There is movement in the Chinese pharmaceutical IP: On 17 October 2020, the Standing Committee of the National People’s Congress formally adopted the fourth amendment to the Chinese Patent Law. The new law will enter into force on 1 June 2021 and will be of great importance for pharmaceutical companies in China, as it contains new provisions on patent term extensions and a patent linkage system for pharmaceutical patents.
The changes include an extension of the regular patent term for new drugs by up to five years with a maximum of 14 years from the date of drug approval. At present, the term “new drug” is not sufficiently defined by the Patent Act, so that further delimitation will be necessary.
The long-awaited patent-linking system will allow both the patent holder and the generic manufacturer to apply to the Court to determine whether the application for marketing authorization of the generic product falls within the scope of the patent. This allows the patent holder to block, at least temporarily, the final authorization of a generic product. The exact period will be determined by the National Medical Products Administration (NMPA) in a regulation.
Following the third amendment of the Chinese Patent Law introducing the Bolar Exemption, the environment for domestic generic producers in China has been relatively lax. From a Chinese perspective, it was therefore time to further improve and balance the patent law to encourage the development of innovative medicines while protecting generic producers.