Unfair
Date
Competition Case number

October 4, 2023
2023 (Ne) 10012

Court

Intellectual Property
High Court, Third
Division- A case in which, in a case of a claim for injunction of an act of an unfair competition
and the like related to a form of a medical pharmaceutical, which is an inhalation
agent for bronchial asthma, since neither of a requirement of special distinctivenessand a requirement of well-known characteristics is satisfied in the form of goods of
the Appellant, it cannot be considered to fall under "indication of goods or business"under Article 2, paragraph (1), item (i) of the Unfair Competition Prevention Act, andin light of actual circumstances of transactions, it was determined that no concern ofconfusion was found between the Appellant's Goods and the Appellees' Goods.
Case type: Injunction, etc.
Result: Appeal dismissed
References: Article 2, paragraph (1), item (i) of the Unfair Competition Prevention
Act
Judgment of the prior instance: Tokyo District Court 2020 (Wa) 19198
Summary of the Judgment
1 This case is a case in which X, who sells a medical pharmaceutical (X Goods),
which is an inhalation agent for bronchial asthma, alleged that a form of a medical
pharmaceutical (Y Goods), which is an inhalation agent for bronchial asthma
manufactured by Y1 company and sold by Y2 company, is similar to the form of the
X Goods, and Ys' acts of manufacture and sales of the Y Goods are transfer and thelike of the goods using the indication of goods or business similar to the indication of
X's well-known goods or business, whereby the Appellant's business interests were
infringed and the like, and claimed against Y for injunction of the transfer of the Y
Goods or business, disposal of the Y Goods, payment of damages, and the like.
The X Goods and the Y Goods are both such goods with chemicals in inhal ers,
and X's assertion is that the form of the inhaler of the Y Goods is similar to the formof the inhaler of the X Goods.

It is to be noted that the Y Goods are generic drugs(so-called generic drugs) of the X Goods.
The Judgment in prior instance dismissed all the claims by X, and X appealed.
2 The Judgment determined that the form of the X Goods is not acknowledged tofall under the "indication of goods or business" in Article 2, paragraph (1), item (i) of
the Unfair Competition Prevention Act or to be likely to create confusion anddismissed the appeal as follows.
(1) Applicability of indication of goods or business of the form of the X Goods
A In order for the form itself of the goods to have the secondary meaning toiindicate a specific origin and to fall under the "indication of goods or business " in thesame item, it is interpreted to require that: [i] the form of the goods objectively has adistinctive feature different from the other goods of the same type (special
distinctiveness); and [ii] the form has been used by a specific business operator in amonopolistic manner for a long time or the goods having the form have become wellknown (well-known characteristics) among consumers as indication of the origin of
the specific business operator by extremely powerful promotional advertisements or
explosive sales achievements and the like.
B The form of the X Goods is similar to the form of another specific inhalant forbronchial asthma and is not considered to objectively have a distinctive feature
different from other goods of the same type.
Moreover, the inhaler of the X Goods has a shape designed to exert efficacies of apharmaceutical of the X Goods so that patients can inhale the pharmaceutical mosteffectively and is considered to have an unavoidable form derived from a
configuration to achieve substantial functions of the X Goods.

However, to giveprotection to such a form as the indication of goods or business since the requirementof special distinctiveness is satisfied would result in inhibition of free competition
among goods having the equal functions, which is not reasonable.
Therefore, it is not approved that the X Goods satisfy the requirement of special
distinctiveness.
C X could monopolistically use the form of the X Goods because X had the design
right related to the form of the inhaler and the patent right related to thepharmaceutical, and it is natural in a sense of presence of the intellectual property
rights generated the monopolistic state, whereby the well-known characteristics are
generated.

And even if a certain well-known characteristic was generated for theform of the X Goods on the basis of the monopolistic state as above, to allow
application of the Unfair Competition Prevention Act only on the basis of the wellknown characteristics as above is, in the end, equal to prevention of the use by a third
party even after expiration of the durations of the aforementioned intellectual property
rights, which is not reasonable.

However, even in the case where the well -known

characteristic was generated from the monopoly based on the intellectual property
rights as above, if such a circumstance is acknowledged that the form of the X Goods
is well-known as the indication of the origin, after the influence of the monopolistic
state based on the holding of the intellectual property right was dispelled due topassage of the duration of the intellectual property right and passage of a considerable
period after competitive goods of the same type were input into the market by a thirdii

party or the like, it should be interpreted that there is room for application of Article 2,paragraph (1), item (i) of the Unfair Competition Prevention Act, but suchcircumstances are not acknowledged in this case.
Therefore, it cannot be approved that the requirement of the well-known
characteristics is satisfied for the form of the X Goods.
D According to the above, it is not acknowledged that the form of the X Goods
falls under the "indication of goods or business" in Article 2, paragraph (1), item (i) of
the Unfair Competition Prevention Act.
(2) Concern of confusion
A Major consumers of the X Goods and the Y Goods, which are medical
pharmaceuticals, are doctors and pharmacists.

Although patients are included in the

consumers, they are positioned merely as secondary consumers.
B The doctors prescribe medication by considering disease states of the patients,
efficacy, side effects, and the like of the pharmaceuticals and examine a whether or
not to change to generic drugs, and there cannot be confusion of the goods because ofsimilarities in the forms between the X Goods and the Y Goods at the prescription
based on the consideration points as above.
The pharmacists prepare medication on the basis of the prescriptions by thedoctors, and original drugs and generic drugs are consciously discriminated at thattime.

Moreover, the X Goods and the Y Goods stored in dispensing pharmacies arein a state where they are held in boxes with product names described or in a state ofbeing capped and labeled with the product names.

Thus, it cannot be acknowledgedthat there is a concern of confusion between the X Goods and the Y Goods due to theforms thereof by the pharmacists, either.
The patients only receive deliveries of the drugs prescribed by the doctors andprepared by the pharmacists in principle.
From such actual circumstances of transactions as above, a concern of confusion
between the X Goods and the Y Goods pursuant to Article 2, paragraph (1), item (i) of
the Unfair Competition Prevention Act cannot be acknowledged.

iii

Judgment rendered on October 4, 2023
2023 (Ne) 10012 Appeal Case of Seeking Injunction Act of Unfair Competition andthe like (court of prior instance / Tokyo District Court 2020 (Wa) 19198)
Date of conclusion of oral argument: July 19, 2023
Judgment
Appellant:

AstraZeneca K.K.

Appellee:

NIHON GENERIC Co., Ltd.

Appellee:

TOA Pharmaceuticals Co., Ltd.
Main Text

1. The appeal is dismissed.
2. The Appellant shall bear the court costs.
Fact and Reason
No. 1 Object of the appeal
1. The judgment in prior instance shall be revoked.
2. The Appellee, NIHON GENERIC Co., Ltd. (hereinafter, referred to as the"Appellee, NIHON GENERIC") shall not transfer or exhibit for transfer each of the
medical pharmaceuticals described in the list of Appellee's Goods in the Attachment
in the judgment in prior instance.
3. The Appellee, TOA Pharmaceuticals Co., Ltd. (hereinafter, referred to as the"Appellee, TOA Pharmaceuticals") shall not manufacture, transfer, or exhibit fortransfer each of the medical pharmaceuticals described in the list of Appellee's Goodsin the Attachment in the judgment in prior instance.
4. The Appellees shall dispose of each of the medical pharmaceuticals
described in the list of Appellee's Goods in the Attachment in the judgment in priorinstance.
5. The Appellees shall pay to the Appellant jointly and severally the amount ofmoney of 238,862,925 yen, and the money at a rate of 5% per annum from March 31,
2020 for 117,564,694 yen in the above, and the money at a rate of 3% per annum from
August 26 of the same year in the case of the Appellee, NIHON GENERIC and from1the 27th day of the same month in the case of the Appellee, TOA Pharmaceuticals
shall be paid for 121,298,231 yen until completion of each of the payments.
No. 2 Background (abbreviations and the like shall be as per description in thenotations in the judgment in prior instance unless otherwise specified.)
1. This case is a case in which the Appellant who manufactures and sells eachof goods (Appellant's Goods) described in the list of the Appellant's Goods in the
Attachment of the judgment in prior instance, which are medical pharmaceuticals forbronchial asthma, alleged that a form of each of the goods (Appellees' Goods)
described in the list of the Appellees' Goods in the Attachment of the judgment inprior instance manufactured by the Appellee, TOA Pharmaceuticals and sold by theAppellee, NIHON GENERIC is similar to the form of the Appellant's Goods, theAppellees' acts of manufacture and sales of the Appellees' Goods are transfer or the
like of goods using the indication of goods or business that is identical or similar to
the Appellant's well-known indication of goods or business, whereby the Appellant's
business gains were infringed and the like, and fall under the unfair competition
pursuant to Article 2, paragraph (1), item (i) of the Unfair Competition Prevention Act(Unfair Competition Prevention Act) and made claims against the Appellees for [i] on
the grounds of Article 3, paragraph (1) of the same Act, injunction of transfer and thelike of the Appellees' goods; [ii] on the grounds of paragraph (2) of the same Article,
disposal of the Appellees' Goods; and [iii] on the grounds of Article 4, Article 5,paragraph (2) of the same Act, payment of 238,862,925 yen as compensation fordamages from December in 2019 to May in 2020 and the delay damages by the rate of
5% per annum prescribed in the Civil Code (before revision by the 2017 Law No. 44)
from March 31, 2020, after the act of the unfair competition committed in the
aforementioned period, to completion of the payment with respect to 117,564,694 yen(the amount asserted by the Appellant to be the total amount of the amount ofdamages of the Appellant estimated from the amount of profits of the Appellees from
December in 2019 to March in 2020 and the attorneys' fees corresponding to 10% of
the same amount), and the delay damages by the predetermined rate of 3% per annum
prescribed in the Civil Code from the day following the date of service of the bill
(August 26, 2020 for the Appellee, NIHON GENERIC and the 27th day of the samemonth for the Appellee, TOA Pharmaceuticals) to the completion of the payment withrespect to 121,298,231 yen (the amount asserted by the Appellant to be the total
amount of the amount of damages of the Appellant estimated from the amounts ofprofits of the Appellees in April and May in 2020 and the attorneys' fees2

corresponding to 10% of the same amount) with respect to the above.
The judgment in prior instance dismissed all the claims by the Appellant, and
the Appellant made an appeal against the judgment in prior instance.
2. Regarding the basic facts, issues, and assertions by the parties against them,the supplemental assertion by the Appellant in this Court is added as in postscript 3
and also as described in "Facts and Reasons" No. 2, 1, No. 3, and No. 4 (from page 3,line 2 to page 64, line 25) in the judgment in prior instance and thus, they shall becited.
However, in the judgment in prior instance, the wording "in light" on page 42,line 2 shall be corrected to "in light of" and "only indicate," on page 48, line 22 to"only indication".
(omitted)
No. 3 Judgment of this court
This Court also determines that none of the Appellant's claims are grounded
and thus, they should be dismissed.

The reasons are as follows.

1. Found facts
The found facts are as described in the "Facts and Reasons" No. 5, 1 (frompage 65, line 2 to page 74, line 13) in the judgment in prior instance and thus, theyshall be cited.
However, the wording "usually" on page 71, line 9 in the judgment in priorinstance shall be corrected to "usual", and "medic pharmaceuticals" on the same page,line 18, page 72, line 13, page 73, lines 12, 14, and 15 to "medical pharmaceuticals".
2. Issue 1 (Applicability of the Unfair Competition Prevention Act)
This Court also determines that the assertion by the Appellees on issue 1
cannot be employed.

The reasons for that are as described in "Facts and Reasons"No. 5, 2 in the judgment in prior instance (from page 74, line 15 to page 75, line 13)
and thus, they shall be cited.
3. Issue 2 (Applicability of indication of goods or business of the form of theAppellant's Goods)(1) Unlike trademarks and the like, the form of the goods does not inherently
have a purpose of indicating an origin of the goods and does not naturally fall underthe "indication of goods or business" in Article 2, paragraph (1), item (i) of the Unfair
Competition Prevention Act, but in some cases the form itself of the goods might havea secondary meaning to indicate the specific origin.
3

And in order for the form itself

of the goods to have the secondary meaning to indicate the specific origin and to fallunder the "indication of goods or business" in the same item as above, it is interpreted
to require that: [i] the form of the goods objectively has a distinctive feature which isdifferent from the other goods of the same type (special distinctiveness); and [ii] theform has been used by a specific business operator in a monopolistic manner for along time or the goods having the form have become well-known (well-known
characteristics) among consumers as indication of the origin of the specific business
operator by extremely powerful promotional advertisements or explosive sal esachievements and the like.
(2) Issue 2-3 (Special distinctiveness)
Regarding the Appellant's goods, it is not found that the form of the goods
objectively has a distinctive feature different from the other goods of the same typeand satisfies the requirement of the special distinctiveness, which are corrected asfollows and are as described in "Facts and Reasons" No. 5, 3(3)A to D (from page 81,
line 5 to page 84, line 12) and thus, they shall be cited.
A. After page 82, line 14 in the judgment in prior instance, the following shallbe added as a new line.
"And the sales of ASMANEX was started in 2009 (entire import of the oral
argument), and the sales of the Appellant's goods was started before 2010 (Basic facts(2)A) and thus, it cannot be acknowledged that the form of ASMANEX imitated theform of the Appellant's Goods."
B. The part on page 84, lines 8 to 12 in the judgment in prior instance shall becorrected as follows.
"D. Moreover, the inhaler of the Appellant's Goods (a main-body portion and amouthpiece portion) has a shape designed to exert performances of the medical agentof the Appellant's Goods, and patients can inhale the drug most effectively (Exhibits
Ko 16, 27, the Exhibits Otsu 38-1, 3, 4, the entire import of the oral argument), and
the Appellee, TOA Pharmaceuticals proceeded with development while consulting thePharmaceuticals and Medical Devices Agency (PMDA) in the development of ageneric drug of the Appellant's Goods and made the structure and shape of the inhaler
similar to the inhaler of the Appellant's Goods in order to obtain determination onequivalence with the Appellant's Goods in points of therapeutic equivalence(equivalence in evaluation by clinical tests) and pharmaceutical equivalence (Exhibit
Otsu 38-1, the entire import of the oral argument).
According to the aforementioned circumstances, although the forms of theinhaler and the mouthpiece portion of the Appellant's Goods are inevitable forms
4derived from the configuration to achieve the substantial functions of the Appellant's
Goods, it is unreasonable to give protection to the forms as above as the indication of
goods or business, because satisfaction of the requirement of the special
distinctiveness would incur such a result that inhibits free competition among thegoods with the equivalent functions.
And a portion obtained by removing the inhaler main-body and the mouthpiece
portion from the Appellant's Goods is a cap and a rotary grip portion, but the shapesof these portions can be considered to be common.
From the aforementioned points, too, it cannot be acknowledged that theAppellant's Goods satisfy the requirement of the special distinctiveness."(3) Issue 2-4 (Well-known characteristic)
A. Regarding the Appellant's Goods, as in the Found facts (8)B, related to theform of the inhaler, it was found that the article related to the design as the "inhaler"
was registered for the design right on January 28, 2000, and the duration expired on
January 28, 2015.

It can be considered that, during the period when the Appellant

had the aforementioned design right related to the form of the inhaler of theAppellant's Goods, manufacture / sales by the others of the goods having the shapesimilar to the form of the Appellant's Goods were limited.
Moreover, as described in the Found facts (8)A(A), regarding combination
drugs of the Appellant's Goods, the patent of the invention titled "New combination"
was registered on August 23, 2002, but it is found that the duration expired on
December 7, 2017.

While the Appellant had the patent right related to the

combination drugs of the Appellant's Goods, it is found that the others cannot receive
approval for manufacture / sales of the generic drugs of the Appellant's Goods, andthe generic drugs could not be manufactured or sold.

And as described above, theforms of the inhaler and the mouthpiece of the Appellant's Goods have shapes
designed so that the functions of the medical agent of the Appellant's Goods areexerted and patients can inhale the drug most effectively, which are in demand fromthe functions of the Appellant's Goods.

Thus, while the Appellant had theaforementioned patent right, and the others could not manufacture or sell the genericdrugs of the Appellant's Goods, it can be considered that the manufacture / sales by
the others of the goods having the form similar to the form of the Appellant's Goods
were substantially limited.
As described above, the Appellant could use the form of the Appellant's Goods
in a monopolistic manner, since the Appellant had the aforementioned design rightand patent right, and it is natural in a sense that the monopolistic state is generated by5

the presence of the intellectual rights, with which the well-known characteristics are
generated.

And even if certain well-known characteristics were generated for theform of the Appellant's Goods on the basis of the monopolistic state as above, toallow application of the Unfair Competition Prevention Act only on the grounds ofsuch well-known characteristics is, in the end, equal to hindrance to the use thereof bya third party even after expiration of the durations of the aforementioned intellectual
property rights.

Such a situation contradicts the purpose of the intellectual property

right system which allows monopoly of the use thereof for a certain period of time asa consideration for provision of valuable information, while it is made open to the
public and the use thereof is allowed after the period has elapsed, and thiscontradiction is not reasonable.

However, even if the well-known characteristics are

generated from the monopoly based on the intellectual property right as above, after
the duration of the intellectual property right has elapsed, a reasonable period of time
has passed since the competitive products of the same type by a third party were input
into the market, and an influence of the monopolistic state based on the holding of theintellectual property right was dispelled, if such circumstances that the form of theAppellant's Goods is still well-known as indication of the origin are admitted, itshould be considered that there is some room for application of Article 2, paragraph(1), item (i) of the Unfair Competition Prevention Act.
B. By examining this case from this point, the manufacture and sales of theAppellees' Goods were approved in February in 2019 (Basic facts (3)A), the sales
started in December, 2019 (Basic facts (3)B), and from January 28, 2015, when the
duration of the design right related to the form of the inhaler in the Appellant's Goods
expired, only relatively short periods of time of approximately 4 years andapproximately 4 years and 10 months had elapsed, respectively.

And only shortperiods of approximately 1 year and 2 months had elapsed since December 7, 2017,
when the duration of the patent right of the combination drugs of the Appellant's
Goods expired, until the Appellees' Goods gained approval for manufacture and sales
thereof and approximately 2 years until the sales of the Appellees' Goods, and no suchcircumstances are found that a third party's generic drugs other than the Appellees'
Goods were sold during this period and thus, it cannot be considered that the
influence of the monopolistic state based on the holding of the intellectual property
right was dispelled during this period by an input of a third party's competitive goodsof the same type into the market for a considerable period of time or that the form of
the Appellant's Goods has been used by the Appellant monopolistically for a long
period of time.

Moreover, even with all the evidence of this case, it cannot be6

acknowledged that the influence of the monopolistic state based on the holding by theAppellant of the intellectual property right for the Appellant's Goods during the
aforementioned period was dispelled or the form of the Appellant's Goods newly
obtained the well-known characteristics by extremely powerful promotional
advertisements, obtainment of explosive sales achievements, and the like by theAppellant during this period.
C. With this regard, the Appellant asserts that the Judgment by the Tokyo High
Court on February 25, 1993 affirmed the indication of goods or business in the case inwhich a period from extinction of the patent right to sales of a competitive product isapproximately 3 years and a half, and in this case, since approximately 5 years havepassed since expiration of the duration of the design right related to the Appellant's
Goods until the sales of the Appellees' Goods was started, the influence of themonopolistic state based on the holding by the Appellant of the intellectual property
right related to the Appellant's Goods was dispelled (No. 4, 5 (Assertion by Plaintiff)
in Judgment in prior instance, (4)C).
However, in the first place, only short periods of approximately 1 year and 2
months to 2 years have passed since the expiry of the duration of the patent right by
the aforementioned combination drugs in this case and thus, even if there is such a
trial case that the indication of goods or business was affirmed by lapse of 3 years anda half, it has no influence on the determination of this case.

Moreover, the Judgmentby the Tokyo High Court on February 25, 1993 cited by the Appellant determined thata part of the goods of the defendant in the first instance of that case was similar to apart of the goods of the plaintiff in the first instance in shape and form, and that there
was a concern of confusion of the origin.

However, these goods of the plaintiff inthe first instance were not registered for the patent right, the design right, or th e otherintellectual property rights (in this case, although it was found that the design right
was registered for some of the forms in the goods of the Plaintiff in the first instance,
it was determined that the goods of the Plaintiff in the first instance for which thedesign right was registered as above were not found to be similar to the shape and theform of the goods of the Defendant in the first instance.).
Therefore, the Appellant's assertion on the premise that the aforementioned
judgment was rendered on the determination affirming the indication of the goods orbusiness in the case where the period from extinction of the intellectual property rightto the sales of the competitive goods was approximately 3 years and a half iserroneous, and it cannot be approved that the influence of the monopolistic state basedon the holding of the intellectual property right of the Appellant's Goods was
7dispelled until the start of sales of the Appellees' Goods on the grounds of the trial
case or that the shape of the Appellant's Goods newly obtained the well-known
characteristics after that.
D. According to the above, it cannot be approved that the requirement of thewell-known characteristics is satisfied for the form of the Appellant's Goods.
(4) According to the aforementioned (2) and (3), the form of the Appellant's
Goods satisfies neither of the requirement of special distinctiveness and therequirement of well-known characteristics required to be applicable to the "indicationof goods or business" in Article 2, paragraph (1), item (i) of the Unfair Competition
Prevention Act and thus, the form, of the Appellant's Goods cannot be acknowledged
to be applicable to the "indication of goods or business" in the same item.
4. Issue 4 (Concern of confusion)(1) As a premise for determination on whether or not there is found to be aconcern of confusion, whether or not patients, besides doctors and pharmacists, areincluded in consumers of the Appellant's Goods and the Appellees' Goods will be
examined.
The Appellant's Goods and the Appellees' Goods are medical pharmaceuticals,
but regarding the medical pharmaceuticals, a doctor examines a patient anddetermines a type and an amount of a drug to be prescribed on the basis of thediagnosis in the examination.

The Appellant's Goods and the Appellees' Goods are

medical pharmaceuticals for the patient to inhale drugs by an inhaler and thus, insome cases the doctor shows actual pharmaceuticals in order to explain how to use theinhaler to the patient at the examination, and it is found that the patient can have achance to state his / her opinion at that time, (Found facts (6) and (7)), but
prescription of drugs are made only by the doctor by considering the disease state of
the patient, efficacy, side effects, and the like of the drugs, and there cannot be suchan occasion that the patient can freely select the type of drugs and the like.
Moreover, the pharmacist prepares the medicine on the basis of the prescription by thedoctor, but if the doctor prescribed drugs with brand names but did not determine thata change cannot be made to generic drugs, and if the doctor prescribed drugs withgeneral names, generic drugs can be prepared.

In that case, the pharmacist confirms

the patient's intention on whether or not the patient prefers the generic drug and then,prepares the medicine (Found facts (7)).

The patient can indicate his / her intention

within the aforementioned range and select between an original drug and a genericdrug at a dispensing pharmacy, but it is not found that the patient can make selectionof medical pharmaceuticals more than the above.
8

By summing up the aforementioned circumstances, the major "consumers"
referred to in Article 2, paragraph (1), item (i) of the Unfair Competition Prevention
Act are doctors and pharmacists, and it is understood that, although the patients areincluded in the "consumers", they are only at a position of secondary consumers.
(2) A. The doctors, who are major consumers of the Appellant's Goods and theAppellees' Goods, make prescriptions with disease states of the patients, efficacy, side
effects, and the like of the medical pharmaceuticals as consideration elements andexamine whether or not to change to generic drugs.

When making prescriptions

based on the consideration elements as above, it cannot be expected that theAppellant's Goods are confused with the Appellees' Goods, since the forms of theAppellant's Goods and the Appellees' Goods are similar to each other, and that should
not occur in the first place.

Even if the doctor might show the Appellant's Goods or

the Appellees' Goods in a state of an in-use form at the examination of the patient inorder to show the shape of the inhaler to the patient, the Appellant's Goods or theAppellees' Goods at the doctor are in a boxed state or at least in a storage form,
product names are printed on the box (Exhibits Ko 143-1 to 4, 144-1 to 4, Exhibits
Otsu 46-1, 47-1), and labels on which the product names are printed are pasted onouter sides in the storage form (List of Appellant's Goods photos in the judgment inprior instance, Lists 1 and 2 of Appellees' Goods photos).

Thus, even if the doctor

pulls out the goods from the box, removes the cap to bring the goods into the in -usestate, and shows it to the patient, there cannot be confusion between the Appellant's
Goods and the Appellees' Goods by the form at that time.
B. The pharmacist prepares drugs on the basis of the doctor's prescription and,except the case where the doctor determines that a change to the generic dru g should
not be made, prepares the generic drug after confirming the patient's intention.

But

when the pharmacist changes the drug to the generic one, the reference on which theselection of the generic drug was based should be explained to the patient, and in an
insurance pharmacy, when a prescribed drug according to the brand name prescription
was changed to the generic drug or the preparation according to the general nameprescription, information on the brand and the like of the dispensed drugs should in
principle be provided to the insurance medical institution which issued theprescription (Found facts (7)B) and thus, it can be considered that the pharmacist
consciously discriminates the original drug from the generic drug in preparation.
Moreover, the Appellant's Goods and the Appellees' Goods stored in thedispensing pharmacy are in the boxed state or in the storage form, and when they aredelivered to the patient, it is considered to be in the storage form.
9

Thus, as describedabove, the goods names are described on the boxes and the appearances of the storage
forms.

From these circumstances, for the pharmacists, too, it cannot be found that

there is a concern of confusion between the Appellant's Goods and the Appellees'
Goods by the forms.
C. The patient in principle only receives the delivery of pharmaceuticals
prescribed by the doctor and prepared by the pharmacist as described in the
aforementioned (1).
When the doctor has not determined that the change to the generic drugs cannot
be made, even if the pharmacist confirms the patient's intention on change to thegeneric drugs, and the patient has a chance to state the intention to change to thegeneric drug to the pharmacist, the pharmacist delivers the Appellant's Goods or theAppellees' Goods in the storage form.

Thus, it cannot be expected that theconfirmation on the intention would be made by changing the form to the in -use one,and it cannot be considered, either, that the patient would confuse the Appellant's
Goods with the Appellees' Goods by the form.
Moreover, even if the doctor shows the Appellant's Goods or the Appellees'
Goods in the in-use form to the patient, as described in the aforementioned A, when
the doctor shows the Appellant's Goods or the Appellees' Goods in the in-use form to
the patient, it cannot be acknowledged that the doctor would confuse the form, and thedoctor makes prescription by considering the disease state of the patient, and efficacy
and side effects of the pharmaceuticals and thus, it can be considered that the doctor
discriminates the Appellant's Goods, which are original drugs, from the Appellees'
Goods, which are generic drugs, and then, shows it to the patient.

Then, even if thepatient saw the in-use form shown by the doctor, it cannot be acknowledged that theconfusion would occur between the Appellant's Goods and the Appellees' Goods by
the form at that time.
(3) In light of the actual circumstances of the transactions from theaforementioned (2)A to C, it cannot be acknowledged that there is a concer n ofconfusion under Article 2, paragraph (1), item (i) of the Unfair Competition
Prevention Act between the Appellant's Goods and the Appellees' Goods.
5. Determination on assertion by the Appellant in this Court(1) The Appellant asserts that the judgment in prior instance stated that theform of the Appellant's Goods does not fall under the indication of goods or businesswithout direct determination on two requirements; that is, the special distinctivenessand the well-known characteristics regarding the form of the goods and that thedetermination was made on the unique finding that the form of the medical
10pharmaceuticals does not fall under the indication of goods or business at all, which isunreasonable.
However, even if the determination that none of the forms of the medical
pharmaceuticals requiring doctors' prescription as in the judgment in prior instancefall under the indication of goods or business is not reasonable, it is not acknowledgedin this case that either of the requirement of the special distinctiveness and therequirement of the well-known characteristics is satisfied in relation with the form of
the Appellant's Goods as taught in the aforementioned 3(2) and (3) and thus, theaforementioned assertion by the Plaintiff does not influence the determination that theindication of goods or business on the basis of the form of the Appellant's Goods is
not approved.
Therefore, the Appellant's aforementioned assertion cannot be employed.
(2) The Plaintiff asserts that in the opinion by Professor A' (Exhibit Ko 110),[i] it is pointed out that doctors, pharmacists, and patients recognize and discriminate
the inhalers by the form; and [ii] it is pointed out that, when the forms of the inhalers
are similar to each other, such an expectation is generated that the same technology isused for the structure inside the inhaler and the drugs, and the same therapeutic
effects will be gained.

According to these circumstances, when the forms of theAppellant's Goods and the Appellees' Goods are similar to each other, and the featuresof how to use are the same, there is a concern that the doctors, pharmacists, andpatients would recognize the Appellees' Goods as an AG or a new version of theAppellant's Goods, which causes confusion of origins in a narrower sense or
confusion in a wider sense.
However, according to the circumstances of the transactions of the Appellant's
Goods and the Appellees' Goods, any of these major consumers; that is, the doctors,
pharmacists, and the patients, who are consumers at the secondary position, do notdiscriminate the Appellant's Goods and the Appellees' Goods by their forms, and it
cannot be found that there is a concern of confusion by the form as taught in the
aforementioned 4(2).

Moreover, according to the entire import of the oral argument,

it is found that the AG of the Appellant's Goods has not been sold at all until now andthus, such a situation that the AG of the Appellant's Goods, which does not exist in
actuality, and the Appellees' Goods being erroneously recognized or confused by the
consumers would not occur.
And even if the doctors, pharmacists, or patients have expectation that theAppellees' Goods, which are generic drugs, would exert the same therapeutic effects
as those of the Appellant's Goods, from the circumstances of the transactions as
11

described in the aforementioned 4(2), the confusion based on the similarity in theforms of the Appellant's Goods and the Appellees' Goods could not occur.
Therefore, the Appellant's aforementioned assertion cannot be employed.
(3) The Appellant asserts that, in the case of prescription of drugs by a doctor,
when the doctor prescribes brand-name drugs and then, leaves the column indicatingthat the change to the generic drug is not allowed blank, or when the doctor prescribes
general-name drugs, there can be two cases; that is, the patient receives theAppellant's Goods or receives the Appellees' Goods, but in either case, there is aconcern that the doctor, pharmacist, and patient misunderstand that the Appellee s'
Goods are the AG of the Appellant's Goods, the same device as that of the Appellant's
Goods is used for the Appellees' Goods, or the Appellees' Goods use the same
technology as that of the Appellant's Goods by technology transfer and the like andthus, there is a concern that confusion in a narrower sense or confusion in a wider
sense could occur.
However, similarly to the aforementioned (2), from the actual circumstances of
the transactions of the Appellant's Goods and the Appellees' Goods, it is not f oundthat any one of the doctors and pharmacists as major consumers and the patients as
secondary consumers discriminates the Appellant's Goods and the Appellees' Goodsby their forms, and it cannot be acknowledged that there is a concern of confusion by
the form.
Therefore, the Appellant's aforementioned assertion cannot be employed.
(4) The Appellant asserts that the Appellees' Goods are not identical to theAppellant's Goods as the device or formulation, or the technology of the Appellant's
Goods is not used, either.

But if the patient switches the Appellant's Goods to theAppellees' Goods and continuously uses it without sufficiently recognizing thecircumstances, this could cause grave disadvantages to the patients.
However, the circumstances cited by the Appellant has nothing to do with thedetermination on presence / absence of a concern of confusion prescribed in Article 2,paragraph (1), item (i) of the Unfair Competition Prevention Act, or there is noevidence sufficient to admit that a problem would occur if the patient continuously
uses the Appellees' Goods approved for manufacture and sales as generic drugs and
sold.
Moreover, the Appellant asserts that, even if a generic drug of the Appellant's
Goods is to be manufactured, forms of a counter (residual amount gauge) and amouthpiece can be largely changed, but the Appellees intentionally employed theform extremely similar to that of the Appellant's Goods regardless of that, and the12Appellees paid attention to the appearance attractive to the consumers and brought theform of the Appellees' Goods closer to the Appellant's Goods.
However, as described in No. 5, 3(3)D in the judgment in prior instance (after
the amendment in the aforementioned 3(2)B), the inhaler of the Appellant's Goods has
such a shape designed to exert the performance of the drugs of the Appellant's Goods
so that the patient can inhale the drug most effectively, while in the development of
the generic drug of the Appellant's Goods, it is found that the Appellee, TOA
Pharmaceuticals

proceeded

with

the

development

while

consultingthePharmaceuticals and Medical Devices Agency (PMDA) and made the structure andthe shape of the inhaler similar to the inhaler of the Appellant's Goods, and it is notfound that the Appellees made the form of the Appellees' Goods similar to the form of
the Appellant's Goods with the purpose of employing the appearance attractive to theconsumers.
Therefore, the aforementioned assertion by the Appellant cannot be employed.
(5) The Appellant asserts that: [i] the AG of the Appellant's Goods has beenreported in industrial papers, the doctors recognize possibility of listing of the AG of
the Appellant's Goods on the market, and the AG of many pharmaceuticals are listedon the market in general and thus, even if the AG of the Appellant's Goods is not
actually sold, there is a concern that the Appellees' Goods, which are GE, might be
confused with the AG, and confusion of the origin would occur; [ii] as shown by theAppellant, more than 50 accidents (medical accident information or near-miss cases)caused by similarity in the appearances, outer shapes, shapes, or forms occurred from2010 to 2021, and the fact that the doctors and pharmacists caused the medical
accidents and near-miss cases indicates that the doctors and pharmacists cannot pay
perfect attention in actuality and thus, the judgment in prior instance which
determined that it cannot be acknowledged that there is a concern of confusion on thebasis of these cases is erroneous; [iii] the judgment in prior instance determined that,regarding the questionnaire of this case presented by the Appellant in the court ofprior instance, it only compares the forms of the Appellant's Goods and the Appellees'
Goods in a state where labels were simply removed and thus, it does not necessarily
indicate actual circumstances of identification or selection of the medical
pharmaceuticals by the consumers at the time of transaction, but in the actual medical
front, prescription and preparation of drugs cannot be performed with the greatest care
at all times without an error, a phenomenon similar to the questionnaire of this casecould occur and even if labels are different, the consumers recognize that one of themis improved goods of the other, products with different dosages, derivative goods of13

the same series, and thus, the aforementioned determination of the judgment in priorinstance is erroneous; [iv] a patient can select a generic-drug manufacturer byselecting a dispensing pharmacy, and particularly for the inhaler, its form is a clue todiscriminate the drug, and when a patient examines an inventory of a dispensing
pharmacy, if there is an inhaler whose form is similar to that of his / her desired
inhaler, the patient erroneously recognizes that the inhaler is the same as his / herdesired inhaler or for which the same technology is used and obtains it and thus, thepatients are included in the consumers.
However, regarding the aforementioned [i], even if the possibility of sales of
the AG of the Appellant's Goods is reported, the AG of the Appellant's Goods is not
sold in actuality.

Thus, it is difficult to consider that the doctors and pharmacists

nevertheless misunderstand that the Appellees' Goods for the AG of the Appellant's
Goods.

Moreover, even if the aforementioned reports were posted in industrial

papers related to medical practice, it is not acknowledged that general patientsrecognize the fact of the reporting, and together with the aforementioned absence ofthe erroneous recognition by the doctors and pharmacists, it cannot be acknowledged,
either, that the patients misunderstand that the Appellees' Goods are the AG of theAppellant's Goods.
Regarding the aforementioned [ii], regardless of the facts of plural occurrencesof medical accidents or near-miss cases caused by the similarity in the appearances,
outer shapes, shapes, or forms, they are considered to be cases in which mistakes
occurred due to negligence of duty of care by the medical workers, and it cannot be
acknowledged that a concern of confusion prescribed in Article 2, paragraph (1), item(i) of the Unfair Competition Prevention Act was generated by the occurrences ofthese cases.

That is, the occurrence of the aforementioned cases should be dealt withseparate measures from the viewpoint of preventing occurrences of medical accidents,
and the occurrences of these cases do not constitute a reason for granting injunction of
the Appellees' Goods or damages to the Appellant, since a concern of confusionprescribed in the same item is generated for the form of the Appellees' Goods.
Regarding the aforementioned [iii], in light of the actual circumstances of thetransactions of the Appellant's Goods and the Appellees' Goods, at the time when the
doctors make prescriptions and at the time when the pharmacists prepare drugs anddeliver the Appellant's Goods or the Appellees' Goods to the patients, the Appellant's
Goods or the Appellees' Goods are in boxes with the product names described or in
the storage form in which labels with the product names printed are pasted and thus,
even if there is a person who erroneously takes the Appellees' Goods in the storage
14

form or in the in-use form in a state where the label with the product name printed has
been removed for the Appellant's Goods, it cannot be acknowledged that there is aconcern of confusion between the Appellees' Goods and the Appellant's Goods by thedoctors, pharmacists, and patients at the transactions of the Appellant's Goods or theAppellees' Goods.
Regarding the aforementioned [iv], there is no evidence sufficient toacknowledge that there are such actual circumstances of transactions that generalpatients select the type of the generic drugs by selecting a dispensing pharmacy.
Moreover, even if there is such a patient who searches a dispensing pharmacy having
an inventory of the Appellees' Goods and makes a choice on the premise that theinhalers of the Appellees' Goods, which are generic drugs, are similar to the inhalersof the Appellant's Goods, it is difficult to presume that the patients who have suchknowledge and search the dispensing pharmacies would confuse that business entitiesof the Appellees' Goods and the Appellant's goods are identical or have anorganizational parent-child relation or an affiliation relation of the companies.
Therefore, none of the aforementioned assertions by the Appellant can be
employed.
(6) The Appellant asserts that: [i] the Appellant's Goods belong to ICS/LABA
in the inhalant for bronchial asthma treatment, while ASMANEX belongs to ICS, andsince the Appellant's Goods and ASMANEX belong to different markets, and in thedetermination on the special distinctiveness of the Appellant's Goods, ASMANEX
should not be used as a comparison target; [ii] even if the markets as ICS andICS/LABA are assumed, the number of prescriptions of ASMANEX is only
approximately 2 to 3% of the Appellant's Goods and thus, ASMANEX does not
influence the special distinctiveness of the Appellant's Goods; and [iii] in theAppellant's Goods, a position of a counter is largely different, shapes of themouthpiece and the cap are also different, and it is different from ASMANEX ineither of the storage form and the in-use form.
However, the Appellant's Goods and ASMANEX are in common in a point thatthey are both inhalants for bronchial asthma treatment, and even though the number ofprescriptions of ASMANEX is smaller than that of the Appellant's Goods,
ASMANEX is sold in the market and thus, in the determination on the special
distinctiveness of the form of the Appellant's Goods, it is not interpreted to be
unreasonable to consider similarity with the form of ASMANEX.
And it is found that ASMANEX includes all the shapes pointed out by theAppellant to be featured in the storage form of the Appellant's Goods and also
15

includes most of the shapes pointed out by the Appellant to be featured in the in -useform of the Appellant's Goods, while all the common parts are ordinary as determinedin No. 5, 3(3) in the judgment in prior instance (after the amendment in the
aforementioned 3(2)).

Therefore, the aforementioned determination is not

influenced even after the examination of the assertion by the Appellant in this court.
Therefore, the aforementioned assertion by the Appellant cannot be employed.
(7) The Appellant asserts that, the Intellectual Property High Court Judgment
on August 29, 2019 (Case of portable / disposable low-pressure continuous aspirator /Intellectual Property High Court 2019 (Ne) 10002) can be referred to in this case, andin that case, the form of the Goods of the medical equipment is not only
acknowledged to be a consideration element when medical personnels select the
goods concerned but it was also determined that, even in the case of the medical
equipment,

by

being

used

by

a

specificbusiness

entitycontinuously/

monopolistically, there can be such a case that the form of the goods having a uniquefeature that can be discriminated from the other goods of the same type obtains afunction to identify its origin indicating that the form of the goods concerned is th e
goods of the business entity concerned and thus, the form of the Appellant's Goods
should be acknowledged to be the indication of goods or business.

In that case, theDefendant of the first court of the case asserted that, for purchase of the aspirator
concerned, its safety and quality should be examined and predetermined proceduresshould be taken and thus, there is no such a case that the Goods are identified only by
the form thereof.

However, since the assertion was proscribed, the assertion by theAppellees that the identification by the form is not made in this case, either, on the
grounds that the doctors and pharmacists prescribe or prepare drugs carefully inaccordance with the predetermined procedures should also be proscribed.
However, the Goods which mattered in the case of the judgment pointed out by
the Appellant are medical equipment, while the Appellant's Goods and the Appellees'
Goods are medical pharmaceuticals.

In the prescription of medical pharmaceuticals

by doctors, even in the case of those with a shape including an inhaler as theAppellant's Goods and the Appellees' Goods, the doctors prescribe drugs byconsidering the disease state of the patient and drug components, and the Goods are
not identified only by the form.

Therefore, the case of the aforementioned judgment

is different from this case, and it is not interpreted that the form of the Appellant's
Goods should be acknowledged to be the indication of goods or business, because theform of the Goods was acknowledged as the goods or business in the aforementioned
judgment.
16

Therefore, the aforementioned assertions by the Appellant cannot be employed.
6. As described above, it shall not be acknowledged that the form of theAppellant's Goods falls under the indication of goods or business or that a concern ofconfusion in pursuant to Article 2, paragraph (1), item (i) of the Unfair Competition
Prevention Act occurred.
The aforementioned determination shall not be influenced even by examining
the contents of the unceasing assertions by the Appellant.
7. Conclusion
According to the above, all the claims by the Appellant should be dismissed,
and the judgment in prior instance with the same gist as this is reasonable.
Therefore, since this appeal is not grounded, it shall be dismissed, and thejudgment shall be rendered as in the main text.
Intellectual Property High Court, Third Division
Presiding Judge: SHOJI Tamotsu
Judge: IMAI Hiroaki
Judge: MIZUNO Masanori

17