To harmonize with the Patent Law amended and the Implementing Regulations of the Patent Law to be amended, the China National Intellectual Property Administration released the Draft of the Revised Guidelines for Patent Examination (Draft for comments) on August 3, 2021 to solicit opinions from all walks of life. The revisions mainly cover the following nine aspects:

I. Proposed provisions regarding the improved design system, concerning the requirements on, and standards for examination of, applications relating to partial designs and graphical user interface products, examination of obvious differences of designs, design applications claiming national priority, procedures for filing and examination of International Design Applications, and relaxed requirements on design drawings (allowing use of parallel double dotted lines, natural fracture lines, indicative lines and etc.)

1. The International Design Application refers to those which applicants having a domicile or habitual residence or industrial or commercial establishment in China may be allowed to file directly or through the CNIPA, with the World Intellectual Property Organization under the Hague International Design System.

2. As for the Chinese partial design application, it shall be noted that where the parent application relates to an overall design, it is not allowed to file a divisional based on a part of the design; and where the parent application relates to a partial design, it is not allowed to file a divisional based on the overall or any other partial design.
II. Proposed procedural provisions related to the Patent Cooperation Treaty, concerning the incorporation by reference, and the priority restoration, addition and correction.

1. Incorporations by reference

The CNIPA propose to allow incorporation by reference, that is, in case of an application with some elements or parts of the claims and specification missing or wrongly submitted when the applicant files the patent application, it is possible for these elements or parts of the corresponding parts of the priority application to be incorporated by reference, with the original filing date retained. The contents incorporated by reference will be deemed as part of the initially filed application documents.

(1) Time Limit: The applicant may submit voluntarily a declaration of incorporation by reference within two months from the filing/entry date, or submit it within the specified time limit in response to a Notification on Correction pointing out that the application has something missing.

(2) Required Documents: Certified Priority Document, Chinese translation of the Priority Document (if the priority document is in a foreign language), Declaration of Incorporation by Reference (which shall specify the position of the supplemented parts in the priority document and the Chinese translation thereof), and Replacement Sheets of the Application Documents.

(3) Official Fees: Upon receipt of a request for incorporation by reference, the CNIPA will re-determine the official fees of excessive claims and specification. If payment of additional fees is found necessary, a Notification on Paying Additional Fees will be issued. The applicant should pay for the relevant additional fees within two months from the filing date of the application, or one month from the issue date of the notification.

(4) Chinese National Phase of PCT International Application: If a request for incorporation by reference is filed in the international stage, the applicant should submit Chinese translation of the priority document when entering the Chinese national phase, and indicate the positions of the incorporated contents in the original application and in the Chinese translation of priority document in the entry request.

2. Restoration, Addition and Correction of Priority

(1) Restoration: Within two months from the initial expiration date of the priority deadline, namely no later than 14 months from the priority date for invention and utility model applications, or no later than 8 months from the priority date for design applications, the applicant may file a request for restoration of the priority right, together with a copy of the certified priority document (and priority assignment if necessary), and pay the restoration fee and priority fee.

(2) Addition and Correction: Within sixteen months from the priority date or four months from the filing date, and before the date on which the Notification of Passing Preliminary Examination is issued, the applicant may add or correct the priority claim, by submitting a written request and a copy of the certified priority document (together with any priority assignment if necessary), and paying for relevant fees for claiming the priority.

(3) Chinese National Phase of PCT International Application: To an application in which the priority has been successfully restored in the international stage, the CNIPA will typically raise no more objection. When an international application enters the national phase in China, the applicant is not required to go through the formalities for restoring the priority; if the applicant does not go through the formalities for the restoration of priority in the international stage, he will still have a chance to file a restoration request with the CNIPA within two months from the entry date.
III. Proposed provisions regarding patent term compensation, including the regular patent term compensation and drug patent term compensation 

1. Patent Term Compensation

The patentee may, within three months from the announcement date of grant of a patent, file a term compensation request, and pay for the relevant fees. The term to be compensated shall be calculated as follows:



Wherein, the "unreasonable delay in the examination process" is the patent grant announcement date, minus the date of four years after the filing of an invention application (for a PCT international application entering the Chinese national phase, the filing date refers to the entry date; and for a divisional application, the filing date refers to the filing date of the divisional application) or the date of three years after the issue of Notification of Entering Substantive Examination, excluding the time for such special proceedings as reexamination, litigation and suspension. The "unreasonable delay caused by applicant" refers to those as caused due to the applicant’s failure in responding, on time, to any notification issued by the CNIPA, deferred examination, incorporation by reference, request for restoration of right, and failure to request "early processing" at the entry into Chinese national phase.

2. Drug Patent Term Compensation: For any innovative drug or modified new drug approved for marketing by the China National Medical Products Administration, the patentee of any valid patent related to the drug may file a request for patent term compensation with the CNIPA within three months from the date of regulatory approval of the drug for marketing, and pay for corresponding annual fees. But the compensated term shall not exceed five years, and the entire patent term shall not exceed fourteen years after the regulatory approval of the drug for marketing. The formula for calculating the days of compensated term goes as follows:


 

It shall be noted that, in the request for drug patent term compensation, the patentee should indicate the name of the drug, approved indication of the drug, and the patent application number for which the term compensation is requested, designate the claims related to the drug approved for marketing, state, with certifying proofs, the reason why the technical solution involved in the drug falls within the scope of protection of the designated claims and the basis on which the requested term compensation has been calculated, and also clarify the claimed technical solution during the compensated term of the drug patent.

IV. Proposed provisions regarding open licensing, including the filing and withdrawal of open licensing declarations, registration and publication of open licenses, legal effect and recordal of open license contracts, and related fee reduction.

V. Proposed provisions regarding examination of invalidation cases in the mechanism for early resolution of drug patent disputes, concerning submission of requests and certifying documents, examination order, examination basis, examination status, and notifications of case closing.

VI. Proposed provisions regarding responses to emergencies, such as epidemic, concerning the novelty grace period, and ex-officio extension of time limit.

VII. Proposed provisions regarding improving examination quality and efficiency, concerning the examination of prominent inventiveness of utility models; ex-officio examination during substantive examination, reexamination and invalidation proceedings of invention patent applications relating to computer programs; provisions on participation, in invalidation proceedings, of parties involved in disputes over ownership; further improvement of delayed examination system; and determination and exemplary cases involving good-faith principle violations.

A special provision to be added is that, for the utility model patent application and invention patent application filed on the same day for the same subject matter, a four-year delayed examination will be performed for the invention patent application by default.

VIII. Proposed provisions regarding implementation of the regulatory concepts of streamlined, de-centralized administration, strengthened regulation, and optimized service provision, concerning the issue of patent evaluation reports, allowed submission of color drawings, simplified ways of submitting the drawing for abstract (for both regular national applications and Chinese national phases of PCT international applications, it is necessary only to designate the drawing for abstract in the request forms, instead of submitting a separate  document for the drawing for abstract), simplified procedure for requests for changes in bibliographic data (e.g. if the same item in the bibliographic data of multiple applications is changed in the same way, it is allowed to submit one request for the bibliographic data change for the whole batch of applications), exceptions to mandatory entrustment of patent agencies, simplified procedures for filing divisional applications, and simplified filing of sequence listings.
It should be noted that, for electronically-transmitted official notices, the date of issue may be regarded as the date of receipt, which is to say, the deadlines for responding to official notices of electronically-filed patent applications will no longer be entitled to a 15-day mailing delay.

IX. Proposed provisions regarding institutional reform, concerning adaptive modification of expressions used by the Patent Reexamination Board.
 

CNMPA and CNIPA Jointly Issued the Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes (interim)

On July 4, 2021, the China National Medical Products Administration (CNMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued the "Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes (interim)" in the No. 89 Announcement of 2021. On July 5, 2021, the CNIPA issued the "Administrative Adjudication Measures for Early Settlement Mechanism for Drug Patent Disputes" in the No. 435 Announcement, and the "Matters Concerning the Acceptance of Administrative Adjudication Measures for Early Settlement Mechanism for Drug Patent Disputes" in the No. 436 Announcement. The above announcements have come into effect from the day of promulgation.  

According to the relevant provisions of early settlement mechanism for drug patent disputes as introduced in Article 76 of the newly amended Patent Law, the CNMPA in conjunction with the CNIPA shall develop practical methods of patent dispute settlement during the application and examination stages of new drug’s marketing approval. Therefore, the Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes (interim) have been formulated and implemented with the approval of the State Council.

The early settlement mechanism for drug patent disputes refers to a system that links the related new drug approval procedure with the settlement procedure for related drug patent dispute. The Regulations are intended to provide parties with a mechanism for resolving related patent disputes, protect the legitimate rights and interests of drug patent holders, and reduce the risk of patent infringement when generic drugs go to market.

Under the regulations, the China's Patent Information Registration Platform for Marketed Drugs (https://zldj.cde.org.cn/home) is officially put into operation. Marketing authorization holders of relevant drugs are required to complete the registration and voluntary disclosure of relevant drug patent information on this Platform in advance as required within 30 days after obtaining drug registration certificates.

In case of filing the application for marketing registration of chemical generics, traditional Chinese medicine of the same name and formula, and biosimilars, applicants shall submit the patent declaration in accordance with the requirements of the Measures by contrasting relevant drug patent information registered at the China's Patent Information Registration Platform for Marketed Drugs. Within 10 days from CNMPA’s receipt of a generic drug application, the drug’s marketing authorization holder shall be notified of the declaration and basis for the declaration.

If the patentee or interested party has any objection to the patent declaration, he can file a lawsuit with the court (i.e. judicial channel) or file a request for administrative ruling with the CNIPA (i.e. administrative channel) within 45 days from the publication date of the drug marketing authorization application, to determine whether the concerned technical solution of the drug for approval falls within the protection scope of the concerned patent right or not. Within the prescribed time limit, the patentee can choose either the judicial channel or administrative channel voluntarily. Any party, who is dissatisfied with the administrative ruling made by the CNIPA, may further file a lawsuit with the court. Where the patentee or interested party files a lawsuit or administrative ruling request, shall submit a copy of the lawsuit filing receipt or administrative ruling request acceptance notice to the National Drug Evaluation Agency and notify the generic drug applicant within 15 working days from the date of filing or acceptance.

After receiving the lawsuit filing receipt or administrative ruling request acceptance notice, the CNMPA will set a 9-month waiting period (only once) for the registration application of chemical generic drug concerned. For registration applications of chemical generic drugs that trigger a waiting period, the patentee or interested party, or the applicant for chemical generic drugs, shall submit relevant documents to the National Drug Evaluation Agency within 10 working days upon receipt of the court’s judgment or CNIPA’s decision.

For the first chemical generic drug that has successfully challenged the patent and been approved for marketing, a 12-month period of market exclusivity will be granted.

For chemical generics, traditional Chinese medicine of the same name and formula, and biosimilars that have been approved for marketing, even if a dispute arises, they will not be cancelled, and their effectiveness will not be affected.