Comparative Study on Patent-Approval Linkage System *Invited Researcher: SHIN, Hye Eun **Drug inventions require enormous time and cost before their completion, and theirdevelopment is highly likely to end in failure. In addition, even if development of a drug
invention succeeds once, it is also necessary to go through efficacy and safety tests forcommercialization. In this manner, drug inventions have different characteristics frominventions in the machinery and electronics fields. Therefore, it is considered that
protection of drug inventions by patents is indispensable for new drug developing andmanufacturing companies.
On the other hand, as drugs are directly linked to the people's lives and health,there are cases where a patent is not granted or where it is necessary to restrict the patentrights from the aspect of public interest.
The ultimate purpose of the Patent Act is the development of industry. The Patent
Act is useful as a means of reasonably achieving such purpose. Therefore, the Patent Act
ensures that voluntary disclosure of the content of technical development by those who
develop new technology forms the foundation for subsequent studies. In addition, thePatent Act gives a consideration (incentive), which can be considered reasonable, to those
who disclose such technology, thereby trying to provide the driving force of technology
development.
On the other hand, if the granted incentive is excessively great, it will inhibit theutilization of the relevant invention, which is likely to produce the result of inhibiting
development of industry. In contrast, if the granted incentive is excessively small, it islikely to cause the lowering of motivation for technology development. Therefore, it is of
the highest importance to ensure a virtuous cycle of development of technology byproviding appropriate incentives in accordance with development in technical fields andthe situation of the time. In addition to this, in the case of drug inventions, public interestrelated elements must also be taken into consideration, and the medical circumstances in
the relevant country must also be taken into account.
This study compares the current situation in South Korea and that in Japan regarding drug
This is a summary of the report published under the 2018 Collaborative Research Project on Harmonization of Industrial Property
Right Systems under a commission from the Japan Patent Office.
** Professor, Chungbuk National University School of Law.
*ipatent linkage, and then suggests a desirable direction for system operation in bothcountries.
In South Korea, the patent linkage system intended for protection of new drugs
came into force in a full-fledged manner on March 15, 2015. On the other hand, in the caseof Japan, a full-fledged patent linkage system like the one in South Korea has yet to be
introduced. However, Japan is a party to the TPP, and a system for patent linkage isprovided in Article 18.53 (Measures Relating to the Marketing of Certain Pharmaceutical
Products) of the TPP. Therefore, it is probably necessary for Japan to seek an idea of
introduction of a desirable system suited for Japanese law and the actual conditions of thepharmaceutical industry through comparison with the systems of other countries that haveintroduced patent linkage.

I. Introduction
Drug inventions require enormous time and cost before their completion, andtheir development is highly likely to end in failure. In addition, even if development ofa drug invention succeeds once, it is also necessary to go through efficacy and safety
tests

for

commercialization.

In

this

manner,drug

inventions

have

different

characteristics from inventions in the machinery and electronics fields. Therefore, it isconsidered that protection of drug inventions by patents is indispensable for new drug
developing and manufacturing companies. 1
On the other hand, as drugs are directly linked to the people's lives and health,there are cases where a patent is not granted or where it is necessary to restrict thepatent rights from the aspect of public interest.
The ultimate purpose of the Patent Act is the development of industry. The Patent
Act is useful as a means of reasonably achieving such purpose. Therefore, the Patent
Act ensures that voluntary disclosure of the content of technical development by those
who develop new technology forms the foundation for subsequent studies. In addition,
the Patent Act gives a consideration (incentive), which can be considered reasonable,
1

Enormou s costs and time are required before creation of a new drug through searching of a n ew sub stance,
and the success prob ability is also v ery lo w. Howev er, it is con sidered th at once succeed ed, th e creator canearn a significant profit, specifically, the profit accounts for 20 to 30% of sales. In terms of su ch characteristicof th e ph armaceutical indu stry, p rotection by patent right is utilized as an important means of co llecting
invested research and development funds. Jo seph A. DiMasi & Hen ry G. Grabowski, Th e Cost ofBiopharmaceutical R&D: Is Biotech Different?, 28 Managerial & Decision Econ. 469, 477 (2007); John R.
Allison & Mark A. Lemley, “Who’s Patenting Wh at? An Empirical Exploration of Paten t Pro secu tion” 53
Vand. L. Rev. 2099(2000).

ii

to those who disclose such technology, thereby trying to provide the driving force oftechnology development.
On the other hand, if the granted incentive is excessively great, it will inhibit
the utilization of the relevant invention, which is likely to produce the result of
inhibiting development of industry. In contrast, if the granted incentive is excessively
small, it is likely to cause the lowering of motivation for technology development.
Therefore, it is of the highest importance to ensure a virtuous cycle of development oftechnology by providing appropriate incentives in accordance with development intechnical fields and the situation of the time. In addition to this, in the case of drug
inventions, public interest-related elements must also be taken into consideration, andthe medical circumstances in the relevant country must also be taken into account.
In South Korea, the patent linkage system 2 intended for protection of new drugs
came into force in a full-fledged manner on March 15, 2015. Three years have alreadypassed since full-fledged enforcement of the system, but the South Korean-style patent
linkage system can be considered to be still in the process of becoming firmly
established.
This study compares the current situation in South Korea and that in Japan
regarding drug patent linkage, and then suggests a desirable direction for system
operation in both countries.
In the case of Japan, a full-fledged patent linkage system like the one in South
Korea has yet to be introduced. However, Japan is a party to the TPP, and a system forpatent linkage is provided in Article 18.53 (Measures Relating to the Marketing of
Certain Pharmaceutical Products) of the TPP. Therefore, it is probably necessary forJapan to seek an idea of introduction of a desirable system suited for Japanese law andthe actual conditions of the pharmaceutical industry through comparison with thesystems of other countries that have introduced patent linkage.

II. Legislative Examples and Present State of Other Countries
Concerning Patent Linkage System
1. What is Patent Linkage?
The term "patent linkage" literally means the linked operation of the drug
approval system and the patent system. In South Korea, before introduction of this2This system is also called approval-p atent linkag e sy stem, but it is called paten t linkag e system in what
follows.

iii

system, the Ministry of Food and Drug Safety (hereinafter referred to as the "MFDS")
had jurisdiction over drug marketing approval while the KIPO had jurisdiction overpatent affairs, and these two kinds of affairs were handled by separate government
offices, respectively. However, after introduction of patent linkage, where anapplication for marketing approval is filed for a patented drug, the MFDS must notify
the patentee of this fact and must also take a measure in the marketing approval
procedure in order to prevent other persons from marketing the relevant product withoutobtaining the consent or tacit approval of the patentee.
The purpose of said system is to promote development of generic drugs andmarket entry of generic drugs through challenge to patents while effectively protecting
patentees' rights, thereby enabling consumers to purchase drugs at a low price.
Therefore, the holders of drug patents are permitted to extend the duration within therange of five years, taking into account the period during which they were substantiallyprevented from exercising the patents due to efficacy and safety tests. On the other
hand, generic drug companies' act of working a patented invention to obtain data
relating to drug marketing approval is free from the liability for infringement.
Furthermore, for a copy drug, its efficacy and safety have already been proven on thebasis of a related new drug, and therefore, an applicant for a generic drug can file anabbreviated new drug application (hereinafter referred to as an "ANDA") only bysubmitting bioequivalence data showing that said copy drug is bioequivalent to therelated new drug.
2. United States(1) Background to the Enactment of the Hatch-Waxman Act(2) Specific Content
1) Registration in the Orange Book
2) Notice to a Patentee and Measures for Marketing Prevention(3) Medicare Act 2003
1) Enforcement of the System and Problems with the Enforcement
2) Major Changes in and after 2003(i) Clarification of Drugs that can be Listed in the Orange Book(ii) Limiting the Number of Times of the 30-Month Automatic Stay Procedure toonce(iii) Litigation to Seek Deletion of a Patent from the Patent Registration List Filedby an ANDA Fileriv

(iv) Sharing of the 180-Day Marketing Exclusivity(v) Forfeiture of the 180-Day Marketing Exclusivity(vi) Timing of Notice to the Patentee, etc.
(vii) Starting Date of the 180-Day Generic Exclusivity(viii) Obligation to Rreport Specific Types of Agreement
3. Canada(1) Background to the Introduction(2) Main Content
1) Registration in the Patent List
2) Statement about Relationships with a Patent3) Measures for Marketing Prevention4) Compensation by an Applicant for Approval of a New Drug in Association with
Marketing Prevention(3) Points to Keep in Mind
Although Canada is a country in North America in the same manner as the UnitedStates, the drug patent linkage system is operated in an extremely different way. In thecase of Canada, generic drugs had already been activated to a considerable extent before
introduction of the system; therefore, it seems that the patent linkage system wasestablished with a central focus on the protection of patentees' rights and prevention ofunjustifiable exercise of rights. On the other hand, unlike other countries, Canada
provides for the patent linkage system not under law or regulation concerning drug
approval but under the authority granted by the Patent Act. This is the biggest
characteristic of Canadian law. This is considered to be a reason that generic exclusivity
was not introduced. This is because, although a patent is deemed to have not existed in
the first place if it is invalidated, establishing another exclusivity on a specific personin exchange for invalidation of a patent goes against the purpose of the Patent Act.
In addition, Canada limits the subject of listing so as to ensure that a patent canbe subject to patent linkage only where it directly contributed to the development andmarket entry of an individual drug. Therefore, the subject of listing is limited to patents
for which an application was filed before filing of an application for marketing approvalof a drug, and examination for registration is very strictly conducted. Therefore, aconsiderable number (about 20%) of patents are refused registration. Moreover, therequirements for marketing prevention are strict, and the probability of citation by thevcourt is relatively low. A considerable number of cases seem to be withdrawn in theprocess of court proceedings through settlement, etc.
4. Australia(1) Background to the Introduction(2) Main Content
1) Absence of the Patent List
2) Certification Concerning Relationships with a Patent3) Patent Litigation Filed by a Patentee and Conditions Thereof4) Compensation by an Applicant for Approval of a New Drug in Association with
Marketing Prevention(3) Point to Keep in Mind
The patent linkage system of Australia is similar to the Canadian system in termsof the basic direction, and it is focused on the preparation of measures for preventing
patentees from abusing rights. Therefore, it is provided that it is necessary to make astatement about the existence of a reasonable ground when filing patent litigation and that
it is possible to impose a pecuniary penalty if such statement is false. These measures canbe considered as systems unique to Australia that are intended to prevent excess protectionof patents and blind filing of patent litigations based thereon. As the system is operated
based on the defensive principle and direction of preventing abuse of the marketing
prevention system under strict conditions, the generic exclusivity system, which is
discussed as falling under the granting of another exclusivity, has not been introduced.
5. Taiwan(1) Background to the Introduction(2) Main Content
1) Registration in the Patent List
2) Certification Concerning Relationships with a Patent3) Stay of Approval
4) Marketing Exclusivity
6. China(1) Operation of the Existing Drug Patent Linkage System(2) Promotion of Improvement of the Systemvi

7. Related Provisions of the TPP

III. South Korea's Patent Linkage System
1. Background to Introduction
The patent linkage system is a system that was introduced in a full-fledgedmanner by legislation for performance of the South Korea-U.S. FTA that was concluded
in 2007 and was put into effect in 2012, but part of the Hatch-Waxman Act that served
as the base of the system had already been in South Korean law. South Korea amended
the Patent Act in 1987 and thereby introduced a system to extend the duration of apatent up to five years for a person who was unable to work the patent due to efficacy
and safety tests on the drug. 3
On the other hand, there were a district court decision 4 and a decision of theIntellectual Property Trial and Appeal Board 5 to the effect that even before theexpiration of the duration of a drug patent, the act of conducting a test for marketing
approval of a drug does not constitute infringement of the patent. In order to make thisclearer, the Bolar provision of the Hatch-Waxman Act was introduced in the amended
Patent Act of 2010. 6
Article 89 (Extension of Patent Terms by Permission, etc.) (1) Notwithstanding Article 88 (1), the term of apatent on an invention may be extended only once by up to five years to co mpen sate fo r th e p eriod during
which th e inv ention cannot be practiced, if th e invention is sp ecified by Presid ential Decree and require s
permission, reg istration, etc. under any other statute (herein after referred to as "p ermission, etc.") to practicepatented invention but it takes a long time to undergo necessary tests for v alidity, safety, etc. for suchpermission, registration, etc.
(2) For the pu rposes of paragraph (1), the period required due to a cause attributable to the person who has
obtain ed p ermission, etc. shall not be includ ed in "p erio d during which th e inv entio n canno t be p racticed" inparagraph (1 ).
4 Southern Bran ch of the Seoul Central District Court, Jun e 15, 2001, 字 2001카 합 1074 d ecision (case ofprovision al disposition of prohibition of patent in fring ement); the court h eld as fo llows with reg ard to a third
party's act of manufacturing a pesticide whose effectiv e ingred ien ts, etc. are th e same as tho se o f a p esticid ethat is a patented invention and asking for a test n ecessary for obtaining a certificate of analysis to b e attached
to an application for registration for the registration of a manufacturing item as prescrib ed in Article 8 of thePesticid e Control Act during the duration of th e p atent: "The act of manufactu ring and using a difeno conazole
drug that is a patented invention for the purpo se o f obtaining v arious certificates o f an aly sis th at are
requirements for the obtainment of registration of a manufacturing item within th e country under the Pesticide
Control Act falls under use for the purpose o f testing referred to in Article 96, p aragraph (1) o f th e Patent
Act and does not constitute infringement of th e paten t."
5 Intellectual Property Trial and Appeal Board, March 24, 2008, 字 2007당 2503 trial ruling (case of a trial toconfirm th e scope of active rights ); Regarding bio equiv alence tests conducted for approval of a g eneric drug
during th e du ration of a patent, the Intellectual Property Trial and App eal Bo ard rend ered th e fo llowing
decision: "Th e demandee manufactured the inv ention subject to con firmation for the purpo se of conducting
the bioequivalen ce tests, an d these tests are recognized as tho se falling und er tests referred to in Article 96,
paragraph (1)1 of th e Patent Act as tests to con firm wh ether th e gen eric drug is b ioequiv alent to the existing
new drug to th e extent th at it can replace th e existin g new d rug. Th erefo re, it is reason able to consider
production of the invention subject to confirmation, that is, the act o f manufacturing it, for th at purpose a s"practice of a patented invention for the pu rpose of research or testing" prov ided in Article 96, p aragraph(1)1 of the Patent Act."
6 Article 96 (Limitation s on Effects o f Patents (1) The effects of a patent shall not extend to the following:
1. Practice of a patented invention for the purpo se of research o r testing (in cludin g research and testing for
3

vii

The patent linkage-related provisions that were newly introduced throughlegislation for performance of the South Korea-U.S. FTA were relating to the system ofa notice to a patentee and measures for preventing marketing approval without rightholder's consent. The part relating to a notice to a patentee was introduced into thesystem of South Korea on March 15, 2012 through coming into force of the South
Korea-U.S. FTA. The part relating to measures for preventing marketing has been in
effect since March 15, 2015 with a three-year grace period granted.
The ultimate purpose sought by the patent linkage system is to promote themarket entry of generic drugs by granting legitimate and sufficient compensation forpatentees' development of new drugs and by providing incentives to those who havepromoted the market entry of generic drugs through challenge to patents. The legislative
purpose can be considered ideal, and it is reported that implementation of the systempromoted the market entry of generic drugs in the United States. 7 However, even in
the United States, implementation of the system caused many problems that were notexpected in the initial stage of designing of the system. The United States amended
relevant law in 2003 in order to correct problems arising from abuse of the system. In
the case of the United States, many problems were improved through legal amendment
in 2003, but not all the problems were solved, and even now, various bills are presented
in order to solve problems caused by the system.
South Korea designed the South Korean-style patent linkage system based on
lessons learned from trials and errors in the United States in conformity to the South
Korean legal system and the environment which the pharmaceutical industry is facing.
The patent linkage system of South Korea is specifically explained below.
2. Related Procedures(1) Provisions of the South Korea-U.S. FTA(2) Provisions of the Pharmaceutical Affairs Act
1) Listing in the Drug Patent List
2) Notice of an Application for Approval3) Measures for Marketing Prevention4) Exclusive Marketing Approval(3) Difference from the U.S. System

obtaining p ermission for items of medicines o r repo rting items of med icines by under th e "Ph armaceutical
Affairs Act" o r fo r registering pesticid es under th e "Pesticid e Control Act") (the rest is o mitted)
7 Fed eral Trade Commission, "Generic Drug Entry Prio r to Patent Expiration: An FTC Study," 2002.

viii

1) Drugs That can be Listed
2) Scope and Procedure of Listing3) Generic Exclusivity(4) Drug Marketing Approval-Related Operations
3. Patent Linkage and Generic Exclusivity
4. Introduction of the Patent Linkage System and Current Situation of Patent
DisputesIV. Japanese Patent Linkage System
1. Current Japanese System
In the case of broadly defining the patent linkage system, that is, in the case ofdefining the patent linkage system as a mechanism whereby the regulatory authority
considers the existence or absence of patents relating to the original drug in theexamination/approval procedure of a generic drug so as to prevent the occurrence of aproblem with the stable supply of the generic drug due to patent infringement litigation,etc. after the start of the marketing of the generic drug, 8 Japan can be considered tohave already partially introduced the patent linkage system.
Under Article 67 of the Japanese Patent Act, the duration of a patent for a new
drug is "20 years" plus five years at most. As a long period of time is required for thedevelopment and examination of a new drug, extension of the duration of a patent ispermitted for a maximum of five years. 9
Unlike the South Korean Patent Act, the Japanese Patent Act does not include
an explicit Bolar provision that "the effects of a patent shall not extend to research or
testing for obtaining marketing approval of a drug." However, the court has determinedthat a generic drug company's act of conducting a bioequivalence test during theSurvey on Actu al Conditions of Intellectual Property Systems, etc. for Biotechno logy-Based Drug s in OtherCountries, Institute o f In tellectu al Prop erty (March 2018), p age 23 (http s://www.mhlw.go.jp/file/06Seisakujouhou-10800000-Iseikyoku/0000202523.pdf) [last access d ate: August 14, 2018]
9 (Paten t Term) Article 67 (1) Th e term of a patent righ t expires after a period o f 2 0 years from the filing dateof th e paten t application.
(2) If th ere is a period during which it is not possible for a person to wo rk th e p atent inv ention due to theneed to obtain permission under the provision s of the law th at is intended to ensu re safety, etc. of working
the p atent inv ention or to be issued any oth er dispo sition that Cab inet Order specifies as one that it requireconsiderab le time to properly reach due to thing s su ch as th e purpo se of th e d ispo sition and pro cedures, etc.,
involved in it, the term of patent right may b e ex tended, upon th e filing of an application to register an
extension for a maximum of five years.
8ix

duration of a patent for a new drug does not constitute infringement of the patentright. 10
In addition to this, for a new original drug, the reexamination period of up to 10
years is set after marketing approval. An original drug manufacturer needs to collectefficacy and safety data concerning the actual use of the original drug at medical
institutions and undergo reexamination after passage of a certain period of time after
approval. Even if the patent term of the original drug has already expired, generic drug
manufacturers are prevented from filing an application for a generic drug during thisperiod. 11
On the other hand, in Japan, as an operation corresponding to "patent linkage,"where there is a valid patent for an effective ingredient of an original drug based on
patent information on the original drug that was reported by the original drug
manufacturer ("drug patent information report sheet"), marketing approval is not to be
granted for a generic drug based on guidance under a Ministry of Health, Labour andWelfare's notice addressed to the prefectural heads of hygiene departments and bureaus,
etc. 12 so as to prevent the occurrence of a problem with the stable supply of the genericdrug product due to patent infringement litigation, etc. after the start of the marketingof the generic drug. 13 However, this provision of information on actual operations is
on a voluntary basis and is not made available to the public.
As a whole, in Japan, it is made a principle that "a generic drug is not approved
if there is a patent for an effective ingredient of the original drug."
As a means thereof, an applicant for a generic drug is required to "makeadjustment for an item involving concerns about a patent among the parties in advance

Judgement of the Second Petty Bench of the Sup reme Court o f Ap ril 16 , 1999 (19 98 (Ju) 153) (Minshu, Vol.
53, No. 4, at 627) [pancreatic disease th erap eutic ag ent case].
"Where a person holds a patent for a chemical sub stance o r a d rug containing it as an effectiv e ingredient, it
is reason able to understand that a third party' s act of producing a ch emical sub stance or a drug that falls
within th e technical scope of the patented invention and conducting a test necessary to obtain a material to
be attached to a written application for app roval prescribed in Article 14 of th e Ph armaceutical Affairs Act
by using the produced chemical substance or d rug durin g the duration of th e patent for the pu rpose of filingthe application for approval in relation to th e manufactu ring of a g en eric drug with the aim of manufacturingand marketing the generic drug after the expiration o f the duration of th e p atent falls und er the 'working of
the p atented invention for experimental or research pu rposes' referred to in Article 69, parag raph (1) of the
Patent Act and does not constitute infringement of the patent."
1 1 Comp etition and Incentives for Research and Dev elo pmen t in th e Drug Mark et – Th rough Verification of
Imp act th at the Entry of Generic Drugs Had on th e Market), Jap an Fair Trad e Commission, p ages 13 to 15.
1 2 "Handling o f Drug Patent Information in Relation to Application fo r Approv al" (Pharmaceutical Affair s
Council's Notice No. 762 of October 4, 1994 ) and "Han dling of Drug Paten ts in Relation to App lication forApproval of Generic Drug for Medical Use und er th e Pharmaceutical Affairs Act and NHI Price Listing"(Notice of th e Director of the Economic Affair Divisio n of th e Health Policy Bu reau No. 0605001/No tice of
the Directo r of the Safety Division of the Pharmaceutical and Food Safety Bureau No. 0605014 of June 5,2009).
1 3 https://blog.goo.ne.jp/hatatomoko1966826/e/0b21b3ab 697d71c3bc1fff7d43108e35
10x

of the (National Health Insurance Drug (NHI) listing of a generic drug and take thelisting procedure only if the item can be stably supplied."That is, in the case of filing an application for a generic drug, a generic drug
company is required to file it after the end of the reexamination period, to examine
whether there are substance patents or use patents for the effective ingredient of thedrug, and to attach material showing that the drug can be promptly manufactured andmarketed after approval if there is any substance patent or use patent. In addition, inthe case of desiring to list an item that seems likely to cause a patent dispute, a genericdrug company is sometimes required to make adjustments with a new drug
manufacturer, who is the patentee, in advance (preadjustment procedure) and take thelisting procedure only if the item can be stably supplied and to submit materials thatcan objectively prove that stable supply of the item is possible (a written consent, etc.
of the patentee (original drug manufacturer, etc.)) as needed. 14
2. Problems with the Current System
In Japan, a patent linkage system in a full-fledged sense has not been introduced.
However, as mentioned above, where there is a patent for an effective ingredient of an
original drug based on patent information reported by the original drug manufacturer(drug patent information report sheet), marketing approval is not granted for a generic
drug. Therefore, in a broad sense, Japan can be considered to have already been
operating the Japanese-style patent linkage system. The Japanese-style patent linkage
system was first introduced in 1994. At first, the system had been operated only in
relation to substance patents. It is considered that the Ministry of Health, Labour andWelfare started operating the system in relation to substance patents on which it is easy
to make a determination because it is not an expert in patents. However, in 2009, thescope of subject patents was expanded, and use patents became subject to the system in
addition to substance patents.
Although the Japanese-style patent linkage system has a relatively long history,
it is said that only about three years have passed since the system started to be discussed
in a full-fledged manner in Japan. It is a fact that there are still not many experts andpersons who have an interest in the system. However, the system is expected to attract
increasing interest in the future.

14

Same as above.

xi

The following are problems with the current Japanese system that the author
came to know through interviews with persons involved in the Japanese academic
circles and industry and related seminars.
(1) Uncertainness of the System(2) Expertness(3) Transparency
3. Possibility of Introduction of a Full-Fledged Patent Linkage System
Japan is a party to the TPP, but it is questioned whether Japan must introduce afull-fledged patent linkage system.
At the time of TPP negotiations, the entire Japanese industry stood in opposition
to the introduction of a patent linkage system. In particular, the generic drug industry
was fiercely opposed to the introduction, and there were concerns about the frequent
occurrence of litigations like in the United States. There was a worry that the
introduction would rather require unnecessary costs and time for litigations thanpromote the market entry of generic drugs. Furthermore, there were many opinions
showing adverse reaction to the introduction of a new system, the result of which is
hard to predict, in the situation where Japan had already operated the current Japanesestyle patent linkage system and the system had been operated without any big problem.
The patent linkage system was suggested based on the assertion of the UnitedStates, but the patent linkage system under the TPP is a very relaxed one unlike thesystem under the South Korea-U.S. FTA. The industry was persuaded to accept theprovision of the patent linkage system for TPP based on the idea that the current
Japanese practice would hardly be changed even if the patent linkage system is
introduced in Japan under the TPP.
In general, from the perspective of the Japanese industry, it is the prevailingview that it is undesirable to introduce the U.S.-style patent linkage system, the impact
on the industry of which cannot be confirmed, because Japan has already been operating
its own patent linkage system through there are a few problems, such as lack oftransparency.
The aforementioned conclusion was probably drawn due to integration of Japan's
unique method of operating the system, national character that does not like adventuresand changes, and above all, social atmosphere that does not like litigation.
4. Future Directionxii

In Japan, the reexamination period can be extended up to 10 years, and it is
impossible to file an application for a generic drug during the reexamination period.
Therefore, it can be considered that original drugs have already been sufficiently
protected. Consequently, oppositions to the necessity of introduction of the U.S.-stylepatent linkage system are also sufficiently convincing in a certain sense.
From the perspective of original drug manufacturers, they oppose theintroduction of the system on the grounds that the U.S. system involves significant costs
and that litigations will be blindly filed. From the perspective of generic drug
companies, many of them consider that the current system is also sufficient because it
is possible to enter the market by invalidating patents through the system of trial forinvalidation. At present, the Japanese patent linkage system does not require thesettlement of a trial for invalidation, and if a trial decision to the effect that the patentis invalid is rendered, an application for approval of a generic drug is accepted.
Although around one year is required before the rendering of a trial decision to theeffect that the patent is invalid, a generic drug company can obtain approval of thegeneric drug with no problem in terms of time by filing a request for a trial forinvalidation six months before the end of the reexamination period.
In addition, although Japan has no explicit Bolar provision that is like the one
in South Korea, the Supreme Court of Japan has determined that the act of conducting
a test for filing an application for approval of a drug by producing and using a chemical
substance or drug that falls within the technical scope of a patented invention during
the duration of the patent falls under the "working of the patented invention forexperimental or research purposes" and does not constitute infringement of thepatent. 15 In this manner, it is widely thought that the Bolar provision is not necessary
in Japan because there is said Supreme Court decision.
Piercing these together, it was concluded that it is more desirable to alleviate
problems with the current Japanese system and restructure the Japanese-style patent
linkage system than to introduce the U.S.-style patent linkage system.
However, the largest problem is that the Ministry of Health, Labour andWelfare's patent list, which forms the basis of the patent linkage system, exists in Japanbut is not publicly available. Furthermore, another problem is that despite great
difficulty in determining the scope of rights of a use patent, the Ministry of Health,Labour and Welfare determines whether a drug falls within the scope of rights and does

15

Judicial precedent cited above (note 67).

xiii

not grant marketing approval if the drug is likely to infringe the patent. Responsible
persons at the Ministry of Health, Labour and Welfare are experts in drugs, but are notexperts in patents. If, despite that fact, approval of a drug is not granted for a genericdrug that is likely to infringe a patent based on the Ministry of Health, Labour andWelfare's determination, it is likely to further delay the market entry of the generic
drug. 1 6
It is necessary to go through the following two stages in order to market a drug.
Marketing approval of a drug – NHI price listing – Marketing
That is, even after obtaining marketing approval of a drug, it is impossible tosell the drug if the NHI price is not listed. In such sense, generic drug companies canbe considered to be double-checked in terms of a generic drug's relationships with apatent. Therefore, the market entry of generic drugs is forced to be even later. It isconsidered possible to further promote the market entry of generic drugs if marketing
approval is granted for an application for marketing approval of a generic drug where
the generic drug fulfills requirements necessary for marketing approval, such as
efficacy and safety information, and the issue concerning relationships with a patent isevaluated at the time of NHI listing.

V. Conclusion
The South Korean patent linkage system was rather introduced throughlegislation for performance of the South Korea-U.S. FTA than was voluntarily
introduced as needed for the environment of the domestic pharmaceutical industry.
However, the South Korean government is continuously making efforts to design thelegal system as the South Korean-style patent linkage that suits the environment of its
own pharmaceutical industry, and the system is evaluated as having been actively
established to a certain extent at the present time after three years have passed since
the full-fledged enforcement of the system.
The United States has continuously increased the level of protection of intellectual
property rights, but in its own legislation, consideration has been given so that the rights
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From th e p ersp ectiv e o f p ractition ers, it was also pointed out that "For cases that are likely to cau se adispute, responsible persons at the Ministry of Health , Labour and Welfare tend to draw a con clu sion in the
direction of not easily granting marketing app roval."xiv

of creators of intellectual property rights and the right to access of users who intend to use
intellectual property can maintain balance, by considering measures for activating
exploitation as well as strengthening of the level of protection. This is also very clear fromthe purpose and content of the Hatch-Waxman Act, which is the representative provision
on drug-related intellectual property rights. On the other hand, if the United States requiresa third country to protect intellectual property rights at a high level that is equivalent to
the level in the United States in FTA negotiations with the third country and the third
country, which differs from the United States in the legal system, increases the level ofprotection to the same level as the United States, a problem of disharmony between therights of right holders and the right to access of users can arise. Therefore, it is necessary
to develop the legal system so that the right to access of users is guaranteed at the samelevel as the level of strengthened protection of right holders, and it is also necessary to
exercise ingenuity in terms of operation so as to ensure that those rights are also
appropriately harmonized in terms of legal interpretation.
Japan has already been enforcing its own patent linkage system. However, it has
yet to implement a patent linkage system in a full-fledged sense that includes a notice to apatentee and measures for marketing prevention. Moreover, the United States has
drastically changed the patent linkage system through the legal amendment in 2003 in order
to alleviate various problems that appeared in the implementation of the system. In thecase of introducing the patent linkage system that started in the United States into a country
that differs from the United States in law, systems, and industrial environment, it isprobably impossible to design a perfect system from the beginning. However, it isnecessary to design the system so that the interests of both parties can be balanced by using
trials and errors in countries that have already implemented the system as teachingmaterials by negative example and by keeping in mind that the purpose of the system is topromote the market entry of generic drugs by ensuring that patentees are granted legitimate
and sufficient compensation for the development of new drugs and by providing those whohave promoted the market entry of generic drugs with incentives therefor. By designing
the system in such manner, it is probably possible to make a success of designing of theJapanese-style patent linkage system.
It would be appreciated if this research report is of help to understand eachcountry's patent linkage system and to build the Japanese-style patent linkage systemand have it be well-established.

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