On 4th July 2021 (as specific celebration to the US?). The link is as below:
www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210703223942131.html
My previous relevant posts/articles are as below:
- https://www.linkedin.com/pulse/chinas-draft-patent-linkage-implementation-method-public-toby-mak
- https://www.linkedin.com/posts/tobymak_cn-activity-6800976094418866177-zYLe
In addition that there is NO 9-month deadline to conclude a trial (at a court of at the CNIPA, which means that the generic application could proceed as normal at the NMPA if a decision could not be made at the court/CNIPA within this 9-month period), I have the following observations:
- Article 7 - If the drug patentee/marketing approval holder filed a complaint at a court/CNIPA within the 45-days period, but the case was not accepted by the court/CNIPA within this 45-days period (due to formalities or whatever other reasons), it is unclear whether the 9-month period would be invoked.
- Article 8 - It is now specified that the 9-month period would be set only once (from the date of acceptance of the case by the court/CNIPA). Presumably this means no extension. Further, the language in this article is that this 9-month waiting period is applicable to chemical drugs only.
- Article 11 – The first one successfully "challenger" (Not clear what does this mean. May be under declaration 4 [the generic drug does not fall within the scope of the patent, or patent is invalidated]), co-challengers (if exist) may obtain drug marketing authorization within the 12-months exclusion period offered to the first challenger.
- Article 12 – For biological drugs, the patents could be registered are limited to sequence structure, and medical use patents (medical use patents have been added). This article also specifies that biological drug could only register relevant patent information with the NMPA according to Articles 2-4 and 7. While Articles 2-4 are indeed related to patent information registration, Article 7 is related to filing of a complaint at a court/CNIPA in reaction to generic drug marketing approval application. It is unclear whether this is a typographical error, or indeed intends to specify that biological drug owner could also file a complaint at the court/CNIPA as for chemical drugs.
- Article 15 – Falsely registering patent linkage information could be legally liable. However, it is unclear what are the punishments. May be put into the bad faith entity list (this could be very intimidating)?
The below are NOT from the trial measures, but contained in the accompanying explanations:
- Point 4 - Patents covering intermediates, metabolites, crystal form, method of manufacturing and testing methods are not considered as relevant patents under the patent linkage system.
- Point 6 – For declaration type 3 [the patent is invalid], the 9-month period will not be invoked if the patent does not request decision on whether the generic drug falls within the scope of the relevant patent.
All in all, there is no much change from the previous draft, while the further clarifications are not drug-innovators-friendly, other than medical use patents could be registered for biological drugs.
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