Why are biological deposits important in biotechnology patents?

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.

Biological deposits are crucial in biotechnology patents because they ensure that the invention is fully disclosed and can be reproduced. MPEP 2401 introduces the rules for deposits of biological materials (37 CFR 1.801 – 1.809), which are essential when written description alone is insufficient to enable the invention.

These deposits allow for:

• Preservation of unique biological materials
• Public access to the materials after patent grant
• Verification of the claimed invention
• Enablement of the invention for future researchers

By referring to these regulations, MPEP 2401 highlights the importance of proper biological material handling in the patent process.