On August 3, 2021, the China National Intellectual Property Administration (CNIPA) released the Draft Revised Patent Examination Guidelines (“Draft Guidelines”) for comments. The revisions in the Draft Guidelines reflect the recently amended Chinese Patent Law that came into effect on June 1, 2021, and the Draft Revised Implementing Regulations (“Draft Regulations”) of the Chinese Patent Law. This article summarizes selected provisions in the Draft Guidelines that are relevant to pharmaceutical products.
Patent Linkage System
In an earlier post, we discussed the patent linkage system implemented in the 4th amendment to the Chinese Patent Law. On July 4, 2021, the National Medical Products Administration (NMPA) of China and CNIPA jointly issued Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Interim) (“Measures”), which became effective on the same day. The Measures provide details on how the Chinese patent linkage system will work.
According to the Measures, when a generic applicant submits its application for marketing authorization in China, it must make one of the four declarations below based on relevant patent information of the corresponding brand drug listed on the registration platform for drugs marketed in China.
- Type 1: There is no relevant patent on the platform.
- Type 2: There is a relevant patent on the platform. However, the relevant patent has expired or has been declared invalid, or the generic applicant has a license from the patentee.
- Type 3: There is a relevant patent on the platform but the generic/biosimilar applicant will not sell its product before expiration of the patent.
- Type 4: There is a relevant patent on the platform, but the patent should be declared invalid, or the generic product does not fall into the scope of the patent.
If the patentee or interested party has objections to the Type 4 declaration of a generic applicant, they may, within 45 days from the publication date of the generic application, file a lawsuit in a court or request the CNIPA to make an administrative ruling as to whether the generic product’s technical specifications fall into the scope of a relevant patent.
The first generic applicant who has (1) successfully challenged a brand drug’s patent and (2) is first approved to enter the market in China, can enjoy a 12-month market exclusivity period. During this period, NMPA may still review but will not approve other generic drug applications (except for co-challengers).
The Draft Guidelines provide that a generic applicant should make the Type 4 declaration before they submit their petition to invalidate the relevant patent before the CNIPA. If the CNIPA receives multiple petitions for invalidating the same patent, the petitions will be processed by the order of the petition dates.
Patent Term Adjustment (PTA)
In accordance with the amended Chinese Patent Law, the Draft Guidelines provide that PTA may be available for a patent granted over four years from its filing date and three years after the date of request for examination. The PTA must be requested by the applicant within three months from the issue date with the payment of a fee.
The Draft Guidelines further clarify that, for a Chinese national stage application from a PCT application, the filing date of the national stage application is used for PTA calculation. Also, for a divisional application, PTA is calculated based on the filing date of the divisional application rather than the parent application. The Draft Guidelines also state that the date of requesting for examination is the mailing date of the notice of entering examination.
The PTA is calculated as the unreasonable delays by the CNIPA subtracted by applicant delays. The Draft Guideline give some examples of applicant delays, including:
- Failure to respond to a CNIPA communication within the specified time period;
- For applications entering the Chinese national stage before the 30-month date, failure to expressly request examination to start prior to the 30-month date;
- Filing a requesting for deferred examination
- Adding inadvertently omitted elements disclosed in priority application in a PCT stage by incorporation by reference of the priority application.
Of notes, according to a publication released by CNIPA on May 27, 2021, PTA is only available for invention patents issued on or after June 1, 2021, and any request for PTA will only be processed after the Regulations are finalized.
Patent Term Extension (PTE)
We have discussed PTE in an earlier post. The Draft Guidelines provide further clarifications on PTE regulations.
Regarding the type of drugs whose patents are eligible for PTE, the Draft Guidelines provide that PTE is available for patents of “innovative new drugs” and some “improved new drugs,” as defined in the Drug Registration Regulations and related guidelines issued by the National Medical Products Administration (NMPA) of China. According to the Draft Guidelines, for “improved new drugs” (i.e., class 2 drugs, which are improved drugs having not been marketed in or outside China), only some kinds of drugs in this category are eligible for PTE. Such class 2 drugs include “class 2.4 drugs” (drugs that contain known active ingredients but are used for a new indication), “class 2.2 prophylactic biologics” (improved vaccines), and “class 2.2 therapeutic biologics” (biologics that contain known active ingredients but are used for a new indication). Thus, according to the Draft Guidelines, patents related to drugs that have already been marketed outside China are not eligible for PTE.
According to the Draft Regulations, PTE is only available for patents directed to active ingredients, manufacturing methods, and medical uses. The Draft Guidelines specify that PTE only applies to the claim scope correlating to the NMPA-approved active ingredients, manufacturing methods, and medical uses.
The Draft Guidelines also set forth some limitations on the request for PTE (some have been included in the draft Regulations):
- PTE must be requested by the patentee within three months from the drug’s approval date. If the patentee is different from the drug marketing authorization holder, the patentee must have the permission from the holder to request the PTE.
- The patent must be granted prior to the drug’s approval date.
- The patent must be alive when PTE is requested.
- There must not be previous PTE granted to the patent.
- When there are multiple patents related to a drug, PTE can only be requested for one patent.
- When a patent covers multiple drugs, the term of the patent can only be extended under PTE for one drug.
Also, the Draft Guidelines provide that if the patentee has requested both PTA and PTE for a patent, the CNIPA should determine on the PTE request after the PTA is determined. If the patentee has not requested PTA but the 3-month time limit for requesting PTA has not expired, the CNIPA should wait until the expiration of the three month limit to determine the PTE (unless patentee expressly waives the request for PTA). Thus, these provisions in the Draft Guidelines suggest that a patent can receive both PTA and PTE.
According to the publication released by CNIPA on May 27, 2021, PTE is only available for patents related to drugs approved on and after June 1, 2021. Also, Similar to PTA, any request for PTE will only be processed after the finalized Regulations take effect.
15-Day Mail Delay Grace Period
Another update in the Draft Guidelines relevant to U.S. applicants is that electronically filed applications will no longer be entitled to the 15-day mail delay grace period when calculating deadlines to respond to CNIPA communications.
Since the amended Patent Law came into effect, only the Measures related to the patent linkage system have been finalized so far. The impacts of the amended Patent Law on other aspects of the Chinese patent system will depend on the finalized Regulations and Guidelines, which have not been promulgated yet. We will provide further updates when the finalized versions of the Regulations and Guidelines are available.