If an international patent application discloses a sequence of four or more amino acids or 10 or more nucleotides that is not identified as being in the prior art, then a sequence listing that complies with WIPO Standard ST.25 must be filed in the Canadian national phase.
Paper and computer readable copies of the sequence listing must be filed by the later of 36 months from the earliest priority date or six months after national entry. Unfortunately, the Canadian Patent Rules state that the application is deemed to be abandoned if the sequence listing requirements are not completed by this date.
The Canadian Patent Office often fails to review applications for compliance with formal requirements within the above-mentioned time period. As a result, the first communication received from the Patent Office concerning the sequence listing requirements may be a Notice of Abandonment for failure to file a sequence listing.
The abandoned application can be reinstated by filing the sequence listing, requesting reinstatement, and paying a $200 government fee within one year of the date of abandonment. If the one-year deadline passes without reinstatement, the application can not be revived for any reason.
It is not known what the Patent Office would do if the failure to comply with the sequence listing requirements were identified only after the expiry of the one-year reinstatement period after the date of deemed abandonment. If it followed its current practices consistently, the Patent Office should declare such an application to be irrevocably abandoned. We do not know if the Patent Office would take this drastic step during examination, but the issue might well be raised during litigation over the validity of a patent issuing on the application.
Moreover, because the Rules speak of deemed abandonment for failure to comply with the sequence listing requirements, an application could be considered abandoned even if the Patent Office never raises the sequence listing requirements during prosecution.
We expect that this anomaly in the Canadian Patent Rules will be corrected in the next amendments to the Rules. But we cannot predict when such corrective amendments will be made, or if they will be of retroactive effect. In the meantime, it is incumbent on applicants entering the national phase in Canada to alert their Canadian agent to the presence of nucleotide or amino acid sequences in the international application.