The Draft Revised Patent Examination Guidelines (“Draft Guidelines“) were posted for public comment on August 3, 2021, by the China National Intellectual Property Administration (CNIPA). The amendments in the Draft Guidelines reflect the newly updated Chinese Patent Law, which took effect on June 1, 2021, as well as the Chinese Patent Law’s Draft Revised Implementing Regulations (“Draft Regulations“).

The aspects of the Draft Guidelines that are applicable to pharmaceutical products are summarised in this article.

System for Linking Patents: The Chinese National Medical Products Administration (NMPA) and the Chinese National Intellectual Property Administration (CNIPA) concurrently published Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Interim) (“Measures“) on July 4, 2021, which went into effect on the same day. The Measures describe how China’s patent linking system will operate.

According to the Measures, a generic applicant must make one of the four declarations below when applying for marketing permission in China, based on relevant patent information of the matching brand drug listed on the registration platform for medications marketed in China.

Type 1: The platform does not have any relevant patents.

Type 2: The platform has a relevant patent. On the other hand, the applicable patent has either expired or been deemed invalid, or the generic applicant has obtained a licence from the patentee.

Type 3: The platform contains a relevant patent, but the generic/biosimilar applicant will not market its product before the patent expires.

Type 4: The platform contains a relevant patent, but the patent should be deemed invalid, or the generic product does not come within the patent’s scope.

Suppose a patentee or interested party objects to a generic applicant’s Type 4 declaration. In that case, they can file a lawsuit in court or ask the CNIPA to make an administrative ruling on whether the generic product’s technical specifications fall within the scope of a relevant patent within 45 days of the generic application’s publication date.

A 12-month market exclusivity term is available to the first generic applicant who (1) successfully challenges a brand drug’s patent and (2) is authorized to access the market in China. NMPA may still consider but not approve other generic medication applications during this time (except for co-challengers).

According to the Draft Guidelines, a generic applicant must make the Type 4 declaration before filing a petition with the CNIPA to invalidate the relevant patent. If the CNIPA receives numerous petitions for the same patent to be invalidated, the petitions will be processed in the order they were received.

Adjustment of Patent Term (PTA): The Draft Guidelines specify that PTA may be available for a patent awarded over four years from the date of filing and three years after the date of the request for examination, in compliance with the modified Chinese Patent Law. The applicant must request the PTA within three months of the date of issue, together with payment of a fee.

The Draft Guidelines also state that the filing date of the national stage application is utilized to calculate the PTA for a Chinese national stage application derived from a PCT application. PTA is also calculated for a divisional application based on the divisional application’s filing date rather than the parent application’s. The mailing date of the notice of entering examination is also included in the Draft Guidelines as the date of seeking examination.

The PTA is derived by subtracting the CNIPA’s unreasonable delays from applicant delays. Some examples of application delays are given in the Draft Guideline, including:

Failure to respond to a CNIPA communication within the time limit indicated;

Failure to clearly seek examination to begin prior to the 30-month date for applications entering the Chinese national stage before the 30-month date;

Obtaining a postponed examination request

Incorporation by reference of a priority application in a PCT stage to add aspects that were mistakenly omitted in the priority application.

PTA is only eligible for inventive patents issued on or after June 1, 2021, according to a CNIPA document posted on May 27, 2021, and any request for PTA will only be processed after the Regulations are completed.

According to the Draft Regulations, PTE is only applicable for patents on active substances, manufacturing techniques, and medical uses. According to the Draft Guidelines, PTE only applies to claims relating to NMPA-approved active substances, manufacturing procedures, and medicinal applications.

The Draft Guidelines also imposed various restrictions on PTE requests (some of which were incorporated into the draught Regulations):

The patentee must request PTE within three months of the drug’s approval date. If the patentee is not the same as the drug marketing authorization holder, the patentee must obtain the holder’s approval before requesting the PTE.

Prior to the drug’s approval date, the patent must be issued.

When PTE is sought, the patent must be active.

The patent must not have had any earlier PTE granted to it.

PTE can only be requested for one patent when there are many patents relating to medicine.

When a patent covers numerous medications, the patent term can only be extended for one of them under PTE.

In addition, the Draft Guidelines state that if a patentee requests both PTA and PTE for a patent, the CNIPA should decide on the PTE request after the PTA. Suppose the patentee has not requested PTA and the three-month period for requesting PTA has not expired. In that case, the CNIPA shall wait until the three-month period has expired before determining the PTE (unless the patentee expressly waives the request for PTA). As a result of these provisions in the Draft Guidelines, a patent may be granted both PTA and PTE.

Grace Period for 15-Day Mail Delay: Electronically filed applications will no longer be eligible for the 15-day mail delay grace period when determining deadlines to respond to CNIPA messages.

Conclusion: Only the Measures relevant to the patent linking system have been finalized since the new Patent Law will be in effect. The finalized Regulations and Guidelines, which have yet to be promulgated, will determine the influence of the modified Patent Law on other parts of the Chinese patent system. When the definitive copies of the Regulations and Guidelines are available, we will give additional updates.

Disclaimer: The present article intends to provide general guidance on the subject, and you can also consult us in your specific case.