Newsletter
New Amendments to the TIPO’s Patent Examination Guidelines in 2023
In accordance with amendments to the Enforcement Rules of the Patent Act and the Regulations for the Extension of Patent Rights Duration, as well as implementation of XML sequence listing based on the WIPO ST.26 standard, the Intellectual Property Office (IPO) has announced the amendment of "Patent Examination Guidelines," including sections 1, 3, 4, 5, 10, 11, 14 of Chapter 2 regarding the examination of invention patents, and sections 1 and 2 of Chapter 5 regarding the examination of invalidation petition, effective July 1, 2023. The following is a summary of the major amendments.
I. Chapter 2, Section 1, specifically "Description, Claims, Abstract, and Drawings"
In Section 1.4 "Examination Notes," a new point (5) is added to clarify the principle of whether the prior art cited in the description can be recognized as evidence, specifically "If the prior art cited in the description fails to specify or cannot confirm the date of publication thereof, based on the principle of good faith or estoppel, it shall generally be considered prior art and can be used as a basis for determining patentability. However, if specific evidence is provided verifying that the technology cited in the description is the applicant's own unpublished internal technology, then the associated prior art cannot be used as a basis for determining lack of patentability of the claimed invention."
II. Chapter 2, Section 3, specifically "Patentability"
In Section 5.7 "Succession of Rights,"point (4) is amended to illustrate a situation in which both invention and utility models are filed for the same invention, and a divisional application is filed before the original application is allowed, with a declaration referring to the original application. The amended section states that the applicant shall confirm that only one invention application can be considered a succession application before the original application or the divisional application is allowed, specifically "If there are still identical creations in either the original application or the divisional application before the allowance of either case, the applicant shall confirm that only one invention application is considered as a succession, in line with the legislative intent of allowing the same invention to be separately filed in this jurisdiction as one invention application and one utility model application on the same day."
III. Chapter 2, Section 5, specifically "Priority"
In Section 2.7 "Examination Notes," referring to the provisions of Chapter 7 in the Examination Guidelines, it is added that, following claiming of domestic priority in a subsequent application and prior to allowance, if the original application has not been pending for over 15 months from the filing date, a divisional application can still be filed for the part not claimed for domestic priority, but the divisional application cannot claim domestic priority again, specifically "If, after claiming domestic priority in a subsequent application and before it is allowed, the original application has not been pending for over 15 months from the filing date, a divisional application can still be filed for the part not claimed for domestic priority, but the divisional application cannot claim domestic priority again."
IV. Chapter 10, Section 2, specifically "Division and Amendment"
1. In Section 2.1 "Formal Requirements," in accordance with Article 28, Paragraph 3 of the Implementing Regulations of the Patent Act, revised on May 1, 2023, the following explanation is added.
"For the description of a divisional application which is not identical to the content of the description of the original application at the time of filing, to protect the rights and interests of the applicant and improve examination efficiency, and accurately determine whether the divisional application exceeds the scope disclosed in the description of the original application at the time of filing, the applicant shall submit marked pages of any differences between the description of the divisional application and the description of the original application at the time of filing. Any deletion of content shall be marked with a line through the deleted text, and any addition of content shall be marked with a line below the added text. The differences can be explained in the divisional application."
2. In Section 1.3 "Effects of Divisional Applications," in accordance with the amendment to Section 5.7 of Chapter 3 regarding the succession of rights, it is explained that, before the allowance decision of the original application or the divisional application, the Intellectual Property Office shall send a letter to the applicant to confirm that there can only be one invention application as a succession, specifically "If there are still identical creations in either the original application or the divisional application before the allowance decision of any of the cases, the applicant shall confirm in writing that there only one invention application is a succession, to comply with the legislative intent of allowing the same creation to be separately applied in this jurisdiction for one invention application and one utility model application on the same day."
V. Chapter 11, Section 2, specifically "Extension of Patent Term"
1. The term "required to obtain a license according to other laws" mentioned in Article 53 of the Patent Act is not limited to licenses obtained according to Article 39 of the Pharmaceutical Affairs Act. It also applies to drugs obtaining licenses according to Article 14 of the Rare Disease Prevention and Treatment and Drug Act. This is to clarify the legal basis thereof.
2. In accordance with the draft amendment to Article 4 of the Patent Term Extension Examination Guidelines announced on February 6, 2023, the Intellectual Property Office can now use review data of the domestic and foreign clinical trial period required for obtaining a drug license, as confirmed by the Ministry of Health and Welfare based on the applicant's submission (i.e., the "Exclusive Data Period and Domestic and Foreign Clinical Trial Data Table" with a stitched seal), as criteria for determining the extension of the patent term, without having to submit such data to the Ministry of Health and Welfare for confirmation again.
VI. Chapter 14, Section 2, specifically "Biological-related Inventions"
In accordance with the Intellectual Property Office implementation of the WIPO ST.26 standard on August 1, 2022, recording requirements for sequence listings are amended.
VII. Chapter 1 of Article 5, "Invalidation of Patent Rights"
In Section 2.4.1.2, "Handling principles of invalidation statements," for claims drafted in a reference-making format, the patent examination guides provide no explanation regarding invalidation reasons covering only certain claims to which the reference-making claim refers.
Explanation of the scope of examination and application of "non bis in idem" and an example thereof are provided, specifically "If the invalidation statement includes requests the revocation of a claim drafted in a reference-making format, if the reasons for invalidation pertain only to the scope covering certain claims to which the reference-making claim refers, the examination shall focus only on the scope involved, which shall be stated in the invalidation decision. If the result of the examination is that no invalidation is established, any subsequent invalidation petition made against the scope of claims not asserted in the previous invalidation decision shall be immune to application of non bis in idem."
VIII. Chapter 2 of Article 5, "Disclosure of Extension of Patent Rights":
1. In accordance with the amendment to Chapter 11 of Article 2 regarding the extension of patent rights, application of Article 53 of the Patent Act to drugs obtained through a license under Article 14 of the Rare Disease Prevention and Treatment and Drug Act is added.
2. In Chapter 11 of Article 2 regarding the scope of approval for extension of the patent term, the wording is amended to clearly define the rights of pharmaceutical or pesticide patents that have been approved for an extended period, specifically "For pharmaceutical or pesticide patents that have been approved for an extended period, the rights during the extended patent term shall apply only to the scope limited by the active ingredient and use specified in the license, and not to other substances, uses, or methods mentioned in the patent application but not in the license."
For a detailed presentation of this amendment, please refer to the marked-up versions of the amendments published on the website of the Intellectual Property Office (https://www.tipo.gov.tw/tw/cp-85-923874-4802d-1.html).