The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in the People’s Republic of China (PRC) issued a notice that the patent information registration platform of drugs approved in the PRC will be put into official operation soon. The CDE attached a user manual to specify (1) that the indications
This article addresses three important changes to pharmaceutical patents in the People’s Republic of China (PRC) in view of the newly amended PRC Patent Law (the Law), which will take effect on June 1, 2021, and the recent amendments to the Patent Examination Guidelines (the 2021 Guidelines) that took effect on January 15, 2021. These changes involve (1) patent term compensation due to delay in patent prosecution and/or marketing approval; (2) patent linkage system for pharmaceutical patents; and (3) relaxed criteria for consideration of post-filing data in patent prosecution. These changes aim to improve patent protection and enhance patent value for inventions in the PRC; they are also consistent with matters addressed in the Economic And Trade Agreement Between the Government of the United States of America And the Government of the People’s Republic of China (the Agreement) issued January 15, 2020.
Continue Reading Three Changes to Pharmaceutical Patents in the PRC
On April 25 this year the China National Drug Administration (CNDA) published a proposed draft on Implementing Measures for Pharmaceutical Trial Data Protection. The measures prevent other drug manufacturers from relying on earlier trial data to receive sales approval without permission from the owner of the earlier trial data. The proposed draft extends the trial data protection term to up to 12 years compared with that of up to 6 years previously. During the protection term, the CNDA will not approve marketing of the same drug[i] from a third party without permission of the owner whose drug gets a trial data exclusivity, except if the third party independently runs a trial and collects trial data.
Continue Reading China plans to increase market exclusivity term for pharmaceuticals based on improved pharmaceutical trial data protection
The State Council of China announced in April this year a plan to extend patent protection for up to five years for innovative drugs due to regulatory delay. However, the State Council has not disclosed specific rules nor timetable for same. Meanwhile, in May this year, China and the United States issued a joint statement…