After more than two years of drafts and revisions, the China National Intellectual Property Administration (CNIPA) issued the finalized version of the revised Rules for the Implementation of the Patent Law, as well as the Guidelines for Patent Examination on 21 December 2023. These changes will become effective as of 20 January 2024.
Both the new rules and examination guidelines include significant changes that will impact various aspects of patent applications and patent enforcement going forward. More detailed provisions corresponding to the 4th amendments of the Patent Law have been unveiled.
We can see a trend in the Chinese patent law system becoming more aligned and compliant with other major jurisdictions while maintaining its individual characteristics, including changes relating to priority claim, incorporation by reference and PTE/PTA, among others.
Changes to the Patent Law regulations in China
We have summarized these below, and encourage you to reach out to our team for further assistance with your patent applications in China.
- The 15-day mailing period deadline is no longer applicable for applications in electronic form.
- Restoration of the priority right can be made for a convention application within 14 months from the priority date, or for Chinese national phase of a PCT application within 2 months of national entry date.
- Correction or addition of priority claim can be made within 16 months of priority date or within 4 months of filing date.
- Incorporation by reference for missing or incorrectly filed claims, specification and drawings are applicable, subject to certain conditions and requirements.
- Drawings can now be in color, while the word count for invention title has increased from 40 to 60 words.
- Request to change inventorship needs to be made within one month from the date of Official Filing Receipt.
- Deferred examination can be requested for invention application by 1, 2 or 3 years, for utility model by 1 year, and for design application by months up to 36 months. It is allowed for the applicant to withdraw the request for deferment before the expiration of the delay period.
- Situations for grace period without loss of novelty further includes first disclosure in 6 months in academic or technical conferences held by international organizations and recognized by relevant authorities of State Council of China.
- Patent Term Adjustment (PTA)
Applicants are entitled to request patent term adjustment within 3 months from patent grant, if the invention patent was granted later than 4 years after the filing date and 3 years after the request for substantive examination.
Where compensation is granted for the patent authorization period, the number of days to be compensated is calculated as grant date minus 4 years from filing date or 3 years from the date of requesting substantive examination (whichever date comes later) and then minus number of days of reasonable delay and the unreasonable delay caused by the applicant.
- Reasonable delays include: (1) re-examination procedure where the patent is granted after amendments made to application documents during re-examination; (2) suspension procedure; (3) preservation measures; (4) other reasonable situations including, for example, administrative litigation.
- Unreasonable delays caused by the applicant include: (1) extensions of deadlines of responses; (2) deferred examination requested by the applicant; (3) delays caused by incorporation by reference; (4) delays caused by restoration; and (5) early entry of China national phase without requesting early processing.
PTA is not applicable to the invention patent via a dual-filing strategy.
- Patent Term Extension (PTE)
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PTE is available for new drug related patents, which refer to product patents, preparation method patents and medical use patents of API contained in a "new drug".
"New drug" refers to innovative drugs and specified improved new drugs according to the definition provisions of the related Laws and Regulations, and in accordance with National Medical Products Administration (NMPA) provisions.
"Improved new drugs" will be eligible if the classes listed on the drug certificates issued by NMPA fall into one of the following categories:
- Chemical drugs of class 2.1 that perform esterification or salification on known active ingredients
- Chemical drugs of class 2.4 (i.e. drugs containing known active ingredients for new indications)
- Preventive biological products of class 2.2 that are vaccines improved against bacterial or viral strains
- Therapeutic biological products of class 2.2 for new indications
- Traditional Chinese medicine of class 2.3 (i.e., traditional Chinese medicine with increased indications).
Referring to NMPA's classification, both innovative drugs and improved new drugs of above classes must be "world-new".
PTE must be requested within 3-months from the date of regulatory approval (RA) in China, and meet the following requirements:
- Issue date of the patent shall be earlier than the RA date
- The patent term has not expired before a PTE request is submitted*
- The patent has never been granted PTE before
- The new drug falls within the protection scope of the patent
- If the drug is covered by multiple patents, PTE request is only available for one patent
- If one patent covers multiple drugs, PTE request can only be based on one drug.
* For patents that expire before 20 January 2024, PTE is still available if requirements for PTE are met.
Compensation period of PTE is calculated as (RA date minus application date) minus 5 years. The compensation period shall not exceed 5 years while maximum term after RA shall not exceed 14 years.
Calculation of compensation period of PTE follows the calculation of compensation period of PTA, if applicable. PTE and PTA can both be applied for one patent.
The protection scopes during PTE period are limited to the approved new drug and approved new indication.
- Patent linkage system related invalidation cases
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For an invalidation request made by generic applicants after submitting Type 4 Declaration, the generic applicants shall make a clear statement that the invalidation request is against patents registered on the Drug Approval Patent Registration Platform, and provide copies of receipt of abbreviated new drug application (ANDA) as well as the Type 4 Declaration documents.
Meanwhile, the patentee shall notify the CNIPA panel the information related to the litigation or administrative ruling related to the patent at issue in time, if applicable.
Multiple invalidation requests filed against one drug patent shall be examined in order, based on the submission dates of the respective requests.
- Computer Implemented Inventions related cases
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Eligibility
Information processing methods where all steps are executed by devices such as computers are NOT disease diagnostic methods.
Computer program (software) can be further protected as computer-readable storage media, or computer program products, while eligible subject matters include "a method", "a computer device/apparatus/system", "a computer-readable storage media", or "a computer program product".
AI and big data algorithms can be eligible subject matters if the algorithm has a specific technical relationship with the internal structure of the computer system, and can solve the technical problem of how to improve hardware computing efficiency or execution results.
Big data processing solutions can be eligible if data mining uses the internal relationships that conform to the laws of nature, and solves the technical problem of how to improve the reliability or accuracy of big data analysis in the specific application field.
Inventiveness assessment
If the algorithm which has a specific technical relationship with the internal structure of the computer system achieves improvement of the internal performance of the computer system, such algorithm shall be considered when assessing inventiveness.
If a solution can bring about improvement in user experience, and such improvement is brought about by technical features, or by technical features and algorithm features or business rules and method features that mutually support and interact with each other, such improvement in user experiences shall be taken into consideration when assessing inventiveness.
- Partial Designs and GUI Designs
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Partial design that does not form a relatively independent region on the product or constitute a relatively independent design unit and that are only designs of patterns or combinations of patterns and colors on the surface of the product are not patentable.
For partial design applications, the views of the whole product should be submitted and the part to be protected should be illustrated by combinations of dashed lines and solid lines or by alternative acceptable ways. Brief statement shall indicate the part to be protected unless it is illustrated by combinations of dashed lines and solid lines in the views of the whole product. For partial designs, the title should include both the name of the overall product and the claimed subject matter.
Where the initial design application is a design for a whole product, it is not allowed to file divisional application based on part of the whole product as a partial design application. Where the initial design application is a partial design application, it is not allowed to file divisional application based on the whole product or the other parts of the product.
Applicants can file GUI design applications incorporated in a whole design or partial design of the product.
Particulars for procedure and examination for international design application through Hague Agreement are specified in a new Part (VI) of the Guidelines for Examination.
- Rewards for inventors increase to RMB4,000 for an invention patent (vs. previous RMB3,000) and RMB1,500 for a utility model or design patent (vs. previous RMB1,000), provided there is no contract or agreement.
- Where a change in applicant has been recorded in the international phase, additional documents in support of the applicant change shall only be provided when necessary at the time of China national entry.
- Principle of "Honesty and credibility" shall be examined at all stages, including preliminary examination, substantive examination and re-examination, as well as during an invalidation procedure.
- The details of Open Licensing system have been stipulated, particularly including the requirements for the eligible patents.
How Spruson & Ferguson can help
Some of the changes to the Rules for the Implementation of the Patent Law of the People's Republic of China are quite detailed, so always seek local expert advice to ensure you understand how they relate to your specific application/s and circumstances.
Spruson & Ferguson has highly skilled local Patents teams with qualifications and experience across a wide range of technologies and disciplines in Beijing and Hong Kong. Please don't hesitate to reach out for further assistance with your patent matters and enquiries.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
