PRC’s Patent Law overhauled in last October is due to take effect from June 1, 2021. In late January, the CNIPA released a set of proposed amendments to the Implementation Rules for the Patent Law. There follows a brief overview on the major amendments to the Implementation Rules with respect of application and prosecution.
On Design Application
Regarding partial design applications which will become acceptable from June 1, 2021, the amendments include: “[the applicant] shall submit drawings for the entire product and manifest the claimed design portion by means of a combination of solid lines and dashed lines, or by other means” (Rule 27) and “the claimed portion is to be described in the brief specification, where necessary” (Rule 28).
On Priority Claim
1. Restoration of Priority Claim
According to the proposed new Rules, where an applicant fails to file an invention or utility model application by the priority deadline, it is permissible to “request for restoration of the priority claim within two months from the deadline, upon specifying the reason [for the delay] and paying the official fees” (Rule 31-1).
2. Addition or Correction of Priority Claim
Again, in an invention patent or utility model application, where an applicant fails to claim priority or fails to claim it correctly at the time of filing, it is permissible to “request for addition or correction of the priority claim within sixteen months from the priority date or within four months from the filing date” (Rule 31-2).
More Flexibility on Deadlines
1. More Administrative Freedom to CNIPA
Rule 6 will include a new clause: “In case of a national state of emergency or extraordinary circumstance, CNIPA may extend any deadlines stipulated in these Rules or designated by the CNIPA itself, and may simplify the related procedures.”
2. Incorporation by Reference a Part of Claims or Specification
According to this new Rule, “where a part of the claims or specification is missing from an invention patent or utility model application [when it is filed], the applicant may submit the same through incorporation of the priority document within two months from the filing date or by a CNIPA-designated deadline, and hence retain the filing date.”
The Rule provides, “in an invention or utility model application, the Applicant is allowed to submit either the Claims or specification by means of incorporation of the priority document within two months from the filing date or by a CNIPA-designated deadline.”
Request for Deferral of Examination
Deferral of examination is not new. Since 2019, the Examination Guidelines have permitted requests for deferral of examination of invention or design patent applications for a maximum period of three years. What the CNIPA proposes now is merely giving the present practice a formal legal backing, saying that “applicants are allowed to submit request for deferral of examination for invention or design applications” (Rule 50).
Patent Term Adjustment
Under the newly introduced Article 42.2 of PRC’s Patent Law, patent term adjustment will be granted, upon request, to compensate for “unreasonable delay not attributable to the applicant” in the examination process of an invention application. What counts as “unreasonable delay not attributable to the applicant?”
According to the proposed new Rules, a delay is not compensable if it is caused by any of the following events:
- Not responding to an Official Letter from the CNIPA within a designated time period;
- Deferral of examination;
- Incorporation [by reference of a priority document]; or
- Other circumstances [the CNIPA deems reasonable], except for suspension of examination due to an entitlement dispute or a preliminary injunction order from the court (Rule 85-3).
Patent Term Extension (PTE)
Definition of “New Drug Patents”
According to the proposed new Rules, the PTE program shall apply to a patent calling for the active ingredients of a new drug as authorized in the new drug’s first marketing approval from PRC’s National Medical Products Administration (NMPA), including “a patent on chemical drugs, bio products, preparation methods, or medical uses.”
How to request for PTE?
- A PTE request shall be made by a patentee to the CNIPA within three months from the date of issuance of the [first] marketing approval for the new drug.
- Where a new drug is covered by multiple patents, the patentee is allowed to request for PTE on one patent only.
- Likewise, where a patent calls for multiple new drugs, the patentee is allowed to request for PTE on one new drug only.
- A PTE can be granted only one time on a patent.
- The remaining duration term of the patent of concern shall not be less than six months at the time when the PTE is requested.
How Is PTE Calculated in PRC?
The proposed new Rules introduce a formula for calculating the PTE, which goes as “issuance date of the new drug marketing approval minus the filing date of the patent application and minus five years.”
Restricted Protection Scope
According to the proposed new Rules, “the protection scope of a new drug patent during the extended term shall be restricted to cover only the indications of the new drug authorized by the NMPA.”
Other Changes Related to Filing and Prosecution
The current requirement of “conducting a license recordal within three months from the date the license takes effect” will be deleted from Rule 14, while a new clause will be added which says “a non-recorded license shall not be held against a bona fide third party.” However, the part of the Rule on assignment recordal remains unchanged.
The Patent Examination Board
According to the proposed new Rules, when reviewing the CNIPA’s rejection of a patent application, the Board will be empowered “to consider a defect [in the application] not indicated in the rejection”, and in an invalidation action it may “consider a cause not raised by the petitioner”, provided it has given the parties an opportunity to express their views on these new issues (Rules 62-1 and 68-1).