For some inventions in the field of biotechnology, particular biological materials, such as vectors, bacteria or hybridomas, are indispensable to carry out the invention. The Budapest Treaty provides a common platform for applicants to deposit the required biological materials to be furnished by a third party from the members of the treaty. However, since Taiwan is not a member of the Budapest Treaty, a deposit made with an international depository recognized under the Budapest Treaty may not constitute a basis to circumvent the statutory deposit requirement in Taiwan. According to Article 27 of the Patent Act and the Patent Examination Guidelines in Taiwan, there are four scenarios with regard to the deposit of biological materials as illustrated and summarized below.

Scenario 1: No deposit is required

No deposit is required for easily obtainable biological materials. Based on the Patent Examination Guidelines, biological materials meeting one of the following criteria are deemed easily obtainable.

a) They are commercially available to the public.
b) They have been deposited at any depository that carries public confidence and were unconditionally available to the public for furnishing samples prior to filing the patent application.

 

A deposit made with the international depositories recognized under the Budapest Treaty may constitute a basis to circumvent the statutory deposit requirement only if samples of the deposited biological material are commonly (i.e. unconditionally) available to the public (even for a person from a country which is not a member of the Budapest Treaty) for furnishing from the international depositories prior to filing the patent application and hence is deemed easily obtainable by a person having ordinary skill in the art.

For instance, according to Rule 11.3(b) of the Regulations Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, in respect of patents granted and published by any industrial property office, such office may from time to time communicate to any international depositary authority lists of the accession numbers given by that authority to the deposits of the microorganisms referred to in the said patents. The international depositary authority shall, on the request of any authority, natural person or legal entity, furnish to it a sample of any microorganism where the accession number has been so communicated. In respect of deposited microorganisms whose accession numbers have been so communicated, the said office shall not be required to provide the certification referred to in Rule 11.3(a). In other words, after the grant and publication of a patent and the communication of the accession number, the biological materials should be deemed unconditionally available.

c) They can be produced by a person having ordinary skill in the art without undue experimentation based on the contents disclosed in the specification. For instance, peptide molecules are generally considered easily obtainable if the amino acid sequences are provided.

Scenario 2: No local deposit is required

Currently, Taiwan recognizes the effects of deposits with depositories designated by Japan and the United Kingdom based on reciprocity. Therefore, local deposit is exempted for biological materials which have been deposited in any one of the following depositories prior to the filing of the patent applications.

International Patent Organism Depositary (IPOD) of the National Institute of Technology and Evaluation (NITE) (JP)

• NITE Patent Microorganisms Depositary (NPMD) (JP)
• CABI Bioscience, UK Centre (IMI) (UK)
• Culture Collection of Algae and Protozoa (CCAP) (UK)
• European Collection of Cell Cultures (ECACC) (UK)
• National Collection of Type Cultures (NCTC) (UK)
• National Collection of Yeast Cultures (NCYC) (UK)
• National Collections of Industrial, Food and Marine Bacteria (NCIMB) (UK)
• National Institute for Biological Standards and Control (NIBSC) (UK)

 

With the prospective reciprocal agreements between Taiwan and other countries, there should be more depositories on the whitelist in the future.

Scenario 3: Local deposit is required

For biological materials which are not easily obtainable but have been deposited with a foreign depository recognized by the Intellectual Property Office (TIPO), e.g. depositories recognized under the Budapest Treaty, other than those discussed in Scenario 2 above prior to the filing of the patent application, local deposit is required. The local deposit may be made after the filing of the patent application. However, as further discussed below, the certificate of deposit has to be submitted to TIPO within four months after the filing date of the patent application (or within sixteen months after the earliest priority date if priority is claimed).

Scenario 4: Local deposit is required by the filing date

For biological materials which are not easily obtainable and have not been deposited with a foreign depository recognized by TIPO prior to the filing of the patent application, local deposit has to be made by the filing date of the patent application.

In Scenarios 2-4 above, the certificates of deposit issued by the foreign depositories and/or the domestic depositories must be submitted to TIPO within four months after the filing date of the patent application (or within sixteen months after the earliest priority date if priority is claimed). Therefore, the time frame is another important issue with regard to the deposit of biological materials.

For most Taiwan applications requiring biological materials and filed by foreign applicants, the required biological materials have been deposited with depositories recognized under the Budapest Treaty. However, if the depositories are not those designated in Japan and the UK, presently, local deposits of biological materials cannot be exempted. Therefore, in the following, the focus will be on the time frame for Scenario 3.

Time frame for Scenario 3

Based on Article 27, Paragraphs 2 and 3 of the Patent Act, if the deposit of biological material is required for a patent application, the applicant shall, within four months after the filing date of patent application (or within sixteen months after the priority date), submit to TIPO a certificate of deposit, indicating the depository, date of deposit and deposit number. In local practices, the certificate of deposit will be issued only after the viability of the sample is tested. In other words, arrival of the biological materials at the domestic depository within four months after the filing date (or within sixteen months after the priority date) does not meet the statutory requirement of local deposit.

If everything goes smoothly, it usually takes two to three months to complete the depositary procedures prior to the issuance of a deposit certificate in Taiwan (including the preparation and review of the application documents, request(s) for import permit(s) from relevant authorities and the examination for request(s), sample delivery, viability test, etc.), which, considering the period for the applicant to submit the deposit certificate (four months from the filing date), results in a considerably narrow time frame.

Besides, there are many uncertainties before the issuance of the deposit certificates. For instance, if the biological materials are on the monitoring list specified by the relevant authorities, the authorities may arrange a visit to confirm the safety measurements of the laboratory/storage space at the domestic depository and/or require quarantine inspection of the samples. These unexpected procedures will prolong the period to obtain the deposit certificates.

To sum up, if local deposit is required for the biological materials in a patent application, the applicant should pay attention to the time frame/progress for the deposit of the biological materials and provide relevant documents as early as possible.