Can a patent applicant rely on the reproduction of biological materials from a written description?
Yes, a patent applicant can potentially rely on the reproduction of biological materials from a written description, but there are important considerations. MPEP 2404 states:
“The invention may rely on biological material which is known and readily available to the public or reproducible from the written description.”
However, the applicant must ensure that:
- The written description is sufficiently detailed to allow reproduction without undue experimentation
- The reproduction process is reliable and consistent
- The resulting material is identical to the original in all relevant aspects
If these conditions are not met, or if there’s any doubt about the reproducibility, a biological material deposit may still be required to satisfy the enablement requirement under 35 U.S.C. 112.
To learn more:
Topics:
MPEP 2400 - Biotechnology,
MPEP 2404 - Need Or Opportunity To Make A Deposit,
Patent Law,
Patent Procedure