What are the legal statutes governing biological deposits for patent applications?
The primary legal statutes governing biological deposits for patent applications are found in 35 U.S.C. 112. According to MPEP 2403:
“The issue of the need to make a deposit of biological material typically arises under 35 U.S.C. 112(a) with regard to the enablement requirement, although the issue may also arise under the written description or best mode requirement of the statute. Deposit issues may also arise under 35 U.S.C. 112(b) with respect to the claims.”
Additionally, the procedural aspects of biological deposits are governed by 37 CFR 1.801-1.809, which provide specific rules for the deposit of biological material for patent purposes.
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Topics:
MPEP 2400 - Biotechnology,
MPEP 2403 - Deposit Of Biological Material,
Patent Law,
Patent Procedure