Newsletter
Announcement of the Amended Implementing Regulations of the Patent Law and the Amended Patent Examination Guidelines in China
The 4th amendment to the Chinese Patent Law was passed on 17 October 2020, and the amended content was officially implemented on 1 June 2021 ("2021 Patent Law"). The 4th amendment to the Patent Law introduced several important provisions, including the principle of good faith, patent open licensing, patent term adjustment, new drug patent term extension, partial design patent protection, domestic priority claim allowed for design patent applications, novelty requirement grace period, strengthened punishment for patent infringement and patent counterfeiting, etc. However, due to the delayed release of the amendment of the corresponding Implementing Regulations of the 2021 Patent Law ("Implementing Regulations") and the amendment of the Patent Examination Guidelines, the China National Intellectual Property Administration ("CNIPA") had successively issued four Temporary Measures to deal with the handling of related patent-related matters during the transitional period. These Temporary Measures mainly involve the following aspects: first, providing necessary procedural guidance related to statutory deadlines for taking specific actions during the transitional period; second, specifying the application scope of the special new patent practices prescribed in the 2021 Patent Law during the transitional period; and third, setting the general direction for handling Hague international design applications during the transitional period. For background information on the implementation of the 4th amendment to the Patent Law, the publication and implementation of 4 Temporary Measures as well as the progress of amendments to the Implementing Regulations and the amendment of the Patent Examination Guidelines, please refer to our article published in December 2023 (https://www.leeandli.com/EN/NewslettersDetail/7154.htm).
Two and a half years after the 2021 Patent Law came into effect, the Chinese government announced the amendment to the Implementing Regulations on 21 December 2023. The amendment of the Patent Examination Guidelines was also announced on the same day. The amendments to the Implementing Regulations and the amendment of the Patent Examination Guidelines mentioned above will be implemented from 20 January 2024. Regarding information of higher importance or special nature in the amended Implementing Regulations and Examination Guidelines, the following key amendments related to patent applications are listed for reference:
I. Restoration of Priority Rights as well as Addition or Correction of Priority Claim
Under the previous Implementing Regulations and Patent Examination Guidelines, if an applicant failed to file an application within a specific priority deadline, it was not allowed to request restoration of the concerned priority claim. In addition, it was not allowed to add a priority claim after filing the patent application. According to the amended Implementing Regulations and the amended Patent Examination Guidelines, an applicant can now request restoration of priority right or add and correct a priority claim, which is explained as follows:
A. Restoration of Priority Claim (Rule 36) - Applicable to Invention and Utility Model Patent Applications
According to the amended Implementing Regulations (Rule 36), if an applicant files an invention or utility model patent application on the same subject matter after the priority deadline without a specific priority claim with a proper reason(s), it can request restoration of such priority claim within 2 months from the priority deadline and before the laying open publication preparation is done by the CNIPA. For a PCT national phase entry patent application filed in China, the deadline for requesting restoration of priority claim is either at the time of entry or within 2 months from the entry date. The specific documents and fees required for submitting the restoration request are explained as follows:
For an invention patent application or a utility model patent application filed under the Paris Convention, if the applicant requests restoration of priority claim, it should submit a request for restoration of priority claim stating the reasons, and pay the restoration request fee and priority claim fee. It should also complete other necessary requirements (e.g., submitting priority document(s), proof of priority claim right assignment, etc.). If these requirements are met, the priority claim will be restored, and the examiner shall issue a notice of approval for the restoration request. If the requirements are not completely met, the examiner shall issue a notice of rejection of the restoration request, stating the reasons for not allowing the restoration.
For a PCT national phase entry patent application filed China, if the applicant has already been approved restoration of priority claim by the PCT Receiving Office during the international phase, the CNIPA generally does not raise any question, and the applicant does not need to go through the restoration procedure again when entering into the national phase in China. If the applicant has not requested restoration of priority claim during the international phase or if the restoration request was not approved by the PCT Receiving Office, the applicant can request restoration of priority claim within 2 months from the entry date, stating the reasons, and paying the restoration request fee and the priority claim fee. If the applicant has not submitted the required priority document(s) to the International Bureau, it should also submit the priority document(s). If the restoration procedure is not completed according to the relevant provisions, the examiner shall issue a notice stating that the priority claim is considered as not requested.
At the same time, the amended Patent Examination Guidelines also stipulate that in the case of any condition prescribed in Article 37 of the Implementing Regulations (addition or correction of priority claim), Article 36 of the Implementing Regulations shall not apply.
B. Addition and Correction of Priority Claim (Rule 37) - Applicable to Invention and Utility Model Applications
In previous practice, an applicant was required to claim priority at the time of filing a patent application, and there would be no opportunity to add a priority claim after the filing date. If the applicant fails to specify or incorrectly specifies the priority claim details in the request for priority claim (such as the priority date, patent application number of the priority application, name of the original receiving office), the examiner will issue a notice for correction, requesting the applicant to make the correction within a prescribed time limit provided that the applicant has already submitted the priority document within the prescribed time limit.
According to the amended Implementing Regulations (Rule 37), for an invention patent application or a utility model patent applicants filed with priority claim, the applicant can request to add or correct the priority claim in the request form within 16 months from the priority date or within 4 months from the filing date. As stated above, the amended Patent Examination Guidelines also stipulate that in the case of any condition prescribed in Article 37 of the Implementing Regulations (addition or correction of priority claim), Article 36 of the Implementing Regulations shall not apply.
II. Novelty Grace Period
1. Article 24 of the Patent Law
According to Article 24 of the 2021 Patent Law, an invention for which a patent is being applied shall not lose its novelty if, within 6 months prior to the application date, any of the following circumstances occurs:
(1) It is first publicly disclosed for the purpose of public interest during a state of emergency or exceptional situation in the country ("Circumstance 1");
(2) It is first exhibited at an international exhibition sponsored or recognized by the Chinese government ("Circumstance 2");
(3) It is first published at a designated academic or technical conference ("Circumstance 3"); and
(4) Its content is disclosed by others without the applicant's consent ("Circumstance 4").
Circumstance 1 mentioned above is a newly added circumstance for requesting a novelty grace period under the 2021 Patent Law.
2. Amended Implementing Regulations and Amended Patent Examination Guidelines
(1) First disclosure for public interest purposes in the event of a state of emergency or exceptional circumstances in the country ("Circumstance 1")
The amended Implementing Regulations (Rule 33) explicitly stipulate that if the invention or creation for which a patent is applied involve Circumstance 1 (first disclosure for public interest purposes in the event of a state of emergency or exceptional circumstances in the country), the CNIPA may, if deemed necessary, require the applicant to submit supporting documents within a specified period.
Regarding Circumstance 1, the amended Patent Examination Guidelines provide the following guidelines:
If the invention or creation for which a patent is applied was first disclosed for public interest purposes within 6 months prior to the application date in the event of a state of emergency or exceptional circumstances in the country, and the applicant was aware of it before the patent filing date, the applicant shall declare it in the request form when filing the patent application and submit supporting materials within 2 months from the filing date. If the applicant becomes aware of it only after the patent filing date, it shall file a declaration to claim the novelty grace period within 2 months from the date of becoming aware of the circumstance 1, and submit supporting evidentiary documents. When deemed necessary, the examiner may request the applicant to submit supporting evidentiary documents within a specified period. If the applicant becomes aware of circumstance 1 only after receiving a notification from the CNIPA, it shall file a response within the reply time period specified in the notification, declaring the claim for the novelty grace period and attach the supporting evidentiary documents. The supporting evidentiary documents proving Circumstance 1 shall be issued by relevant departments of the People's government at or above the provincial level. The supporting evidentiary documents shall indicate the reason(s), date, form, and content of the public disclosure for public interest purposes, as well as the date on which the invention or creation is disclosed, which should be stamped with an official seal.
(2) Circumstance 2 (First exhibited at an international exhibition sponsored or recognized by the Chinese government)
The amended Implementing Regulations (Rule 33) still adopt the definition of "international exhibition recognized by the Chinese government" as stated in the original Implementing Regulations (Rule 30). That is, the "international exhibition recognized by the Chinese government" refers to "international exhibitions registered with or recognized by the International Exhibitions Bureau as stipulated in the International Exhibitions Convention." According to the amended Patent Examination Guidelines, the provisions regarding the timing, content, and form of the declaration and supporting materials for claiming novelty grace period for Circumstance 2 (first exhibited at an international exhibition sponsored or recognized by the Chinese government) are basically consistent with those stated in the original Patent Examination Guidelines. However, according to the amended Patent Examination Guidelines, in addition to the "organizer of the exhibition" as specified in the original Patent Examination Guidelines, the "organizing committee of the exhibition" can also provide the required supporting evidentiary documents as to the concerned international exhibition.
(3) First published at a designated academic or technical conference ("Circumstance 3")
According to the amended Implementing Regulations (Rule 33), the definition of first published at a designated academic or technical conference ("Circumstance 3") as stated in the original Implementing Regulations remains. However, the first published at a designated academic or technical conference ("Circumstance 3") also include "academic or technical conferences organized by international organizations recognized by the relevant competent department of the State Council." The provisions in the amended Patent Examination Guidelines regarding the timing, content, and form of the declaration and supporting materials for claiming novelty grace period for Circumstance 3 are consistent with those stated in the original Patent Examination Guidelines.
(4) Circumstance 4 (Disclosed Without the Applicant's Consent)
Regarding Circumstance 4, the amended Patent Examination Guidelines keeps the provisions of the original Patent Examination Guidelines, which state the following:
"If the applicant was already aware of Circumstance 4 before the filing date, they should declare it at the time of patent filing and submit supporting evidentiary documents within 2 months from the filing date. If the applicant becomes aware of Circumstance 4 only after the filing date, it should submit a declaration requesting not to lose the novelty grace period within 2 months after becoming aware of Circumstance 4, along with supporting evidentiary documents. The examiner may request the applicant to submit supporting evidentiary documents within a specified period as deemed necessary."
The amended Patent Examination Guidelines further state that "if the applicant becomes aware of Circumstance 4 only after receiving a notification from the CNIPA, it should submit a response within the specified deadline specified in the notification, stating their opinion regarding not losing the novelty grace period and attaching supporting evidentiary documents."
3. Other Important Guidelines
According to the amended Patent Examination Guidelines, in the case of Circumstance 1 (public disclosure for the purpose of public interest in a state of emergency or exceptional circumstances), if another person discloses the invention or creation again after becoming aware of the disclosure under Circumstance 1, it shall be considered Circumstance 1 described in Item (1), Article 24 of the 2021 Patent Law; in the case of Circumstance 4 (disclosure of the invention without the consent of the applicant), if a third party discloses the invention or creation again after becoming aware of the disclosure under Circumstance 4, it shall be considered as Circumstance 4 described in Item (1), Article 24 of the 2021 Patent Law.
III. Incorporation by Reference
In the amended Implementing Regulations, a provision regarding "incorporation by reference " has been added, which is very helpful to patent applicants. After January 20, 2024, if an applicant discovers that any part of the submitted specification, claims and drawings is missing in the Chinese patent application filed thereby, the applicant is allowed to supplement the missing part and retain the original filing date. To proceed with "incorporation by reference," the applicant must have had claimed a valid priority at the time of filing the Chinese patent application, and the missing content must be included in the patent text filed for the claimed priority application. As to how to proceed with "incorporation by reference," please refer to the following explanation:
A. Non-PCT Patent Applications
According to Article 45 of the amended Implementing Regulations, for an invention patent application or a utility model patent application filed with priority claim, if any part of the submitted specification, claims and drawings is missing or if any of the said documents are incorrectly submitted, the applicant can supplement the missing part or the incorrect part based on the patent text filed for the prior application within 2 months from the filing date or within the deadline designated by the CNIPA (i.e., the incorporation by reference). If the supplemented documents comply with the relevant regulations, the filing date of the patent application will be maintained. According to the amended Patent Examination Guidelines, when proceeding with incorporation by reference, a declaration for the incorporation by reference should be submitted, and the location of the supplemented content in the patent text of the prior application (the Chinese translation of the foreign-language patent text as needed) should be specified. The applicant should also submit relevant documents (such as revised replacement pages of the patent filing document). If the Chinese patent application is filed with a foreign priority claim, the applicant must also submit a scanned copy of the priority document issued by the original Receiving Office and its Chinese translation; if a domestic priority is claimed, a copy of the priority document is not required.
B. PCT National Phase Entry Patent Applications
In the past, due to the reservation made by China as to the provisions of the Implementing Regulations of the Patent Cooperation Treaty, the CNIPA did not accept incorporation of any element or any part by a patent applicant through incorporation by reference when entering a PCT international patent application into the national phase in China for the purpose of preserving the original international filing date.
According to the amended Patent Examination Guidelines, for a PCT national phase entry application filed in China, the CNIPA shall accept incorporation of a specific portion through incorporation by reference so as to preserve the original international filing date. That is, where in a PCT international patent application there exists incorporation by reference to incorporate any element or any part at the international phase (the "element" refers to the entire description or all claims, and the "part" refers to a part of the description, a part of the claims, or the entire or a part of the drawings), the CNIPA will also allow the applicant to incorporate the missing element or the missing part through incorporation by reference so as to preserve the original filing date when this case enters into the Chinese national phase.
C. Exclusion of Application of Incorporation by Reference
According to the amended Patent Examination Guidelines, incorporation by reference is not applicable to any of the following patent applications:
(1) divisional patent applications;
(2) patent applications involving restoration of priority claim, addition of priority claim and/or corrections; and
(3) patent applications of which the deadlines for processing incorporation by reference has been delayed and restoration of right cannot be requested through a restoration procedure.
IV. Patent Term Adjustment ("PTA")
According to Article 42 of the 2021 Patent Law, the term of an invention patent, a utility model patent and a design patent is 20 years, 10 years and 15 years respectively, which shall be calculated from the filing date. If an invention patent is granted 4 years after the filing date and 3 years after the date of filing a request for substantive examination, the CNIPA, upon a request for patent adjustment ("PTA") by the patentee, shall provide compensation for any unreasonable delay occurring in the patent grant process. However, any reasonable delay occurring on the side of the CNIPA and any unreasonable delay caused by the patent applicant are excluded from the application of a PTA.
In response to the implementation of the new PTA practice, the amended Implementing Regulations and the amended Patent Examination Guidelines provide definitions of the so-called "reasonable delays", "unreasonable delays", and "specific calculation methods for a PTA. The major contents of the implementation of PTA in the amended Implementing Regulations and the amended Patent Examination Guidelines are summarized as follows:
A. Filing a PTA Request
A request for a PTA should be made by the patentee within 3 months from the date of patent grant publication, along with payment of the official PTA request fee.
B. Calculation of PTA Time Period
The grant for a PTA request shall be calculated based on the "actual number of days" of the unreasonable delay(s) occurring in the patent grant process of an invention patent. Please refer to the below-listed information for details.
|
1. Number of Days Allowed for PTA
According to Paragraph 1 of Rule 78 of the amended Implementing Regulations, in the case of a request for a PTA filed pursuant to Paragraph 2, Article 42 of the Patent Law, the CNIPA shall grant a PTA, of which the number of days shall be "the actual number of days for the unreasonable delay in the patent grant process of an invention patent." Paragraph 2 of Rule 78 further states that the so-called "actual number of days for the unreasonable delay in the patent grant process of an invention patent" as stated above shall be decided based on the following four steps:
(1) deciding the date when the 4-year time period has elapsed (4 years from the filing date) and the 3-year time period has also elapsed (3 years from the date of filing a request for substantive examination) – hereafter referred to "Date A";
(2) deciding the date on which the patent grant is published - hereafter referred to "Date B";
(3) deciding the number of days between Date A and Date B (hereinafter referred to as "Initial Number of Days"); and
(4) using "Initial Number of Days" minus "the number of days for reasonable delay" in the CNIPA"'s Patent Grant Process, of which the result will be the "actual number of days allowed for a PTA".
2. Reasonable Delay in the CNIPA's Patent Grant Process
Paragraph 3 of Rule 78 states that any of the following situations shall be considered as a "reasonable delay made by the CNIPA":
(1) delay occurring in the reexamination procedure due to the applicant's amendment(s) of the patent application documents in accordance with Rule 66 before patent grant;
(2) delay caused by any of the circumstances prescribed in either Rule 103 (i.e., in case of suspension of patent-related procedure due to a suit or a mediation request filed for a dispute involving the right to apply for patent or the right on a patent grant) or Rule 104 (i.e., in the case of a suspension of a patent-related procedure due to the issuance of a preservation measure order by the court for the concerned patent case); and
(3) delay caused by any other reasonable reason.
3. Unreasonable Delays Attributable to a Patent Applicant
Rule 79 of the amended Implementing Regulations as well as Part 5, Chapter 9 of the amended Patent Examination Guidelines define the "unreasonable delay(s) attributable to a patent applicant", which include the following:
(1) Where a patent applicant fails to file a response to a notification or an office action issued by the CNIPA within the specified time limit, the delayed time period attributable to the applicant shall be the time period from the expiration date of the original response period until the date of filing a response.
(2) Where a request for postponed examination of a patent application is filed, the delayed time period attributable to the applicant shall be referred to as the actual time period for the postponed examination.
(3) Where a delay is caused by a patent applicant's submission of a missing specification, claims and/or drawings through "reference by incorporation" pursuant to Rule 45 of the Implementing Regulations of the Patent Law, the delayed time period shall be the time period delayed by submitting the missing filing documents through "reference by incorporation".
(4) Where a delay is caused by filing a reinstatement procedure to revive a patent application, the delayed time period shall be the time period between the original deadline and the date on which the CNIPA issues a Notification of Allowing Reinstatement of Patent Application. However, the above shall not apply if the delay can be proven to be caused by and attributable to the CNIPA.
(5) Where a PCT international patent application is entered into the national phase in China before the 30-month entry deadline expires, but the applicant has not checked the "early processing" box on the Request Form (asking the CNIPA to process and examine the concerned PCT national entry patent application in advance), the delayed time period shall be the time period between the date of the national phase entry and the date of expiration of the 30-month time period from the priority date (or the earliest priority date) claimed for the CN national phase entry patent application or the filing date of the PCT international patent application where no priority claim is made for the CN national phase entry patent application.
4. PTA Does Not Apply to Dual-filing Patent Applications
According to Paragraph 3 of Rule 78, if the same applicant files both a utility model patent application and an invention patent application for the same invention on the same day under the dual-filing approach and the applicant later chooses to keep the invention patent case to avoid a double patenting issue, after the applicant obtains an invention patent grant in accordance with Paragraph 4 of Rule 47, the said invention patent right shall not be subject to a PTA as prescribed in Paragraph 2, Article 42 of the 2021 Patent Law.
5. "Filing Date" and "Date of Filing a Request for Substantive Examination"
As stated in the Patent Examination Guidelines (Part 2.2, Chapter 9), for a PCT national phase entry patent application, its "filing date" shall be the date on which the PCT international application is entered into China. For a divisional patent application, its "filing date" refers to the date on which the divisional application is filed. In addition, the "date of filing a request for substantive examination" refers to the date on which the applicant files a request for substantive examination in accordance with Paragraph 1, Article 35 of the 2021 Patent Law with the full amount of the substantive examination fee paid for the said invention patent application in accordance with Rule 113. If the date of filing a request for substantive examination is earlier than the laying open date as referred to in Article 34 of the Patent Law, the "3-year time period from the date of filing a request for substantive examination" as referred to in Paragraph 2, Article 42 of the Patent Law (one of the requirements for seeking a PTA) shall start to run from the above-mentioned laying open date.
6. Decision on a PTA Request
If, through CNIPA's examination, a request for PTA is found not meeting all the requirements for seeking a PTA (including the Patent Grant Timing Requirement and the PTA calculation requirements), the CNIPA shall give the patentee at least one opportunity to present his/her opinion and supplement the PTA request documents. If the patentee fails to prove that his/her patent meets the requirements for seeking a PTA within the time limit specified by the CNIPA for presenting opinions or supplementing the PTA request documents (as stated above), a decision shall be issued by the CNIPA rejecting the PTA request. If a PTA request meets all the requirements for seeking a PTA, the CNIPA shall issue a decision granting the PTA and inform the patentee of the actual number of days allowed for the PTA grant.
According to Interim Measures No. 560 announced by the CNIPA on 21 December 2023, if a patentee is dissatisfied with a decision issued by the CNIPA on a PTA request, he/she may file a request with the CNIPA for administrative reconsideration.
7. Official Fee for Seeking PTA
The CNIPA has not yet announced the official fee standard for filing a PTA request. We expect that the CNIPA will announce the said official fee standard soon. Once the fee standard is announced, a patentee will be required to pay such fee as needed for the PTA request.
The above represents what has been stated in the 2021 Patent Law and its Implementing Regulations as well as the Patent Examination Guidelines. When the amended Implementing Regulations and the amended Patent Examination Guidelines take effect on 20 January 2024, the specific practice and examination standards for the CNIPA's handling of PTA requests will be clearer. We will certainly keep our clients duly informed of any important details regarding its implementation in due course.
V. Patent Term Extension for Invention Patents Covering New Drugs ("PTE")
According to Article 42 of the 2021 Patent Law, the term of an invention patent is 20 years calculated from the filing date. Paragraph 3, Article 42 of the 2021 Patent Law stipulates that, in order to compensate for the time taken to conduct clinical trials and to seek approval of new drugs, the CNIPA shall, upon request by a patentee, grant a patent term extension ("PTE") for invention patents obtained for drugs, for which market approval has been granted in China. The period for a PTE shall not exceed 5 years, and the total effective patent term after the approval of the new drug shall not exceed 14 years. The specific details regarding the drugs and types of patents eligible for PTE, application requirements, calculation methods, scope of protection, approval procedure and remedies are further specified in the amended Implementing Regulations and the amended Patent Examination Guidelines. Major details regarding this new PTE practice are provided below:
1. Types of Drugs and Patents Eligible for PTE
Rule 80 of the Implementing Regulations stipulates that the "invention patents for new drugs" referred to in Paragraph 3, Article 42 of the 2021 Patent Law include patents for new drug products, preparation methods, and medical uses. Section 3.4, Chapter 9, Part V of the amended Patent Examination Guidelines further states that drugs qualified to seek a PTE refer to the innovative drugs approved by the State Drug Administration as well as improved new drugs that meet the following requirements:
(1) Chemical drugs in Class 2.1 that are esters of known active ingredients or salts of known active ingredients.
(2) Chemical drugs in Class 2.4, which are drugs with new indications for known active ingredients.
(3) Improved vaccines for vaccine strains in Class 2.2 of preventive biological products.
(4) Biological products with new indications in Class 2.2 of therapeutic biological products.
(5) Chinese medicines in Class 2.3, which have increased functions and indications.
2. Patent Term Extension ("PTE") for New Drug Patents
According to Rule 81 of the Implementing Regulations, to seek a PTE in accordance with Paragraph 3, Article 42 of the 2021 Patent Law, a request for PTE must be filed within 3 years from the date on which the new drug approval is issued. The following requirements, among others, must be also met:
(1) If there are multiple patents for the same new drug, the patentee can only request a PTE based on one of the patents.
(2) If one patent covers multiple new drugs, a PTE can only be requested for one of the new drugs covered by the patent.
(3) The patent based on which a PTE is sought must remain valid and has not previously received a PTE grant.
According to Section 3.4, Chapter 9, Part V of the amended Patent Examination Guidelines, the below-listed requirements must also be met:
(1) The date of the patent grant publication should be earlier than the date of obtaining approval of the drug market application;
(2) The patent is in force at the time of filing the PTE request; and
(3) The claims of the patent based on which a PTE is sought include the technical solution related to the new drug for which market approval is issued.
3. Calculation of Compensation Period
According to Rule 82 of the amended Implementing Regulations, for an application seeking a PTE which meets Article 42(3) of the Patent Law, the time period allowed for the PTE shall be calculated by subtracting 5 years from the number of days between the patent filing date and the date on which the new drug market approval is issued in China.
4. Scope of Patent Protection during the PTE Period
According to Rule 83 of the amended Implementing Regulations, during the time period allowed for a PTE for a new drug, the scope of patent protection during that time period shall be limited to the new drug and its approved indications-related technical solutions. Within the scope of protection, the rights and obligations borne and assumed by the patentee shall be the same as before the PTE time period.
5. Examination of PTE Requests
According to Section 3.7, Chapter 9, Part V of the amended Patent Examination Guidelines, if it is determined through examination that a request for PTE does not meet the requirements for obtaining a PTE, the CNIPA shall give the patentee at least one opportunity to present arguments and/or correct the PTE request. If the PTE request still does not meet the requirements, a decision rejecting the PTE request shall be made.
If it is determined, through examination, that a drug is eligible for PTE and the patentee has already filed a request for patent term adjustment (PTA) for which the CNIPA has not yet made a decision, the examiner handling the PTE request shall wait until the decision on the PTA request is made before determining the time for granting the PTE. If the patentee has not filed a request for PTA and the 3-month deadline for filing the PTA request has not expired, the examiner handling the PTE request shall wait until the deadline for filing a request for PTE expires before determining the time for granting the PTE, unless the patentee explicitly waives the right to file a request for PTA.
If it is determined, through examination, that a request for PTE meets the all the requirements, the CNIPA shall make a decision to grant the PTE and inform the patentee of the number of days allowed for the PTE.
6. Remedial Procedure
According to Interim Measures No. 560 announced by the CNIPA on 21 December 2023, if a patentee is dissatisfied with a decision issued by the CNIPA on a PTE request, he/she may file a request with the CNIPA for administrative reconsideration.
VI. Early Resolution Mechanism for Pharmaceutical Patent Disputes
According to Article 76 of the 2021 Patent Law, if disputes arise between the applicant for marketing approval of a drug and the relevant patentee or an interested party regarding the patent covering the said drug during the review process of an application for marketing approval, the parties concerned can file a lawsuit with the People's Court to seek a judgment on whether the technical solution related to the said drug falls within the scope of protection of its drug patent. Within the prescribed time limit, the drug regulatory authority under the State Council can make a decision on whether to suspend the marketing approval for the drug based on an effective judgment issued by the People's Court. The applicant applying for marketing approval of a drug and the relevant patentee or an interested party can also request an administrative ruling from the CNIPA regarding patent disputes related to the drug.
Section 3, Chapter 9 of Part IV of the Patent Examination Guidelines provides for special guidelines for the examination of invalidation actions involving the early resolution mechanism for pharmaceutical patent disputes. Since this newsletter is mainly to introduce the key amendments in patent filing, patent prosecution and patent maintenance aspects, specific provisions regarding the above-mentioned early resolution mechanism and invalidation actions involving early resolution mechanism will not be elaborated here.
VII. Principle of Good Faith
In response to the 2021 Patent Law, the amended Implementing Regulations stipulate that patent applications should adhere to the principle of good faith established in the 2021 Patent Law. All types of patent applications should be based on genuine inventive activities and should not involve any fraudulent behavior. If there is evidence or sufficient reason to believe that the applicant has violated the principle of good faith during the patent application process, the application should not be granted patent right.
Correspondingly, the amended Patent Examination Guidelines stipulate that examiners can proactively introduce the principle of good faith into the examination process, whether as a reason for rejection during the examination or as grounds for invalidation in the invalidation procedure.
VIII. Open Licensing
The 2021 Patent Law (Articles 50 to 51), for the first time, brought the "patent open licensing" practice into China, with the following key points:
1. A patentee can voluntarily declare in writing to the CNIPA its willingness to grant licensing to any entity or individual to implement its patent, and specify the payment method and standards for license fees. The CNIPA will publish such open licensing declaration.
2. A patentee who submits an open licensing declaration for a utility model patent or a design patent should provide a patent right evaluation report.
3. A patentee can withdraw its open licensing declaration, and such withdrawal will be published by the CNIPA. The withdrawal of an open licensing declaration does not affect the validity of any prior granted open licensing.
4. Any entity or individual interested in practicing a patent under open licensing should notify the patentee in writing and, after paying the license fees according to the announced payment method and standards, can obtain a license for practicing the patent.
5. During the time period for an existing open licensing, reduction or exemption in patent annuity fees will be granted to the patentee.
6. A patentee implementing open licensing can negotiate and grant ordinary licenses for license fees after consultation with the licensee, but the patentee must not reach with another party an exclusive licensing or a licensing excluding others for the same patent.
The amended Implementing Regulations (Rules 85 to 88) provide further details on the open licensing system, which are mainly listed below:
1. A patentee who voluntarily declares open licensing for its patent should submit a declaration after the patent is granted. The content of the open licensing declaration should be accurate and clear, without commercial promotional language. The following items should be specified in the declaration:
(1) Patent number;
(2) Name or title of the patentee;
(3) Payment method and standards for license fees;
(4) Duration of the patent license;
(5) Other necessary details.
2. A patentee shall not offer its patent for open licensing under any of the following circumstances:
(1) It is still during the time period of an existing exclusive licensing or an licensing excluding others;
(2) The patent involves "suspension circumstances" specified in Articles 103 and 104 of the amended Implementing Regulations;
(3) The annuity fee is not paid on time;
(4) The patent right is pledged without the consent of the pledgee; and
(5) Any other circumstance(s) that hinders the effective practice of the patent.
3. If patent licensing is obtained through an open licensing arrangement, the patentee or the licensee should file a written document proving the licensing agreement with the CNIPA.
4. A patentee is not allowed to declare open licensing by providing false materials or concealing facts, or to obtain a reduction or exemption in patent annuity fees during the open licensing time period. An applicant or a patentee who violates this provision will be warned by a patent enforcement department at or above the county level, and may be fined up to 100,000 yuan.
The amended Patent Examination Guidelines further clarify that patent open licensing should adhere to the principles of voluntariness, legality, and openness. The said Patent Examination Guidelines also specify the submission, withdrawal, registration, announcement, and effectiveness of open licensing declarations, as well as the filing of open licensing implementation contracts, the procedures for fee reduction during the open licensing implementation period, and the handling of relevant procedures for patents that have already been implemented under open licensing.
IX. Design Patent Practice
1. Partial Design
In response to the 2021 Patent Law allowing design patent protection on partial designs, the amended Implementing Regulations have clarified, among others, the below-listed requirements for seeking design patent protection on partial designs:
(1) Submission of views of the entire product with indication of the claimed portion through a combination of solid and dashed lines or other manners; and
(2) Indicating in the Brief Description the claimed portion, except for cases where such has already been indicated in the views of the entire product through a combination of solid and dashed lines.
It is worth noting that each design in the design application of a set of products should be the design of the overall product, rather than a partial design of the product.
Correspondingly, the amended Patent Examination Guidelines further clarify the definition of partial design and related documentation requirements. If the original design application is for the overall design of the product, it is not allowed to file a divisional application from the original design patent application for a partial design. Similarly, if the original application is for a partial design of the product, it is not allowed to file a divisional application for the overall design or other partial designs of the same product. The amended Patent Examination Guidelines also specify that if the applicant makes the following amendments after the two-month period of voluntary amendments or when responding to an office action, the amendments shall not be considered as eliminating any existing defects of the originally filed application documents or as be in response to defects indicated in the office action, and thus will not be accepted:
(1) Amending the overall design to a partial design;
(2) Amending a partial design to the overall design; and
(3) Amending one partial design of the same overall product to another partial design.
2. Domestic Priority Claim
In response to the 2021 Patent Law which allows an applicant to claim domestic priority for a design patent application, the amended Implementing Regulations clarify that invention applications, utility model applications and design applications can all serve as the basis for claiming domestic priority for a design patent application. They also specify that if the earlier patent application, which serves as the basis for claiming priority of a design patent, is also a design patent application, the earlier patent application will be deemed withdrawn from the date of filing the subsequent design application. However, if the earlier patent application is an invention application or a utility model applications, the earlier application will not be deemed withdrawn.
X. Hague International Industrial Design
According to the 2021 Patent Law, the term of a design patent was changed from 10 years to 15 years, and such amendment was in line with China's subsequent accession to the Hague Agreement Concerning the International Registration of Industrial Designs. On 5 February 2022, China submitted the Instrument of Accession to the World Intellectual Property Organization for the Geneva Act (1999) of the Hague Agreement Concerning the International Registration of Industrial Designs (referred to as the "Hague Agreement" hereafter). The Hague Agreement entered into force in China three months later, on 5 May 2022. Therefore, starting from 5 May 2022, patent applicants can submit international applications for industrial designs to the International Bureau designating China or to the China National Intellectual Property Administration (to be transmitted to the International Bureau) under the Hague Agreement.
Correspondingly, the amended Implementing Regulations added a new chapter (Chapter 12: Special Provisions on International Applications for Industrial Designs, Articles 136-144) and the amended Patent Examination Guidelines also added a new section (Section 6: International Applications for Industrial Designs, including two chapters: Chapter 1: Transaction Handling for International Registration Applications of Industrial Designs; Chapter 2: Examination of International Applications for Industrial Designs) to govern the handling of Hague international design registration applications. These newly added chapters specifically stipulate the requirements for applicants to submit international registration applications for industrial designs through the China National Intellectual Property Administration, as well as the relevant matters for the examination of international applications for industrial designs designating China by the China National Intellectual Property Administration.
XI. Request for Delayed Examination
According to Article 56 of the amended Implementing Regulations, a patent applicant can request a delayed examination for its patent application. In accordance with the amended Patent Examination Guidelines, the following types of patents are eligible for delayed examination:
1. For an invention patent application, a request for delayed examination should be filed by the applicant at the same time when filing a request for substantive examination. However, the request for delayed examination for invention patents will only take effect from the date when the request for substantive examination becomes effective. The delayed examination period can be 1 year, 2 years, or 3 years from the effective date of the request for delayed examination.
2. For a utility model patent application, a request for delayed examination should be filed by the applicant at the same time when filing the utility model patent application. The delayed examination period is 1 year, 2 years, or 3 years from the effective date of the request for delayed examination.
3. For a design patent application, a request for delayed examination should be filed by the applicant at the same time when filing the design patent application. The delayed examination period is measured by number of months, with a maximum delayed examination period of 36 months from the effective date of the request for delayed examination.
After the expiration of the delayed time period, the patent application will be examined in order. If necessary, the CNIPA may initiate the examination process on its own and notify the applicant that the requested delayed examination period has terminated. Before the expiration of the delayed examination period, the applicant can request to withdraw the request for delayed examination. If the requirements are met, the delayed examination period will be terminated, and the patent application will be examined in order.
XII. Determination of Date of Receiving Service
The amended Implementing Regulations included important provisions as to electronic delivery of notifications and decisions from the CNIPA, under which the most important change is to delete "the 15-day mailing time period" (i.e., the date of receiving documents served by the CNIPA is the actual receiving date plus 15 days). According to Rule 4 of the Implementing Regulations, as of 20 January 2024, notifications, decisions and other official documents served electronically by the CNIPA to patent applicants, patentees, invalidation requesters, and other receipts will no longer enjoy the 15-day mailing period. The date of receiving service of such documents delivered electronically by the CNIPA will be the date on which the CNIPA electronically transmits these official documents into the electronic systems used and recognized by the receipts.
The amended Patent Examination Guidelines further state that if the date of electronically transmitting official documents into the electronic system used and recognized by the receipts does not coincide with the date of issuance of the documents, unless receipts can provide evidence proving otherwise, the date of issuing the official documents shall be considered as the date of service. It is unclear yet how to determine the "electronically transmitting official documents into the electronic system used and recognized by the parties." The answer to this question still needs clear handling guidelines to be adopted by the CNIPA.
XIII. Addition and Correction of Inventor(s)
In the past, the CNIPA accepts an application for adding/removing an inventor(s) or correcting inventor information at any time without affecting the filing date of the patent application. However, the amended Patent Examination Guidelines adopt a stricter standard regarding the timing for adding/removing an inventor(s) or correcting inventor information. If an inventor is not listed or if the inventor information is incorrected listed when filing a patent application, the applicant must submit a request for adding/removing an inventor(s) or correcting inventor information within 1 month from the date of receiving the CNIPA’s notice confirming receipt of the new patent application. In addition, the applicant must submit evidentiary document signed by all the applicants and all the inventors on official record before and after the request for adding/removing an inventor(s) or for correcting inventor information. The said evidentiary document should indicate the basis for the change and declare that, in accordance with the Implementing Regulations, the inventors after change have made substantial contributions to the inventive features of the invention.
XIV. Amendments in the Patent Examination Guidelines Which Are Not Related to Changes in the 2021 Patent Law or the Amended Implementing Regulations
The following items are included in the amended Patent Examination Guidelines but are not related to the amendments in the 2021 Patent Law and the amended Implementing Regulations.
1. Examination ex officio of Reexamination Cases and Invalidation Cases
As to examination of reasons and evidence in reexamination cases and invalidation cases, in the amended Patent Examination Guidelines, concrete examples of the below-listed two situations are added:
(1) where there is a defect(s) that is the same in nature as the one pointed out in the rejection decision; and
(2) where there is any other substantive defect(s) that was not pointed out in the rejection decision.
As to the examination ex officio of reexamination cases, the amended Patent Examination Guidelines further stipulate that, for evidence related to the defect(s) pointed out in the rejection decision, a Collegiate Panel may properly adjust the way of using the said evidence. For example, the Collegiate Panel may, based on the evidence relied upon in the rejection decision, alter the closest prior art reference or disregard a piece of the evidence among all. In addition, the Collegiate Panel may bring common knowledge in the same technical field into the review or supplement by relevant technical dictionaries, textbooks which may be considered as evidence commonly known in the same technical field.
As to the scope of collegial examination of invalidation cases, the amended Patent Examination Guidelines stipulate that, the Collegiate Panel may, when necessary, examine other facts which may obviously violate the provisions of the Patent Law or its Implementing Regulations, but the Collegiate Panel is not obliged to examine the case comprehensively. Depending on the actual case situation, the Collegiate Panel may conduct an oral examination, paper examination, or in a combination thereof. The oral examination may include offline examination, online examination, or in a combination thereof.
According to the amended Patent Examination Guidelines, the time limit for responding to a notification of oral examination in an invalidation case or a reexamination case shall not exceed 7 days in general. In an invalidation case, the patentee shall amend the patent text in consideration of the defect(s) pointed out in the invalidation brief or pointed out by the Collegiate Panel.
As to foreign-originated evidence, the below-listed requirement is deleted from the amended Patent Examination Guidelines:
"The foreign-originated evidence refers to evidence created in jurisdiction outside of China. Such foreign-originated evidence must be certified by the government agency in the jurisdiction in which the said evidence was created, or be certified by means of certification agreed upon in a treaty signed by China and the country in which the evidence was created."
In the amended Patent Examination Guidelines, the below-listed situation is also added, under which either party to an invalidation case can waive the requirement for certifying the evidence:
"The evidence has been verified by a judgment issued by the People's Court, a decision issued by an administrative agency or a decision issued by an arbitration institution."
2. Regarding the invention of genetic resources
The amended Patent Examination Guidelines, Part II, Chapter 1, Section 3.2, has added the following: (1) genetic resources, as referred to in the Patent Law, include genetic information generated from materials containing genetic functional units obtained from human beings, animals, plants, microorganisms, etc., which have actual or potential value; and (2) the genetic function of an invention utilizing genetic resources includes the analysis and utilization of genetic information generated from genetic functional units to complete the invention. In addition, this section also stipulates that, in accordance with the provisions of the "People's Republic of China Biosafety Law" and the "People's Republic of China Regulations on the Management of Human Genetic Resources," if the genetic resource information of our country is provided or made available to foreign organizations, it should be reported in advance to the competent administrative department of the State Council for science and technology and a backup of the information should be submitted. If it may affect public health, national security, and social public interests, it should also undergo a security review. If the completion of a certain invention relies on the provision of genetic resource information of our country to foreign organizations and the relevant procedures are not fulfilled, the patent right cannot be granted for that invention.
3. Invention re Diagnostic Methods
With the development of medical technology, the Patent Examination Guidelines have modified the criteria for judging the diagnosis and treatment methods of diseases.
Specifically, in the field of medicine, especially in new areas such as smart healthcare, devices with information processing capabilities such as computers are being more widely used to implement information processing methods related to diagnosis. In response to the protection needs of innovative entities for such inventions, the amended Patent Examination Guidelines, Part II, Chapter 1, Section 4.3.1.2, lists "information processing methods entirely implemented by devices such as computers" as an example that does not fall under diagnostic methods.
4. Invention Patents in the Field of Traditional Chinese Medicine
In order to further strengthen the guidance and protection of inventions in the field of traditional Chinese medicine, the amended Patent Examination Guidelines added into Part 2 Chapter 11 entitled "Several Provisions on the Examination of Invention Patent Applications in the Field of Traditional Chinese Medicine," which includes six sections. The major content of the Chapter includes the following:
(1) Subject Matters of Traditional Chinese Medicine Invention for Patent Protection: this section defines the subject matters of traditional Chinese medicine invention eligible for patent protection and the subject matters barred from invention patent protection.
(2) Specification and Claims: this section provides examination criteria as to "sufficient disclosure in a specification" and "clarity and support of claims" and also illustrates the same by case examples.
(3) Novelty: this section includes two parts: "Component Dosage Ratio of Chinese Medicinal Compositions" and "Diseases and Patterns Involved in Pharmaceutical Uses of Chinese Medicines". When evaluating the novelty, attention should be paid to the conversion of units of measurement in ancient prescriptions, the diseases and patterns in traditional Chinese medicine, as well as the relationship between them and the diseases or mechanisms of action of Western medicines.
(4) Inventiveness: this section provides examination principles and methods for determining the inventiveness of inventions regarding traditional Chinese medicinal compositions, with an emphasis that such determination shall be made in consideration of the characteristics of innovation of traditional Chinese medicine inventions. This section categorizes the traditional Chinese medicine inventions as "Modification of Prescription Inventions" and "Self-composed Prescription Inventions" and further specifies the types of "Modification of Prescription Inventions," and also provides respectively the principles and methods for determining the inventive step of each category of inventions with case examples as further illustration.
(5) Utility: this section clearly states that "doctor's prescription" and "methods for obtaining Chinese medicinal raw materials from animal bodies" cannot be practiced in industry and they lack utility.
XV. Regarding Drawings
In the past, all patent drawings must be prepared by using black ink. This requirement has been relaxed. Section 7.3 of Chapter 2 in Part 1 of the amended Patent Examination Guidelines specify that drawings should generally be prepared by using black ink, and color figures can be submitted if necessary to clearly describe the relevant technical content of the patent application.
The amendments and implementation of the Implementing Regulations of the 2021 Patent Law and the amended Patent Examination Guidelines provide more clear guidance for patent applicants as to the implementation of the 2021 Patent Law. However, some implementation details and examination criteria of specific new practices still need clarification after the amended Implementing Regulations and the amended Patent Examination Guidelines go into force on 20 January 2024. We will continue to monitor and share such information with our clients in a timely manner.