As reported in my previous article (see below), the Chinese Patent Examination Guidelines 2023 (the Guidelines 2023) was announced by the CNIPA on 21 December 2023 at the link below, the same day as the Implementation Regulations 2023 (the IMR 2023) of the Chinese Patent Law 2020 (the Law 2020):
https://www.cnipa.gov.cn/art/2023/12/21/art_526_189193.html?xxgkhide=1
Unlike the IMR 2023 (for which the last draft that could be commented on was in November 2020), the last draft available for comment of the Guidelines 2023 was in November 2022, with an earlier draft in August 2021. There are quite a number of changes in this final 2023 version compared with the draft in November 2022, while many things remain unchanged. The article below are my views highlighting the differences between the November 2022 draft, and the final 2023 version. I do this as I was involved in providing comments to the CNIPA for all drafts either at the AIPLA or the IPO. My article on the Aug 2021 draft of the Guidelines is available at the link below:
As this this Guidelines 2023 was announced in conjunction with the IMR 2023, it may be useful to refer to IMR 2023, for which my relevant article is available at the link below:
[As usual, my own comments are in italic and square brackets below]
CHANGES in the final Guidelines 2023 version compared with the Nov 2022 draft
Part 1 (this part concerns preliminary examination of all three types of patent applications in China)
· By default, incorporation by reference is considered to be requested using the CNIPA application forms (Chapter 1, section 4.7; Part 5, chapter 3, section 2.3.3). [Good change, as the wordings in the November 2022 draft requires separate request to be made. Comments from both AIPLA and IPO were provided suggesting making this request being a default, for which the comments appeared to have been listened to.]
· Bad faith application may be deemed to be not filed (this part did not change), with the addition of an example of providing false certifying materials added, and further added that for applications accepted could also be cancelled (Chapter 1, 6.7.5). [Bad change, as it is not clear what and how to prove such "false certifying materials". Further, this remains as a concern on whether such could be used as a tool to refuse accepting certain applications/applicant due to whatever purpose.]
· The whole and partial designs could now be included in one multiple application (Chapter 3, section 9.1). [Good change. In the November 2022 draft, it was restricted that the whole and the partial designs could not be filed in one application. Comments from both AIPLA and IPO were again provided suggesting allowing the whole and the partial designs to be filed in one application (subject to the maximum 10 similar designs rules) for cost saving, for which the comments appeared to have been listened to.]
Part 2 (this part concerns substantive examination of invention patent applications)
· Only genetic information derived from organisms belong to non-patentable subject matter (Chapter 1, Section 3.2). [Good change, as the November 2022 draft does not have the word "genetic", which in the broadest sense could include any information including clinical trial data. Again, comments from both AIPLA and IPO were provided suggesting specifying the information to be genetic information, for which the comments appeared to have been listened to.]
· Specific diagnostic methods are allowed, IF the direct purpose is not to obtain diagnostic results or health condition, or information handling methods for which all steps are carried by a computer (Chapter 1, 4.3.1.2). [Good change, at least expanding the scope of allowable diagnostic methods, particularly those for which the results are directly spitted out from a computer. The changes in the final 2023 version from the November 2022 draft version are mainly directed to conciseness of the wordings.]
Part 3 (This part concerns handling of PCT national phase entries into China)
· Issues in abstract and abstract will not result in the deemed withdrawal of the PCT national phase entry (Chapter 1, section 3.2.3). [Great change, preventing loss of rights due to issues in abstract and/or abstract figures.]
· Incorporation by reference within 2 months from the Chinese date of entry of a PCT application, with submission of the Chinese versions (Chapter 1, section 5.3) [Although not specified in the IMR 2023, correction of specification by incorporation by referring to priority document is allowed, though need separate submission of Chinese translations at PCT entry into China (which is reasonable).]
Part 5 (This part concerns with various day-to-day handling, including calculation of deadline)
· Foreign filing license (FFL, the actual term in China is secrecy examination notification) could take at most 6 months to be issued, although now recited that examiner shall issue FFL in two months for application that foreign filings are allowed. Further, specific recitation that foreign filings can be done if no FFL notification is issued in 4 months has been removed (Chapter 5, section 6.1.2). [These changes could be problematic, as applicant could now be hung dry if the CNIPA keep on delaying the issuance of the FFL. What could be worse is the CNIPA could keep on refusing even the FFL request itself for months without any sound reason, which was my personal experience in one case.]
· For patent term adjustment PTA calculation, now clarifies what is the date of filing request for examination (the calculation basis for the 3 years in the PTA calculation). Specifically, such is the date of the filing of this request for examination and the relevant fees are paid. However, for an application with request for examination filed earlier than the publication date, the publication date is then deemed to be the date of the filing of the request for examination for PTA calculation. As an aside, for PCT national phase entry and divisional, the 4 years is calculated from the date of PCT national entry into China, and the divisional filing date, respectively (Chapter 9, section 2.2). [Although it is always good to have better clarification, it appears that the CNIPA is determined to grant as few and as little PTA as possible, notwithstanding their pledge to conclude examination within 14.5 months announced in early 2023, and other new restrictions below.]
· Newly specifying reasonable delay that are not included in PTA calculation, which are in line with IMR 2023 Article 78(3), including re-examination (due to rejection of an application), having ownership dispute, and so on (Chapter 9, section 2.2.1). [Reasonable changes in line with the IMR 2023, but will reduce the PTA.]
· Newly specifying that alleged infringer (who is qualified to obtain a patentability evaluation report for utility model or design patent) is the one that received "lawyer's letter" [I believe such refer to cease and desist letter], complaint notification from e-commerce platform, and so on (Chapter 10, section 2.1). [While these are good change that makes things clearer, such requirements already exist in section 2.3(3) in the 2023 and the November 2022 draft.]
Problematic points that remain the SAME as in Nov 2022 draft
· Heavy restrictions on adding or correcting inventorship, specifically within one month from the filing receipt. To correct inventorship, it is also necessary to provide proof that the inventors after change provide substantive contributions to the invention (Part 1, chapter 1, section 6.7.2.3). [While this is problematic, the CNIPA has become extremely cautious on changing inventorship, as it appears that the CNIPA was sued for changing inventorship without any substantive check. As inventorship is not one of the grounds of invalidation, unless absolutely necessary, it is now not advisable to make any such change in China. However, this could bring another bigger issue, inventor renumeration.]
· For re-examination (filed for a rejected application) at the CNIPA's Re-examination and Invalidation Department RID, removal of time limit (used to be within one month) to finish preliminary examination that is to be done by the original examiner (Part 4, chapter 2, section 3.1). [This could be problematic, as re-examination could drag on for a long time. In fact, it is not unusual that nothing happened in two years after the filing of the request for re-examination. Well, the CNIPA may not care, as PTA will not be granted for the time spent on re-examination.]
· Ex officio reasons could be added during re-examination when necessary (Part 4, chapter 3, section 4.1). [While this could raise concerns, my recent in-person visit at the CNIPA with the CNIPA/ABA liaison council delegation revealed by the RID examiners that there are very few such cases. Further, evidence could not be added (so no new novelty and/or obviousness objections, but only new rejection reason could be added, mostly due to added matter. At least some relief.]
· At invalidation proceedings, restricting amendments to be directed to defects pointed out by the RID only (Part 4, chapter 3, section 4.6.1) [After grant amendments are always restrictive. This is just another layer.]
· For drug patent linkage dispute related invalidations, various stipulations are specified but without any requirement on acceleration and timeline (Part 4, chapter 3, section 9). [This is eye candy in my view anyway, as under the Chinese drug patent linkage, whether the generic drug supplier to file an invalidation request does not matter – there is no delay in the grant of the drug marketing approval anyway if the generic drug supplier only alleges that the relevant drug patent should be declared invalid.]
· Deadlines are now counted from the date of issuance of any notice including office actions, no more 15-days mail period (15 days to deem that the notice has been delivered), as now specified that electronic notification is considered to have been delivered on the date of issuance unless proven otherwise (Part 5, chapter 6, section 2.3.1). This change is for notice issued on or after 20 January 2024 (Article 7 of the transition measure, see my IMR 2023 article). [Although this is the world trend (see EPO change in November 2023), this is particularly problematic for re-examination notice that has only one-month deadline, and for 2nd and subsequent office actions that has only two-months deadline.]
· PTA requires filing of a specific request within 3 months from the date of grant, and paying a fee (Part 5, chapter 9, section 2.1). [Well, CNIPA wants to grant as few and as little PTA as possible anyway.]
· Drug patent term extension is applicable
to innovative drugs, and improved new drugs "in compliance
with regulations" (Part 5, chapter 9, section 3). [The
problem is, according to the NMPA definitions (see https://www.nmpa.gov.cn/directory/web/nmpa/images/ufq80tKpxre84La9udzA7b7WMjAyMMT
qtdo0NLrFzai45ri9vP4uZG9j.doc), innovative drugs, and
improved new drugs "in compliance with regulations" refer
only to those that have not been marketed in and outside of China.
Again, it appears that even though China introduced drug patent
term extension and PTA due to the US-CN trade agreement phase 1
signed in 2020 (seemingly unwillingly), China is desired to grant
as few and as little of these as possible. Typical in accordance
with the play book of the Chinese government.]
Other points to note
· Color figures could be submitted for invention patent and utility model applications (Part 1, chapter 1, section 4.3; Chapter 2, section 7.3). [This remains unchanged since the August 2021 draft. Good news, as there are indeed many occasions that color figures could help explaining the invention better than black and white figures.]
· Restoring, adding or changing priority has to be done before the CNIPA has finished preparing the publication of the application (Part 1, chapter 1, sections 6.2.3 and 6.2.6.2). [Be careful if a request to accelerate publication is filed due to whatever reason, which may reduce the time to restore/add/correct priority.]
· Correction of incorrect information at PCT national phase entry is allowed within one month from the entry, provided that entry fees are paid (Part 3, chapter 1, section 2.2.2), retained. [This remains unchanged since the August 2021 draft. Good news that makes the Chinese patent system to be more forgiving.]
· Restoration of priority at international phase of a PCT application would generally not be questioned at the Chinese national phase entry, and allowing restoration of priority within 2 months from Chinese date of entry if not done so at the international phase (Part 3, chapter 1, section 5.2.5.1) [This remains unchanged since at least the November 2022 draft. Good news, as this allows more streamlined and forgiving priority restoration for PCT national phase entry.]
· Re-examination and invalidation decisions shall all be published except when the application itself is not yet published (Part 4, chapter 1, section 6.3). [This remains unchanged since at least the November 2022 draft. Good news, as availability of these decisions could help understanding the CNIPA practice better. However, the time of publication is not specified......]
· Other than Chinese patent attorney firms, patentee and invalidation petitioner are now restricted to appoint only close relatives or working staffs at invalidation proceedings, with specific detailed definitions and requirements, for example marriage or birth certificate for close relative, or employment contract and salary records for working staff (Part 4, chapter 3, section 3.6). [This remains unchanged since at least the November 2022 draft. This could be useful in preventing unrelated and often unqualified persons to represent, which should have happened and caused issues, otherwise the CNIPA would not make this change.]
· Allowing parties involved in ownership dispute to participate in invalidation proceeding as 3rd party to provide observations (Part 4, chapter 3, section 3.7 and 3.8). [This remains unchanged since at least the November 2022 draft. Reasonable change.]
· For invalidation involving international designs, if a notice from the RID is sent through official publication, the notice is deemed delivered one month after the official publication (Part 4, chapter 3, section 7). [This remains unchanged since at least the November 2022 draft. International design owners may have to watch out for such official publications to prevent absence at the relevant invalidation proceeding.]
· Two major changes for notification on oral proceeding of an invalidation petition. 1) More flexible manner of notification including fax, email, and even SMS. 2) No longer specifying that the notification has to be replied in 7 days, but a date specified by the RID, though mentioning that generally the reply date does not exceed 7 days (Part 4, chapter 4, section 3). [Hmm.... SMS...... interesting. Why not including WeChat?]
· Request to delay examination could be withdrawn by the applicant proactively (Part 5, chapter 7, section 8.3). [This remains unchanged since the August 2021 draft. Although it is always good to have more flexibility, this may not be useful in many cases. See my article at https://www.linkedin.com/pulse/tobys-article-using-pph-china-toby-mak/ ]
Part 6, handling of Chinese entry of International Design Applications
The following are points that I believe should be noted:
· CNIPA could be receiving office for Chinese entities. However, there are the following points to note:
1) The international filing date may be delayed if the International Bureau IB failed to receive the application from the CNIPA within one months, and if so, the international filing date would become the date of the IB receiving the application (Chapter 1, 2.2.1).
2) The international application has to be filed in English, but address has to be in Chinese. Further the filing documents shall not contain information against the law, social ethics, and public interest (Chapter 1, 2.2.2). [It is not clear what is the basis of the law, social ethics, and public interest. It would be very restrictive if these are those in China.]
· For changes recorded at the IB like assignment, such changes have to be recorded again in China, fulfilling the Chinese requirements (Chapter 1, 3.6.1). [This is the same as for PCT national phase entry into China.]
· Chinese examiners are not allowed to reject an international design application based on formality defects in accordance with the Hague Convention texts of 1960 and 1999 (Chapter 2, section 2). [It would be interesting to see how Chinese examiners could make formality defects into substantive defects.]
· When responding to an office action (so-called rejection notification), the observations should be in Chinese, but the amendments to the specification should be in English (Chapter 2, section 3.3) [!]
· No fees for priority if the priority claim has been accepted by the IB (Chapter 2, section 6.2).
Overall observations
The Guidelines 2023 have many significant changes bringing the Chinese patent system closer to international norm, and more forgiving. Examples include allow restoration of priority, correcting specification by incorporation by reference, and not killing PCT national entry into China due to abstract issues, and many others mentioned above.
Meanwhile, there are also some worrying changes, including allowing the CNIPA to deem an application to be not filed by unclear (at least to me) bad faith accusation.
Another major disappointment is the handling of PTA and drug patent term extension, which appears to be very restrictive, and there is an apparent desire to grant as few and as little as possible.
In any event, the IMR 2023 and the Guidelines 2023 will bring the Chinese patent practice into a new era, with many opportunities ahead.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
