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.

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Topics: MPEP 2400 - Biotechnology, MPEP 2407.05 - Exemption From Replacement, Patent Law, Patent Procedure
Tags: Biological Deposits, Budapest Treaty, patent procedure, Replacement Deposits