What are the specific viability requirements for biological material deposits?

What are the specific viability requirements for biological material deposits?

The viability requirements for biological material deposits are outlined in MPEP 2410.01. According to the manual:

“The deposit of biological material must be viable at the time of deposit.”

Additionally, the depositor must provide a viability statement at the time of making the deposit. The MPEP states:

“A viability statement for each deposit of a biological material defined in paragraph (b) of this section not made under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain:

  • (1) The name and address of the depository;
  • (2) The name and address of the depositor;
  • (3) The date of deposit;
  • (4) The identity of the deposit and the accession number given by the depository;
  • (5) The date of the viability test;
  • (6) The procedures used to obtain a sample if the test is not done by the depository; and
  • (7) A statement that the deposit is capable of reproduction.”

It’s important to note that the viability statement must be filed either before or with the application for patent or during any period for reply to any Office action.

To learn more:

Topics: MPEP 2400 - Biotechnology, MPEP 2410.01 - Conditions Of Deposit, Patent Law, Patent Procedure
Tags: Biological Material Deposit, Budapest Treaty, Viability Requirements, Viability Statement