In 2021, China’s Patent Linkage regulation went into effect, and both the Chinese National IP Administration (CNIPA) and Beijing IP Court have the responsibility for determining patent linkage. To date, the Beijing IP court has reviewed over 12 patent linkage cases, and the CNIPA has evaluated over 30 cases. Some cases have been won by the originator drug, some by the generic maker, and some applications have been withdrawn. Generally, these 2 patent bodies have made decisions within 9 months. Original drug manufacturers have 45 days to react to a Chinese generic drug.
Also in 2021, patent term extensions (PTE) became law. If the patent after drug approval is less than 14 years, innovative drugs can apply for a 5-year patent extension. Despite this law, PTE laws are still evolving. For example, if the drug has many patents under PTE, the drug is only allowed one patent. While most foreign drugs are approved outside of China first and fall into Class 5 drugs, only Class 1 and Class 2 drugs are eligible for PTE. Given this, some foreign drug companies may want to initiate drug development, clinical trials, etc. earlier in China.