China’s National Intellectual Property Administration to Allow Third-Party Challenges to Pharmaceutical Patent Term Extensions

On December 21, 2023, China’s National Intellectual Property Administration (CNIPA) announced (关于专利权期限补偿和专利开放许可相关行政复议事项的公告（第560号)) it would allow third parties to challenge the grant of patent term extension (PTE) for Chinese pharmaceutical patents effective January 20, 2024. PTE extends the life of a patent due to a potentially lengthy regulatory review process. Per the recently released Implementing Regulations of the Patent Law PTE is calculated by deducting 5 years from the interval between the date of filing of the patent application and date of licensing of the drug. The announcement also allows for a patentee to challenge annuity fee reduction decisions when registering for open licensing.

A translation of the announcement follows:

I. Where a patentee or any interested party, which is involved in a dispute over infringement upon the relevant patent or has filed an application for drug registration, refuses to accept the decision made by the CNIPA according to paragraphs 2 and 3 of Article 42 of the Patent Law on whether to grant compensation for the duration of the patent right, it/he may apply to the CNIPA for administrative reconsideration.

II. Where a patentee is dissatisfied with the decision made by the CNIPA in accordance with paragraph 2, Article 51 of the Patent Law on whether to reduce the annual fee during the exploitation period of the patent opening license, he/it may apply to the CNIPA for administrative reconsideration. The decision made by the CNIPA on whether to announce the declaration of patent opening license does not fall within the scope of administrative reconsideration.

The full text of the announcement is available here (Chinese only).

 

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