Adopted as of 1 July 2023, changes made to the Taiwan Patent Examination Guidelines, including changes made to Part II Substantive Examination for Invention Patents Claimed (Chapter 1, Chapters 3 ~5, Chapters 10, 11 and 14) and Part V Conducting of Invalidation Proceedings.

　The changes are proposed and made in line with the revision of the Enforcement Rules of the Patent Act and the Regulations Governing the Determination of Patent Term Extension as well as the implementation of the WIPO ST-26-compliant XML sequence listing to timely answer the calls for consistency and optimized quality of patent examination in practice.

　In addition to text modification, additional principles and points for attention in conducting examination are introduced to enhance the practicality of the Examination Guidelines. 

Key takeaways of the changes made:

1.  Part II, Chapter 1 Written Description, Scope of Claim, Abstract and Drawing

Section 1.4 regarding the points for attention:  A subparagraph numbered (5) is added to expound the principle to determine whether or not the prior art cited in the written description should be taken. 

2.  Part II, Chapter 3 Patentability Requirements

Section 5.7 about the continuation of patent rights:  Subparagraph numbered (4) is revised to explain that, where the applicant has filed a patent application for invention and a patent application for utility model on the same creation on the same date and has requested for division based on the declaration made for the original patent application for invention, a written notice shall be issued to the applicant for the applicant to select either the original patent application for invention or the divisional application before the approval decision of either of them is rendered to be the subsisting application, which selection made shall be irrevocable.

3.  Part II, Chapter 5 Priority Claim

Section 2.7 about the points for attention in conducting examination:  By reference to Part I, Chapter 7 on procedural examination, it is newly provided that after claiming domestic priority of the later application and before the examination decision is rendered, if the time period lapsed counting from the filing date of the earlier application is yet to attain 15 months, the applicant still may request for division of the part of the patent application not covered by the domestic priority claimed.  In such case, no domestic priority may be claimed for the divisional application.

4.  Part II, Chapter 10 Division and Conversion
Section 1.2.1 about formality requirements:  Further explanation is added in line with the 1 May 2023 revision of paragraph three, Article 28 of the Enforcement Rules of the Patent Act.

Section 1.3 about the effects of a request for division:  Explanation is given in line with the revision of Section 5.7, Chapter 3 regarding continuation of patent rights that the applicant shall be notified in writing to select the patent application to subsist before the approval decision on the original patent application or the divisional application is rendered.

5.  Part II, Chapter 11 Patent Term Extension [“PTE”]

5.1  “Where a regulatory approval shall be obtained in accordance with other laws and regulations….” as provided in Article 53 of the Patent Act refers to not only inventions involving a pharmaceutical for which a drug permit must be obtained pursuant to Article 39 of the Pharmaceutical Affairs Act but also inventions involving a pharmaceutical for which a drug permit must be obtained under Article 14 of the Rare Disease and Orphan Drug Act.  Therefore, change is made to clearly provide the legal basis for the aforesaid applicability. 

5.2  In line with the proposed revision of Article 4 of the Regulations Governing the Determination of Patent Term Extension announced on 6 February 2023, the Taiwan IPO will be able to determine the PTE being sought for based on the relevant approval document issued by the Taiwan FDA as produced by the applicant proving legal compliance of the duration of the clinical trial conducted at home and abroad for the purpose of seeking the drug permit.  That is, the Taiwan IPO no longer needs to refer the relevant materials presented by the applicant to the Taiwan FDA for verification.

6.  Part II, Chapter 14 Invention involving a biological material or utilization of a biological material

Required content of the sequence listing is revised in accordance with the overall implementation as of 1 August 2022 of the WIPO ST.26 sequence listing standards. 

7.  Part V, Chapter 1 Invalidation of Patent As Issued

Section 2.4.1.2 about the principle of examining the statement of invalidation received addressed the examining of statements making reference to a claim cited in the form of quotation, but not explaining the reasons alleged for which the quoted part of the claim cited should be invalidated.  Explanation is therefore added with examples given to explicate the scope of the examination and the operability and operation of the doctrine of non bis in idem.

8.  Part V, Chapter 2 Invalidation of Patent As Approved of PTE

8.1  This change is made in line with the revision of Chapter 11 about the examination of requests for PTE to provide that Article 53 of the Patent Act applies as well to inventions claimed involving a drug for which a drug permit must be obtained pursuant to Article 14 of the Rare Disease and Orphan Drug Act.

8.2  Text is modified in line with the revision of paragraph numbered 6. Scope of Claim Granted for Extension of Patent Term of Chapter 11 about the examination of requests for PTE to clearly define the scope of claim of a pharmaceutical patent or agricultural chemical patent granted for PTE.

9.  Other revisions
Relevant text is modified in accordance with the revision of the Enforcement Rules of the Patent Act and the Regulations Governing the Determination of Patent Term Extension with typographical errors cleared.  (Released 2023.06.27)