On December 21, 2023, more than three years after the amendments to the Patent Law in 2020 (2020 Patent Law), the Implementation Regulations of the Patent Law (Rules) and the Guidelines for Patent Examination (Guidelines) were issued and came into force on January 20, 2024.¹ The amended Rules and Guidelines may impact your patenting strategy in China, including topics such as the Chinese versions of Patent Term Adjustment (PTA) and Patent Term Extension (PTE). We highlight below some of the most important changes that have been implemented in the Rules and Guidelines:

• Chinese version of PTA, offering extra patent term to make up for unreasonable delays in patent examination;
• Chinese version of PTE, allowing for compensation of patent term for delay by regulatory review;
• Design Patent, extending the protection to partial designs and graphical user interface (GUI);
• Restoration of Priority, allowing for correction of a priority issue after the filing of a patent application; and
• Incorporation by Reference, allowing applicants to fix inconsistency issues and bring the application in line with its priority application.

Patent Term Adjustment (PTA)

For the first time, the 2020 Patent Law incorporated the concept of PTA, which allows an extension of a patent term to compensate for any unreasonable delays due to patent examination carried out by the Chinese Patent Office, provided that the delay is not attributable to the applicant. Notably, the use of PTA at the China National Intellectual Property Administration (CNIPA) harmonizes with the general principle of PTA at the U.S. Patent and Trademark Office.

In order to qualify for PTA consideration by the CNIPA, the patent has to be issued i) four years or more after the filing date, AND ii) three years or more after the request of substantive examination. The request for PTA must be made within 30 days of issuance.

PTA is calculated according to the below formula:

PTA = Date of Issuance – the later of four years from filing and three years from substantive examination – Reasonable Delay – Applicant’s Delay

Reasonable Delay includes the delay due to reexamination, ownership dispute, or patent application preservation in civil procedures. Applicant’s Delay includes any extensions and the use of deferred examination.

Patent Term Extension (PTE)

The Chinese version of PTE makes up the term of a patent “pertaining to” a drug marketed in China for regulatory review delay for up to five years, provided that the total patent term with PTE after market approval is no more than 14 years. This approach to PTE is generally similar to that used in the U.S. Importantly, for a patent to be PTE eligible, the patent must be directed to a new drug that has not yet been marketed in China or abroad.

Only new drug product patents, preparation method patents, and medical use patents are eligible for PTE. For each new drug, only one patent is eligible for PTE, and for a patent covering multiple new drugs, the patent is eligible for only one of the new drugs covered. The scope of the patent during PTE is limited to the new drug or the approved indications for which PTE is granted. In the case of a conditional approval of a drug by the National Medical Products Administration (NMPA), the calculation is based on the time of conditional approval, but the request for PTE cannot be made until a regular approval by the NMPA. The request for PTE has to be made within three months of the NMPA approval and has to be before the expiration of the eligible patent.

Design Patent

The 2020 Patent Law expands the eligible subject matter of design patents by introducing partial designs that protect the aesthetic value of a portion of a product and GUI designs. The term for a design patent is extended to 15 years from the filing date; it was previously only 10 years. Domestic priority for a design patent and international design patents are also made available.

Restoration of Priority

As a designated Office, CNIPA now accepts restoration of the right to priority. Request for restoration has to be made within two months of filing or two months of national entrance. Addition or correction of priority claim may be requested within 16 months of the priority date or four months of the filing date.

Incorporation by Reference

As a designated Office, CNIPA now accepts incorporation by reference as a tool to correct any mistakes made to applications filed under the Patent Cooperation Treaty (PCT). When anything is missing or mistaken in a PCT application, but the priority application has the missing or correct information, incorporation by reference is available to bring anything in the claims, specification, and drawings of the priority application to the PCT application. In addition to the request for incorporation by reference during the international stage, a Chinese translation of the priority application has to be provided and a reference to the corresponding disclosure in the priority application has to be made upon Chinese national entrance.

We will monitor the additional impact of the Rules and Guidelines on patent practice before the CNIPA and provide updates accordingly.

For questions relating to the Chinese amended Rules or Guidelines, or any China-related patent questions, please contact Karen Wong, Richard Wang, or any member of the patents and innovations practice.

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[1] https://www.wipo.int/wipolex/en/legislation/details/13395. This abstract links to the main Chinese text.