Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in patent applications are compulsory to satisfy patent office requirements for the written descriptions and disclosures that are necessary to obtain a patent for biologic products. The sequence listings are used by patent offices during examinations to search for identical or similar sequences when assessing novelty and nonobviousness of the invention sought to be patented. Sequence listings also become publicly available when a patent application is published, allowing the public to access the sequence information. This is especially important when reviewing the patent landscape for freedom to operate analyses for third-party patents.
Starting July 1, 2022, all World Intellectual Property Organization (WIPO) member patent offices, including the U.S. Patent and Trademark Office (USPTO), will transition to new sequence listing procedures that will require sequence information be provided in .xml format. Since 1992 – the first year the USPTO required a separate sequence listing – the format for sequence listings has been ASCII .txt.
The new format, designated WIPO standard ST.26, is intended to synchronize sequence listings among different patent offices and various international sequence repositories and therefore enable better sequence searches. Where ASCII .txt files are generally smaller in size and easier to interpret, XML files allow for more in-depth annotation via computer tags that also expedite structured information retrieval.
More information about the sequence listing changes is available from WIPO and can be found here. In order to comply with the new standards, WIPO has developed a software tool ("WIPO Sequence tool") that both generates and validates sequence listings. The WIPO Sequence tool can also be used to convert the previous WIPO standard ASCII ST.25 listings from .txt format to .xml format. There is no transition period in the new rules, and the ability to file a sequence listing in the previous ST.25 format will disappear as of July 1, 2022.
The new sequence listing standard will apply to any patent application filed on or after July 1, 2022, including any continuation or divisional application in which the original sequence listing had been prepared in the ST.25 ASCII .txt format. If an applicant desires to continue prosecution of an application family with a new patent filing, the preparation of the sequence listings must be made or converted to the new format. Practitioners and applicants should be aware of the extra time that may be needed to implement the new format. In addition, due to the format differences under the new rules, care also should be taken to ensure that a new matter is not being added when a sequence listing is converted to the new ST.26 format.
The sequence listing changes may also have a profound negative impact on the ease with which patent sequences from any published application can be reviewed by the public. XML files are not instantly readable and will require a dedicated display program in order to interpret the sequence input. When downloaded, XML listings will include various coding elements, and it will be necessary to upload an XML file on the WIPO Sequence tool (or another XML viewing platform) in order to decipher the information. While WIPO has indicated that Patent Cooperation Treaty (PCT) applications will have their listings available as XML files, it is not clear how individual patent offices will publish listings under the new standards. Producing a PDF copy of the XML file will most likely present a very difficult task for any practitioner or applicant because there is no way to convert the file via the WIPO Sequence tool.
These changes are significant and will impact the accessibility and ease with which applicants and practitioners alike approach the preparation and analysis of sequence listings. Life sciences patentees are encouraged to seek input from counsel to discuss the sequence listing changes in order to ensure compliance with the new rules.
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
© Morrison & Foerster LLP. All rights reserved