The Patent Reexamination and Invalidation Department (PRID) of the China National Intellectual Property Administration (CNIPA) maintained the validity of CN Invention Patent No. ZL02123000.5 (the ’000 patent) in an invalidation proceeding. The PRID held that the claimed invention is inventive because: (1) one person of ordinary skill in the art would not have been motivated to increase the water-solubility of butylphthalide by complexation with hydroxypropyl-β-cyclodextrin; and (2) one person of ordinary skill in the art would not have expected that the increase of the water-solubility would be sufficient to allow a therapeutically effective amount of butylphthalide to be delivered in aqueous formulations. The PRID appeared to adopt the “reasonable expectation of success” requirement in the U.S. patent practice. Although prior art references establish that cyclodextrin derivatives can improve water solubilities of compounds having low or no water solubilities, the claimed invention is not obvious because one person of ordinary skill in the art would not have had reasonable expectation that the increase of the water-solubility of the complex of butylphthalide with hydroxypropyl-β-cyclodextrin allows the therapeutic use of butylphthalide in aqueous formulations.
Patent Consultant Jonathan Wen is experienced in providing patent-relevant services for multinational companies based in the U.S., Europe and Asia on patent prosecution, translation and drafting.
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 May 25, 2021, the China National Intellectual Property Administration (CNIPA) issued the interim measures for processing of related examination businesses regarding the implementation of the amended patent law (the Measures). Both the Measures and the amended patent law (the Law) will take effect on June 1, 2021.
Continue Reading Interim Measures for Implementation of the Amended Patent Law in the PRC
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) launched a patent information registration platform for public testing of drugs approved in the People’s Republic of China (PRC). The CDE further specified 1) patents eligible for the registration; 2) the deadline for generic applicants to submit a patent declaration; and 3) the four types of patent declarations.
Continue Reading Patent Linkage Registration Platform Launched in China for Public Testing
On May 15, 2019, the Zhejiang High People’s Court (the Appellate Court) reversed the trial court decision and found the defendant infringing the plaintiff’s Chinese Patent No. ZL 200880118796.3. The Appellate Court concluded that the term “the luggage strap . . . guided adjustably along the wall of the luggage” does not require the luggage…