連邦國際專利商標事務所 TSAI, LEE & CHEN : Patent Attorneys & Attorneys at Law

In October of 2020, China passed the new Patent Law which was then scheduled to be effective on June 1^st, 2021. Patent Law is a structural framework at a superior hierarchy to navigate patent policy. Phrasing is usually short and concise. How a specific statutory clause is to be carried out, it is sometimes resorting to auxiliary laws of lower level such as the Implementation Rules. To correspond to the new Patent Law in advance, CNIPA released a proposed version of the new Implementation Rules for Patent Law (new Rules) to invite public review and inputs.[1] Here are the digest for the new Rules.

Summary of invention is a necessary component for a complete filing of invention or utility model. For a patent application having drawings, the applicant must designate one figure which best illustrate the technical features of the invention or utility model as the drawing in the summary section.[2] Particularly, the new Rules relieve the drawings from possessing a minimal resolution that each detail remains discernable when a figure zooms in to the size of 4 cm x 6 cm. What is more, although the Patent Act requires conciseness of summary, the word count ceiling does not limit to 300 words anymore.

Partial design will become eligible subject matter as per new Patent Law. The scope of a design is defined by the drawings. To present the claimed part, the drawings shall present the entire product by solid lines and specific claimed part by dotted lines respectively.[3] Besides, the section of description shall include a paragraph to state explicitly the claimed part.

Restoration of priority is made possible.[4] For inventions and utility models beyond the 12-month period to file an application in China claiming priority to a first-filed foreign application, the applicant is able to restore the priority within two (2) months from the expiration of the 12-month period with paying additional fees. For erroneous or oblivious claim of priority at the time of filing an invention or utility model application, correction or addition of priority is available within 16 months from the priority date or four (4) months from the Chinese application day.[5]

In a PCT application that claimed priority but the international filing is made within two (2) months beyond the expiration of the 12-months period for priority, the applicant is able to restore priority within two (2) months from the entrance to the Chinese national phase, if the applicant fails to restore successfully the same during the international phase.[6]

According to the new Rules, any entity or individual is able to request for a patent evaluation report for a granted patent. The patent applicant can request for the same at the time to register an allowed patent application.[7] The CNIPA shall duly finish a report, against a granted patent within two (2) months from the time receiving a request, or against an allowed patent application within two (2) months from the time of the grant publication.[8] For one utility model or design’s granted patent or allowed application, there is only one evaluation report will be made.

CNIPA will have expanded powers to examine more proactively in the two proceedings. In re-examination, when necessary the CNIPA may raise new grounds of non-patentability that are not previously rejected during the first examination, while CNIPA shall offer the applicant an opportunity to respond.[9] Similarly, in invalidation, when necessary the CNIPA may examine other grounds of invalidity not previously challenged by the petitioner, and then shall offer the applicant an opportunity to respond.[10]

The patentee may voluntarily declare in writing that any entity or individual is able to obtain a license. A declaration shall include the patent number, the name of patentee, the royalty payment, any prerequisite(s), term of license, etc. The patentee may withdraw a license declaration. But the granted license before such a withdrawal remains binding until the license term ends. Unanimous consent of a declaration or withdrawal of an open license is necessary if a patent is owned by multiple parties.

Under any of the following circumstances, an open license declaration is not permitted:[11] The patent has been licensed to another exclusively or solely and meanwhile the patent license has been recorded; the patent has involved in a dispute or the court orders a preliminary injunction to suspend the patent; the patent has been behind an annuity payment; the patent has been pledged without a permission from the pledger; and others.

For an invention patent granted after four (4) years from filing or three (3) years from examination, the patentee may request a term adjustment to make up for the unreasonable delay attributable to the examiner during examination.[12] A request for adjustment shall be made within three (3) months from the patent grant.[13] Notably, any of the following circumstances of delay does not count into adjustment:[14] (1) applicant’s failure to duly make a response to the CNIPA’s Office Action within a designated period; (2) a postponement of examination; (3) incorporation by reference; and (4) others. Besides, a halt in patent prosecution owing to dispute of ownership or owing to a court’s order of preliminary injunction is not a delay countable to adjustments.

There will be a mechanism to compensate for the time of unenforceability of a drug patent due to a market approval examination by the National Medical Products Administration (NMPA, f.k.a. the CFDA). The patentee may request a term extension to compensate for the unenforceable period for a maximum of 5 years and the remaining patent term in total caps at 14 years after the launch of a new drug.[15] Extension will be available for patents of composition, method of preparation, or medical use, for (a) new chemical entities, (b) biologics, or (c) Chinese traditional medicines.[16] The mathematical formula to calculate the total timeframe of extension is:

“(Date of drug approval issuance) – (date of patent filing) – (5 years)”[17]

The scope of enforceable patent right during the extended term limits to only the “overlap” of the patent and the approval - namely the specific drug and indication(s) granted in the approval.[18] A request for extension must be made within 3 months from the issuance of approval, and the patent requested shall have a remainder of term no less than 6 months.

[19] A patent can only be extended once. Only one patent can be extended if one approved drug product associates with multiple patents; whereas only one approved drug product can be used to extend the patent if the patent involves multiple approved drug product

[1] https://www.cnipa.gov.cn/art/2020/11/27/art_75_155294.html

[2] Implementation Rules for Patent Law (2020; Draft) §23

[3] Id. §27

[4] Id. §31-1

[5] Id. §31-2

[6] Id. §110-1

[7] Id. §56

[8] Id. §57

[9] Id. §62-1

[10] Id. §68-1

[11] Id. §72-3

[12] Patent Law (2020) §42(2)

[13] Implementation Rules for Patent Law (2020; Draft) §85-2

[14] Id. §85-3

[15] Patent Law (2020) §42(3)

[16] Implementation Rules for Patent Law (2020; Draft) §85-4

[17] Id. §85-5

[18] Id. §85-6

[19] Id. §85-7

CNIPA proposed a new draft for the Implementation Rules for Patent Law