Newsletter
2024 Amendments to TIPO Patent Examination Guidelines
In line with amendments to relevant laws and regulations, and to fully support the needs of examination practice, the Intellectual Property Office (IPO) recently announced amendment of its Patent Examination Guidelines, including Sections 1, 3, 11, and 14 of Chapter 2 regarding examination of invention patents, and Section 1 of Chapter 5 regarding examination of invalidation petitions, effective July 1, 2024. A summary of the major amendments follows.
I. Chapter 2, Section 1: Description, Claims, Abstract, and Drawings
Section 1.3.1 "sufficient for it to be carried out" is amended according to Paragraph 7 of Article 17 of the Enforcement Rules of the Patent Act regarding submission of sequence listing. Specifically, the original "submitting electronic data as specified" is amended to "the sequence listing may be in the form of an electronic file as specified by the patent authority (refer to Chapter 14, Section 4.3 "Sequence Listing")."
II. Chapter 2, Section 3: Patentability
Section 2.6.4 "Criteria for Judging Lack of Novelty Based on Legal Fiction" adds Example 1, which specifically explains determination of lack of novelty based on legal fiction.
In determining the "identical content" of fictitious novelty, criteria include not only that listed in "Criteria for Judging Novelty" (1) identical, (2) differing only in the form of writing or in technical characteristics that can be directly and non-differently known, (3) differing only in matters such as the superior and inferior concepts of the corresponding technology, but also (4) differing only in technical characteristics that can be directly replaced by common knowledge. This new Example 1 uses a wafer package structure as an example to illustrate that it conforms to the attitude of "(4) differing only in technical characteristics that can be directly replaced by common knowledge."
III. Chapter 11, Section 2: Extension of Patent Term
In connection with the integration of the Board of Agriculture into the Department of Agriculture, the departmental name thereof is amended throughout the chapter.
Section 3.1.3.1.1 "Duration of Domestic and Foreign Clinical Trials for Medicinal Products" refers to the amendment of the ICH regulations, with the current English name of the ICH organization added as International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
IV. Chapter 14, Section 2: Biological-related Inventions
Sections 4.1 and 4.3 are amended in line with the contents of Paragraph 7 of Article 17 of the Enforcement Rules of the Patent Act and IPO implementation of the WIPO ST.26 standard.
Section 4.3.2 "Submission of Sequence Listing Data" explains that the application should be submitted electronically, and sequence listing thereof should be in XML format consistent with the WIPO ST.26 standard. If the application is submitted in writing, the paper sequence listing should comply equally with noted standard, and a fully compliant electronic file in XML format may also be submitted.
V. Chapter 1 of Article 5: Invalidation of Patent Rights
Section 2.1.2 "Interested Parties" defines qualified interested parties in the invalidation petition, and appropriate levels of investigation and decision the IPO should exercise during examination.
Definition of interested parties is amended based on judgment of the Supreme Administrative Court in 2020, Case No. 1145, which states "The interested parties mentioned in the invalidation petition are defined as legal interested parties, meaning those whose rights or legal interests are directly impacted by the contested application or patent rights."
Procedures for examination of interested parties are amended with reference to No. 57 and No. 70 judgments of the Intellectual Property and Commercial Court in 2022, specifically "If the invalidation petitioner has submitted verification of interest in the case and the same is undisputed by the patentee, and the examiner observes no issue therewith, an investigation into the interest may not be necessary, and substantive examination may proceed, with relevant reasons recorded in the decision. If the patentee does dispute the interest, a reasonable investigation should generally be conducted for a formal determination. If the interest cannot be established, the decision may be made on the grounds of the petitioner's lack of standing. The sufficiency of the evidence provided can be clarified by the invalidation petitioner producing support for immediate investigation, to meet the formal determination of interested parties' qualifications."
Section 4.3.1.1 "Disputes over the ownership of patent application rights" has been amended in accordance with Item 3 of Paragraph 1 of Article 71 and Paragraph 1 of Article 35 of the Patent Act. These provisions stipulate that disputes over the ownership of patent application rights can be resolved through invalidation procedures. The original content of this section, which stated "However, with regard to the ownership of patent application rights, it is not within the jurisdiction of the patent authority and is a matter of fact determination, interested parties with doubts or who believe their rights have been infringed should seek resolution through judicial remedies," has been removed in order to avoid misunderstanding.
In connection with the amendment to Section 2.1.2 "Interested Parties" mentioned previously, the example in Section 4.3.1.1.1 "Applicant without Patent Application Rights" has been revised, and examination items for output in the course of work duties have also been modified.
Regarding the examination items for creations output in the course of work duties, the following content is added in reference to No. 57 and No. 70 judgments of the Intellectual Property and Commercial Court in 2022: "The examination of creations output in the course of work duties includes examining whether there is an employer-employee relationship between the parties, the period of creation, and whether the content of the creation is related to the nature of the job during the employment period, as well as whether the creation by the employee is substantially identical to the disputed patent. If any of these criteria are not sufficient to establish authenticity and fail to reach the level of proof, no creation output in the course of work duties will be recognized. For example, if the employee was not assigned to participate in relevant research and development work by the employer, or if the creation was completed before the period of employment, compliance with the 'Applicant without Patent Application Rights' provision will be confirmed."
Section 9 "The Relationship between Invalidation Petition and Patent Infringement Litigation," has been revised consistent with Article 44 of the Intellectual Property Case Adjudication Act, which replaces Article 17. The amendment removes the provision for the IPO to participate in litigation and adds a system for seeking the opinion of the specialized patent agency. Accordingly, the criteria for patent examination is now compliant with the provisions of the law and legislative explanations thereof.
To read the detailed content of this amendment to the patent examination guidelines, please refer to the marked versions of the amendments listed on the website of the IPO（https://www.tipo.gov.tw/tw/cp-85-962661-e1b69-1.html）.