological materials are required to practice the invention if those biological materials can be made or isolated without undue experimentation.”

This means that if the biological materials needed for the invention can be obtained through routine procedures and without excessive effort, a deposit may not be required.

To learn more:

Topics: MPEP 2400 - Biotechnology, MPEP 2404.02 - Biological Material That Can Be Made Or Isolated Without Undue Experimentation, Patent Law, Patent Procedure
Tags: biological material, biotechnology patents, Patent Deposit, Undue Experimentation