This is related to my earlier article below:

https://www.linkedin.com/pulse/cn-patent-inkage-measures-trial-finalized-issued-nmpa-toby-mak/?trackingId=UtK3oBGzQpe%2FL%2BFSPHB1tQ%3D%3D

These stipulations were announced by the CN Supreme People's Court on 5 July 2021, one day after the announcement of the NMPA's measures. The announcement is as below:

http://www.court.gov.cn/fabu-xiangqing-311791.html

My observations are as below:

  • Again, there is NO 9-month deadline to conclude a trial at a court (the Beijing IP Court, more specifically, which is named in the stipulations to be the court to handle such patent linkage cases, Article 1). It should also note that there is no provision in these stipulations to put such trials at high priority, specifically to be concluded more quickly. Whether this would make the patent linkage system toothless in China (if many of such cases could be delayed by the generic drug applicant to be decided beyond the 9-month deadline, the NMPA would process these generic drug applications as normal), let's wait and see.
  • The trial generally would not be suspended even if there is a parallel invalidation petition against the relevant patent at the CNIPA (Article 6). By contrast, at a typical patent infringement trial at a court, the trial usually would be suspended in light of a parallel invalidation petition.
  • Generic applicant could invoke prior-art defense (Article 67 of the CN Patent Law) and prior-use defense (Article 75(2) of the CN Patent Law) (Article 7).
  • Patentee could request preservation order (equivalent to the Anton Pillar order, but good luck with this in China), and/or prohibition of actions from the generic applicant that would infringe the relevant patent at the trial. However, request to prohibit the generic drug marketing approval application itself and its relevant examination process would be refused by the court. (Article 10).
  • If the patentee knows (the patent has already been invalidated is a relatively clear condition) or should have known (how to determine this?) that the patent should be invalidated, or the generic drug falls outside the scope of the relevant patent, but the patentee still instigated the trial, the generic drug applicant could ask for damages at the court. (Article 12).

The above sounds reasonable to encourage generic drugs.

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