Snapshot: the essentials of pharmaceutical trademarks in Japan

Overview

Legislation

What is the primary law governing trademarks in your jurisdiction?

The Trademark Act is the primary law governing trademarks in Japan. Further, although the Unfair Competition Prevention Act does not govern Japanese trademarks, it is relevant for the protection of well-known or famous indicia including trademarks regardless of whether the mark is registered in Japan or not.

The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Product, Gene Therapy Products, and Cosmetics (the PMD Act) and its related regulations set out the legal requirements on the brand names of certain drugs.

Agencies

Which agency is responsible for the grant and registration of pharmaceutical trademarks?

There is no dedicated agency responsible for exclusively granting pharmaceutical trademarks in Japan. The Japan Patent Office (JPO) is the primary agency responsible for the grant and registration of all trademarks in Japan, regardless of whether it classifies as a pharmaceutical trademark or not.

However, thorough investigation must be conducted when choosing pharmaceutical brand names since under the Notification No. 76 of the Chief of Pharmaceutical Safety and Environmental Health Bureau, brand names wherein the trademark rights are held by a different company can only be used with the permission of such trademark holder. In such a case, the Pharmaceuticals and Medical Devices Agency (PMDA) will review the drug application including the brand name.

Further, for generic names (JAN) of a drug, it is registered with the PMDA based on the International Non-proprietary Name (INN) registered on WHO. This generic name of a drug cannot be registered as a trademark.

Regulators

What are the relevant national and international regulatory bodies and requirements that need to be considered when clearing a pharmaceutical trademark?

There are a number of requirements that need to be overcome when clearing pharmaceutical trademarks. The challenges that need to be addressed will depend on the type of pharmaceutical trademark that the company intends to protect.

The initial stage is the identification of the type of mark and type of drug that the company intends to protect. The most traditional type of pharmaceutical trademark is the proprietary name of a drug (ie, the brand name). However, these types of trademarks (ie, proprietary or brand name) are not the only type of trademark protection available for pharmaceutical companies. In fact, in Japan, there is an increasing trend for pharmaceutical companies to seek non-traditional trademark protection for branding new pharmaceuticals including colour and sound marks.

After identifying the type of trademark protection being sought, as well as the type of drug that the brand name is associated with, the first hurdle is ensuring that the trademark registrability requirements are met.

The JPO conducts a substantive examination of trademark applications in Japan. Accordingly, a trademark, under the Trademark Act, means ‘any character, figure, sign, three-dimensional shape or any colour, or any combination thereof, sounds or other marks provided by Cabinet Order, as is recognisable with human perception’. Such trademark may be used to distinguish goods or services in relation to the trademark holders’ business. Therefore, in principle, the JPO only registers distinctive marks (ie, not generic) that are not against public policy.

The Trademark Act also provides that no trademark shall be registered if the trademark is likely to mislead as to the quality of the goods or services. This legislation is parallel with some of the regulations on pharmaceutical brand names as will be discussed below.

A pharmaceutical company must also ensure that the trademark (or any of the names that they will use for the drug) will comply with the requirements imposed for pharmaceutical brand names.

It is important to note that the brand name chosen for a particular drug, even after it receives a trademark registration with the JPO, will not necessarily be approved during the drug marketing approval process unless such name complies with the law and regulations on pharmaceutical nomenclature of brand names. One of the general requirements is that such brand name does not present any threat or harm to public health and hygiene. Further, it must not put the reputation of a drug in jeopardy. This is pursuant to an administrative directive and pharmaceutical regulation practice, Notification No. 935 of the Chief of the Pharmaceutical and Food Safety Bureau (PFSB) and Notification No. 879 of the (Federation of Pharmaceutical Manufacturers’ Associations of Japan). Examples of these are the following:

names that are considered fallacious or exaggerated are not allowed;
names that include only a part of the approved indication or includes an unapproved indication are not allowed;
names whose trademarks are held or owned by another company must not be used
use of characters in the name must be avoided other than those in the JIS specification (i.e., the Japanese Industrial Standards for encoding the Japanese language) levels 1 and 2;
article 218 of the Regulation for Enforcement of the PMD Act indicates that the brand name must be in Japanese language, however, use of alphabet may be allowed in the event that such alphabet letters is used before, in between or after the Japanese characters.
names will not be approved if it uses alphabet characters that have a meaning in a foreign language (for instance, ‘health’ even if combined with Japanese characters) and wherein the meaning is considered inappropriate.

Generally, the dosage and concentration of the active pharmaceutical ingredients must also be included in the brand name.

A brand name must also not be identical to a previously approved product, even if the previously approved product is no longer being manufactured or marketed unless it can clearly be established that there is no possibility for confusion. Further, when a brand name is abbreviated, it must not be confusingly similar to or identical with another existing pharmaceutical product.

Special regulations are also provided for naming of ethical generic drugs (Precautions Regarding the Naming of Ethical Generic Drugs, Notification No. 0922001 of the PFSB), brand names for heparin (Handling of Nomenclature of Brand Names for Medical Combination Drugs and Herapin Preparations and Labelling of Solutions attached to Injectibles, Notification No. 0922002 of the PFSB as amended) and insulin preparations, medical combination drugs and follow-on biologics. Depending on the type of pharmaceutical product that the pharmaceutical company is applying for, these special regulations should be taken into consideration in the drug marketing approval process. This is the reason why identifying the type of drug is also important for purposes of the brand name.

Other than the above general principles, the regulations also clarify that brand names should not create misunderstanding regarding the nature of the drug. If a non-proprietary name or the names in the Japanese pharmacopeia is used, then a brand name should be in the following order: name, dosage form, concentration, company or trade name.

Non-traditional trademarks

What non-traditional trademarks are available in your jurisdiction and how are they registered?

In Japan, non-traditional trademarks are those that do not constitute the traditional word or figurative marks. In the past, 3D marks were considered as non-traditional, however, in recent years the JPO considers characters, figures, or three-dimensional shapes as a conventional trademark protected in Japan. From 1 April 2015, the Trademark Act provides protection to colour marks, sound marks, position marks, motion marks and hologram marks.

One of the earliest sound mark registration in 2015 is for a pharmaceutical company, Hisamitsu Pharmaceutical Co Inc, involving their sound logo that is often used in their advertising initiative. Further, in 2017, the JPO announced that one of the very first protection granted to a sound mark solely consisting of a sound element is for a pharmaceutical company, Taiko Pharmaceutical Co Ltd. These examples are indicative of the dynamic trademark portfolio of Japanese pharmaceutical companies.

A brief outline of each type of the non-traditional trademarks is provided below.

Colour mark

A colour mark is a trademark that consists solely of colours. The application must indicate that the mark is a colour and must include a detailed description of the mark including the colour and the description of the colour as defined in the RGB colour chart or any other commonly known system that describes the colour with numbers. Additional description on the position is also required if the colour mark is characterised by a position in an item.

Position mark

A position mark is a trademark that consists of the specific position of the elements of the mark. The elements may be letters, graphics or a combination thereof. The application must indicate the specimen or goods in broken lines and the specific position where the elements are located.

Sound mark

A sound mark is a trademark that consists of sound or combination of sounds including but not limited to musical notes, clef, tempo, linguistic elements, echoic words or combinations thereof. The application must indicate a description of the sound by indicating the musical notations (ie, the staves), a linguistic description of the sound. An MP3 description is commonly submitted and the MP3 sound data has to be submitted through a CD-ROM or DVD-ROM with the JPO.

Motion mark

A motion mark is a trademark that consists of movement or a change in the position of the elements of the mark. The application must indicate the description of the movement by submitting a series of sequential frames to show the change in movement accompanied by a description of the movement. In Japan, drawing a dotted line can also signify a movement thus, a single frame may be acceptable if a dotted line is included indicating the movement of the elements of the mark. The application should also indicate the time frame of such movement. The application may also be described with a video file submitted through a CD-ROM or DVD-ROM with the JPO.

Hologram mark

A hologram mark is a trademark that consists of elements of the mark having holographic characteristics. The application must include a detailed description of the mark including the variations showing the holographic characteristic of the mark. This description may be shown in a series of frames showing the visual variations of the hologram. The application may also be described with a video file submitted through a CD-ROM or DVD-ROM with the JPO.

Similar to the traditional trademarks, all the above non-traditional marks must meet the registrability requirement on distinctiveness.

Cannabis-derived products

Does your jurisdiction allow the registration of cannabis-derived products?

A trademark application that designates ‘cannabis’, etc, has been legally registered before the JPO even though Japan has a severe restriction on the usage of cannabis as governed by the Cannabis Control Act and the Narcotics and Psychotropics Control Act.

The JPO, generally, will not deny the registrability of the trademark application by the mere fact that such mark designates ‘cannabis-derived products’. However, in view of the restriction of the Cannabis Control Act and the Narcotics and Psychotropics Control Act, if a certain mark designated clear illegal goods, then, the JPO may deny the registration of the same under the Trademark Act, which provides that no trademark shall be registered if the trademark is likely to cause damage to public policy.

Parallel imports

Regulation

What are the rules governing parallel imports of pharmaceutical goods?

In Japan, unlike in other jurisdictions, parallel imports of genuine goods do not constitute as trademark infringement, even if the importer does not have any trademark licence from the Japanese trademark holder. This has been supported by numerous case laws upholding that genuine goods may be legitimately imported in Japan with no damage to the trademark owner, by establishing the ‘following conditions:

the trademark has been legally affixed to the import goods by a holder of a trademark right in a foreign country or a person licensed by the trademark right holder;
the trademark right holder in the foreign country and the trademark right holder in Japan are the same person or have a relationship wherein they can be regarded as being legally or economically identical with each other, and hence the trademark affixed to the import goods indicates the same source as that indicated by the registered trademark in Japan; and
since the trademark right holder in Japan is in the position to be able to control the quality of the import goods directly or indirectly, the import goods and the goods carrying the registered trademark held by the trademark right holder in Japan are judged to be not substantially different in terms of the quality guaranteed by the registered trademark.’

(Japanese Supreme Court, Case No. 2002 (Ju) 1100).

This principle is applied regardless of whether the parallel goods are pharmaceutical goods or not.

However, there is one important distinction when it comes to importation of pharmaceutical goods or products in Japan. The importation of drugs in Japan is regulated by the PMD Act and the Customs Law. Therefore, even if what will be imported is a genuine parallel pharmaceutical goods, the importer must still seek a licence before the Minister of the Ministry of Health Labour and Welfare (MHLW) either by obtaining a licence for a marketing authorisation holder or a licence for a manufacturer for importation on commercial basis.

Below are the procedures for clearing importation of pharmaceutical products. Note that the pharmaceutical inspectors stationed in the regional bureaus of health and welfare will assess whether the import is on a commercial or a non-commercial basis. This assessment will be made based on an analysis of the import report that the importer is required to submit before the Customs.

Import on a commercial basis

If the pharmaceutical inspector assesses that it is for commercial purposes, then the PMD Act provides that the importation of drugs, quasi-drugs, cosmetics or medical equipment for the purpose of business activities is only granted for those persons who have the business licence (either a licence as a marketing authorisation holder or a licence as a manufacturer) to import and sell in Japan. Furthermore, the importer should also present the drug marketing application, drug marketing approval or the drug marketing notice. For importers who present a manufacturing licence, a master file (DMF) registration certificate will also be required.

Import on a non-commercial basis

If the pharmaceutical inspector assesses that it is for non-commercial purposes, then the requirements will depend on which classification the import will fall under. There are two primary classifications for importation on a non-commercial basis. The first is for personal use and the second is for purposes of clinical trial.

For personal use of small quantity, importation shall be granted without any licence, provided that the import volume is within a permitted scope for a volume of ‘two-month’ consumption or less.

For purposes of clinical trials, the documents required for importation depends on whether a clinical trial notice had already been filed in accordance with the PMD Act.

For the purposes of trademark enforcement, parallel importation of genuine pharmaceutical goods is considered legitimate and such importation will not be held legal unless the regulations in relation to the PMD Act and the Customs Law are complied with.

Strategies against parallel imports

What strategies are available to police and enforce against parallel imports?

the trademark has been legally affixed to the import goods by a holder of a trademark right in a foreign country or a person licensed by the trademark right holder;
the trademark right holder in the foreign country and the trademark right holder in Japan are the same person or have a relationship wherein they can be regarded as being legally or economically identical with each other, and hence the trademark affixed to the import goods indicates the same source as that indicated by the registered trademark in Japan; and
since the trademark right holder in Japan is in the position to be able to control the quality of the import goods directly or indirectly, the import goods and the goods carrying the registered trademark held by the trademark right holder in Japan are judged to be not substantially different in terms of the quality guaranteed by the registered trademark.’

(Japanese Supreme Court, Case No. 2002 (Ju) 1100).

This principle is applied regardless of whether the parallel goods are pharmaceutical goods or not.

Import on a commercial basis

Import on a non-commercial basis

For personal use of small quantity, importation shall be granted without any licence, provided that the import volume is within a permitted scope for a volume of ‘two-month’ consumption or less.

For purposes of clinical trials, the documents required for importation depends on whether a clinical trial notice had already been filed in accordance with the PMD Act.

Anti-counterfeiting and enforcement

Types of proceedings

What types of legal or administrative proceedings are available to enforce against infringing products?

Under the Trademark Act, the following proceedings are available to enforce a trademark registration.

Civil proceedings

A trademark owner may file a civil action against an infringer. During this civil proceeding, the plaintiff may seek an injunction against the alleged infringer or against a party who is likely to infringe. The plaintiff can seek either a preliminary or permanent injunction against the defendant. Along with an injunction, the plaintiff can also seek an order for destruction of the infringing goods.

In the case of negligent or intentional infringement, damages are also available, which include, actual damages, consequential damages, and even reasonable attorneys’ fees. It is important to note, however, that in Japan, there are no punitive damages.

If there is an allegation that there was a damage on the reputation, an order may be sought for restitution to restore such reputation, including putting remedial advertisements.

Criminal proceedings

Criminal action may also be filed for intentional trademark infringements. This would be subject to penal sanctions of up to 10 years of imprisonment or a fine not exceeding ¥10 million. In criminal proceedings, however, negligence alone will not be sufficient. Rather, it is necessary to establish that the infringement was intentional to constitute a criminal offense.

Administrative proceedings

Administrative proceedings are also available when enforcing trademark rights. One of the most established procedures is the application for suspension, which is an administrative proceedings before the Japanese Customs. This generally starts with the trademark holder filing an application for suspension request with the Japanese Customs to initiate the identification procedure to determine if a product is genuine or not. Such trademark holder will be notified should there be importation of suspected counterfeit goods. If the products are infringing, the Customs will destroy the products. Such a decision will be based on the declarations from the trademark holder and the importer.

Remedies

What are the available remedies for infringement?

The following remedies are available for infringement cases:

demand that the alleged infringer stop such infringement;
demand for injunction (or any other preventive measure) against a person who is likely to infringe on the IP right (this is not only a district court procedure but also a procedure available in the customs office). This remedy is available even if the alleged infringer has not carried out any infringing acts yet. The mere likelihood of engaging in the infringing activity will give rise to this remedy;
demand the destruction of products constituting or resulting from such infringement, the elimination of equipment used for such infringement, or any other measures necessary to prevent such infringement; and
demand for damages from the person who manufactures, sells, or imports counterfeits infringing on the IP right.

Border enforcement

What border enforcement measures are available to halt the import and export of infringing goods?

The Customs Law provides that articles infringing intellectual property rights shall not be imported. Based on this provision, border measures were enacted.

In Japan, a trademark holder can file an application for suspension request with the Japanese customs to initiate the identification procedure to determine if a product is genuine or not. After such application, should there be importation of suspected infringing products, the Customs office will notify the trademark holder. If the products are infringing, the Customs will destroy the products. Such decision will be based on the declarations from the trademark holder and the importer.

Online pharmacy regulation

What rules are in place to govern online pharmacies?

Generally, pharmaceutical products cannot be sold online. However, there are limited exceptions. If the company selling it online has the requisite licence, then sale of pharmaceutical products online may be considered legitimate provided that the pharmaceutical product being sold is approved by the MHLW and that the product is considered as a non-prescription drug wherein its safety has already been proven.

If the online sale does not fall within the limited exception provided above, then such online marketing of pharmaceutical product and online pharmacy are considered illegal in Japan. As a general guideline, however, the revised Pharmaceutical Affairs Law dated 12 June 2014, states that non-prescription drugs may be retailed via the Internet in accordance with the governing rule and only if they are also marketed in an actual store with an applicable licence as mentioned above.

Recent cases

What are the most notable recent cases regarding the enforcement of pharmaceutical marks?

In one Tokyo District Court decision dated August 28, 2014 (Case No. 2014 (Wa) 770), the Court found that a commonly used abbreviation of a generic does not constitute as a trademark infringement since the consumers understand that the term “ピタバ (pi-ta-ba) is used as an abbreviation of active ingredient of the generic drug.

In the appeal, the Intellectual Property High Court (IPHC) reached the same conclusion but applying article 26, paragraph 1(vi) of the Trademark Act, which states that a trademark right has no effect if it is not used in the mode that consumers may recognise the goods or services as those pertaining to the business of a particular person.

In this case, Pitavastatin is a name registered as an International Non-proprietary Name andピタバスタチンカルシウム (Pitavastatin Calcuim) is a name registered Japanese Accepted Name (JAN). Pitavastatin, in accordance with the Japanese regulations should be used as a whole or a part of the generic drug’s trade name.

The plaintiff, who holds a trademark right PITAVA, alleges that the defendant’s act of selling a generic medicine that indicates katakana characters, ピタバ (Pitava) is affixed, constitutes infringement of the trademark right. The IPHC, however, indicated that the abbreviation of the generic name was commonly used, and consumers can recognise that the abbreviation stands for the active ingredient of the drug (ie, pitavastatin calcium). Specifically, medical professionals such as doctors and pharmacists are aware that the brand name of a generic drug is composed of the dosage form, content and company name in addition to the general name of the active ingredient contained. Therefore, this group of people would be aware that there is no trademark infringement but, rather, it is a generic name and only an abbreviation for pitavastatin calcium, which is the active ingredient. For patients on the other hand, since the indication is pitavastatin calcium then such patients will recognise that Pitava is a mere abbreviation for the ingredients contained in the product.

From the Court’s perspective, the source of the product cannot be identified from the Pitava label attached to each allegedly infringing product, since such use is not a trademark use but rather a use of the abbreviation of the active pharmaceutical ingredient, regardless of whether it is a medical professional or patients.

Another important decision that impacts pharmaceutical trademarks can be found in a judgment made by the IPHC, dated 28 September 2006, Case No. 2006 (Ne) 10009), wherein the IPHC confirmed that the colours of capsule and press through package sheet in relation to an originator company’s pharmaceutical trade dress is not entitled to unfair competition protection as it lacked distinctiveness and was not significantly unique enough to be granted unfair competition protection against the generics’ versions in view of the fact that the colour can be observed in other capsules in the market.

Advertising

Regulatory bodies

Which bodies are responsible for oversight of pharmaceutical advertising in your jurisdiction (and what are their powers)?

The Minister of the Ministry of Health Labour and Welfare (MHLW) and the prefectural governors may appoint pharmaceutical inspectors. These pharmaceutical inspectors are in charge of, among other things, pharmaceutical labelling, advertisements or marketing. The scope of pharmaceutical inspection system encompasses falsely labelled drugs, misleading, false or exaggerated advertising.

Advertising rules

What specific rules are in place regarding the advertising of pharmaceutical products?

Among other things, the main rules in place for advertising pharmaceutical products are discussed below.

Under the PMD Act, statements that are explicitly or implicitly, advertising, describing or falsely circulating or exaggerating the name, manufacturing process, efficacy and effects or performance of pharmaceuticals, quasi-pharmaceutical products, cosmetics, medical devices or regenerative medicine products are prohibited.

A specific provision is also provided for restrictions on advertising of pharmaceuticals and regenerative products for designated diseases that are intended for use in the cure of cancer or other special diseases specified by Cabinet Order, particularly those for which the use not under the guidance of doctors is highly hazardous.

Further, the Standard for Adequate Advertisement of Pharmaceutical Products also mandates that content of the advertisement must be closely inspected to ensure that the advertisement does not include false information or exaggerated statement and to disseminate accurate information so that users may use the drug, etc, properly.

Generic substitution

Legality

Is generic substitution permitted in your jurisdiction?

Generic substitution by pharmacists is allowed in Japan unless the physician who provided the prescription explicitly prohibits the same. This change came about when the prescription format was changed giving pharmacists the right to substitute generic drugs for original drugs unless the prescription format explicitly prohibits such substitution.

Regulations

Which regulations govern generic substitution by pharmacists of brand-name drugs?

The most recent change in the prescription format in Japan promoting use of generic drugs can be found in the 24 September 2012 policy report of the MHLW regarding the Promotion of the Use of Generic Drugs.

Update and trends

Key developments and future prospects

What were the key judicial, legislative, regulatory and policy developments of the past year in relation to the protection and enforcement of pharmaceutical trademarks? What are the prospects for future developments?

The Trademark Examination Guidelines by the Japan Patent Office (JPO) were revised on 24 August 2020 to respond to changes in law, as well as to address societal changes and changes in consumer needs. Few of the main revisions are as follows.

Web-based interviews are temporarily available to facilitate communication between the JPO and the applicant. This measure will be in place temporarily, as necessary.
Traditionally, amendments are sent via facsimile; however, at this time, the JPO will accept amendments made by email.

Another update on the trademark practice that came about earlier this year is the Fast track examination for trademarks. This system allows the expedited commencement of the examination, provided that the application meets the conditions provided by the JPO.

This fast-track examination is only applied to the following applications:

for trademark registration in which only the goods or services published in the Examination Guidelines for Similar Goods and Services, Regulation for Enforcement of the Trademark Act, or International Classification of Goods and Services are designated at the time of filing; and
for trademark registration with respect to which no amendment of the designated goods or designated services has been made until the commencement of the examination.

This fast-track examination is available to applications filed on or after 1 February 2020.

Law stated date

Correct on

Give the date on which the above information is accurate.

21 October 2020.

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Snapshot: the essentials of pharmaceutical trademarks in Japan

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