In order to ensure the effective implementation of the newly revised Patent Law, further improve China's patent protection system, and align with relevant international rules, the State Council issued the "Decision on Amending the Implementing Regulations of the Patent Law of the People's Republic of China" on December 11, 2023. The revised "Implementing Regulations" has come into effect as from January 20, 2024. This revision involves significant changes and adjustments to the system, overall representing an important response to the needs of innovation entities and an optimization of the patent legal system.
The "Implementing Regulations of the Patent Law of the People's Republic of China" was promulgated by Decree No. 306 of the State Council of the People's Republic of China on June 15, 2001. It underwent its first revision based on the Decision of the State Council on Amending the Implementing Regulations of the Patent Law of the People's Republic of China issued on December 28, 2002, and its second revision based on the Decision of the State Council on Amending the Implementing Regulations of the Patent Law of the People's Republic of China issued on January 9, 2010. The current third revision is in accordance with the Decision of the State Council on Amending the Implementing Regulations of the Patent Law of the People's Republic of China issued on December 11, 2023.
To assist you in better understanding the significant changes in the revised "Implementing Regulations of the Patent Law" and to better serve your needs regarding patent prosecution and protection, we have summarized and explained the relevant contents and procedures. We hereby introduce the new regulations concerning compensation for patent term, in conjunction with the related content from the newly revised "Guidelines for Patent Examination."
1. Situations for Patent Term Compensation:
Situation One: Where an invention patent is granted after the expiration of four years from the date of filing and after the expiration of three years from the date of the request for substantive examination, the patent administrative department under the State Council shall, at the request of the patentee, provide patent term compensation for the unreasonable delay in the granting process of the invention patent ("delayed grant"); or
Situation Two: To compensate for the time taken for the review and approval process before the marketing of a new drug, the patent administrative department under the State Council shall, at the request of the patentee, provide patent term compensation for invention patents related to new drugs which have been approved for marketing in China ("drug patents").
2. Scope of Compensation for "Delayed Grant":
Patent term compensation is provided for the unreasonable delay in the granting process of invention patents.
3. Exclusions from "Delayed Grant":
Where an applicant applies for both a utility model patent and an invention patent on the same day for the same invention-creation and then obtains the invention patent by declaring the abandonment of the utility model patent, the patent term of the invention patent shall not be subject to patent term compensation.
4. Filing of the Request for Patent Term Compensation Regarding "Delayed Grant":
① Filing Entities: Patentee, representative of co-owners, patent agency (if appointed).
② Filing Timeframe: Within 3 months from the date of announcement of grant of patent.
③ Document Required: Request for Patent Term Compensation and Drug Patent Term Compensation.
④ Fees: Official fees are applicable and must be paid within 3 months from the date of announcement of grant of patent.
5. Determination of Term Compensation Regarding "Delayed Grant":
For patent term compensation provided, the compensation period shall be calculated based on the actual number of days of unreasonable delay in the granting process of the invention patent. The actual number of days refers to the number of days calculated by deducting the number of days of reasonable delay and the number of days of unreasonable delay caused by the applicant from the number of days between the date on which four years have elapsed since the filing date of the invention patent application and three years have elapsed since the date of the request for substantive examination and the date of announcement of grant of the patent.
* For Chinese national phase applications of PCT applications, the calculation of the above-mentioned deadlines is based on the date of entering the national phase in China.
* For divisional applications, the calculation of the above-mentioned deadlines is based on the date of filing the divisional application.
* The effective date of the request for substantive examination is determined based on the later date between the date of submission of the request and the date of full payment, and if the date of the request for substantive examination and the date of payment for substantive examination fee are prior to the date of publication, the calculation starts from the date of publication.
6. Reasonable Delays in "Delayed Grant":
Delay caused by reexamination proceedings in which amendments to patent application documents are made; delay caused by suspension of procedures, delay caused by preservation measures, delay caused by administrative litigation procedures, and delay caused by other reasonable circumstances
7. Unreasonable Delays Caused by the Applicant in "Delayed Grant":
① delay caused by failure to respond within the specified time limit to the notifications issued by the Patent Office, and the period of delay is from the expiration date of the time limit to the date on which the response is actually submitted;
② delay caused by the request for a deferred examination, and the period of delay is the actual period of the deferral of examination.
③ delay caused by incorporation by reference;
④ delay caused by the request for restoration of rights, and the period of delay is from expiration date of the original time limit to the issuance date of the Notification of Decision on Request for Restoration of Right that approves the restoration, except where it can be shown that the delay was caused by the Patent Office;
⑤ delay caused by the applicant's failure to request expedited processing for a PCT application’s Chinese national phase application filed within 30 months from the priority date, and the period of delay is from the date of entering the national phase in China to 30 months from the priority date.
8. Approval of Requests for Term Compensation Regarding "Delayed Grant":
①Where it is determined after examination that the request for patent term compensation meets the conditions for compensation, the Patent Office shall make a decision to grant the term compensation and inform the number of days for the compensation;
②Where it is determined after examination that the request for patent term compensation does not meet the conditions for compensation, the Patent Office shall provide the requester with at least one opportunity to present their arguments and/or make rectifications. If the request still does not meet the conditions for compensation, a decision of denial of term compensation shall be made.
9. Registration and Announcement of "Delayed Grant":
Once the decision to grant patent term compensation is made, the Patent Office shall register the relevant matters in the patent register and announce them in the patent gazette.
10. Conditions for "Drug Patent" Term Compensation:
① The date of announcement of grant of a patent for which compensation is requested should be earlier than the date of approval of the application for drug marketing;
② The patent is in force at the time of the filing of the compensation request;
③ The patent has not previously been granted a drug patent term compensation;
④ The claims of the patent for which compensation is requested include the relevant technical solutions of the new drug with marketing approval.
⑤ Where multiple patents exist for the same drug, the patentee may only request drug patent term compensation for one of those patents;
⑥ Where a single patent pertains to multiple drugs, a request for drug patent term compensation may only be made for one drug in relation to that patent.
11. Filing of Request for “Drug Patent” Term Compensation
① Filing Entities: Patentee (where there is a discrepancy between the marketing approval holder and the patentee, written consent from the marketing approval holder should be obtained), representative of co-owners, patent agency (if appointed).
② Timing of Filing: Within 3 months from the date of obtaining drug marketing approval in China; for drugs with conditional approval, the filling should be made within 3 months from the date of obtaining formal marketing approval in China, but the calculation of the compensation period is based on the date of obtaining the conditional marketing approval.
③ Fees: Official fees are applicable, and must be paid within 3 months from the date of obtaining drug marketing approval in China.
12. Materials Required for “Drug Patent” Term Compensation:
① Supporting documentation of the drug marketing approval;
② Where there is a discrepancy between the patentee and the marketing approval holder, materials such as written consent from the drug marketing approval holder shall be submitted;
③ Relevant technical information used to determine the scope of patent protection during drug patent term compensation, for example, where patent term compensation is requested for a method of preparation, documents about the drug manufacturing process approved by the drug supervision and administration department of the State Council shall be submitted;
④ Request for Patent Term and Drug Patent Term Compensation, which shall indicate: drug name, drug registration classification, approved indications, and the patent number for which compensation is requested; it should specify the claims related to the new drug approved for marketing and provide detailed explanations, supported by relevant evidence, on how these claims encompass the technical solutions related to the new drug; the Request should also provide the basis for calculating the compensation period and clearly identify the technical solutions protected during the drug patent term compensation; and
⑤ Additional supporting documentation required by the Patent Office.
13. Application Scope of “Drug Patent” Term Compensation:
Innovative drugs that have been approved for marketing by the drug supervision and administration department of the State Council and improved new drugs that meet relevant regulations may be eligible for drug patent term compensation for product invention patents, preparation method invention patents, or medical use invention patents related to the active pharmaceutical ingredient. The definitions of innovative drugs and improved new drugs are determined in accordance with relevant laws and regulations, as well as the specific provisions of the drug supervision and administration department of the State Council.
Improved new drugs eligible for term compensation are limited to the following categories as recorded in the drug registration certificate issued by the drug supervision and administration department of the State Council:
(1) Category 2.1 chemical drugs that contain esters formed from known active ingredients or salts formed from known active ingredients;
(2) Category 2.4 chemical drugs for new indications that contain known active ingredients;
(3) Vaccines with improved vaccine strains in Category 2.2 biological products for prophylactic use;
(4) Biopharmaceuticals with new indications in Category 2.2 therapeutic biological products;
(5) Category 2.3 traditional Chinese medicines with enhanced functionality and therapeutic effects.
14. Examination of Whether the Specified Claims of a "Drug Patent" Include a Technical Solution Related to a New Drug:
The technical solutions related to new drugs should be based on the structure, composition, and content of new drugs approved by the drug supervision and administration department of the State Council, as well as the approved manufacturing process and indications. If the specified claims do not include the technical solutions related to the new drug approved for marketing, no term compensation will be granted.
During the drug patent term compensation period, the scope of protection for the patent is limited to the new drugs approved for marketing by the drug supervision and administration department of the State Council, and is limited to the technical solutions related to the approved indications of the new drug. Within this scope of protection, the rights and obligations of the patentee remain the same as before the patent term compensation. The scope of protection for product claims is limited to the marketed new drug products used for the approved indications. The scope of protection for medical use claims is limited to the approved indications of the marketed new drug product. The scope of protection for preparation method claims is limited to the production process recorded with the drug supervision and administration department of the State Council for the marketed new drug product used for the approved indications.
15. “Drug Patent” Term Compensation:
The duration of drug patent term compensation shall be determined by deducting five years from the number of days between the filing date of the patent application and the date on which the new drug obtains marketing approval in China. The compensation period shall not exceed 5 years, and the total effective patent term shall not exceed 14 years from the marketing approval of the new drug.
16. Approval of Request for "Drug Patent" Term Compensation:
If it is determined through examination that drug patent term compensation should be granted, and if the patentee has already submitted a request for patent term compensation but the Patent Office has not yet made a decision, the examiner shall wait until a decision on the patent term compensation request has been made to determine the drug patent term compensation period granted. If the patentee has not yet filed a request for patent term compensation and the three-month deadline from the date of announcement of grant of patent has not expired, the examiner shall wait until the expiration of the deadline for filing the request for patent term compensation to determine the drug patent term compensation period granted, unless the patentee explicitly states that they are waiving the right to file a request for patent term compensation.
Where it is determined after examination that the request for drug patent term compensation meets the conditions for compensation, the Patent Office shall make a decision to grant the term compensation and inform about the number of days for the compensation.
Where it is determined after examination that the request for drug patent term compensation does not meet the conditions for compensation, the Patent Office shall provide the requester with at least one opportunity to present their arguments and/or make rectifications. If the request still does not meet the conditions for compensation, a decision of denial of term compensation shall be made.
17. Registration and Announcement of “Drug Patent” Term Compensation:
Once the decision to grant drug patent term compensation is made, the Patent Office shall register the relevant matters in the patent register and announce them in the patent gazette.
18. Termination of Patent Term:
If patent term compensation for delayed grant or drug patent term compensation is granted, the expiration date of the patent will be the termination date of the patent term in which the term compensation has been taken into account.
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