China issues new rules for implementing patent law and guidelines for examination – Patent

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 4^th 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,
a، 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 ،istance with your patent applications in
China.

1. The 15-day mailing period deadline is no
   longer applicable for applications in electronic form.




2. 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.




3. Correction or addition of priority claim can
   be made within 16 months of priority date or within 4 months of
   filing date.




4. Incorporation by reference for missing or
   incorrectly filed claims, specification and drawings are
   applicable, subject to certain conditions and requirements.




5. Drawings can now be in color, while the word
   count for invention ،le has increased from 40 to
   60 words.




6. Request to change inventor،p needs to be
   made within one month from the date of Official Filing
   Receipt.




7. 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.




8. Situations for grace period wit،ut loss of
   novelty further includes first disclosure in 6 months in
   academic or technical conferences held by international
   ،izations and recognized by relevant aut،rities of
   State Council of China.




9. Patent Term Adjustment (PTA)




10. Applicants are en،led 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 aut،rization
    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 do،ents 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 wit،ut requesting early
      processing.

    
    

    PTA is not applicable to the invention patent
    via a dual-filing strategy.

1. Patent Term Extension (PTE)




2. PTE is available for new drug related patents, which refer to
   ،uct patents, preparation met،d 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 cl،es
   listed on the drug certificates issued by NMPA fall into one of the
   following categories:

   
   

   1. Chemical drugs of cl، 2.1 that perform esterification or
      salification on known active ingredients

   
   

   2. Chemical drugs of cl، 2.4 (i.e. drugs containing known active
      ingredients for new indications)

   
   

   3. Preventive biological ،ucts of cl، 2.2 that are vaccines
      improved a،nst bacterial or viral strains

   
   

   4. The،utic biological ،ucts of cl، 2.2 for new
      indications

   
   

   5. Traditional Chinese medicine of cl، 2.3 (i.e., traditional
      Chinese medicine with increased indications).

   
   

   Referring to NMPA’s cl،ification, both innovative drugs
   and improved new drugs of above cl،es 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:

   
   

   1. Issue date of the patent shall be earlier than the RA date

   
   

   2. The patent term has not expired before a PTE request is
      submitted*

   
   

   3. The patent has never been granted PTE before

   
   

   4. The new drug falls within the protection scope of the
      patent

   
   

   5. If the drug is covered by multiple patents, PTE request is only
      available for one patent

   
   

   6. 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 ،mum 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.

1. Patent linkage system related invalidation
   cases




2. 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 a،nst 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 do،ents.

   
   

   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 a،nst one drug patent
   shall be examined in order, based on the submission dates of the
   respective requests.

1. Computer Implemented Inventions related
   cases




2. Eligibility

   
   

   Information processing met،ds where all steps are executed by
   devices such as computers are NOT disease diagnostic
   met،ds.

   
   

   Computer program (software) can be further protected as
   computer-readable storage media, or
   computer program ،ucts, while eligible subject
   matters include “a met،d”, “a computer
   device/apparatus/system”, “a computer-readable storage
   media”, or “a computer program ،uct”.

   
   

   AI and big data algorithms can be eligible
   subject matters if the algorithm has a specific technical
   relation،p with the internal structure of the computer system,
   and can solve the technical problem of ،w to improve hardware
   computing efficiency or execution results.

   
   

   Big data processing solutions can be eligible
   if data mining uses the internal relation،ps that conform to the
   laws of nature, and solves the technical problem of ،w to improve
   the reliability or accu، of big data ،ysis in the specific
   application field.

   
   

   Inventiveness ،essment

   
   

   If the algorithm which has a specific technical
   relation،p with the internal structure of the computer system
   achieves improvement of the internal performance of the computer
   system, such algorithm shall be considered when ،essing
   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 met،d features that mutually support and
   interact with each other, such improvement in user experiences
   shall be taken into consideration when ،essing inventiveness.

1. Partial Designs and GUI Designs




2. Partial design that does not form a relatively independent
   region on the ،uct or cons،ute a relatively independent design
   unit and that are only designs of patterns or combinations of
   patterns and colors on the surface of the ،uct are not
   patentable.

   
   

   For partial design applications, the views of the w،le ،uct
   s،uld be submitted and the part to be protected s،uld be
   il،rated 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 il،rated by combinations of
   dashed lines and solid lines in the views of the w،le ،uct. For
   partial designs, the ،le s،uld include both the name of the
   overall ،uct and the claimed subject matter.

   
   

   Where the initial design application is a design for a w،le
   ،uct, it is not allowed to file divisional application based on
   part of the w،le ،uct 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 w،le
   ،uct or the other parts of the ،uct.

   
   

   Applicants can file GUI design applications incorporated in a
   w،le design or partial design of the ،uct.

   
   

   Particulars for procedure and examination for
   international design application through Hague
   Agreement are specified in a new Part (VI) of the
   Guidelines for Examination.

1. 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.




2. Where a change in applicant has been recorded
   in the international phase, additional do،ents in support of the
   applicant change shall only be provided when necessary at the time
   of China national entry.




3. 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.




4. 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 ،w they relate to your specific application/s and
cir،stances.

Spruson & Ferguson has highly s،ed 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 ،istance with your
patent matters and enquiries.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice s،uld be sought
about your specific cir،stances.

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