Gesheng George Huang April 14 2023 New York NY 1 Legal Framework of Chinas Drug P atent L inkage S ystem 2 3 Critical Events in the Drug Patent Linkage System 4 Patent Registration Eligible ID: 1043091
Download Presentation The PPT/PDF document "Drug Patent Linkage System of China" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
1. Drug Patent Linkage System of China Gesheng “George” HuangApril 14, 2023, New York, NY1
2. Legal Framework of China’s Drug Patent Linkage System2
3. 3Critical Events in the Drug Patent Linkage System
4. 4Patent Registration: Eligible Patents for Registration
5. Who Generic applicants for chemical drugs, traditional Chinese medicines and biosimilarsWhere CDE websiteWhen At the time of filing generic MA applicationsWhat One of the following four categories5Patent Statement
6. How the Bifurcated Judicial & Administrative Mechanism Works6
7. 7Trial Procedure of a Typical A76 SuitA76 SuitFiling CheckTrialLiteral InfringementDoctrine of EquivalentsA76 JudgmentIneligible PatentsRegistrationNo Literal InfringementDoctrine of DonationDoctrine of EstoppelIneligible Patent Statements
8. StatementChemical genericsTraditional Chinese medicines & biosimilarsI/IIMA upon technical reviewMA upon technical reviewIIIMA upon technical review & marketing till expiry of related patentsMA upon technical review &marketing till expiry of related patentsIV9M holding periodMA, or MA suspended prior to expiry of related patents, (if a negative lawsuit or administrative adjudication conclusion comes out)12M market exclusivity for the generic MA applicant first successfully challenging related patents and first getting MANo holding periodMA, or MA & marketing till expiry of patents (if a negative lawsuit or administrative adjudication conclusion comes out)No 12m market exclusivity8NMPA’s Treatments for Different Statements
9. Patent linkage systemUSCN1. Drugs to be covered Chemical drugs onlyChemical drugs, Biological products andTraditional Chinese medicines2. Patents to be coveredPolymorph patent can be listedPolymorph patent is excluded3. Holding period30 months9 months4. Marketing exclusivity for the first generic drug180 days12 months5. Nature of patent linkage litigationArtificial infringementAffirmative action6. Competent authorityCourt only (patent validity can be initiated either at court or USPTO)Court and/or SIPO (patent validity can only be initiated at SIOP at first)9Differences of Patent Linkage System between US and China
10. 10Patent Information Registration Platform: Patented Drug Distribution Classification of DrugsNumber of Registered DrugsPercentageChemical Drugs73661.08%Biological Products12210.12%Traditional Chinese Medicines34728.80%Total1205100.00%Note:The data is from the Patent Information Registration Platform as of March 31, 2023
11. 11Patent Information Registration Platform: Generic Drug DistributionClassification of DrugsNumber of StatementPercentageChemical Drugs437398.71%Biological Products561.27%Traditional Chinese Medicines10.02%Total4430100.00%Note:The data is from the Patent Information Registration Platform as of March 31, 2023
12. 12Patent Information Registration Platform: Patent Statement DistributionCategory of StatementNumber of StatementPercentageCategory I356681.34%Category II2465.61%Category III3497.96%Category IV.1541.23%Category IV.21693.86%Total4384100.00%Note:The data is from iphouse.cn as of March 31, 2023
13. 13Review on the Execution of the Patent Linkage System in ChinaBoth Brand and Generic companies have shown great interest in the systemMost of A76 cases are accompanied with patent invalidation casesNo generic company has successfully challenged a patent as the first and obtained the 12-month marketing exclusivityNo procedure to correct or update the patent statement registered on the PlatformDiscrepancy on filing standard between Beijing IP Court and CNIPAPossible discrepancy on the judgement/adjudication as to whether the generic drug falls into the scope of patent
14. Gesheng “George” Huanggshuang@zhongziip.com14Thank you!