Important notice of 24 June 2022
on the entry into force of the Ordinance Amending the Patent Ordinance and the Utility Model Ordinance Concerning Nucleotide and Amino Acid Sequence Listings (Verordnung zur Änderung der Patentverordnung und der Gebrauchsmusterverordnung im Hinblick auf Nukleotid- und Aminosäuresequenzprotokolle) of 14 June 2022
On 1 July 2022, the Ordinance Amending the Patent Ordinance and the Utility Model Ordinance Regarding Nucleotide and Amino Acid Sequence Listings of 14 June 2022 Federal Law Gazette I, p. 878 will enter into force.
This ordinance will amend the requirements of the Patent Ordinance for the filing of sequence listings and, for the first time, incorporate provisions on sequence listings into the Utility Model Ordinance. In particular, in order for the form to be valid, a sequence listing relating to a patent or utility model application filed on or after 1 July 2022 must be filed as an electronic document in XML.
The reason for the amendment is the new international WIPO Standard ST.26 for the presentation of nucleotide and amino acid sequence listings using XML (eXtensible Markup Language). WIPO Standard ST.26 modernises and specifies the requirements as to the content and form of a sequence listing and replaces the current WIPO Standard ST.25 for the presentation of nucleotide and amino acid sequence listings in patent applications. In particular, WIPO Standard ST.26 provides that the uniform format for sequence listings is the presentation as a single file in XML using the document type definition (DTD) set out in the standard. To generate sequence listing files in ST.26 format, WIPO provides the software “WIPO Sequence”, which can be downloaded from the WIPO website free of charge.
1. Amendment of the Patent Ordinance
To implement this international standard, the new requirements for the filing of sequence listings will be provided in sections 11 to 11b of the Patent Ordinance in the future. Annex 1 to the Patent Ordinance, which has essentially implemented WIPO Standard ST.25 so far, will be repealed.
Section 11 (1) of the Patent Ordinance will define in the future which nucleotide and amino acid sequences will have to be included in a sequence listing. If such nucleotide or amino acid sequences are disclosed in a patent application, the description must include, along with the main section of the description (section 10 of the Patent Ordinance), a sequence listing as a separate part.
Pursuant to section 11 (2) of the Patent Ordinance, such a sequence listing must comply with the standard for the presentation of nucleotide and amino acid sequence listings using XML as amended, published by the DPMA in the Federal Gazette.
The requirements of this standard, published by the DPMA in the Federal Gazette, are consistent with the internationally agreed WIPO Standard ST.26.
The standard for the presentation of nucleotide and amino acid sequence listings using XML pursuant to section 11 (2) of the Patent Ordinance will be published in the Federal Gazette (www.bundesanzeiger.de) in June 2022. The standard is also available on the Website of the DPMA.
The standard published by the DPMA in the Federal Gazette is divided into a main body document and seven annexes. The key provisions on the content and form of a sequence listing are contained in the main body document and in Annexes I, II and IV. Annex III contains a link to a sequence listing specimen. In addition, Annex VI contains a detailed guidance document on how to apply the standard, illustrating the application of the standard by a number of examples. Finally, Annex VII contains recommendations on how to transform a sequence listing compliant with the current requirements (section 11 in conjunction with Annex 1 to the Patent Ordinance in the version valid until 30 June 2022; WIPO Standard ST.25) to a sequence listing compliant with the new requirements (sections 11 to 11b of the Patent Ordinance in the version valid as of 1 July 2022; WIPO Standard ST.26).
The standard provides which sequences must be included in a sequence listing and – as opposed to such mandatory inclusions – which sequences must not be included. In particular, the standard also considers sequence types such as linear regions of branched sequences, D-amino acids and nucleotide analogues.
The standard provides that the uniform format for sequence listings is the presentation as a single file in XML using the document type definition (DTD) set out in Annex II to the standard. Accordingly, by way of derogation from section 3 sentence 1 of the Patent Ordinance, a sequence listing relating to an application filed on or after 1 July 2022 must be filed as an electronic document in XML in order for the form to be valid. Sequence listings can no longer be validly filed as paper or PDF documents, for example. We recommend that sequence listings be filed using the e-filing systems of the DPMA. However, sequence listings are also accepted if stored on data carriers. This is again emphasised by section 11a (1) of the Patent Ordinance, which also refers to the fact that the provisions of the Ordinance on Electronic Legal Transactions with the DPMA (Verordnung über den elektronischen Rechtsverkehr beim Deutschen Patent- und Markenamt) are decisive for the filing of this electronic document.
As regards the content of the sequence listing, the standard provides that the sequence listing must consist of a general information part and a sequence data part.
The general information part is used for the association of the sequence listing to the relevant patent application and essentially contains bibliographic information of that patent application.
The sequence data part contains detailed information about the individual sequences. The information to be given using the elements and attributes provided for by the standard includes, among other things, the length and molecule type of the sequence, the sequence itself and the features of the sequence or individual regions or locations in the sequence. The standard also contains precise requirements for presenting modified nucleotide and amino acid sequences, coding sequences and variants.
With regard to the language, too, the standard largely determines the terminology to be used in the sequence listing. However, the language requirements of the standard are not exhaustive with regard to the description of the invention to be made in the general information part and the language-dependent free text contained in the sequence data part. In this respect, section 11a (2) and (3) of the Patent Ordinance provides that the title of the invention and the language-dependent free text must be written in the German language. In addition, the title of the invention can also be indicated in other languages. The language-dependent free text can additionally be written in the English language.
In addition, section 11a (4) of the Patent Ordinance provides how to file the translation of a sequence listing.
Ultimately, section 11b of the Patent Ordinance sets out the requirements for changing the sequence listing and for changing the description by filing a sequence listing subsequently.
2. Amendment of the Utility Model Ordinance
Since nucleotide or amino acid sequences that must be included in a sequence listing in accordance with the corresponding provisions set out in the Patent Ordinance are also disclosed in some utility model applications, sequence listing provisions are also incorporated into the Utility Model Ordinance. In this respect, section 6 (4) of the Utility Model Ordinance provides that sections 11 to 11b of the Patent Ordinance will apply accordingly in the future.
3. Entry into force
The new requirements will apply to all patent and utility model applications filed with the DPMA on or after the date of entry into force of the amending ordinance on 1 July 2022 (see section 22 of the Patent Ordinance, section 11 of the Utility Model Ordinance). The new requirements will also apply to applications filed on or after 1 July 2022 that claim the priority of an application filed before 1 July 2022 which, because of its date of filing, contains a sequence listing pursuant to the provisions applicable until 30 June 2022. The new requirements will also apply to divisional applications even if the parent application has been filed before 1 July 2022.
Important: With respect to patent and utility model applications filed with the DPMA before 1 July 2022 and the following procedures, the provisions continue to apply in the version applicable until 30 June 2022. As a result, a sequence listing filed in relation to an application filed before 1 July 2022 must still meet the requirements set out in section 11 in conjunction with Annex 1 to the Patent Ordinance in the version applicable until 30 June 2022 even if the sequence listing is filed after 1 July 2022.
4. "WIPO Sequence"
To generate sequence listing files in ST.26 format, WIPO provides the software "WIPO Sequence", which can be downloaded on the WIPO website free of charge. For additional information on this software and on training and information offered by WIPO concerning the new requirements, please see issue 3/2022 of the DPMA newsletter (in German).
Last updated: 24 June 2022