Newsletter
TIPO Promulgated the Draft Amendments of Article 4 and Article 10 of the "Regulations Governing the Determination of Patent Term Extension"
Paragraph 1 of Article 53 of the Patent Act provides that, where a regulatory approval is required for the exploitation of an invention patent involving a pharmaceutical or agrichemical, or the manufacturing process thereof, the patentee may apply for extension of the patent term[1]. Paragraph 5 of the same article also authorizes the competent authority to formulate regulations regarding the decision of the patent term extension[2]. Therefore, the Taiwan Intellectual Property Office ("TIPO") promulgated the "Regulations Governing the Determination of Patent Term Extension" ("Regulations") on and effective from 1 January 1997. The Regulations have been revised four times to date, wherein the last revision was made on 1 April 2018.
On 6 February 2023, the TIPO further promulgated the draft amendments to Articles 4 and 10 of the Regulations. The amended Article 10 is related to the effective date of the amendment, which however has not been explicitly decided yet. The amendment to Article 4 is to simplify the examination procedure for the patent term extension applications by removing the requirement for the TIPO to send the clinical trials list or the relevant documents/data submitted by the applicant to the Ministry of Health and Welfare ("MOHW") for its confirmation.
The legislative intent of the patent term extension system is to compensate patentees of pharmaceutical inventive patents for the terms during which they are unable to exploit patents to obtain relevant regulatory approval, including the term of domestic and/or foreign trials in which they are unable to exploit patents. However, under the current examination practice, if an application for patent term extension is made based on the term of domestic and/or foreign trials, the TIPO shall under all circumstances send the aforementioned documents to the MOHW for confirmation of whether the clinical trials are required for obtaining the market approval so as to determine the extension term.
However, under the current practice of issuing the market approval, the MOHW will check, examine, and return the "Table of Data Exclusivity Term and Domestic and/or Foreign Clinical Trials" submitted by applicants. Therefore, according to the explanation of the amendments, during the application for the patent term extension, if applicants have already submitted the MOHW-confirmed "Table of Data Exclusivity Term and Domestic and/or Foreign Clinical Trials,'' the TIPO can determine "the period of domestic and/or foreign clinical trials conducted for obtaining a pharmaceutical approval" based on the table, which means that there seems to be no need to send documents to the MOHW for confirmation regardless of any circumstances, since it would result in duplicative procedures. Thus, the amendments are made to simplify the administrative procedures. However, if the TIPO considers that there are still doubts about the documents, it is feasible to send them to the MOHW for further confirmation.
For the full draft amendments in detail, please visit the TIPO's website: https://www.tipo.gov.tw/tw/cp-86-918116-8aab5-1.html
[1] Paragraph 1 of Article 53 of Patent Act: "Where a regulatory approval shall be obtained in accordance with other laws and regulations for the exploitation of an invention patent involving a pharmaceutical or agrichemical, or the manufacturing process thereof, if such regulatory approval is obtained after the publication of the concerned invention patent, the patentee may apply for one and only one extension of the patent term of said invention patent based on the first regulatory approval. The said regulatory approval is allowed to be used only once for seeking patent term extension."
[2] Paragraph 5 of Article 53 of Patent Act: "When making a decision on an application for patent term extension, the Specific Patent Agency shall take into consideration the impact on public health and shall coordinate with the central competent authorities in charge of the business to formulate the regulations concerned."