Are international patent applications required to incorporate “Sequence Listings” by reference?

No, international patent applications during the international stage are exempt from the requirement to incorporate “Sequence Listings” by reference. This exemption is specifically stated in 37 CFR 1.823(b)(2):

37 CFR 1.823(b)(2) specifically exempts international applications during the international stage from the incorporation by reference requirement in 37 CFR 1.823(b)(1).

This means that while domestic U.S. patent applications and national stage applications of international applications must include an express incorporation by reference of the “Sequence Listing” in the specification, international applications in the international phase do not need to meet this requirement.

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Topics: MPEP 2400 - Biotechnology, MPEP 2424.01 - Informational Requirements For The "Sequence Listing", Patent Law, Patent Procedure
Tags: international patent applications, PCT, sequence listing, USPTO requirements