[Editor Note: The PCT Rules and Administrative Instructions reproduced in this section are applicable to international applications, including national phase applications, having an international filing date on or after July 1, 2022. For international applications having an international filing date before July 1, 2022, the applicable rules and instructions may be found at: www.wipo.int/pct/en/texts/.]

PCT Rule 13ter

Nucleotide and/or Amino Acid Sequence Listings

1. (a) Where the international application contains disclosure of nucleotide and/or amino acid sequences that, pursuant to the Administrative Instructions, are required to be included in a sequence listing, the International Searching Authority may invite the applicant to furnish to it, for the purposes of the international search, a sequence listing complying with the standard provided for in the Administrative Instructions, unless such listing is already available to it in a form, language and manner acceptable to it, and to pay to it, where applicable, the late furnishing fee referred to paragraph (c), within a time limit fixed in the invitation.
2. (b) [Deleted]
3. (c) The furnishing of a sequence listing in response to an invitation under paragraph (a) may be subjected by the International Searching Authority to the payment to it, for its own benefit, of a late furnishing fee whose amount shall be determined by the International Searching Authority but shall not exceed 25% of the international filing fee referred to in item 1 of the Schedule of Fees, not taking into account any fee for each sheet of the international application in excess of 30 sheets.
4. (d) If the applicant does not, within the time limit fixed in the invitation under paragraph (a), furnish the required sequence listing and pay any required late furnishing fee, the International Searching Authority shall only be required to search the international application to the extent that a meaningful search can be carried out without the sequence listing.
5. (e) Any sequence listing not contained in the international application as filed, whether furnished in response to an invitation under paragraph (a) or otherwise, shall not form part of the international application, but this paragraph shall not prevent the applicant from amending the description in relation to a sequence listing pursuant to Article 34(2)(b).

Rule 13ter.1 shall apply mutatis mutandis to the procedure before the International Preliminary Examining Authority.

No designated Office shall require the applicant to furnish to it a sequence listing other than a sequence listing complying with the standard provided for in the Administrative Instructions.

PCT Administrative Instructions Section 513

Sequence Listings

1. (a) [Deleted]
2. (b) Where the international search report and the written opinion of the International Searching Authority are based on a sequence listing not forming part of the international application but furnished for the purposes of the international search, the international search report and the written opinion of the International Searching Authority shall so indicate.
3. (c) Where a meaningful international search cannot be carried out and a meaningful written opinion, as to whether the claimed invention appears to be novel, to involve an inventive step (to be non-obvious) and to be industrially applicable, cannot be established because a sequence listing is not available to the International Searching Authority in the required form, language and manner that Authority shall so state in the international search report or declaration referred to in Article 17(2)(a), and in the written opinion.
4. (d) Where a sequence listing for the purposes of the international search is furnished on a physical medium, that Authority shall physically label that medium with the words "SEQUENCE LISTING NOT FORMING PART OF THE INTERNATIONAL APPLICATION" in accordance with the procedures in Annex C.
5. (e) The International Searching Authority shall:
   1. (i) keep in its files one copy of any sequence listing which does not form part of the international application but was furnished for the purposes of the international search; and
   2. (ii) transmit one copy thereof to the International Bureau together with the copy of the international search report. If that listing is furnished on a physical medium in less than the number of copies required by the International Searching Authority, that Authority shall be responsible for the preparation of the additional copy and shall have the right to fix a fee for performing that task and to collect such fee from the applicant.
6. (f) Each International Searching Authority shall notify the International Bureau of the means of transmittal of the sequence listing accepted by it in accordance with Annex F. The International Bureau shall promptly publish details of the notification in the Gazette.

I. REQUIREMENTS FOR SEQUENCE LISTINGS UNDER WORLD INTELLECTUAL PROPERTY OFFICE STANDARD ST.26 (WIPO STANDARD ST.26)

[Editor Note: This subsection is applicable to all international applications, including national phase applications, having an international filing date on or after July 1, 2022, that disclose one or more nucleotide and/or amino acid sequences as defined in WIPO Standard ST.26.]

Patent applications that disclose a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in WIPO Standard ST.26, must present each sequence and associated sequence data in a standardized electronic eXtensible Markup Language (XML) format as a separate part of the specification. This standardized format is set forth in WIPO Standard ST.26, and applies to sequence listings in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications filed in the intellectual property offices (IPOs) of WIPO member states. As a result, a single sequence listing in compliance with WIPO Standard ST.26 can be prepared for use in all IPOs of WIPO member states.

The sequence listing part of the description must be an electronic file in WIPO Standard ST.26 XML format. Where sequences are included in a sequence listing, they are not required to also appear in the main part of the description. In the description, claims or drawings of the application, the sequences included in the sequence listing shall be referred to by the sequence identifier preceded by "SEQ ID NO:", even if the sequence is also embedded in the description, claims or drawings.

Where an international application, filed under the PCT, contains a disclosure of nucleotide and/or amino acid sequences that are required to be listed within a sequence listing, PCT Rule 5.2 requires that the description shall include a sequence listing part of the description complying with the standard provided for in the Administrative Instructions. In accordance with Section 208, any sequence listing, whether forming part of the international application or not forming part of the international application, shall comply with Annex C of the Administrative Instructions. Where applicant has not provided a sequence listing in accordance with Annex C of the Administrative Instructions and the USPTO acts as International Searching Authority (ISA) or International Preliminary Examining Authority (IPEA), the ISA/IPEA may invite applicant to furnish a sequence listing, with a late furnishing fee, under PCT Rule 13ter . This invitation will specify a time limit for a proper response. A proper response to such an invitation would include, the submission of a sequence listing in accordance with Annex C of the Administrative Instructions, the late furnishing fee specified in 37 CFR 1.445(a)(5), and a statement to the effect that the sequence listing does not go beyond the disclosure of the international application as filed. If a sequence listing compliant with WIPO Standard ST.26 has not been furnished to the ISA/IPEA within the time limit set forth in the invitation, the ISA/IPEA will only search / examine the international application to the extent that a meaningful search or examination can be performed without the sequence listing. See PCT Rule 13ter.1(d). Where the application discloses sequences that are required to be within a sequence listing, it is advisable for the applicant to submit a sequence listing compliant with WIPO Standard ST.26 XML format together with the international application on the international filing date rather than to wait for an invitation by the International Searching Authority or International Preliminary Examining Authority.

For a detailed discussion of the World Intellectual Property Organization (WIPO) Standard ST.26, see MPEP § 2412 - 2419, in particular MPEP § 2414.05.

For ease of access, WIPO Standard ST.26 can be found at: www.wipo.int/standards/en/ part_03_standards.html.

II. REQUIREMENTS FOR SEQUENCE LISTINGS UNDER WORLD INTELLECTUAL PROPERTY OFFICE STANDARD ST.25 (WIPO ST.25)

[Editor Note: This subsection is only applicable to international applications, including national phase applications, having an international filing date before July 1, 2022, that disclose one or more nucleotide and/or amino acid sequences as defined in WIPO Standard ST.25.]

Where an international application contains disclosure of a nucleotide and/or amino acid sequence, the description must contain a listing of the sequence complying with the standard specified in Annex C of the Administrative Instructions. A copy of the Administrative Instructions in force before July 1, 2022 can be found at: www.wipo.int/wipolex/en/text/584509. See MPEP § 1823.02, subsection II. If the International Searching Authority finds that an international application contains nucleotide and/or amino acid sequences in the disclosure, but finds that the description does not contain a sequence listing or that the sequence listing provided in the international application does not comply with the PCT Administrative Instructions Annex C, the International Searching Authority may invite the applicant to furnish a listing that complies with the standard and pay a late furnishing fee.

An invitation from the International Searching Authority to furnish a sequence listing that complies with the standard specified in the Administrative Instructions and pay a late furnishing fee will specify a time limit for complying with the invitation. Any sequence listing furnished by the applicant in response to the invitation must be accompanied by a statement to the effect that the listing does not include matter which goes beyond the disclosure in the international application as filed and must be submitted to the International Searching Authority. If the applicant does not furnish the required sequence listing and pay any required late furnishing fee within the time limit specified in the invitation, the search undertaken by the International Searching Authority may be limited. See MPEP § 1823.02, subsection II.

Any sequence listing provided after the international filing date and in response to the invitation to furnish a sequence listing by the International Searching Authority, is not considered part of the international application. If the applicant wishes to include such a listing as part of the international application, appropriate amendments to the description may be made later under PCT Article 34, provided that the applicant files a Demand for international preliminary examination and does not go beyond the disclosure in the international application as filed.