China's Draft Amendments to ANDA Rules Encourage Earlier Invalidity Challenges

China's Draft Amendments to ANDA Rules Encourage Earlier Invalidity Challenges

December 7, 2022, Covington Alert

On October 31, 2022, the China National Intellectual Property Administration (the “CNIPA”) issued the “Proposed Amendments to Guidelines for Patent Examination (Draft for Further Public Comments)” (the “Third Draft”).  This is the third time since November 2020 that the CNIPA has solicited public comments on the amendments to the country’s Patent Examination Guidelines.  Among all proposed amendments, the Third Draft added a new section titled “Special Provisions on Adjudicating Invalidity Petition Cases Concerning the Early Resolution Mechanism of Drug Patent Disputes”, aiming to provide rules for invalidity petitions relating to ANDA challenges, which have long been absent from China’s ANDA rules.