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
Tags: Biological Material Reproduction, patent applications, Written Description