Drug Patent Linkage System of China
Drug Patent Linkage System of China
Gesheng “George” Huang
April 14, 2023, New York, NY
1
Legal Framework of China’s Drug
P
atent
L
inkage
S
ystem
2
3
Critical Events in the Drug Patent Linkage System
4
Patent Registration: Eligible
P
atents for Registration
Who
Generic applicants for chemical drugs, traditional Chinese medicines and biosimilars
Where
CDE
website
When
At the time of filing generic MA applications
What
One of the following four categories
5
Patent Statement
How the Bifurcated
J
udicial & Administrative
M
echanism Works
6
7
Trial Procedure of a Typical A76 Suit
A76 Suit
Filing Check
Trial
Literal
Infringement
Doctrine of
Equivalents
A76 Judgment
Ineligible
Patents
Registration
No Literal
Infringement
Doctrine of
Donation
Doctrine of
Estoppel
Ineligible
Patent
Statements
8
NMPA’s Treatments for Different
S
tatements
9
Differences of Patent Linkage System between US and China
10
Patent Information Registration Platform:
Patented Drug Distribution
Note:
The data is from the Patent Information Registration Platform as of March 31, 2023
11
Patent Information Registration Platform:
Generic Drug Distribution
Note:
The data is from the Patent Information Registration Platform as of March 31, 2023
12
Patent Information Registration Platform:
Patent Statement Distribution
Note:
The data is from iphouse.cn as of March 31, 2023
13
Review on the Execution of the Patent Linkage
S
ystem in China
•
Both Brand and Generic companies have shown great interest in the system
•
Most of A76 cases are accompanied with patent invalidation cases
•
No generic company has successfully challenged a patent as the first and obtained the 12-month
marketing exclusivity
•
No procedure to correct or update the patent statement
registered
on the Platform
•
Discrepancy on filing standard between Beijing IP Court and CNIPA
•
Possible discrepancy on the judgement/adjudication as to whether the generic drug falls into the
scope of patent
Gesheng “George” Huang
gshuang
@zhongziip.com
14
Thank you!
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.
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Presentation Transcript
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
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
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
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
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
H ow the B ifurcated Judicial& A dm inistrative M echanismW orks 6
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
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
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
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
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
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
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
Thank you! G esheng G eorge H uang gshuang@zhongziip.com 14
