On November 20 2014 Taiwan and Japan signed a memorandum of understanding regarding cooperation on the deposit of biological materials in relation to patent procedure. The purpose of the memorandum was to eliminate the need for patent applicants to make duplicate deposits in each country. To implement a framework for Taiwan-Japan biological material deposit cooperation, on May 14 2015 the Taiwan Intellectual Property Office (TIPO) announced draft guidelines on Taiwan-Japan cooperation on deposit of biological materials in relation to patent procedure.
Taiwan is not a signatory to the Budapest Treaty and as such does not enjoy mutual recognition of foreign depository institutions. Article 27 of the Patent Act requires an applicant filing a patent application for an invention involving a biological material to make a deposit of the biological material with the Bio-resource Collection and Research Centre under the Food Industry Research and Development Institute no later than the filing date. No deposit is required if the biological material involved is easily obtainable by a person with ordinary skill in the particular field in question. Article 27 also provides that if biological material concerned has been deposited in a foreign depository recognised by the patent authority before filing the patent application, the applicant is exempt from the requirement of making a deposit no later than the filing date of the application. Therefore, even if before filing an application the biological material has been deposited with an international depository institution recognised by the Budapest Treaty, it should still be deposited with a depository institution in Taiwan in compliance with the Patent Act.
With respect to deposit of biological materials in Taiwan, Article 27(5) of the act provides that:
"If an applicant has deposited the biological material in a depository designated by a foreign country in its territory with which [Taiwan] recognises the effects of deposits based on reciprocity, and if the applicant has submitted the certificate(s) of deposit issued by the said foreign depository, the applicant is exempted from the requirement of making a deposit in the [Taiwan]."
Following the signing of the memorandum, which removes the need to make duplicate deposits of biological materials in both Taiwan and Japan, TIPO released its draft guidelines, the most salient provisions of which are as follows:
- Clarification is given regarding the scope of effectiveness of mutual recognition of deposits as a result of cooperation between Taiwan and Japan and the depository institution designated by the patent authority.
- As designated depositories are unable to distribute samples of deposit biological material, provisions are made with respect to:
- the procedure for re-submission;
- the subject that performs the submission;
- requirements to the effect that the original deposit date is regarded as the deposit date; and
- exceptions which disallow re-submission.
- Requirements are stipulated for restrictions regarding the import and export of biological materials.
- Qualifications are described for designated depository institutions.
- Requirements are defined for the relevant patent authority to ensure transfer of biological materials and complementary measures to be taken by it upon the designated depository institution ceasing the execution of its assignment.
- Provisions are indicated for handling by the patent authority on the designated depository's refusal to accept a deposit of a particular type of biological material.
- It is effectively stipulated that applications for the deposit of biological materials, the re-submission procedure and the deposit of biological materials are irrevocable.
- Grounds for refusal by a depository institution to accept a deposit of biological materials and process such a submission are established.
- The duration of the deposit of biological materials with a designated depository institution and confidentiality regulations are defined.
- Qualifications are provided for the sub-licensing of biological materials and the procedure for sub-licensing by applicants with different qualifications.
On implementation of the guidelines, patent applicants with biological material inventions can follow these provisions to avoid making duplicate deposits of such materials in Taiwan and Japan.
For further information on this topic please contact Kate Shu-Yin Chu at Lee and Li Attorneys at Law by telephone (+886 2 2715 3300) or email (firstname.lastname@example.org). The Lee and Li website can be accessed at www.leeandli.com.