Being ready to get Patent Term Adjustment (PTA) in China

Being ready to get a Patent Term Adjustment (PTA) in China

Gasoll Feng

On June 1, 2021, with the latest amendment of the Patent Law in effect, a system called Patent Term Adjustment (PTA) and Patent Term Extension （PTE）for invention patents was introduced in China.

Article 42.2(PTA) If 4 years have passed since the filing date of the invention patent, and 3 years have passed since the date of the Substantive Examination Request when the invention patent is granted, the CNIPA shall, at the request of the patentee, extend the term of the invention patent for the unreasonable delay in the authorization process, excluding delays caused by the applicant.

Article 42.3(PTE) To compensate for the time occupied by the review and approval of a new drug for marketing, for relevant invention patents to the new drug that have obtained marketing approval in China, the CNIPA shall, at the request of the patentee, extend the term of the invention patent. The patent term extension shall not exceed 5 years, and the resulting total effective patent term shall not exceed 14 years from the approval for marketing of the new drug.

On December 21, 2023, the newly amended "Implementing Rules" and "Examination Guidelines," which will take effect on January 20, 2024, have been promulgated. The implementation of PTA and PTE is also clearly defined, making it possible for patentees to seek term extensions. This article will combine the detailed provisions of the rules and guidelines to explain the execution of the PTA under Article 42.2.

(1) Determination of the Term

For the grant of PTA, the compensation period is calculated based on the actual number of days of unreasonable delay in the authorization process of the invention patent. This actual number of days (X) is calculated as the number of interval days (A) from the issue date of the patent to the later one the date of the filing date plus 4 years or the substantive examination request date plus 3 years, minus the number of days (B) of reasonable delay, and the number of days (C) of unreasonable delay caused by the applicant, i.e., X = A - B - C.

1.1 Determination of the Interval Days (A)

When determining A, the issue date should be compared with the later of the patent filling date plus 4 years or the substantive examination request date plus 3 years. For example:

For an invention patent with a filling date of January 1, 2023, and a substantive examination request date of February 1, 2024, four years after the filling date is January 1, 2027, and three years after the substantive examination request date is February 1, 2027.

If the issue date is January 20, 2027 (any day from January 1 to January 31), since it does not meet the requirement of "three years from the date of the substantive examination request," the patent does not meet the requirement of Article 42.2. If the issue date is March 10, 2027, the actual interval days A should be 38 days, which is the number of days three years from the substantive examination request date.

1.2 Determination of Reasonable Delay (B)

Delays caused by the following circumstances are considered reasonable delays during the authorization process:

(1) Delays caused by modifying the patent application documents during the reexamination process under Rule 66;

(2) Delays caused by the suspension of proceedings due to litigation over the ownership of application rights under Rule 103;

(3) Delays caused by the suspension of proceedings due to a court ruling on the preservation measures for application rights under Rule 104;

(4) Other reasonable circumstances, such as administrative litigation procedures.

The delay related to the reexamination process mentioned in (1), is based on the premise that the applicant modifies the patent application documents. If the applicant has not modified the application when filing the reexamination request or replying to the reexamination office action, the corresponding delay time in the reexamination process will not be considered a reasonable delay.

1.3 Determination of Unreasonable Delay Caused by the Applicant (C)

The number of days of unreasonable delay caused by the applicant includes:

(1) Delays caused by not responding to the office actions issued by the CNIPA within the specified deadline, and the delay is calculated from the day after the expiration of the deadline to the actual date of submission of the response.

(2) Delays caused by requesting a delay in examination, and the delay is the actual number of days of delay in the examination.

(3) Delays caused by invoking accession, and the delay is the number of days of delay according to Rule 45.

(4) Delays caused by requesting the restoration of rights, and the delay is from the day after the expiration of the original deadline to the day when the approval notice of the restoration of rights is issued. This excludes delays that can be proven to be caused by the CNIPA.

(5) Delays caused by international applications entering the national phase within 30 months from the priority date, and the applicant did not request early processing. The delay is calculated from the day of entering the national phase in China to 30 months after the priority date.

(2) Request-Based System

Differing from the USPTO's automatic review of whether patent term adjustment is required, in China, PTA of invention patent rights must be requested by the patentee within three months from the issue, and the corresponding official fees must be paid.

According to the provisions of the Examination Guidelines, the Patent Office will examine the patentee's request. If, after examination, it is deemed that the request for patent term extension meets the conditions for term compensation, the Patent Office shall decide to grant term compensation, inform the patentee of the number of days of term compensation, and subsequently register the relevant matters in the patent register and announce them in the patent gazette. This process, compared to the United States where the corresponding extended days are directly stated in the published patent, has a certain lag.

(3) Remedial Measures

The Examination Guidelines also point out that if, after examination, the request for PTA does not meet the conditions for term compensation, the CNIPA should give the patentee at least one opportunity to state their opinions and/or submit correction documents. For cases that still do not meet the conditions for term compensation after this, a decision denying PTA should be made, and the patentee who made the request should be notified.

Considering the previous regulations, since the patentee cannot request specific days of extension, the author believes that if considering that the patent meets the requirements for term extension, the CNIPA will directly make a decision containing the number of days of PTA, without leaving any chance to make any comments on the number of days the patentee gets. Referring to the announcement (No. 560) issued by the CNIPA on December 21, 2023, if disagree with the decision of the CNIPA under Article 42(2) and (3) on whether to grant PTA or PTE, the patentee or an interested party can apply for administrative reconsideration. Therefore, from the current signs, whether it is during the examination process or in the administrative relief process after the decision, patentees cannot argue against the specific days of term extension made by the CNIPA.

(4) Invention Patents of Dual-Applications

Dual application in China specifically refers to the applications filed both for utility models and invention patents based on the same invention on the same day. Referring to Rule 78.4, the applicant applying for both a utility model patent and an invention patent on the same day, and gaining the invention patent based on Rule 47.4 by waiving the previously granted utility model, means that the invention patent does not apply to Article 42.2.

The author believes that the provision of Rule 78.4 only excludes one rather than all the situations of the dual application. If the invention patent is obtained not based on Rule 47.4 by waiving the utility model patent applied for on the same day, then the invention patent applied for on the same day can still request PTA according to Article 42.2. Therefore, the provision is significant for applicants and patentees to regain confidence in the dual application system, to some extent offsetting the negative impact of rumors in the industry about the "four-year delay in examination of same-day filed invention patent applications." Because even if the same-day filed invention is delayed in the examination for four years, patentees still have the opportunity to request PTA based on Article 42.2, and overcoming Rule 78.4 is not difficult to gain such an opportunity.

(5) Conclusion

According to Article 13 of the "Transitional Measures for Handling Examination Business Related to the Implementation of the Amended Patent Law and its Implementing Rules" issued by the CNIPA on December 21, 2023, for invention patents granted and announced since June 1, 2021, if the patentee, according to Article 42.2, requests for PTA of patent right within three months from the issue date and pays the relevant fees, the CNIPA will apply the amended Implementing Rules for examination from January 20, 2024. As of the time of writing, CNIPA has not announced the fee schedule. According to the Transitional Measures, if the patentee requests for PTA of the patent right before the fee schedule is published, they can pay the relevant fees within the period specified by the CNIPA after the fee schedule is published.

Therefore, patentees can check whether their patents meet the condition of interval days A greater than 0, and submit a request PTA within 3 months from the issue date.