Sequence Listings

October 9, 2007

This practice notice is intended to provide guidance on current Canadian Intellectual Property Office (CIPO) practice and interpretation of relevant legislation and should not be quoted as, or considered to be, a legal authority. In the event of any inconsistency between this notice and the applicable legislation, the legislation must be followed. It is the responsibility of the applicant/patentee to decide how to proceed with respect to a particular application or other matter.

Rules amending the Patent Rules were published in the Canada Gazette, Part II, Vol. 141, No. 10 , on May 16, 2007, and came into force on June 2, 2007. Within this new rules package, there were a number of changes regarding the format of sequence listings. This practice notice attempts to clarify the amendments and considers the impact these changes will have on stakeholders.

Within these new rules significant changes were implemented regarding the format of sequence listings. The amendment brings the Canadian format for submitting sequence listings in line with the Patent Cooperation Treaty (PCT) standard by referencing the latter in the Patent Rules. The advantage of using the reference technique is that the Canadian standard will automatically change whenever the PCT standard changes, thereby ensuring that our standard is always in keeping with the international standard and reducing the regulatory burden for applicants. Specifically, sections 111-131 were repealed and replaced with new section 111 which reads:

111.

  1. If an application contains disclosure of a nucleotide or amino acid sequence other than a sequence identified as forming a part of the prior art, the description shall contain, in respect of that sequence, a sequence listing in electronic form, and both the sequence listing and the electronic form shall comply with the PCT sequence listing standard
  2. If an application originally filed without a sequence listing is amended to include a sequence listing, the applicant shall file a statement to the effect that the listing does not go beyond the disclosure in the application as filed.
  3. If a sequence listing initially filed in paper form or in an electronic form that does not comply with the PCT sequence listing standard is replaced by a sequence listing in an electronic form that does comply with that standard, the applicant shall file a statement to the effect that the replacement listing does not go beyond the disclosure in the application as filed.

PCT sequence listing standard is defined in section 2 of the Patent Rules and reads as follows:

"PCT sequence listing standard" means the Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings in International Patent Applications under the PCT provided for in the Administrative Instructions under the Patent Cooperation Treaty;

Further information regarding the PCT sequence listing standard can be found as standard 25 (Annex C) in the administrative instructions online.

The new rules also contain a transitional provision for those applications that were filed prior to June 2, 2007. New transitional provision 43 reads as follows:

43. In respect of applications filed before the coming into force of these Rules, the applicant may substitute the requirements of sections 111 to 131 of the Patent Rules as they read immediately before the coming into force of these Rules for the requirements of section 111 of the Patent Rules.

Applicants should clearly indicate the choice of Rules to apply in a covering letter and comply accordingly.

The intent of new Rule 111(1) is to require that the sequence listing be present only in an electronic form. Therefore, when a sequence listing submitted in accordance with subsection 111(1) of the Patent Rules is part of an application of record in the Office, it is not permissible for a paper copy of the sequence listing to also be part of that application. Applicants will be requisitioned to withdraw any paper copy of a sequence listing for which a PCT sequence listing standard compliant electronic sequence listing has been made of record.

The office recognizes that there is currently no means for the public to easily access the electronic form of the sequence listing from CIPO. However, our IT team is actively working on making the electronic sequence listings publicly available on the Canadian Patent Database (CPD). Once available on the CPD clients will be able to view the complete sequence listing online. CIPO wants to assure our clients that sequence listings will be available online on the CPD in a near future. In the meantime, the sequence listings are available for public inspection, once an application is laid open, upon request at CIPO.

If you have questions regarding the format for sequence listings please contact Doug Lloyd at 819-639-5185.

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