Drug Patent Linkage System of China

Analysis of China's drug patent linkage system, including the recent fourth amendment of the Chinese Patent Law and the regulations and measures governing early resolution of drug patent disputes. It covers the eligible patents for registration, patent statements, the bifurcated judicial and administrative mechanism, trial procedures, NMPA's treatments for different statements, and the differences between the patent linkage systems of the US and China. Relevant data from the Patent Information Registration Platform is also included.

• drug patent linkage system
• Chinese patent law
• patent registration
• generic applicants

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1. D rug Patent L inkage System of C hina G esheng G eorge H uang A pril 14, 2023, N ew York, N Y 1

2. L egal Fram ew ork of Chinas D rug PatentL inkageSystem Fourth A m endm ent of the C hinese Patent L aw A rticle 76 June 1, 2021 Regulations for E arly Resolution of D rug Patent D isputes by N M PA & C N IPA Judicial Interpretations by SPC A dm inistrative M easures by CN IPA July 4, 2021 July 5, 2021 July 5, 2021 2

3. C ritical E vents in the D rug Patent L inkage System Patent registration by M A H s Patent statem ent by generic M A applicants G eneric M A applicants notice C D E & M A H s/Patentees B ifurcated drug patent dispute resolution m echanism H olding period N M PA approval or rejection or suspension Patent challenge & 12m m arket exclusivity 3

4. Patent Registration: E ligible Patentsfor Registration A ctiveingredientcom pound(s) Pharm aceuticalcom position(s)com prisingactiveingredient(s) M edicaluse(s) C hem ical drugs Sequencestructureofactiveingredient(s) M edicaluse(s) B iological products TCM com position(s) TCM extract(s) M edical use(s) Traditional C hinese M edicines (TC M ) Interm ediates, m etabolites, polym orphous form s, preparation m ethods and detecting m ethods E xclusive of 4

5. Patent Statem ent W ho G enericapplicantsforchem icaldrugs,traditionalC hinesem edicinesandbiosim ilars W here C D Ew ebsite W hen A t the tim e of filing generic M A applications W hat One of the follow ing four categories C ategory I N oregisteredpatent Registered patents have term inated or have been declared invalid, or generic applicanthasobtainedlicensingfrompatentee. C ategory II There are registered patents but generic applicants m ake com m itm ent of no m arketingtill expiry of related patents. C ategory III IV.1--Registered patents should be invalidated; and/or IV.2 G eneric drug does not fall w ithinprotection scope of the registered patents. C ategory IV 5

6. H ow the B ifurcated Judicial& A dm inistrative M echanismW orks 6

7. Trial Procedure of a Typical A 76 Suit L iteral Infringem ent A 76 Suit Filing Check Trial A 76 Judgm ent N o L iteral Infringem ent D octrine of E quivalents Ineligible Patents Registration Ineligible Patent Statem ents D octrine of D onation D octrine of E stoppel 7

8. N M PA s Treatm ents for D ifferent Statem ents Statem ent C hem icalgenerics TraditionalC hinesem edicines&biosim ilars I/II III M Aupontechnicalreview M Aupontechnicalreview& m arketingtillexpiryofrelatedpatents 9Mholdingperiod M Aupontechnicalreview M Aupontechnicalreview& m arketingtillexpiryofrelatedpatents N oholdingperiod IV M A ,or M Asuspendedpriortoexpiryofrelatedpatents, (if a negative law suit or adm inistrative adjudication conclusioncom esout) M A ,or M A&m arketingtillexpiryofpatents (if a negative law suit or adm inistrative adjudication conclusioncom esout) 12Mm arketexclusivityforthegenericM Aapplicantfirst successfully challenging related patents and first gettingM A N o12mm arketexclusivity 8

9. D ifferences of Patent L inkage System betw een U S and C hina Patent linkage system 1. D rugs to be covered U S C hem ical drugs only C N C hem ical drugs, B iological products and Traditional C hinese m edicines Polym orph patent is excluded 9 m onths 12 m onths 2. Patents to be covered 3. H olding period 4. M arketing exclusivity for the first generic drug 5. N ature of patent linkage litigation A rtificial infringem ent Polym orph patent can be listed 30 m onths 180 days A ffirm ative action 6. C om petent authority C ourt only (patent validity can be initiated either at court or U SPTO) C ourt and/or SIPO (patent validity can only be initiated at SIOP at first) 9

10. Patent Inform ation Registration Platform : Patented D rug D istribution C lassification of D rugs N um ber of Registered D rugs Percentage C hem ical D rugs 736 61.08% B iological Products 122 10.12% Traditional C hinese M edicines 347 28.80% Total 1205 100.00% N ote: The data is from the Patent Inform ation Registration Platform as of M arch 31, 2023 10

11. Patent Inform ation Registration Platform : G eneric D rug D istribution C lassification of D rugs N um ber of Statem ent Percentage C hem ical D rugs 4373 98.71% B iological Products 56 1.27% Traditional C hinese M edicines 1 0.02% Total 4430 100.00% N ote: The data is from the Patent Inform ation Registration Platform as of M arch 31, 2023 11

12. Patent Inform ation Registration Platform : Patent Statem ent D istribution C ategory of Statem ent N um ber of Statem ent Percentage C ategory I 3566 81.34% C ategory II 246 5.61% C ategory III 349 7.96% C ategory IV.1 54 1.23% C ategory IV.2 169 3.86% Total 4384 100.00% N ote: The data is from iphouse.cn as of M arch 31, 2023 12

13. Review on the E xecution of the Patent L inkage Systemin China B oth B rand and G eneric com panies have show n great interest in the system M ost of A 76 cases are accom panied w ith patent invalidation cases N o generic com pany has successfully challenged a patent as the first and obtained the 12-m onth m arketing exclusivity N o procedure to correct or update the patent statem ent registeredon the Platform D iscrepancy on filing standard betw een B eijing IP Court and C N IPA Possible discrepancy on the judgem ent/adjudication as to w hether the generic drug falls into the scope of patent 13

14. Thank you! G esheng G eorge H uang gshuang@zhongziip.com 14