Patent Linkage System in Korea September 16, 2014 | Young Kim
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• Legislative Process
Contents
• Phase 1: Patent Listing & Generic Notice
• Phase 2: Stay of Generic Sale
• Observations
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Legislative Process
3/15/2012 6/14/2012 3/21/2014 7/25/2014 3/15/2015
PHASE 1 PHASE 2Patent Listing & Generic Notice
Stay of Generic Sales
Patent Listing for existing products 1st Draft Bill
2nd Draft Bill
KOR-US
Free Trade Agreement
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Phase 1: Patent Listing & Generic Notice (from March 15, 2012)
MAHolder MFDS*
GenericCompany
1 Request patent listing
4 Send a notice to patentee/MA holder if challenging listed patent
2 List patent relevant to product
* MFDS: Ministry of Food and Drug Safety
Green List
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Patents Eligible for Listing
Claims directed to following subject matters can be listed:
• Pharmaceutical substance (API)
• Formulation
• Composition
• Medicinal use
Listable Not‐listable
Salt, Hydrate, Solvate, Amorphous, Polymorph, Product‐by‐Process, and Antibody defined with amino acid sequences of variable regions
Device, Intermediate, Metabolite,Kit comprising instructions (package leaflet), Host cell, and Vector
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MFDS’ Examination of PLA: Relevancy
MFDS strictly requires exact matching between patent claims and product approval dossier
• Pharmaceutical Affairs Law states that listed patent must be “directly” relevant to the product approval
Extrinsic evidence is accepted in limited cases:
• Reference materials supporting direct relationship (e.g., batch records prepared according to GMP, research paper, etc.)
• Merck Index, US Pharmacopeia and public information are generally accepted
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MFDS’ Editing of Patent Claim
MFDS edits patent claim for listing to match with product approval dossier
wherein R1 is –CN.
A camsylate salt of the compound of formula I
Listed Claim Direct Relationship Basis
or a pharmaceutically acceptable salt thereof,
wherein R1 is ‐halo, ‐OR, ‐C(=O)R, ‐CO2R, ‐COCOR, ‐COCH2COR, ‐NO2, ‐CN, …
Original Claim
A compound of formula I
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Appeals against MFDS’ Patent Claim Editing
Oppositions & Appeals filed against MFDS’ Claim Editing Practice
• Under recent draft bill, stay will be based on patent claim
During administrative appeals, MFDS indicated that generic’s notice obligation is based on the patent claim
Until recent draft bill, it was unclear whether stay will be based on patent claim or edited claim Appeals are pending before the Administrative Court
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Statistics of Patent Listing and Generic Notice
Total PLAs 1132 products
Listed 962 products (85.0%)
Rejected 13 products (1.1%)
Voluntary withdrawal 129 products (11.4%)
Under review 28 products (2.5%)
PLAs as of end of 2013 Generic Notices as of end of 2013
Submission of “confirmation of patent
relationship” before MFDS477 products
Generic notification to patentee/approval holder
385 products (80.7%)
(Source: KPMA Brief, May 2014, vol. 01)
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Stay of Sales (March 15, 2015): under Draft Bill
MAHolder
(patentee)MFDS
Court orIPT*
4 File patent action
* IPT: Intellectual Property Tribunal
GenericCompany
6 Decide stay of sales
5 Request for stay of generic sales within 45 days
1 File patent action
2 Apply for MA
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Korean Patent Litigation: Separation of Jurisdictions
• Invalidation Action• Scope Confirmation Action• Correction Action
• Patent Application• Infringement
CivilCriminal
SupremeCourt
KIPO
Patent Court High Court
District CourtExaminer
Intellectual Property Tribunal
Validity Issues (Mainly) Infringement Issues (Mainly)
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Key Provisions of Draft Bill
Stay of “sales” (not stay of “approval”) up to 12 months
No automatic stay: Request for stay MFDS’ review and decision to stay
First generic exclusivity for 12 months
Duty to submit settlement information to MFDS & KFTC
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First Generic Exclusivity
Requirements for first generic
• files first application* for market approval , and files first patent action**and obtains a favorable decision***; or
• files first application for market approval, and files patent action and obtain a favorable decision before the first patent action decision
* MA applications filed on the same day
** Patent actions filed within 14 days from the first patent action of the favorable decision
Excluding the generic who receives a favorable decision after the generic stay period is over
***
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Scenario (based on draft bill): When Patentee Wins
Data Exclusivity (4 or 6 years)Stay of Sales (up to 12 months from date
of receipt of notification)
OriginalApproval
P’s filing of infringement or scope confirmation action
Request for Stay of Sales within 45 days from notice
G’s filing of invalidation or scope confirmation action
Patent Listing
Favorable decision from IPT or Court (6 ‐15 months from filing)
G’s approval application & notification in 20 days from application date
Decision regarding Stay
Generic Approval
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Scenario (based on draft bill): When Patentee Loses
Data Exclusivity
Stay of Sales
First Generic Exclusivity (12 months)Original
Approval
Request for Stay of Sales within 45 days from notice
Patent Listing
Reduction of original drug price
Sales of Other Generics
Sales of First Generic
G’s approval application & notification in 20 days from application date
G’s filing of invalidation or scope confirmation action
P’s filing of patent action
Decision regarding Stay
Generic Approval
IPT/Court decision
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US vs. Korean Linkage System (1)
US Linkage System Korean Linkage System
Product for Listing
small molecule products ‐ Biological products are regulated under separate system
Both small molecule & biological products
Requirement for Listing
No requirement except for use patents
Proof of “direct relationship” between individual claims to the information in the approved product dossier
Substantial Review FDA has administrative role Substantive review by MFDS
selectively lists patent/claims
Listed Information Patent No. in Orange Book Patent No. and claims in Green List
(showing direct relationship basis)
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US vs. Korean Linkage System (2)
US Linkage System Korean Linkage System
Change/ Delist of Listed Information
FDA has no authority to change/delist listed patent information
MFDS has authority to change/delist listed patent information
Generic Stay
• Stay of generic “approval”• Automatic stay
• Stay of generic “sales”• No automatic stay: Review & Decision by MFDS
Stay Period 30 months 12 months
Generic Exclusivity Period 180 days 12 months
Based on Draft Bill
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Restitution for Unjust Enrichment
• Patentee should reimburse government/generic company its resulting profits (e.g. for higher price it was able to maintain during stay), if patentee is found to have prevented legitimate generic launch by using generic stay mechanism
Generics’ Opinion Submitted on Draft Bill of PAA
Draft Bill of National Health Insurance Act• Announced on June 20, 2014
• Provision requiring MA holder to reimburse government for its profits from higher price during stay, if MA holder loses patent action
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Brand Companies’ Efforts during Legislation
Achievements
Various Approaches
• File many oppositions and administrative appeals• Actively submit opinions to Korean governments• Work with KRPIA, PhRMA, INTERPAT, JPMA
• Minimize negative impacts of MFDS’ patent claim editing practice Generic notice and stay will be based on patent claims, not edited claims
• Revise/delete negative provisions in the first draft bill of PAA
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Revision of Draft Bill of PAA
First Draft Bill
MFDS’ Decision on Request for Stay• MFDS grants stay if there
is “a need to prevent significant damage”
Publication of PLA for 3rd party’s opinion• Any one can submit
opinion on PLA eligibility
Opinion
• This requirement should be deleted
• No clear standards on this requirement
• PLA should not be published
• May disclose trade secrets or product approval information
Second Draft Bill
• The requirement is deleted
• Only review formalities
• No publication
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Generic Companies’ Strategy
File invalidation and/or scope confirmation actions • much earlier than before (well before the PMS period is over) so as to
minimize impact of stay mechanism
Apply for product approval immediately after the PMS period is over, even if the product patents have not yet expired, to avoid stay mechanism (before March 15, 2015)
Apply for product approval next day after PMS period is over to acquire first generic status (from March 15, 2015)
→ Fully prepare for invalidation actions at the very early stage
Young Kim +82‐2‐3703‐[email protected]