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China publishes new patent law amendment Posted 24/07/2020

On 3 July 2020, China’s Standing Committee of the National People's Congress published a second draft amendment to its Patent Law. This introduces patent linkage, patent term extension and patent term adjustment. It expands on several provisions to improve protection for new drugs laid out in the first draft amendment published in 2019.

Article 42 of this second draft amendment patent term extension/restoration (PTE) states that the China National IP Administration can add up to five years to the invention patent of a new drug that has obtained marketing authorization approval. This is to compensate commercialization delays caused by regulatory review and approval. In addition, the total patent term cannot exceed 14 years following new drug launch.

Article 42 also incorporates the concept of patent term adjustment (PTA). Here, the patent term of invention patent is adjusted to compensate for unreasonable delays due to patent examination by the patent administrative authority. However, the PTA calculation method for PTA needs to be further clarified.

In addition, Article 75 introduces patent linkage and addresses China’s commitment in the 2020 US-China Economic Trade Agreement. This includes details of protocols for legal challenges by the originator/patent holder and for regulatory review and administrative appeal. In addition, it mentions the establishment of coordination between drug and patent administrative authorities.

It has been noted that there are parallels between China’s second draft amendment and the US patent linkage regime. However, the second draft amendment presents some uncertainties and differences to the US patent linkage system.

Overall, this second draft amendment makes it clear that China hopes to balance pharmaceutical innovation and affordability.

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