Newsletter
Existing Status of Deposits of Patented Biological Materials under the Revised Patent Act
Article 27 of the revised Patent Act, which came into effect on January 1, 2013, concerns applications for invention patent that involve biological materials or the use of biological materials. It provides that: "An applicant shall, within four (4) months after the filing date of patent application, submit to the Specific Patent Agency a certificate of deposit, indicating the depository, date of deposit and deposit number. If such document is not submitted within the specified time period, the deposit shall be deemed not to have been made." Compared with the pre-amendment Patent Act, the deadline for submission of certificate of deposit has been extended from 3 months to 4 months.
In conjunction with the revisions to the Patent Act, the certificate of deposit of biological materials now includes "certificate of deposit" and "certificate of viability." No separate certificates will be issued for each as required under the old system. An advantage of merging the certificates is consistency with international practice. Internationally, most depository institutions recognized by the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure adopt a merged-certificate system. Thus, the merger of certificates in Taiwan will be beneficial to its position during any related negotiations with other countries.
Since the implementation of merged certificates, the Food Industry Research & Development Institute ("FIRDI") has been making coordinated efforts to expedite implementation of the new system by completing viability tests within as short a time as possible, so that patent applicants can submit certificates within the 4 month deadline stipulated in Article 27 of the Patent Act. For the majority of biological materials, the FIRDI is able to complete viability testing and issue certificates to the satisfaction of general users. However, for special biological materials or those which are sensitive to their environment such as viruses or special cell strains, there have been instances in which viability testing could not be completed in time to verify the status of deposit. This in turn meant the applicants were unable to submit certificates of deposit within the mandatory 4 month deadline. In order to protect applicants' rights, one suggestion would be to cite "other cause(s) not attributable to the applicant" provided under Article 17 of the Patent Act, and for the applicants to give written explanation to the TIPO within 30 days of the extinguishment of such causes for restoration of status.