Amendment to Patent Examination Guidelines in June 2023

TIPO released a notice regarding a draft revision of certain sections of the Patent Examination Guidelines as an adjustment in line with the reformation of examination practices and recent judicial opinions. With the of the patent term extension (PTE) and the introduction of the WIPO ST.26 XML sequence standard as the two principal focuses, the summary of the main revision points is as follows.

1.      Undated prior art references

When the dates of publication of the cited references in the patent description cannot be ascertained or are not specified, they shall be considered to predate the filing date or priority date of a claimed invention. However, if the applicant provides in a response to an Official letter with clear supporting evidence demonstrating that said cited references are literature containing its own internally confidential information, said literature does not constitute prior art to evaluate the patentability of the claimed invention. This approach based on good faith or estoppel was affirmed in a previous court judgement and has been adopted as one of the review notes, but only now is it about to be included in the Examination Guidelines.

2.      Divisional applications

Whereas now only one divisional application is permitted, in the event of parallel filing, the applicant will have the liberty to file more than one divisional application. Nevertheless, when the parent or any divisional application proceeds to allowance, the applicant shall decide in the reply to TIPO which application sharing the same invention with the earlier granted utility model is the one to relay the patent right.

On the other hand, division from a domestic priority basis is now possible. An earlier application which has served as the basis of domestic priority will be deemed withdrawn 15 months from its own filing date. The TIPO would no longer attend to the earlier application anymore as if it enters dormancy because essentially the later-filed application has replaced it as a result of priority. However, in order to offer the applicant a greater degree of procedural freedom, before a decision of patentability of the later-filed application is made, the applicant is permitted to file for a new divisional application from the earlier-filed application to include matters that are not joined in the later-filed application.

3.      Patent term extension

The sale of orphan drugs requires a special approval under rare disease-related regulations, instead of the Pharmaceutical Affairs Act. In the current examination guidelines, there is no mention of whether such an approval awarded likewise by the TFDA is a qualifying document that serves to extend the term of a patent as if it were an ordinary marketing approval for other non-rare disease medicines. The draft revision provides the legal basis for confirming the admission of an orphan drug’s approval in the event of an application for patent extension. Moreover, the legal degree of usability is the same for the approval of a drug for conventional diseases and one for rare diseases. Both of them can only be used one time to extend a patent. Once said patent is extended by either approval, the same patent cannot be extended again by the other.

The time spent for examining an application for term extension can be shortened thanks to a streamlining procedure. When the extension applicant submits to the TIPO a specifically sealed package enclosing documents of the clinical trial data issued by the TFDA, the TIPO will no longer forward the package to the TFDA for verification of the authenticity of the same.

4.      WIPO ST.26 sequence format

As of August 1, 2022, TIPO discontinued its own format and adopted the WIPO Standard ST.26 as the new format rules to be followed for patent applications disclosing nucleotide and amino acid sequences. Some outdated requirements inconsistent to the ST.26 standard are therefore compelled to be revised in the examination guidelines. For instance, the term “specifically defined” is to be added to designate nucleotides and amino acids presented in an application. An XML sequence list does not need to denote “sequence” in Chinese as a title, nor will the numbering of the pages of a sequence be permitted. The ST.26 does not allow coexisting presentation of a nucleotide sequence and its corresponding translated amino acid sequence. In contrast to TIPO’s abandoned style that accepts a three-letter code to denote an amino acid residue, the ST.26 accepts only a one-letter code. The examination guidelines are to be revised accordingly.

5.      Double jeopardy and invalidation

When an invalidity challenge against a multiple dependent claim where the present challenge only addresses a portion of the patent right comprised by said multiple dependent claim and some claims dependent therefrom, if the present challenge ultimately fails, another new invalidity challenge against the unaddressed portion of the patent right can still be instituted without the risk of double jeopardy. Here is an example. Suppose that, in a patent, Claims 1, 2 and 3 respectively cover components A, B and C, while Claim 4 depending from any of Claims 1, 2 and 3 relates to a composition comprising any of components A, B and C respectively. An invalidation action challenges Claims 3 and 4, whereas the supportive reasons submitted to the TIPO state only that Claim 3 as well as Claim 4 depending from Claim 3 lack inventiveness, without addressing the non-patentability of Claim 4 depending from the matters recited in Claims 1 and 2. The Office will only examine Claim 3 along with Claim 4 that depends from Claim 3. If at the end of the examination procedure the Office finds the challenge to have failed, another new challenge against Claim 4 dependent from the matters recited in Claims 1 and 2 shall remain open.

Please contact info@tsailee.com for any inquiries.