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.

Law stated date

Correct on

Give the date on which the above information is accurate.

21 October 2020.