Sequence Listings in International Applications

Patent applications containing nucleic acid and/or protein sequences are required to include a sequence listing, typically submitted electronically as an ASCII text file. Applicants are advised to include an electronic sequence listing at the time of filing and ensure that the sequence listing is a part of the international application. However, submission at the time of filing is not always possible, and applicants should be aware of the rules and procedures when providing the sequence listing after filing. Failure to adhere to these procedures can result in serious consequences for the international application and subsequent national stage entry.¹

Sequence Listings at the Time of Filing

When filing an international application, the electronic sequence listing must be identified as part of the international application in the PCT Request (i.e., item (f) or (g) must be checked in Box No. IX of the PCT Request form). Failure to do so may have serious consequences at the national stage, especially if sequences are not otherwise disclosed in the application, as any sequences added at the national stage may be considered new matter, even if the sequence listing was provided on the international filing date.

If Sequence Listings Not Provided at the Time of Filing

If sequences are disclosed in the application, but no electronic sequence listing was filed with the application (or if a filed sequence listing did not comply with WIPO requirements), applicants will receive an Invitation to Furnish a Sequence Listing from the designated ISA. ² Typically, the Invitation sets forth a two-month period for reply. Importantly, sequence listings filed in response to the Invitation are not considered to be part of the international application, as they are considered to be furnished only as a search tool. The international application must be amended to include the sequence listing as a part of the international application.

Amendments may be made either during the international stage as Amendment under PCT Article 34,³ or during the national/regional stage as a preliminary amendment.⁴ The International Preliminary Examining Authority (if the amendments are made during the international stage) or the national/regional Office (if the amendments are made during the national stage) will determine whether the sequence listing contains new matter.

National Phase Entry

At the time of national phase entry, the international application and any sequence listing that form part of the application are communicated to each designated Office. If the sequence listing is part of the international application, there is no requirement to file the sequence listing at the time of U.S. national phase entry. If a sequence listing is filed, it must be accompanied by a statement that the sequence listing is identical to the sequence listing forming part of the international application.

If the sequence was not part of the international application, i.e., it was provided only for the purpose of searching, the International Bureau will not communicate the sequence listing to the designated Office. In this case, at the time of U.S. national phase entry, the sequence listing must be filed as a preliminary amendment, including a statement that the sequence listing does not include new matter, indication of support for the amendment, and incorporation by reference of the sequence listing in the Specification.⁵

Transfer Requests

In some cases, a “Request for Transfer of Computer Readable Form” can be used to furnish a sequence listing in a new application,⁶ allowing applicants to “transfer” a compliant electronic sequence listing from a prior-filed application to the new application. Applicants should ensure that the sequence listings in the prior-filed and the new applications are identical. Additionally, a “paper copy” of the sequence listing⁷; must be provided in the new application, along with a statement that the electronic sequence listing in the prior application and the paper copy in the new application are identical.

Submission of an electronic sequence listing is typically preferred over the transfer request, since the transfer request may cause delays in the application if there is no paper copy of the sequence listing as part of the application, if the prior application is not properly identified, or if the prior application does not actually have a compliant sequence listing on file. Thus, the transfer request is usually reserved for the relatively rare instances in which the applicant does not have access to the electronic sequence listing, for example, if the sequence listing in the prior application is not available on PAIR or PatentScope.