The Implementing Rules of the Patent Law and the Guidelines for Patent Examination will be issued in the following sectionsIt will come into force on January 20, 2024The business involving the compensation and fee of patent term will be implemented after the development and reform department, the financial department and the State Intellectual Property Office issue the patent fee standard and payment reduction policy (hereinafter referred to as the "fee policy"). The relevant matters are hereby notified as follows:
part. 01
How to submit
If the request for compensation for the term of the patent right is submitted on or after January 20, 2024 (inclusive), or the request for compensation for the term of the patent right on paper submitted from June 1, 2021, and the subsequent business needs to be processed, the current business handling method of the patent in question shall be followed, and the electronic application shall be submitted in electronic form and the paper application shall be submitted in paper form.
part. 02
Timing of submission
Where a patentee requests compensation for the term of a patent right in accordance with Paragraph 2 of Article 42 of the Patent Law, it shall submit a request to the State Intellectual Property Office within three months from the date of publication of the patent grant.
If the patentee requests compensation for the term of the patent right of a drug in accordance with paragraph 3 of Article 42 of the Patent Law, it shall submit a request to the State Intellectual Property Office within three months from the date on which the new drug is approved for marketing in China.
If a request for compensation for the term of a patent right submitted in accordance with Paragraphs 2 and 3 of Article 42 of the Patent Law is delayed by the above-mentioned period, there shall be no period for restoration.
part. 03
About fees
If a request for compensation for the term of the patent right is submitted before the promulgation and implementation of the fee policy, the fee shall be paid in accordance with the patent fee standard published in the fee policy within three months from the date of implementation of the fee policy.
After the promulgation and implementation of the fee policy, if the patentee submits a request for compensation for the term of the patent right in accordance with the second paragraph of Article 42 of the Patent Law, it shall pay the fee in accordance with the patent fee standard published in the fee policy within three months from the date of the announcement of the patent grant. In accordance with the third paragraph of Article 42 of the Patent Law, a request for compensation for the term of the patent right of a drug shall be paid in accordance with the patent fee standard published in the fee policy within three months from the date on which the new drug is approved for marketing in China.
If the above-mentioned fees are not paid within the time limit or in full, the State Intellectual Property Office will make a decision not to compensate for the term of the patent right.
If the State Intellectual Property Office makes a decision to compensate for the term of the patent right, the patentee shall pay the relevant fees in accordance with the requirements of the decision on the approval of the compensation for the term of the patent right and in accordance with the patent fee standard published in the fee policy.
part. 04
Submissions
From January 20, 2024, if the patentee submits a request for compensation for the term of the patent right of a drug in accordance with Paragraph 3 of Article 42 of the Patent Law, it shall follow Chapter 9, Paragraph 3 of Part 5 of the Patent Examination GuidelinesSection 3 "Supporting Materials" submits materials used to prove that the designated claims include technical solutions related to new drugs and explains the reasons.
If the request for compensation for the term of the drug patent right is submitted before January 20, 2024, the applicant can either take the initiative to submit the supporting materials and explain the reasons through the statement of opinions, or submit the supporting materials by replying to the Notice of Amendment to the Formalities or the Notice of Examination Opinion on the Compensation of the Term of the Drug Patent Right.
The supporting materials mainly include:
(1) Chemicals
1.The drug registration certificate and its annexes (including instructions, production processes, quality standards and other relevant materials), the characteristics of the relevant technical solutions of the new drug and the specified claims (see annex).
2.If the designated claim relates to the claim of the preparation method of the active ingredient (API), the API production process information table and its annexes shall also be submitted, or the basic information and production chapter of the API in the M4: General Technical Document (CTD) for Registration Application for Human Drugs (hereinafter referred to as the "General Technical Document") (hereinafter referred to as the "General Technical Document") (23.s.1 to 23.s.2) and other materials.
3.If the designated claims involve an active ingredient with a specific morphology, the section on basic information, production and characterization of the API in the general technical document shall also be submitted (23.s.1 to 23.s.3) and other materials.
4.Other materials used to prove that the designated claims include a technical solution related to the new drug.
(2) Biological products
1.The drug registration certificate and its attachments (including instructions, production process and quality standards and other related materials), "I. Basic Information" in the technical review report of the drug application for marketing, the characteristic comparison table between the relevant technical solutions of the new drug and the specified claims (see annex), the drug name, structure, dosage form, product composition and prescription composition chapter in the general technical document (3.)2.s.2.s.2.p.2.p.2.1) and documents such as cover letters.
2.Other materials used to prove that the designated claims include a technical solution related to the new drug.
(3) Traditional Chinese medicine
1.The drug registration certificate and its attachments (including relevant materials such as instructions, production process and quality standards), "I. Basic Information" in the technical review report of the drug application for marketing, and the characteristic comparison table between the relevant technical solutions of the new drug and the specified claims (see annex).
2.Other materials used to prove that the designated claims include a technical solution related to the new drug.
If the above-mentioned submitted materials involve trade secrets, the relevant content may be coated and covered, but the coating and masking treatment shall not affect the judgment of whether the designated claims include the relevant technical solutions of the new drug.
part. 05
Review & Notification
If a request for compensation for the term of a patent right is submitted in accordance with paragraphs 2 and 3 of Article 42 of the Patent Law from June 1, 2021, and the fee is paid within the prescribed time limit, the CNIPA shall initiate the examination.
If a request for compensation for the term of a patent right is submitted in accordance with paragraph 2 of Article 42 of the Patent Law, and the conditions for compensation for the term of patent right are met after examination, the State Intellectual Property Office shall issue a Decision on the Examination and Approval of Compensation for the Term of Patent Right, make a decision on the compensation for the term of patent right, and inform the number of days for compensation for the term of compensation; If the conditions for compensation within the time limit are not met after examination, the State Intellectual Property Office shall issue a Notice of Amendment to the Formalities or a Notice of Examination Action, as appropriate, and if the amendment or opinion statement still does not meet the conditions for compensation within the time limit, the State Intellectual Property Office shall issue a Decision on the Examination and Approval of Compensation for the Term of Patent Right and make a decision not to compensate within the time limit.
In accordance with the third paragraph of Article 42 of the Patent Law, if a request for compensation for the term of a drug patent is submitted and the conditions for compensation for the term of the drug patent are met after examination, the State Intellectual Property Office shall issue the Decision on Examination and Approval of the Compensation for the Term of the Drug Patent Right, make a decision on the compensation of the time limit, and inform the number of days of the time limit compensation. If the conditions for compensation for the term of drug patent are not met after examination, the State Intellectual Property Office shall issue a Notice of Amendment to the Formalities or a Notice of Examination Opinion on the Compensation of the Term of a Drug Patent Right, as the case may be, and if the conditions for compensation for the term of the drug patent are still not met after the amendment or statement of opinions, the State Intellectual Property Office shall issue the Decision on the Approval of the Compensation for the Term of the Drug Patent Right and make a decision not to compensate for the time limit.
In the procedure for examining compensation for the term of a patent right, the time limit for responding to the notification is one month.
part. 06
Registration and Announcements
After the State Intellectual Property Office makes a decision to compensate for the term of the patent right, it shall register the relevant matters in the patent register and announce them in the Patent Gazette, including: IPC main classification number, application date, patent number, date of announcement of authorization, name of the drug and approved indication (only compensation for the term of the patent right of drugs), the expiration date of the term of the original patent right, and the expiration date of the term of the current patent right.
part. 07
Information inquiry
The decision on the examination and approval of the compensation for the term of the patent right can be found in the "Patent Examination Information Inquiry" of the patent business handling system.
part. 08
Remedies
If the applicant is dissatisfied with the decision on the examination and approval of the compensation for the term of the patent right, he or she may apply to the State Intellectual Property Office for administrative reconsideration.