Why are biological deposits necessary for patent applications?

Biological deposits are necessary when words alone cannot sufficiently describe how to make and use the invention in a reproducible manner. The MPEP states:

“Where the invention involves 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.“

This requirement ensures that the invention can be reproduced and used by others skilled in the art, which is essential for meeting the enablement and written description requirements of patent law. The MPEP cites relevant court cases:

• Ajinomoto Co. v. Archer-Daniels-Midland Co. (explaining how deposit may help satisfy enablement requirement)
• Enzo Biochem, Inc. v. Gen-Probe, Inc. (deposit may satisfy the written description requirement)

To learn more:

• biological deposits
• patent requirements
• enablement
• written description
• 35 U.S.C. 112