When is a replacement deposit not required for biological materials?
A replacement deposit of biological materials is not required under certain conditions, even if the depository cannot furnish samples to requesters outside its jurisdiction. According to MPEP 2407.05, these conditions are:
- National security reasons
- Health reasons
- Environmental safety reasons
As stated in the MPEP: “The provisions of 37 CFR 1.805(h) indicate that a replacement deposit is not required even though the depository cannot furnish samples, under certain conditions, to those requesting a sample outside of the jurisdiction where the depository is located.” This exemption aligns with Article 5 of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.
To learn more:
Topics:
MPEP 2400 - Biotechnology,
MPEP 2407.05 - Exemption From Replacement,
Patent Law,
Patent Procedure