06.14.2024
Proposed Amendments to the Patent Examination Guidelines
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In the recently proposed draft amendments to the Patent Examination Guidelines, the Taiwan Intellectual Property Office (TIPO) specified additional details about (a) the calculation of patent term extension when the document of proof evidencing the date of receiving the Notice for Collecting the Approval is not available and (b) who qualifies as an interested party in patent invalidation.
(a) Calculation of Patent Term Extension
For patents relating to pharmaceutical inventions, if a regulatory approval shall be obtained in accordance with the Pharmaceutical Affairs Act or the Rare Disease and Orphan Drug Act for the exploitation of the patent, the patentee may apply for a patent term extension for the period in which the inventions cannot be exploited due to the absence of a regulatory approval.
According to the Patent Examination Guidelines, the period from the day after the date of receiving the Notice for Collecting the Approval to the day of actually collecting the approval should be deducted from the term to be extended. Therefore, the patentee should submit a document of proof regarding the date of receiving the Notice for Collecting the Approval.
In the draft amendments proposed by the TIPO, it is specified that if such document of proof is not available, the TIPO may presume that the Notice for Collecting the Approval is received on the day after the Taiwan Food and Drug Administration issues the Notice. However, if the applicant of the regulatory approval collects the Notice in person on the issuance date, the issuance date would be deemed as the receipt date.
(b) Interested Party in Patent Invalidation
According to the Patent Act, if a patent is not filed by all the joint owners or the patentee is not the owner of the right to apply for the patent, an invalidation on these grounds can only be filed by an interested party.
In the draft amendments proposed by the TIPO, an interested party is specified as a legally interested party, i.e., a party whose rights or legal benefits are directly impaired due to the controversy of the patent right or the right to apply for a patent. If the invalidation petitioner provides a document of proof to establish such interest, as long as the patentee does not argue against it and the examiner does not foresee any problems, it is unnecessary to investigate the existence of such interest. However, if the patentee doubts the existence of the interest, in principle, an investigation would be required to make a formal decision.
(Elaborated based on the news published by the TIPO.)
* Section Chief of International Patent Division at Tai E International Patent & Law Office
(a) Calculation of Patent Term Extension
For patents relating to pharmaceutical inventions, if a regulatory approval shall be obtained in accordance with the Pharmaceutical Affairs Act or the Rare Disease and Orphan Drug Act for the exploitation of the patent, the patentee may apply for a patent term extension for the period in which the inventions cannot be exploited due to the absence of a regulatory approval.
According to the Patent Examination Guidelines, the period from the day after the date of receiving the Notice for Collecting the Approval to the day of actually collecting the approval should be deducted from the term to be extended. Therefore, the patentee should submit a document of proof regarding the date of receiving the Notice for Collecting the Approval.
In the draft amendments proposed by the TIPO, it is specified that if such document of proof is not available, the TIPO may presume that the Notice for Collecting the Approval is received on the day after the Taiwan Food and Drug Administration issues the Notice. However, if the applicant of the regulatory approval collects the Notice in person on the issuance date, the issuance date would be deemed as the receipt date.
(b) Interested Party in Patent Invalidation
According to the Patent Act, if a patent is not filed by all the joint owners or the patentee is not the owner of the right to apply for the patent, an invalidation on these grounds can only be filed by an interested party.
In the draft amendments proposed by the TIPO, an interested party is specified as a legally interested party, i.e., a party whose rights or legal benefits are directly impaired due to the controversy of the patent right or the right to apply for a patent. If the invalidation petitioner provides a document of proof to establish such interest, as long as the patentee does not argue against it and the examiner does not foresee any problems, it is unnecessary to investigate the existence of such interest. However, if the patentee doubts the existence of the interest, in principle, an investigation would be required to make a formal decision.
(Elaborated based on the news published by the TIPO.)
* Section Chief of International Patent Division at Tai E International Patent & Law Office
