CHINA Law and Practice Contributed by: Hans She, Muran Sun, Andy Zhu and Ray Cao, Fangda Partners
for sale until patent expiry in the relevant coun - tries” could not justify an infringement of offering for sale under the PRC’s Patent Law. Regarding infringement, current laws or regula - tions in China do not provide special consid - eration for second medical-use patents, skinny labelling, etc. Regarding parallel imports, Article 75(1) of the PRC’s Patent Law is usually interpreted as an exemption for patent infringement for parallel importation activities, regardless of country of origin. 2.2 Regulatory Data and Market Exclusivity Current Chinese laws lack specific provisions for data and market exclusivity related to orphan drugs, paediatric formulations, new indications or combinations. For generic chemical drugs, only the first applicant successfully challenging a listed patent and obtaining the first marketing approval receives a 12-month exclusivity period. On 9 May 2022, the National Medical Products Administration of the PRC released a draft revi - sion of the Implementation Regulations of the Drug Administration Law of the PRC for pub - lic comments. Notably, Article 28 proposes a 12-month market exclusivity for the first approved paediatric new variety, dosage form or specification, and for those with new indications, usage or dosage. Article 29 suggests a seven- year market exclusivity for new orphan drugs, contingent on the drug marketing authorisation holder’s commitment to ensuring drug supply. It is important to monitor the status of this draft for any formal approval updates. That said, the newly revised Implementation Regulations of the Drug Administration Law issued in Decem -
ber 2024 has not adopted the aforesaid draft provisions. 2.3 Acceptable Pre-Launch Preparations Article 75(5) of the PRC’s Patent Law is often viewed as the country’s Bolar exemption, per - mitting the production, use or importation of patented drugs or medicinal equipment for the purpose of obtaining administrative approval or providing required information. It also excludes the production or importation of such items from patent infringement, specifically for the appli - cant. Similarly, Article 76 of the PRC’s Patent Law, after its fourth amendment, is considered the country’s Hatch-Waxman Act, as it establishes an early dispute resolution system for generic market entry. 2.4 Publicly Available Drug and Patent Information The National Medical Products Administration (NMPA) and the CNIPA jointly issued the Imple - mentation Measures for the Early Settlement Mechanism of Drug Patent Disputes on 4 July 2021. According to Article 3, the China Patent Information Registration Platform for Marketed Drugs (the “Platform for Marketed Drugs”, akin to the Orange Book), is managed by the Centre for Drug Evaluation, NMPA. On this platform, the drug marketing authorisa - tion holder is obliged to disclose various infor - mation, including: • drug details; • related patents; • patent status; and • contact information (Article 4).
60
CHAMBERS.COM
Powered by FlippingBook