In applying for biotechnology-related inventions, apart from submitting to the Taiwan Intellectual Property Office a copy of the specification with claims and necessary drawings, inter alia, the applicant should also pay attention to:
Whether the claimed invention involves a sequence of nucleotides or amino acids and hence a sequence listing needs to be filed; and
Whether it is necessary to make a domestic deposit of the involved biomaterials to meet the enabling requirement.
An announcement in July 2022 by TIPO relating to the above requirements is summarised as follows.
WIPO Standard ST.26 WIPO Standard ST.25 now only applies to any and all biotechnology-related invention applications filed before July 1 2022; i.e., it is only necessary to submit TIPO sequence listings in electronic 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 the 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 (for example, In English) and requests a belated submission of the Chinese version specification, Chinese version sequence listings prepared in accordance with WIPO Standard ST.26 need to be filed as well.
With regard to divisional applications, the applicant may choose to file sequence listings prepared in accordance with WIPO Standard ST.26 or sequence listings in TXT files, as is its parent application.
Viability statement
As Taiwan is not a member country of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, the effect of a deposit made in an international depository under the treaty is generally not recognised in Taiwan. Hence, although certain biomaterials have been deposited in an international depository to meet the enabling requirement, the applicant is still required to make a corresponding deposit in a domestic depository designated by TIPO.
A domestic deposit can be exempted only when the international deposit was made in the UK, Japan, or South Korea, with which Taiwan has signed respective reciprocity agreements with regard to the depositing of biomaterials. In this respect, the certificates of deposit issued from the depository in the above three countries still need to be filed within four months from the filing date or 16 months from the earliest priority date claimed, whichever is applicable.
Furthermore, according to the announcement, a statement of viability must be indicated on the certificate 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.
