In applying for biotechnology-related inventions, apart from submitting to Taiwan’s IP Office (TIPO) a copy of the Specification with Claims and necessary drawings, inter alia, the applicant should also pay attention to (1) whether the claimed invention involves a sequence of nucleotides or amino acids and hence a sequence listing needs to be filed; and (2) whether it is necessary to make a domestic deposit of the involved biomaterials to meet the enabling requirement.
A recent announcement made by TIPO relating to the above requriements are summarized as follows:
1. WIPO Standard ST.26
WIPO Standard ST.25 now applies only to any and all biotechnology-related invention applicaitons filed prior to July 1, 2022, i.e. it is only necessary to submit to TIPO sequence listings in electronic TXT txt format for such cases. Following the adoption of a new standard by WIPO, starting from August 1, 2022, sequence listings in XML files prepared in accordance with WIPO Standard ST.26, rather than ST.25 standard, must be submitted with the relevant biotechnology-related invention applications in Taiwan. Although nucleotide or amino acid sequences associated with biotechnogy-related inventions are mostly referred to in the Specifications, in order to facilitate exchange of sequence information and the necessary prior art searching and analysis, the applicant is required to prepare WIPO Standard sequence listings in XML files separately and attach the same to the electronic copy of the Specification as part of the disclosure of the invention. When a foreign applicant obtains the filing date of a patent application in the original language (e.g., In English) and requests a belated submission of the Chinese Version Specification, Chinese versiion sequence listings prepared in accordance with WIPO Standard ST.26 need be filed as well. As to divisional applications, the appilcant may choose to either file sequence listings preparepd in accordance with the WIPO Standard ST.26 or sequence listings in TXT files, as is its parent application.
2. A viability statement must be indicated on the certificate of deposit as filed.
As Taiwan is not a member country to the Budapest Treaty, the effect of a deposit made in an International Depository under the Budapest Treaty is generally not recognized in Taiwan. Hence, although certain biomaterials have been deposited in an International Depository in order to meet the enabling requirement, the applicant is still required to make a corresponding deposit in a domestic depository designated by TIPO. Such domestic deposit can be exempted only when a correspoding deposit was made in the U.K., Japan or Korea with which Taiwan has signed respective reciprocity agreements in regard to deposit of biomaterials. In this regard, the certificates of deposit issued from the depository in said three countries still need to be filed within four months from the filing date or sixteen months from the earliest priority date claimed, whichever is applicable.
Further, according to the announcement, a statement of viability must be indicated on the cettificate of deposit. If a certificate of deposit does not contain a viability statement, or contains an unclear statement, the applicant shall be notified to submit a certificate of viability within the statutory period mentioned above. Otherwise, the biomaterials shall be deemed not deposited in the first place.