New Dispute Resolution Mechanism for Pharmaceutical-related Patent Disputes

CHANG TSI
Insights

May11
2022

China's Fourth Amendment of Patent Law has been effected since June of 2021, Article 76 of which generally stipulates the early dispute resolution mechanism for pharmaceutical-related patent disputes, allowing drug patent holders to request an administrative determination from the people’s courts or patent-related administration under the State Council. China's Supreme People's Court later issued a judicial interpretation, stating that the Beijing Intellectual Property Court has exclusive jurisdiction over the above cases. Also, the mentioned “patent-related administration” is CNIPA.

On 15 April 2022, Beijing Intellectual Property Court made its decision on the very first lawsuit on pharmaceutical patent linkage in China, namely Japan's Chugai Pharmaceutical Co., Ltd. v.s. Wenzhou Haihe Pharmaceutical Industry. The court decided that the generic drug did not fall within the scope of the patent protection.

In addition, the recently closed administrative cases involved three patents related to Oxycodone Hydrochloride sustained-release tablets of Purdue Pharma, which requested CNIPA to confirm that the generic drugs produced by Yichang Renfu Pharmaceutical Industry fall within the scope of the patent protection. CNIPA has reviewed but rejected the request. 

According to official sources, CNIPA has received 59 requests for administrative decisions, 39 of which have been under review. 

All four patent linkage cases released do not fall within the scope of the patent protection, as shown above.

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