A “sequence listing” is required in the invention description if a patent application includes any nucleotide or amino acid sequences. A list of biological sequences with specified terms for certain properties is called a sequence listing. This includes annotations, which are brief descriptions of each sequence.
When no sequence listing has been provided for the sequences mentioned in the description, claims, or figures in a patent application, the Indian Patent Office (IPO) requires applicants to submit sequence listings in a prescribed manner. As a result, when an application is being released, information collection is made simpler. Once the application is published, these patent sequences are readily searched not just within the IPO but also in public databases.
According to Rule 9(3) of the Patents Rules, 2003, if a patent application discloses a sequence listing of nucleotides or amino acid sequences, the sequence listing of nucleotides or amino acid sequences must be filed along with the application in computer-readable text format; a print version is not necessary.
Format for sequence listings
It is preferable for sequence listings to be prepared by specialized software like PatentIn (WIPO STANDARD ST.25). As of right now, a sequence listing must follow the following format:
a. A nucleotide sequence to be listed with a maximum of 60 bases per line, with a space between each group of 10 bases.
b. The bases of a nucleotide sequence (including introns) to be listed in groups of 10 bases, except in the coding parts of the sequence.
c. Leftover bases, fewer than 10 in number at the end of non-coding parts of a sequence, to be grouped together and separated from adjacent groups by a space. The bases of the coding parts of a nucleotide sequence to be listed as triplets (codons).
This format for sequence listings is required, however, there are some problems with it. The International Nucleotide Sequence Database Collaboration (INSDC) standards are not met by the ST.25 format, which causes data loss when it is entered into public databases. Additionally, because the rules are not very explicit, different patent offices around the world have varying interpretations and applications of them.
The World Intellectual Property Organization (WIPO) has so proposed a new standard for patent applications that include sequence listings, which will go into effect on July 1, 2022, at the IPO. This new standard, WIPO ST.26, fixes problems with the current format that do not comply with the INSDC’s standards. The inclusion of some sequence types that are popular today, such as nucleotide analogs, D-amino acids, and branching sequences, is a significant change in the new standard. The ST.25 format did not cover these.
If a non-compliant sequence listing is submitted with a patent application, the applicant will have 15 months from the date of filing to submit a compliance sequence listing.
A sequence listing can also be sent to the receiving office within two months of the international filing date in order to complete an international application if it cannot be incorporated by reference. In this case, the international filing date will be the date the sequence listing was submitted.
Currently, the IPO imposes a page fee on applications that are longer than 30 pages, including pages devoted to sequence listings. This price is charged whether the listings are supplied electronically or not, even in cases with hundreds to thousands of sequence listing pages.
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