[Editor Note: The PCT Rules and Administrative Instructions reproduced in this section are applicable to international 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/.]

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

[Editor Note: This subsection is applicable to all international applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in WIPO ST.26.]

Patent applications that contain disclosures of nucleotide and/or amino acid sequences, as defined in WIPO ST.26 must present the associated biological sequence data in a standardized electronic eXtensible Markup Language (XML) format, or a “Sequence Listing XML” as a separate part of the specification. In particular, World Intellectual Property Organization (WIPO) Standard ST.26 permits applicants to submit a single, internationally acceptable sequence listing in a language-neutral format using specified International Nucleotide Sequence Database Collaboration (INSDC) identifiers in international applications filed under the Patent Cooperation Treaty (PCT) and in national and regional applications 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 the IPOs of WIPO member states.

Where an international application, filed under the PCT, contains a disclosure of nucleotide and/or amino acid sequences, the description shall include a sequence listing part of the description complying with the standard provided for in Annex C of the Administrative Instruction. However, 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) for, 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 XML” accordance with Annex C of the Administrative Instructions, the late furnishing fee in 37 CFR 1.445(a)(5), and a statement that the information recorded does not go beyond the disclosure in the international application as filed. If a compliant “Sequence Listing XML” has not been furnished to the ISA/IPEA within the time limit set forth in the invitation, the ISA/IPEA will only search and examine the international application to the extent that a meaningful search or examination can be performed without the “Sequence Listing XML.” It is advisable for the applicant to submit a listing of the sequence in WIPO Standard ST.26 XML format, if such a listing is required by the competent International Searching Authority or International Preliminary Examining Authority, together with the international application 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, seeMPEP §§ 2412 – 2419, in particular MPEP § 2414.05.

For ease of access, WIPO Standard ST.26 can be found at: www.wipo.int/export/sites/www/ standards/en/pdf/03-26-01.pdf.

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 having an international filing date before July 1, 2022, disclosing one or more nucleotide and/or amino acid sequences.]

Where an international application discloses one or more nucleotide and/or amino acid sequences, the description must contain a sequence listing complying with the standard specified in the Administrative Instructions. A copy of the Administrative Instructions in force before July 1, 2022 can be found at: www.wipo.int/export/sites/ www/pct/en/texts/pdf/ai_22.pdf . The standard is set forth in detail in Annex C – Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings in International Patent Applications Under the PCT. The standard allows the applicant to draw up a single sequence listing which is acceptable to all receiving Offices, International Searching and Preliminary Examining Authorities for the purposes of the international phase, and to all designated and elected Offices for the purposes of the national phase.

Under PCT Rule 5.2(a), the sequence listing must always be presented as a separate part of the description. When filing an international application (PCT) using EFS-Web, the sequence listing part of the description may be submitted either as a single ASCII text file with a “.txt” extension (e.g., “seqlist.txt”) or as a PDF file. Note that 100 megabytes is the size limit for submitting a sequence listing text file via EFS-Web.

A single ASCII text file will serve both as the sequence listing part of the description under PCT Rule 5.2 and the electronic form under PCT Rule 13ter.1(a) in the absence of a PDF sequence listing file. The check list of the PCT Request (PCT/RO/101) provided via EFS-Web together with the international application (PCT) must indicate that the sequence listing forms part of the international application. Furthermore, the statement as set forth in paragraph 4(v) of the AI Annex C (Administrative Instructions under the PCT, Annex C), that “the information recorded in electronic form furnished under PCT Rule 13ter is identical to the sequence listing as contained in the international application,” is not required.

Submission of the sequence listing part of the description in a PDF file is not recommended because the applicant would also be required to supply a copy of the sequence listing in an ASCII text file to the appropriate authority for purposes of international search and/or international preliminary examination in accordance with paragraph 40 of AI Annex C. When a sequence listing is filed via EFS-Web in a new PCT international application in both a PDF file and an ASCII text file, but the Request form Box No. IX does not indicate which one forms part of the international application, the PDF copy of the sequence listing will be considered to form part of the application and the ASCII text file will be considered an accompanying item for search purposes under PCT Rule 13ter.1(a) only.

In cases where a sequence listing does not meet the necessary requirements, such as it has been submitted in PDF format or .txt file does not comply with Annex C, the International Searching Authority and the International Preliminary Examining Authority may invite the applicant to furnish, within a fixed time limit, a sequence listing complying with the required standard. The invitation may also, in accordance with PCT Rule 13ter.1(c), request the payment of a late furnishing fee. Where such an invitation has been issued, the sequence listing and late fee must be submitted to the International Searching Authority or the International Preliminary Examining Authority. It is advisable for the applicant to submit a listing of the sequence in electronic form (text), if such a listing is required by the competent International Searching Authority or International Preliminary Examining Authority, together with the international application rather than to wait for an invitation by the International Searching Authority or International Preliminary Examining Authority.

The electronic form (text) is not mandatory in international applications to be searched by the United States International Searching Authority or examined by the United States International Preliminary Examining Authority. However, if an electronic form (text) of a sequence listing is not provided, a search or examination will be performed only to the extent possible in the absence of the electronic form (text). The U.S. sequence rules (37 CFR 1.821 – 1.825) and the PCT sequence requirements are substantively consistent. In this regard, full compliance with the requirements of the U.S. rules will generally ensure compliance with the applicable PCT requirements. However, the requirements of 37 CFR 1.821 through 37 CFR 1.825 are less stringent than the requirements of WIPO Standard ST.25. See MPEP § 2422, subsection II, MPEP § 2422.03(a), subsection IV, and MPEP § 2422.07 for information specific to filing sequence listings in international applications.

For a detailed discussion of the U.S. sequence rules, see MPEP §§ 2420 – 2429.

The calculation of the international filing fee for an international application (PCT), including a sequence listing, filed via EFS-Web is determined based on the type of sequence listing file. A sequence listing filed in an ASCII text file will not be included in the sheet count of the international application (PCT). A sequence listing filed in a PDF file will be included in the sheet count of the international application (PCT). Therefore, the sheet count for an EFS-Web filed international application (PCT) containing both a PDF file and a text file sequence listing will be calculated to include the number of sheets of the PDF sequence listing.