The latest draft implementation guidelines for China’s Drug Administration Law (“Guidelines”) are out and open for comment. Previously, the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage Measures”) came into effect on July 4, 2021. The Guidelines indicate that the final approval of generic chemical drug applications for marketing approval will be stayed pending Paragraph IV litigation results. Technical review for things like safety and efficacy will proceed regardless. Although previously published Patent Linkage Measures indicate that the maximum stay period is 9 months, these Guidelines only say “a certain period.” The regulatory approval process for generic biologics and traditional Chinese medicines will not be…
-
-
Patent Eligibility for Software in China
Technology has progressed significantly since the early days of patent law, when US lawmakers in 1952 could only envision patentable subject matter into categories like “process, machine, manufacture, or composition of matter.” The recent explosion of new types of innovations that don’t fall neatly into these categories has resulted in a game of catch-up, where patent practitioners dream up creative ways to protect these new innovations using existing (sometimes archaic) formats to comply with outdated rules. We saw this in the US through the past decades as people tried using a myriad of creative ways to protect business methods, computer software, and other less tangible innovations that were still practical…
-
China Joins Two WIPO Treaties, the Hague System and the Marrakesh Treaty
It has been two challenging years, yet there are many reasons to still have hope. We wish you a blessed Lunar New Year as we welcome the year of the Tiger. We wanted to highlight a few new developments in China. China has joined the Hague System for the International Registration of Industrial Designs, submitting its instrument of accession to the 1999 Geneva Act of the Hague Agreement on February 5, 2022. The Act will go into effect in China on May 5, 2022. The Hague System provides a way for designers to file a single international design application to register up to 100 designs in up to 94 countries.…
