㸲 The System for Registration of Extension of theDuration of Patent Rights of Pharmaceuticals or the like andthe Appropriate Operation Thereof (*)
In Japan, there is the system to register for an extension of the duration of a patent right, in which theduration of a patent right may be extended by an application for the registration of extension and according to
the Examination Guidelines for Patent and Utility Model in Japan, the examinations of applications for theregistration of extension have been carried out. However, on May 30, 2014, the Grand Panel of the Intellectual
Property High Court rendered the opinion with respect to the interpretation in the current Examination
Guidelines. While this judgment has not become final and binding, the current operation of the system toregister for an extension of the duration of a patent right is called into question. The state of approvals andlicenses based on the provisions of laws enacted for the purpose of securing safety or the like, which is the groundof the extension, is affected by the globalization of businesses and the complications and advancements oftechnology. Considering the intensified race to develop novel pharmaceuticals with expanding development of
new forms or new dosages and means of administration, and emerging of regenerative medical products, thisresearch was conducted aiming to prepare such basic materials that contribute in studying the system to registeran extension of the duration and the appropriate operation thereof in the future, such as the Japanese users'
evaluation on the current system and the operation thereof as well as the survey of similar systems in foreigncountries and the status and actual circumstances of the operation thereof.

Ϩ Introduction
Article 67(1) of the Japanese Patent Act 1
provides that “the duration of a patent right shall
expire after a period of 20 years from the filingdate of the patent application.” The system toregister for an extension of the duration of apatent right under paragraph (2) of said Article2
is provided as an exception to such duration.
Currently, the types of the disposition prescribedin said paragraph, which are set forth under
Article 2, items (i) and (ii) of the Order for
Enforcement of the Patent Act, are (a)registration of agricultural chemicals under the
Agricultural Chemicals Control Act; and (b)approval and certification of pharmaceuticals,
in-vitro
diagnostic
pharmaceuticals
andregenerative, cellular-therapy and gene-therapy
products (including veterinary medicines) underthe Act on Securing Quality, Efficacy and Safetyof Pharmaceuticals, Medical Devices, etc.
(hereinafter referred to as the “Pharmaceuticals
and Medical Devices Act”).
With respect to a litigation seeking
rescission of a trial decision rendered by theJapan Patent Office (JPO) for an application forregistration of extension of the duration of apatent right, the Intellectual Property High Court(“IP High Court”) rendered a judgment to rescind
the JPO decision on May 29, 2009, and theSupreme Court dismissed the appeal filed by the
JPO. In response to these judgments, theexamination guidelines were examined forrevision in the Working Group Studying the
System for Extending the Duration of a Patent
Right under the Patent System Subcommittee of
the Intellectual Property Committee of theIndustrial Structure Council and were revised to
avoid any inconsistencies with respect to the
judgment of the Supreme Court. However, on
May 30, 2014, the trial decision rendered by the
JPO based on the revised examination guidelines
was rescinded by the judgment of the Grand
Panel of the IP High Court. The Grand Paneldenied the operations made by the JPO withrespect to the interpretation of the revised
examination guidelines. While a petition for
acceptance for final appeal has been filed withrespect to the abovementioned judgment andsuch judgment has not become final and binding,the operation of the system to register for an
extension of the duration of a patent right iscalled into question.
The state of approvals and licenses based onlaws enacted for the purpose of securing safety,
etc. is affected by the globalization of businesses(*) This is an English summary by Institute of Intellectual Property based on the FY2014 JPO-commissioned researchstudy report on the issues related to the industrial property rights system.
IIP Bulletin 2015 Vol.24● 20 ●

and the complications and advancements oftechnology. In particular, in the field ofpharmaceuticals, the system to register for an
extension of the duration of a patent right has
become increasingly important due to theintensified race to develop pharmaceuticals madeof novel active ingredients, pharmaceuticals withnew forms or new dosages and means ofadministration,andregenerative
medicalproducts. Amidst this situation, the users'
increasing interests in the system to register foran extension of the duration of a patent right andthe operation thereof require basic materials that
contribute to their study of the system to registeran extension of the duration of a patent right andthe appropriate operation thereof in the future,such as the Japanese users' evaluation on thecurrent system and the operation thereof as wellas the study of similar systems in foreigncountries and the status and actual circumstancesof the operation thereof.

ϩ Japanese system of application
for the registration of extensionof the duration of a patent right1

Intent and purpose of the system for theregistration of extension of the durationof a patent right
The purpose of the Japanese patent system
is to seek development of industry by allowing amonopoly of rights for an art covered by aninvention for a certain period of time tocompensate for the disclosure of such art, thereby
protecting the invention while offering it for use
by the public. However, in some fields, aconsiderably long period of time is required tocollect data, due to the necessary experiments toobtain approvals and licenses based on
government laws and safety regulations as well as
the examination thereof. Consequently, there wasan issue that, although the patent right iseffective during such period of time, the patentee
cannot fully enjoy the benefits of the monopoly ofrights and suffers encroachment of the patentterm for such period of time.
Although such laws and regulations
themselves are essential in terms of their
purpose, as a result of the enforcement thereof, inthe entire field subject to the abovementioned
laws and regulations, the patentees are inevitably
unable to enjoy the patent term, which could haveoriginally been enjoyed for the abovementioned
period of time. In addition, there were limitations
on the reduction in the examination period undersuch laws and regulations due to security of safety,
etc.
Since this situation concerns the basis of thepatent system, the system to register for an
extension of the duration of a patent right was
created upon the revision of the Patent Act in
1987.
The system to register for an extension of
the duration of a patent right was created for the
purpose of seeking balance between theprotection and use of inventions. The system
extends the duration of a patent right and fully
protects inventions in light of the fact that, in thefields where patent inventions cannot be
immediately worked due to the long period oftime required for experiments and examinations
that are necessary for receiving dispositions
under laws and regulations stipulated for securingsafety, etc., inventions were protected in aconsiderably insufficient manner and third parties
that only use patented inventions were in an
overly advantageous position.
2

Outlines of the system for theregistration of extension the duration ofa patent rightThe current Japanese system to register foran extension of the duration of a patent right was
created by the revision of the Patent Act in 1999.
The outline of the system is as follows.
(1) Dispositions that serve as grounds forthe registration of extension
The dispositions that serve as grounds forthe registration of extension are listed in Article
2 of the Order for Enforcement of the Patent Act
mentioned in I. above.
(2) Period to be extended
The period to be extended is provided for in
Article 67(2) of the Patent Act. While various
tests are conducted according to the purpose, gist
and contents of the regulatory law, it is prescribedthat only the period for carrying out the test thatsatisfies all of the requirements mentioned in (i)through (iii) below may be included in the “period
during which the patented invention is unable tobe worked.”(i) The test is essential to receive thedisposition;(ii) Companies are limited in their freedom tocarry out the test since it must be carried out
in line with the standards prescribed bygovernment ministries and agencies withrespect to the method and contents, etc.; and● 21 ●IIP Bulletin 2015 Vol.24

(iii) The test is closely related to the receipt of
disposition.
More
specifically,
in
the
case
of
pharmaceuticals, in-vitro diagnostic medicines
andregenerative,
cellular-therapy
andgene-therapy products, the abovementioned
period is prescribed to begin on the day that theclinical test has commenced or the registration ofa patent right has been established, whichevercomes later, and to end on the day immediately
prior to the day of arrival of the notice of approvalto the applicant (the day on which the applicant isplaced in a situation in which he/she actuallyknows or is able to know the grant of suchapproval). In the case of agricultural chemicals,
the abovementioned period is prescribed to begin
on the day of commencement of the entrusted
field test, which is carried out by clearly stating
the name of the compound (the request date, etc.)
or the day on which registration of a patent righthas been established, whichever comes later, andto end on the day immediately prior to the day ofarrival of the notice of approval to the registeredapplicant (the day on which the applicant is placedin a situation in which he/she actually knows or isable to know the grant of such approval).
(3) Application for the registration ofextension
The application requesting the registration ofextension of the duration of a patent right shall be
filed by the patentee within the time limit
prescribed by Cabinet Order (3 months) after the
disposition prescribed by Cabinet Order under
Article 67(2) is obtained in Article 67(1). The
application requesting the registration ofextension of the duration of a patent right may
not be filed after the expiration of the duration ofa patent right (Article 67-2(3) Patent Act).
Where a patent right is jointly owned, noneof the joint owners may file an application for theregistration of extension of the duration of apatent right unless jointly with all the other joint
owners (Art. 67-2(4)).
(4) Effects
ofapplicationfortheregistration of extension
Where an application for the registration ofextension of the duration of a patent right is filed,the duration shall be deemed to have been
extended; provided, however, that this shall not
apply where the examiner's decision to the effectthat the application is to be refused has become
final and binding or where the extension of theduration of a patent right has been registered (Art.

IIP Bulletin 2015 Vol.24

67-2(5)).
(5) Examination of application for theregistration of extension
Where an application for the registration ofextension of the duration of a patent right falls
under any of the items listed in Article 67-3(1),the examiner shall render the examiner's decision
to the effect that the application is to be refused.
Where the examiner intends to render an
examiner's decision to the effect that an
application is to be refused, the examiner shallnotify the applicant of the reasons therefor andgive the said applicant an opportunity to submit awritten opinion, designating an adequate time
limit for such purpose.
An applicant who has received an examiner's
decision to the effect that an application is to berefused and is dissatisfied may file a request for a
trial against the examiner's decision of refusal.
Where no reasons for refusal are found forthe application for the registration of extension of
the duration of a patent right, the examiner shallrender an examiner's decision to the effect thatthe extension is to be registered.
(6) Effects of patent right for which
duration is extended
Where the duration of a patent right is
extended, such patent right shall not be effective
against any act other than the working of thepatented invention for the product which was the
subject of the disposition designated by Cabinet
Order under Article 67(2) which constituted thereason for the registration of extension (where thespecific usage of the product is prescribed by thedisposition, the product used for thatusage)(Article 68-2).

Ϫ Outcome from questionnaire
survey and interview survey
In the entire field of pharmaceuticals, bothnew drug manufacturers and generic drug
manufacturers tend to appreciate the operations
that the JPO conducted prior to the rendition of
the judgment of the IP High Court on May 29,
2009. While they regarded conventional
operations to have been carried out based on
certain balance for cases other than those forwhich the judgment of the Supreme Court was
rendered on April 28, 2011, they also appreciatedto a certain degree the operations conducted by
the JPO based on the revised examination
guidelines after the abovementioned judgment of● 22 ●

the Supreme Court was rendered.
With respect to the judgment of the Grand
Panel of the IP High Court rendered on May 20,
2014, many of both new drug manufacturers andgeneric drug manufacturers answered that theinterpretation of the effect of a patent right whose
duration has been extended presented in theobiter dictum of the judgment of the Grand Panelof the IP High Court destabilizes the scope ofeffect of a patent right whose duration has been
extended. Notably, some new drug manufacturers
presented their opinions that a system revisionmust be made if the effect of a patent right whose
duration has been extended would be interpreted
as in the judgment of the Grand Panel of the IP
High Court.
However, companies have shown different
levels of understanding with respect to the impact
on practices to be caused by the effect of a patentright whose duration has been extended, which
has been presented in the judgment of the Grand
Panel of the IP High Court. Moreover, companies
have different levels of understanding withrespect to the revision of the system, such as theactual revision to be made and the practicalrevision.
Since the field of agricultural chemicals issubject to conditions different from those ofpharmaceuticals, such as the high safety requiredof agricultural medicines and long data protection
period, in some cases, the needs of agriculturalchemical manufacturers do not correspond to
those of pharmaceutical manufacturers.
In the field of agricultural chemicals, whilemore importance is placed on the patent right
until the agricultural chemical has beenregistered, once the agricultural chemical has
been registered, substantial protection of such
agricultural chemical is secured by the
Agricultural Chemicals Regulation Act and thesystem for registration of agricultural chemicals
and the operation thereof.
The field of regenerative medicine has only
recently been covered by the system to register
for an extension of the duration of a patent rightand, thus, there are no cases in which theregistration of extension of the duration of apatent right has become an issue. However,various cases are expected to occur in the future.

ϫ Systems for the registration ofextension of the duration of apatent right and related systems
in major foreign countries
1

United States
In September 1984, the Drug Price
Competition and Patent Term Restoration Act of1984 came into force. This law is generally called
the Hatch-Waxman Act after Representative
Waxman, who promoted “competition of drug
prices,” and Representative Hatch, who promoted“restoration of patent term.” The Act contains
the Abbreviated New Drug Application (ANDA)
approval supported by the generic industry andthe method of restoration of patent term
supported by research-and-development-oriented
companies.
The system to register for an extension of
the duration of a patent right in the U.S. isprescribed in Section 156 of the Patent Law andSections 1.710 through 1.791 of the Patent Rules(37 C.F.R.), “Adjustment and Extension of Patent
Terms,” as well as in Section 2710 of the Manualof Patent Examining Procedure (MPEP). The
outline of the system is as follows.
(1) Products that serve as grounds forregistration of an extension
Human drugs, animal drugs, medical devices,
food additives and coloring agents are productsthat serve as grounds for registration of an
extension.
(2) Period to be extended
With respect to pharmaceuticals, the total ofhalf of the period starting from the day of
Investigational New Drug (IND) Application until
the day of New Drug Application (NDA) and theperiod from the day of NDA until the day of
approval (Section 156(c) and (g)(1) of the Patent
Law) will be extended for a maximum of 5 years.
However, the period of extension will be
reduced for the period during which the applicant
did not act with due diligence (Section 156(c)(1)of said Law), and the period from the day of
permission (the day of approval in the case ofpharmaceuticals) until the date of expiration of
the patent term (if the patent term has been
extended) shall not exceed 14 years (Section
156(c)(3) of said Law).
The patent term is extended form the firstdate of expiration of the patent term (the day of
expiration when the patent term is not extended)(Section 156(a) of said Law). (The detailed● 23 ●IIP Bulletin 2015 Vol.24

method for calculating the extension of patentterm is provided in Sections 1.775 through 1.779
of the Patent Rules.)(3) Patents eligible for extension
Patents eligible for extension are thoserelated to products, those related to the processof using products and those related to a process
for manufacturing products. The patent term canonly be extended for one patent selected by thepatentee (this is not necessarily the first patent
granted) for one product in relation to the
one-time approval of a New Drug Application(NDA) granted for the first time.
(4) Application
The owner of record of the patent or its
agent must submit an application within 60 days
from the day on which the product received
permission, based on the provision of law (the dayof acquisition of approval of NDA in the case ofpharmaceuticals) (Section 156(d)(1) of the Patent
Law).
There is a system where, if the owner ofrecord of the patent or its agent reasonably
expects that the review period may extend
beyond the expiration of the patent term in effect,
the owner or its agent may submit an application
to the Director of the United States Patent andTrademark Office (USPTO) for an interim
extension. Therefore, for example, the patentterm may be allowed an extension even if thepatent term were to expire prior to the grant ofapproval of NDA.
(5) Review
The USPTO decides the extension period
after the regulatory review period has been
decided by the notification to the Food and Drug
Administration (FDA) by the USPTO.
(6) Effects of patent right for which
duration is extended
The effect of a patent right whose duration
has been extended only extends to approved
products that have the same scope of protection
as that of the basic patent. However, with respect
to use, such effect extends to the use subject tosubsequent new approvals. (In this part, the term
products refer to the active ingredients of theapproved product.)2

EuropeIn Europe, movements requiring the creationof a system similar to the systems to register for

IIP Bulletin 2015 Vol.24

an extension of the duration of a patent right usedin the United States, Japan and the Republic ofKorea were increasing due to the loss of term ofuse of exclusive right based on patents, decline in
the share of pharmaceuticals originated in Europe,
deterioration in the quality of pharmaceuticalresearch activities caused by an insufficient
source of revenue and concerns over movementof research base to non-member countries of the
EU that give better protection to patents.
Consequently, the amendment of Art.63EPC was
adopted on 17 December 1991 (Official Journal
EPO 1992, 1ff.) but did not come into force until 4
July 1997.
Art.63EPC1973 was taken over by
Art.63EPC2000, of which Art. 63(2) and(b) statesthat nothing shall limit the right of a Contracting
State to extend the term of a European patent, or
to grant corresponding protection that follows
immediately on expiry of the term of the patent,
under the same conditions as those applying tonational patents, if the subject-matter of theEuropean patent is a product or a process for
manufacturing a product or a use of a product thathas to undergo an administrative authorization
procedure required by law before it can be put on
the market in that State.
Meanwhile in the EEC (European Economic
Community), after the European Commission’s
proposal of 8 May 1990 (Com 90/0101 Final)
designated to the introduction of an institution of
SPC (Supplementary Protection Certificate)corresponding to the system for the registrationof extension of the duration of a patent right inJapan or the U.S. was deliberated in the European
Parliament, the Council Regulation (EEC) No.
1768/92 of 18 June 1992 was promulgated andcame into force on 2 January 1993 for theMember States. Meanwhile, non-EU member
states such as Switzerland, Iceland, Lichtenstein,
and Norway also provided similar national
regulations on obtaining extensions of patentrights for medical products.
In the preamble of Council Regulation (EEC)
No. 1768/92, it is stated that medicinal products,
especially those that are the result of long, costly
research will not continue to be developed in theCommunity and in Europe unless they arecovered by favourable rules that provide forsufficient protection to encourage such research;and consideration has already been made to thefact that the manufacturers of generic products
would suffer delay with respect to the market
entry for such products.
The Council Regulation (EEC) No. 1768/92● 24 ●

was revised and superseded by the Council
Regulation (EEC) No. 469/2009 of 6 July 2009.
In addition, in order to apply the system ofsupplementary protection certificate (SPC) to
plant protection products, on July 23, 1996, theEuropean Parliament and the European Council of
Ministers adopted the Council Regulation (EC)
1610/96, which came into force in 1997, in
response to the proposal made by the European
Commission in 1994 and 1995 (Com 94/0597 Final
and Com 95/0456 Final).
While the SPC system of EU applies to the
EU member countries, the applicant must apply
for and obtain SPC for each member country.
(1) Products covered by the SPC system
Human medicines, veterinary pharmaceuticals
and plant protection products are covered by the
SPC system.
(2) Period to be extended
The effective period for SPC is determinedby deducting five years from the date of patentapplication until the date of issuance of first
approval for the distribution of pharmaceuticals(the period of extension is not more than five
years and the period from the day of approval
until the day of expiration is a maximum of 15
years). The date of registration of the patent has
no impact on the period to be extended.
(3) Patents eligible for extension
With respect to pharmaceuticals, the patentterm may be extended for patents granted for theprotection of products as well as methods ofproduction of products and use of products andthat have been designated by the owner in theprocedures to obtain SPC (hereinafter referred toas the “basic patent”).
With respect to agricultural chemicals, thepatent term may be extended for patents granted
for products, drug formulations, manufacturingmethod, and use of products and that have been
designated by the owner in the procedures toobtain SPC (hereinafter referred to as the “basic
patent”).

(5) Scope of protection of SPC
The scope of protection of SPC is prescribedin Articles 4 and 5 of the Regulation (EC) No.
469/2009 of the European Parliament of theCouncil of 6 May 2009, Articles 4 and 5 of theRegulation (EC) of No. 1610/96 of the European
Parliament and of the Council of 23 July 1996 andthe respective case laws.
SPC protects the use of pharmaceuticals or
agricultural chemicals of a “product” that has
been approved to be sold within the scope ofprotection of the basic patent. The use protectedby SPC is not limited to the use referred to in thefirst approval for sale (which serves as the basisof the SPC), and it includes every use protected
and approved by the patent that serves as thebasis during the applicable period of SPC. Thissystem is also applicable to the case where theperson who obtained approval for sale for asubsequent use is a third party.
In the Novartis; C-574/11 case, the Court ofJustice of the European Union (ECJ) held that, incases where the SPC has been granted for asingle active ingredient (A), the effect ofprotection under the SPC extends to the
combination of two active ingredients (A+B) thatcover active ingredient (A), as in the case where
the effect of a patent that serves as the basis for asingle active ingredient (A) also extends to theprotection of the use of the active ingredient (A),which is covered by the combination of two active
ingredients (A+B).
Only one certificate is granted to eachproduct and a product is construed to be a single
active ingredient in a strict sense. Accordingly, an
SPC will not be newly granted for any change inthe product, such as a new dosage of an active
ingredient or its different salt or ester, and thus
the scope of protection of an SPC extends to thesalt and ester of the relevant active ingredient inaddition to its major medicinal benefits. If an
extension of the period is allowed for an SPC that
protects pediatric medicines, the scope ofprotection would not be limited to the pediatricuse of the relevant medicine.
3(4) Application
The patentee or its successor must file anapplication. The patentee or its successor shallapply with the competent office for industrial
property rights of the member country after thebasic patent has been granted and approval andlicense for distribution of the product have beenobtained.

Republic of Korea
In the Republic of Korea, in cases where along period of time is required for tests
confirming effectiveness and safety, etc. that arenecessary for permission or registration ofpharmaceuticals and agricultural chemicals, theperiod during which the patentee can enjoy amonopoly would be substantially shorter. Thus inorder
toachievebalancebetween● 25 ●IIP Bulletin 2015 Vol.24

pharmaceuticals and agricultural chemicals andother products in terms of the patent term byextending the patent term of the patent right of
the relevant pharmaceuticals and agriculturalchemicals within the scope of five years, thesystem for the registration of extension of theduration of a patent right was introduced by therevision of law on December 31, 1986 (Article 53,
paragraph (2) of the former Patent Act). At thattime, the system was one wherein theCommissioner of the Korean Intellectual
Property Office examined the application forextension and approved the extension inaccordance with the subject matter of thepatented
inventionandother
relevant
requirements prescribed by the President Decree,which is equivalent to the Cabinet Order in Japan.
As a result of subsequent revisions, a newprocedure was introduced wherein the patentee
files an application for the registration ofextension of a patent term and then the examiner
examines the application and renders a decisionof registration or refusal. Moreover, a system fora trial for invalidation of the registration ofextension was provided.
Later, in connection with the conclusion of
the Free Trade Agreement (FTA) between the
Republic of Korea and the United States, therevised Korean Patent Act was enacted on March
15, 2012, the day on which the U.S.-Korea FTA
came into effect.
The past system for the extension of thepatent term used in Korea was more similar to
the Japanese system than those of the UnitedStates and Europe. However, after the revision of
the Enforcement Decree of the Patent Act in 2013,
the Korean system became more similar to thoseof the United States and Europe and started toshow some difference with the Japanese system.
For example, unlike the opinions presented by theJapanese Supreme Court on April 28, 2011, evenif permission were additionally granted for a newform of the pharmaceutical product within the
Republic of Korea, if the active ingredient were
the same as those of the previously permitted
product, an additional extension of the patentterm would not be allowed.
(1) Products that may serve as grounds forthe registration of extension (Article 7of the Enforcement Decree of the Patent
Act)
These products include human or animal
pharmaceuticals (Article 31, paragraphs (2) and(3) or Article 42, paragraph (1) of the

IIP Bulletin 2015 Vol.24

Pharmaceutical Affairs Act) and agrochemicals(Article 8, paragraph (1), Article 16, paragraph (1)or Article 17, paragraph (1) of the Agrochemicals
Control Act).
(2) Period to be extended
Extension of a patent term is allowed for the
total of the period of clinical test or testnecessary for registration of agrochemicals andthe period for administrative disposition up to five
years (Article 89 of the Patent Act).
Moreover, the waiting period prior to thetest will not be included in the extended period,and only the period during which the test was
actually carried out will be included in theextended period. In cases where clinical tests arecarried out in foreign countries, only the period
for administrative review in the Republic of Korea
is approved.
The extension of a patent term following
delayed registration (Articles 92-2 through 92-5of the Patent Act) and the extension of a patentterm based on permission, etc. will not be
aggregated.
(3) Patents eligible for extension (Article 7of the Enforcement Decree of the Patent
Act)
Patents eligible for extension are all of thepatents related to the pharmaceutical or
agrochemical (or intermediate) whose active
ingredient is a new substance (a substance whose
chemical structure of the active part that presents
medicinal benefits is new) for which the firstpermission was granted (e.g., inventions ofcompounds, composition whose use is limited,
manufacturing method and form).
(4) Application
If any disposition including permission andregistration has been granted pursuant to theprovision of other laws and regulations to work apatented invention, the patentee must file anapplication for extension of the term of the patentright within three months from the day on whichsuch permission or registration was granted andsix months prior to the expiration of the patentright. In addition, in cases where a patent right isowned by joint owners, an application must be
jointly filed (Article 90 of the Patent Act).
(5) Examination
An examiner examines the application(Article 91 of the Patent Act). Any person who
has received a decision to reject an application to● 26 ●

register extension of the term of a patent rightand has an objection to such decision may file arequest for a trial against the decision to reject
the application (Article 132-3 of the Patent Act).
(6) Effects of the patent right in cases
where its term has been extended
The effect of a patent right whose term has
been extended only extends to the act of working
the patent invention that covers the approved
product and use (Article 95 of the Patent Act).
In terms of the legal wording used in Article
95 of the Patent Act, it is construed that such
effect does not extend to additionally approved
use or approval obtained by a third party. In thissection, the term “use” refers to the “functionand effect of the active ingredient for which
permission has been obtained.” If such use isidentical, the effect of a patent right whose term
has been extended extends to the form ofworking of the patented invention using different
dosage and administration or manufacturingmethod.

Ϭ Conclusion
When the system to register for an extensionof the duration of a patent right was introduced,
importance was placed on the incentives fordevelopment of novel active ingredients andefficacy or effects; much weight was placed on theprotection of substance patent and use patent as
an outcome of the research and development.
However, it is true that the art related to Drug
Delivery System (DDS) has become one of the
major pillars for research activities in thepharmaceutical field with the advancement ofsocial technology, and, thus, it is also important toincrease incentives for research and development
activities for DDS. Based on this viewpoint, if
approval has been granted to a pharmaceutical
whose active ingredient and efficacy of effect is
identical to those approved but that has a different
form, etc., it would be appropriate to allow theregistration of extension of the duration of apatent right with respect to patented invention
related to DDS in light of the purpose of thesystem to register for an extension of theduration of a patent right. The examination
guidelines revised in response to the judgment of
the Supreme Court rendered on April 28, 2011
complies with the abovementioned purpose.
In the judgment rendered on May 30, 2014,
the Grand Panel of the IP High Court allowed theregistration of extension of the duration of thepatent right of a substance patent and use patentin cases where approval has been granted to apharmaceutical whose effective ingredient andefficacy or effect is identical to those approved
but that has a different form, etc. This judgment
is essentially different from allowing theregistration of extension of a patent right of apatented invention related to DDS. The judgmentof the Grand Panel of the IP High Court should
not have an adverse effect on the incentives forresearch activities carried out for the discovery of
a novel active ingredient or efficacy or effect,
which are the main pillars of research activities in
the pharmaceutical field. In fact, many users
raised questions about the judgment of the Grand
Panel of the IP High Court concerning adverse
effects over incentives for research activities
carried out for the discovery of novel effective
ingredients or efficacy or effect in the survey
conducted in this research study and interviews
as well as in expert committees.
Among the requirements for the registrationof extension, with respect to the requirement of“where the disposition designated by Cabinet
Order under Article 67(2) of the Patent Act is notdeemed to have been necessary to obtain for theworking of the patented invention,” it isprescribed in the revised examination guidelinesthat the JPO makes determination on therelationship with the prior disposition based on
the patented invention (matters specifying theinvention) stated in the scope of claims.
As long as the purpose of the system toregister for an extension of the duration of apatent right is to restore “the period during which
the patented invention could not be worked,” it isappropriate to determine the patented invention
the working of which became possible by a priordisposition based on the matters specifying theinvention in interpreting the phrase “working of apatented invention” under the Patent Act.
Even if such interpretation were made, if anapproval were granted to a pharmaceutical whose
effective ingredient and efficacy or effect is
identical to those previously approved but which
has a different form, etc., it would be obvious
from the revised examination guidelines that apatented invention related to DDS would becovered in the scope of patents eligible forregistration of extension of the duration of apatent right. The appropriateness of including asubstance patent or use patent in the scope of
patents eligible for registration of extension of
the duration of a patent right in cases where an
approval has been granted to a pharmaceutical● 27 ●IIP Bulletin 2015 Vol.24

whose effective ingredient and efficacy or effect is
identical to those previously approved but thathas a different form, etc., should be discussed
separately from the inclusion of the patented
invention related to DDS in the scope of patents
eligible for the registration of extension of theduration of a patent right from the standpoint of
incentives for research and development
activities carried out for discovery of novel
effective ingredients and efficacy or effects.
With respect to the interpretation of theeffect of a patent right whose duration has been
extended, the Supreme Court made no referencein its judgment rendered on April 28, 2011. Since
there is no other case of infringement litigation
where the effect of a patent right whose
extension of duration has been registered became
an issue, the court's opinion on the interpretationof such effect is yet to be fixed. However, since
the scope of monopoly of the working of thepatented invention after the registration ofextension of the duration of the patent right isdefined by the scope to which the effect of apatent right whose extension of duration has beenregistered extends, it is appropriate to makeinterpretations based on the patented invention
stated in the scope of claims (matters specifying
the invention) as an interpretation of the PatentAct. Even if such interpretation were made, thescope to which the effect of a patent right related
to DDS for which extension of the duration has
been registered extends would not be unjustly
limited (although it is possible that some parts
may overlap with the effect of another patentright whose extension of duration has beenregistered). However, if interpretation has been
made in line with the opinions presented in theobiter dictum of the judgment of the Grand Panelof the IP High Court and the effect of a patentright whose duration has been extended by priordisposition is limited, there is concern that the
incentives for research activities for novel
effective ingredient and efficacy or effect, whichis the purpose of the system to register an
extension of the duration of a patent right, may be
negatively affected.
In the expert committee held in relation tothis research study, some members of the Japan
Pharmaceutical Manufacturers Association statedtheir opinions such that “it is unacceptable toagree to the idea of dividing the effect of a
substance patent by the dosage or administrationthat is subject to the disposition for extension of
the duration of the patent right.”
The interpretation of the effect of a patent

IIP Bulletin 2015 Vol.24

right whose duration has been extended made in
the judgment of the Grand Panel of the IP High
Court is different from the interpretation madewith respect to the effect of the patent rightwhose duration has been extended under thesystem to register for an extension of theduration of patent rights of other countries. There
are opinions that the effect of a substance patentor use patent whose duration of the patent righthas been extended should be interpreted in aconventional manner. These opinions are basedon the fact that the purpose of the system toregister for an extension of the duration of apatent right is to increase incentives fordiscovering novel efficacy or effects to novel
effective
ingredients
andintroducing
pharmaceuticals
withsecuredquality,effectiveness and safety to the world.
As such, the interpretation of the effect of apatent right whose duration has been extended
should be considered from the standpoint ofbalance between the protection and use of
inventions (considerations to the protection of theinvention and the parties who use the outcome of
the research activities made by other companies).
Moreover, since the effect of the patent rightwhose duration has been extended by a priordisposition is limited and the interpretation of“equivalents or those which may be evaluated as
substantially identical” as mentioned in the
judgment of the Grand Panel of the IP High Court
remains unclear, if an approval has been granted
to a pharmaceutical whose effective ingredientand efficacy and effect is identical to those
approved but that has a different form, etc., thepatentee must file an application for registrationof extension of the duration of the patent right forthe substance patent or use patent for which theduration of the patent right has already been
extended. In this case, attention should be paid tothe fact that not only would the burden to manage
patents increase (increase in the costs required
for filing an application for registration ofextension of the duration of a patent right andincrease in the burden to manage to file anapplication during the period in which theapplication for registration of extension of theduration of a patent right may be filed) for thepatentee who files an application for theregistration of extension of the duration of apatent right, but so would the burden ofmonitoring, which is borne by those who intend
to join the market upon the expiration of theduration of the patent right. While it may benecessary for those who intend to join the market● 28 ●

upon the expiration of the duration of the patentright to fix as early as possible the possible timeof market entry and to make necessary
preparations, if operations and interpretation of
the scope of effect were made in line with thedeterminations made in the judgment of theGrand Panel of the IP High Court, this would
cause problems to both the patentee who intends
to register the extension of the duration of thepatent right and those who intend to join themarket upon expiration of the duration of thepatent right.
Since a petition for acceptance of final appeal
has been filed with respect to the judgment of theGrand Panel of the IP High Court, thedetermination of the Supreme Court isanticipated. The registration of extension of theduration of a patent right should be examinedfrom the standpoints of balance between thepatentee and third party relevant to thedisposition and contribution to the developmentof innovation based on the purpose of the Patent
Act, and it is expected that the Supreme Court
makes determinations from such standpoint.
㸦Senior Researcher: Hidehiko NAKAJIMA㸧

1

2

http://www.japaneselawtranslation.go.jp/law/detail/?ft=
2&re=01&dn=1&yo=&ia=03&x=15&y=15&kn[]=%E3%81%A8&ky=&page=43“Where there is a period during which the patented
invention is unable to be worked because approvals
prescribed by relevant Acts that are intended to ensure
the safely, etc. or any other disposition designated by
Cabinet Order as requiring considerable time for theproper execution of the disposition in light of the
purpose, procedures, etc., of such a disposition isnecessary to obtain for the working of the patented
invention, the duration of the patent right may be
extended, upon the filing of a request for theregistration of extension of the duration, by a period
not exceeding 5 years.”● 29 ●IIP Bulletin 2015 Vol.24