What You Need to Know: Sequence Listing Requirements in Canada
To match the requirements of the Patent Cooperation Treaty (PCT), Canada’s Patent Rules on biological sequence listings were changed on June 2, 2007. The changes included amending how sequence listings are formatted. This applies retroactively to patent applications filed before June 2, 2007. For patent applications filed before June 2, 2007 a patent applicant can still elect to follow the old rules. Section 111(1) of the Patent Rules is new; sections 111-131 were repealed.
Here are some points concerning these rule changes:
- Sequence listings forming part of patent applications filed in Canada on or after June 2, 2007 must be submitted in electronic format. If a patent application is filed along with a paper copy of a sequence listing, the Patent Office will request withdrawal of the paper copy.
- If an application originally filed without a sequence listing is amended to include one, the applicant needs to state that the listing does not go beyond the disclosure in the application as filed. Our professionals here at Kirby IP Canada can prepare an appropriate statement for you.
- A sequence listing initially filed in paper or electronic form that does not comply with the PCT sequence listing standard can be replaced with an electronic form that does comply. In this case, however, the applicant needs to state that the replacement listing does not introduce new matter. Again, Kirby IP can prepare an appropriate statement for you.
- The PCT format for sequence listings is in the WIPO Handbook on Industrial Property Information and Documentation, Standard ST.25 (Annex C). Many patent applicants are familiar with this format; below are some points specific to Canadian listings.
- It is still unnecessary to provide sequences that form part of the prior art.
- A sequence listing is required if the application discloses an unbranched sequence of four or more amino acids or an unbranched sequence of ten or more nucleotides.
- Consistent with PCT standards, the Canadian Intellectual Property Office accepts sequence listings generated using PatentIn® software.
If the sequence listing has already been generated for a corresponding foreign application (e.g., the priority application), it will include data elements that precede the actual nucleotide or amino acid sequence. Mandatory data are listed in paragraph 25 of the PCT standard:
|<120>||Title of invention|
|<160>||Number of SEQ ID NOs|
|<210>||SEQ ID NO: x|
If the patent application number is not yet assigned, a file reference should be included as <130>.
When a patent application number is assigned, the data elements <140> and <141> may need to be added and populated with the application number and the filing date. Also, the earlier application to which the Canadian application claims priority and its filing date may need to be introduced as data elements <150> and <151>.
We are here to help
Kirby IP Canada can help you prepare your sequence listing or amendment using PatentIn® software, specified in PCT standards. We can also advise you on best practices, such as including the sequence listing in the text of your patent specification.