The Japanese legal system covers two types of intellectual property rights in relation to the protection of inventions: patent rights and utility model rights. Both systems are based on statutory laws, namely the Patent Act and the Utility Model Act.
Patents
The Patent Act employs a substantive examination principle for the patent grant procedure. A patent application must first be filed with the Japan Patent Office (JPO) to obtain a patent right for an invention. A request for examination must also be filed within three years from the date of filing the patent application, or the patent application will be deemed withdrawn.
An examination will be carried out by an examiner of the JPO, who will decide whether the patent application fulfils all the requirements prescribed by the Patent Act.
Utility Models
In contrast to patent applications, the Utility Model Act does not require a substantive examination for applications for utility model registration (i.e., for all applications that have passed formal examinations); the utility model right will automatically be registered without going through a substantive examination. The registration fees for the first three years must be paid at the time of filing the utility model application.
Patents
According to statistics issued by the JPO, the average period from filing a request for examination to issuing a final decision (either a decision to grant or a decision to reject) was 13.8 months in 2023. Also, the average grant rate was 76.0% in 2023.
Domestic applicants do not need representation in order to initiate grant proceedings, but foreign applicants do. The typical costs incurred from filing to grant are USD8,000, comprising official fees of USD1,500 and lawyers’ fees of USD6,500. The official fees vary depending on the number of claims. Also, additional fees for translating certain documents (eg, the specification and notice of the reason for rejection) may be incurred where necessary.
Utility Models
The typical costs incurred from filing to grant are USD2,000, comprising official fees of USD200 and lawyers’ fees of USD1,800. The official fees vary depending on the number of claims. Also, additional fees for translating certain documents (eg, the specification) may be incurred where necessary.
Patents
The term of a patent right is 20 years from the date of filing the patent application. There are, however, some exceptions:
Utility Models
The term of a utility model right is ten years from the date of filing the utility model application. A utility model application or right may be converted to a patent application within three years from the date of filing the utility model application.
Both patent and utility model owners have the right to an injunction, claim damages, and claim for unjust enrichment. Also, patent owners and utility model owners are under an obligation to pay annual renewal fees in order to maintain their rights.
Notably, a substantive examination is not required for utility model registration applications. As a result, a utility model owner can only enforce their rights against an infringer after issuing a warning and providing a Utility Model Technical Opinion Report for the registered utility model. This report assesses the novelty and inventive step of the registered utility model, conducted by a JPO examiner based on a search of prior art documents. A request for a Utility Model Technical Opinion Report can be made at any time after the application for a utility model has been submitted.
In Japan, there is no public information listing applicable patents regarding certain products or processes. Although there is a public database of patent information in Japan called J-PlatPat, J-PlatPat does not have any functions to search applicable patents in relation to certain products or processes.
There is no further protection for technical intellectual property rights after their maximum term has lapsed.
Anyone may file a third-party observation at any time after filing a patent application or an application for utility model registration, even after a patent or utility model right has been granted. Third-party observations may include prior art information or a submitter’s comments regarding the novelty or inventive step of the claimed inventions, as well as other information or comments regarding other requirements, such as the addition of new matter, the support requirement, or the enablement requirement. Third-party observations may be filed anonymously.
Patents
An applicant may file an appeal with the JPO against a rejection decision issued by a JPO examiner. A panel of three appeal examiners will then review the patent application to determine whether the rejection decision was appropriate.
When filing an appeal against the rejection, the applicant can amend the claims, specifications, or drawings. If any amendments are made, the application will first be re-evaluated by the initial examiner who issued the rejection decision before it is sent to the appeal board.
If the initial examiner finds that the amended application has been sufficiently improved, they may issue a decision to grant the application without further involvement from the appeal board. However, if the initial examiner still believes the application should be rejected, it will be forwarded to the appeal stage for examination by the panel of appeal examiners.
Utility Models
No remedy is available or applicable for utility model applications because the Utility Model Act does not require a substantive examination for the granting of a utility model right.
If a patent owner or a utility model owner fails to pay the annual fees by the specified deadline, they can still make a late payment by paying a surcharge in addition – and equal to the annual fee – within the six-month grace period after the expiry of the deadline.
Furthermore, if the patent owner or the utility model owner is unable to meet the payment deadline, they can still make an additional payment to restore the patent right or the utility model right, except in the case of a “willful” failure to meet the payment deadline. This additional payment can be made within two months of the applicant’s ability to make the payment or within one year after the payment deadline, whichever comes first.
Both patent and utility model owners may file a request for a trial to correct the description, scope of claims, or drawings attached to the application.
The purpose of the correction is limited to the following:
The correction cannot be made beyond the scope of the matters disclosed in the description, the scope of claims or the drawings attached to the application.
Utility model owners are allowed to make a request for correction only once, except for the deletion of claims, whereas patent owners may request a trial for correction as many times as they wish, except where the patent has been invalidated by an invalidation trial or revoked by a patent opposition. Patentees may not request a correction while a patent opposition or invalidation proceeding is pending but may instead request a correction in the proceedings of the patent opposition or patent invalidation trial.
If the owner of a technical intellectual property right (eg, a patent) finds that a third party is infringing upon their patent, they can take one or more of the following actions:
Only an interested person may file a request for a trial for patent invalidation. The term “interested person” means a person who has, or potentially will have, their legal interest/standing directly affected by the existence of the patent right. On the other hand, in the Patent Opposition System, any person (not limited to interested persons) may file an opposition to a patent within six months of the publication date of the Gazette containing the patent.
The Japanese Patent Act also provides for three types of non-exclusive licences granted by the JPO Commissioner’s award (eg, compulsory licences). In 2021, a request for a compulsory license was filed for Japanese Patent No 6518878, marking the first time a council was convened in Japan to address such a request. However, in 2024, the parties reached a settlement, resulting in the withdrawal of the request. As of the end of 2024, no compulsory license has been granted in Japan.
The Tokyo District Court and the Osaka District Court have exclusive jurisdiction over litigation relating to patent rights and utility model rights in the first instance. The court where a plaintiff should file a lawsuit depends on the defendant’s corporate address and the location of the infringing activity. The Japanese Intellectual Property High Court (IPHC) has exclusive jurisdiction over appeals from District Court decisions. The IPHC is a special branch of the Tokyo High Court. Parties may appeal decisions of the IPHC to the Supreme Court.
The Japan Intellectual Property Arbitration Center (JIPAC) provides alternative dispute resolution services such as mediation or arbitration in the field of intellectual property. In addition, the International Arbitration Center in Tokyo (IACT) – an international arbitration organisation expected to provide dispute resolution services – commenced operation in September 2018.
There are no statutory prerequisites for filing a lawsuit. However, as patent rights and registered exclusive licences become effective upon the establishment of registration with the JPO, such registration will be required when a patentee or registered exclusive licensee brings a claim for damages and/or an injunction based on that patent right or registered exclusive licence. It is, however, generally considered that such registration will not be required when a non-registered exclusive licensee brings a claim for damages based on a non-registered exclusive licence.
In Japan, a party may choose at their own discretion whether to have legal representation. However, in practice, it is common for lawyers to represent parties in intellectual property matters. Patent lawyers can also represent parties for certain intellectual property cases under certain conditions.
Preliminary injunctions are available in cases where such injunctions are necessary for a rights owner to avoid any substantial detriment or imminent danger with respect to the rights in dispute. If a request for a preliminary injunction is granted, the rights owner will usually be required to deposit a certain amount of money as security. The court will determine the amount of that security in consideration of the circumstances of the specific case. A relatively large amount of money may be required to be deposited as security.
Since a preliminary injunction substantially achieves an injunction against the other party’s conduct before the lawsuit is finalised, in a preliminary injunction case, a hearing of both the rights-owner and the other party is required, and prima facie evidence of a similar level to the proof required in the lawsuit is often required. In general, preliminary injunctions are intended to resolve disputes more quickly than litigation; however, the speed of trial is often not so different from that of litigation because of the need for prima facie evidence, as mentioned above.
A potential defendant can file a request for a patent invalidation trial before the JPO and/or initiate a lawsuit for a declaratory judgment to confirm the absence of the right to demand an injunction, etc. There is no need for a potential opponent to lodge a protective brief in order to take these actions. It should be noted that a potential opponent is not entitled to require the owner to post a bond under the Civil Preservation Act, but a court usually orders the owner to deposit a certain amount as a security when issuing an interim injunction order.
There are no special limitations applicable only to intellectual property matters.
Claims for injunctions based on patent rights may be filed at any time if infringement of the patent rights exists or a threat of infringement of the patent rights is recognised.
The claim for compensation for loss or damage by the tort of patent infringement is extinguished by prescription if the right is not exercised within three years from the time when the patentee comes to know the damage and the identity of the infringer or if the right is not exercised within 20 years from the time of the tortious act, pursuant to the provisions of the statute of limitations provided in the Civil Code of Japan, which is a general law. Please note that the above prescription period may be renewed, or the expiry of the prescription period may be postponed for statutory reasons.
Although there is no discovery procedure in Japan, the Patent Act provides that a court can order a party to produce documents upon the other party’s request for the purposes of:
However, this will not apply where the accused infringer possessing the documents has reasonable grounds to refuse to produce them.
When the court finds it necessary to determine whether there are reasonable grounds, it may demand that the person with the documents present them for review in camera. Furthermore, on 1 July 2019, the amended Patent Act introduced a procedure in which the court can determine the necessity of document production by way of in-camera procedures. The amended Patent Act also introduced a procedure that allows expert advisers to participate in such a procedure.
Moreover, by way of the 2019 amendment to the Patent Act, an inspection system was introduced on 1 October 2020, under which an inspector designated by the court will be entitled to enter into the factories, offices, etc, of a defendant and collect evidence necessary to make a decision on the existence of facts regarding the alleged infringement. However, the requirements for conducting an inspection are strictly stipulated as follows:
A complaint must contain both parties’ names and addresses, the plaintiff’s lawyer’s name and address (if appointed), the gist of the demand and the grounds for the demand. In particular, each accused product and act of infringing conduct must be specified in detail, and the relevant features of the product must be described and compared with each element of a claim. In general, supportive evidence – to prove both the act of infringing conduct and the relevant features of the product – is submitted together with the complaint. A patentee is expected to conduct a sufficiently detailed investigation and analysis of a case prior to initiating a lawsuit to identify these facts and find the relevant evidence.
No special provisions for lawsuits in intellectual property proceedings differ from those for non-intellectual property proceedings.
It is acceptable to supplement pleadings with additional arguments. A court examines the case through periodic hearing procedures (generally once a month), and each party is allowed to add its legal/factual arguments or evidence in the course of these procedures. The plaintiff may even expand or amend the claim or statement of claim until oral arguments are concluded. However, the courts may limit such additional arguments or evidence if they consider that they would substantially delay court proceedings.
The legal system does not allow for representative or collective actions for intellectual property rights proceedings, although if the subject matter of the suits is common to two or more persons or is based on the same factual or statutory cause, these persons may sue or be sued as co-parties.
Civil Code
As an abuse of rights is prohibited under the Civil Code, the same will apply to the execution of patent rights, and therefore, where the execution of such rights is abusive, that execution will be restricted.
For example, the act of filing a lawsuit may cause tort liability where such litigation is found to be significantly unreasonable in light of the purport of the litigation system (eg, the allegation of infringement is entirely baseless and the owner of the intellectual property right is fully aware of the lack of legal grounds). In addition, based on judicial precedents, a patent right-holder who has made a declaration of fair, reasonable and non-discriminatory (FRAND) terms will not be permitted to claim for an injunction or for licence fees against a party who intends to be licensed under FRAND terms beyond those terms, as this will fall under an abuse of rights.
Guidelines for the Use of Intellectual Property
In addition, the Japan Fair Trade Commission (JFTC) has stipulated that its Guidelines for the Use of Intellectual Property (IP Guidelines) under the Antimonopoly Act clearly show the principles of the use of intellectual property rights, including patent rights, under the Act. In January 2016, the JFTC partially amended the IP Guidelines and supplemented descriptions related to the Standard Essential Patent under the Antimonopoly Act. If a patent right has been exercised in a manner that violates these Guidelines, the act may be considered a violation of the Antimonopoly Act.
Unfair Competition Prevention Act
Furthermore, if the owner of the intellectual property right makes or disseminates a false allegation of infringement of that intellectual property right, that act could constitute an act of unfair competition under the Unfair Competition Prevention Act, and the owner of the intellectual property right may be subject to a claim for injunction and/or damages.
A patent owner and an alleged infringer are usually the necessary parties to patent infringement litigation. A registered exclusive licensee is entitled to file an action without the patent owner, based on an infringement of the registered exclusive licence, seeking the same remedies as the patent owner. In this regard, there are arguments over whether non-exclusive or non-registered exclusive licensees can initiate an action for infringement.
Regarding injunctions, it is generally understood that neither a non-registered exclusive licensee nor a non-exclusive licensee has the right to seek an injunction. However, when it comes to claims for damages, a non-registered exclusive licensee can pursue such claims, while a non-exclusive licensee is not permitted to seek damages.
For a direct infringement to be constituted, the product in question needs to satisfy all of the component features of a patented invention. If any one of the constituent features is not satisfied, a direct infringement has not been constituted.
However, even if the product does not satisfy all of the component features, the following cases will constitute indirect infringement, thus constituting patent right infringement.
In any instances where direct or indirect infringement is constituted, a patentee may claim injunctions and damages against an infringer. In a claim for damages, provisions such as those on the presumption of the amount of damage or those on the presumption of negligence may be applied.
In the Japanese Patent Act, inventions are classified as the invention of a product, the invention of a process, or the invention of a process for producing a product, and an act of working on a patented invention is stipulated for each of these categories. Specifically, for the invention of a process, the act of using the process is specified as an act of working. Additionally, for an invention that involves a process for producing a product, the following activities are considered acts of working: using the process, as well as producing, using, assigning (including lending and providing via telecommunications lines), exporting, importing, or offering to assign the product created by that process. Conversely, for an invention that pertains to a product, the acts of producing, using, assigning (including lending and providing via telecommunications lines), exporting, importing, or offering to assign the product itself are defined as acts of working.
No clear rule exists regarding whether patent infringement in Japan can be recognised when part of a process is executed abroad. In some cases where steps of a patented process were conducted outside Japan, a District Court ruled that this cannot be considered as working the patent in Japan because the relevant technical steps of the patent are not completed within the country. However, this ruling is not regarded as a well-established precedent that applies universally to process inventions in Japan.
In principle, the scope for protection of a patent right (eg, the technical scope of a patented invention) is determined based on the statements in the scope of claims. In addition, the meaning of each term used in the scope of claims is interpreted in conjunction with the statements in the description and drawings. The prosecution history of the application and the prior art may also be taken into consideration. Accordingly, to say that infringement of a patent right has taken place in principle, the subject product must satisfy all of the constituent features of the patented invention. However, even if the product does not satisfy all of the constituent features of the patented invention, there may be a case that amounts to indirect infringement or infringement under the doctrine of equivalents (see 3.2 Direct and Indirect Infringement).
If a patent right is exercised abusively, it can lead to certain defences for the accused party. For example, if a patent holder who has declared their commitment to FRAND (fair, reasonable, and non-discriminatory) terms later seeks an injunction against a party that intends to be licensed under those terms or demands damages exceeding what would normally be considered a fair licensing fee, the defendant may invoke the defence of abuse of rights.
If the defendant has practised a patented invention or prepared for such practice at the time of the patent application filing, the defendant can claim “prior use” as a defence.
If the patentee, when filing an application, makes assertions that exclude the technology that is to be included in the technical scope of a patented invention (based on the common meaning of the term being used), it is typical for the technical scope of the patented invention to be construed in a limited manner as a result.
Where the products in question were assigned from a patentee or person with legitimate rights, no patent infringement will be admitted, as the patent right will have been exhausted.
In addition, the defendant may claim that their use of the patented invention was experimental and, therefore, beyond the scope of the patent right.
Even though the Patent Act provides for three types of non-exclusive licences to be granted by the JPO Commissioner (eg, compulsory licences), as of the end of 2024, no such compulsory licence has ever actually been granted in Japan (see 2.2 Third-Party Remedies to Remove the Effects of Intellectual Property).
The fact that the defendant’s infringing conduct was an exercise of their patent right cannot be used as a defence against the patentee’s infringement claim.
As to the statute of limitations, the patentee cannot claim damages for an infringement if more than three years have passed since the date on which the patentee became aware of an infringement and the identity of the infringer who caused the damage. There is an overall limit of 20 years from the act of infringement.
Experts involved in patent litigation are mainly judicial research officials and expert advisers.
Judicial research officials are full-time court employees who conduct examinations on technical matters necessary for judicial decisions and report to a judge. Judicial research officials are primarily appointed from the pool of JPO employees or patent lawyers.
Expert advisers are part-time employees appointed by the courts who get involved in proceedings to arrange issues and evidence, to examine evidence, and to enter into a settlement in the court proceedings. Expert advisers are usually involved in proceedings to arrange issues and evidence (preparatory proceedings, etc) and make oral explanations on technical matters. In patent litigation, in order to have a proper understanding of technical issues, expert advisers are often involved and conduct technical explanation sessions in preparatory proceedings. It is common for an expert in the technical field to which a patented invention belongs (usually a university professor or patent lawyer) to be appointed as an expert adviser.
In addition, in litigation, experts selected by a party may prepare expert opinions, which are submitted as evidence by the party but rarely testify in court as witnesses.
There is no separate procedure for claim construction in Japan.
A system by which the court can seek third-party opinions in lawsuits relating to patent infringement was introduced on 1 April 2022. Under this system, if a party requests it and the court finds it necessary, the court may request the public to submit documents stating public opinions on the application of the Patent Act of Japan or any other necessary matters after hearing the other party’s opinion. It is envisioned that this system will be used in patent infringement cases where the judgments may have significant impacts not only on an industry to which the parties belong but also on companies in other industries.
Case No 2018 (Ne) 10046
In the recent Case No 2018 (Ne) 10046, the Intellectual Property High Court issued a request for third-party opinions for the first time. In this case, the patent at issue claimed a certain system comprising a server and a plurality of terminal devices. The issue here was whether or not the defendant’s act of creating a new system can be considered “production” (a form of working of invention as defined in Article 2(3)(i) of the Patent Act) of the patented system, even when the server in the alleged infringing system is located outside Japan. The court issued the request for third-party opinions regarding whether the defendant’s act can be considered “production” of the patented system and, if so, what requirements are necessary for it to fall under the category of “production”. Various organisations have submitted multiple statements in response to the court’s request for opinions. The IP high court eventually determined infringement in its judgement, as opposed to the district court, which denied the “working of invention” within Japan in the first instance.
Case No 2023 (Ne) 10040
The latest case of the Intellectual Property High Court issuing a request for third-party opinions is Case No 2023 (Ne) 10040, which concerns a patented invention for a breast augmentation composition containing multiple drug substances. According to Article 69(3) of the Patent Act, the effect of a patent right for an invention related to “a pharmaceutical product to be produced by mixing two or more drugs” does not extend to “acts of preparation performed based on a prescription by a physician or dentist.” In this case, the court has requested third-party opinions, such as whether the act of a nurse or assistant nurse mixing multiple drugs to produce a combined medication, as instructed by a physician without issuing a prescription, can constitute an “act of preparation performed based on a prescription by a physician or dentist”.
Patents
There are two procedures available for seeking the revocation/cancellation of a patent – namely, an opposition or an invalidation trial before the JPO.
Anyone may file an opposition within six months from the issue date of a patent Gazette based on the following grounds:
An interested party may file an invalidation trial at any time after a patent has been granted, even if it has expired, based on the following grounds:
Utility Models
There is only one procedure for revocation/cancellation of a utility model registration: an invalidation trial before the JPO.
An interested party may file an invalidation trial at any time after a utility model has been granted, even after the utility model has expired, based on the following grounds:
In Japan, an opposition or an invalidation trial for a patent or a utility model registration may be filed for each individual claim.
Amendments (“corrections” in opposition or invalidation proceedings under the Patent Act or the Utility Model Act) may be filed in opposition or invalidation proceedings.
In opposition proceedings, a patent owner may file amendments in the period for responding to a notice of cancellation issued by the board of trial examiners who examined the request for opposition.
In invalidation trial proceedings, the owner of a patent or utility model right may file amendments in the period for filing an answer in response to a request for an invalidation trial. The owner may also file amendments in the period for responding to a notice of reasons for invalidation or an advance notice of appeal decision, both issued by the board of trial examiners who examined the request for invalidation trial.
In patent or utility model infringement litigation heard before the courts, both infringement and invalidation issues may be heard together because the defendant may challenge the validity of a patent or utility model registration as a defence before a court. The courts examine both infringement and validity together and render a decision based on the examination of infringement and/or validity.
There are no specifically applicable provisions with respect to trial and settlement for intellectual property rights proceedings. However, in practice, the trial will be divided into two parts. At the first stage (the stage for examination on infringement), the court focuses on determining whether the infringement of the intellectual property right is established. At the second stage (the stage for examination of damages), a court will assess the damages incurred by a plaintiff only after it has tentatively concluded the establishment of the infringement.
In this regard, the Intellectual Property Division of the Tokyo District Court has a trial model for patent infringement litigation. According to this trial model, it is assumed that six court hearing dates are held at the first stage (stage for examination on infringement). If courts find no patent infringement, they will either:
If courts find that there is patent infringement, the courts will either:
It is assumed that three court hearing dates are held at the second stage, and both parties make arguments and counterarguments with regard to the amounts of damages. Then, the courts will either:
However, as the progress of trials (including the number of court hearing dates) depends largely on the complexity of cases, trials rarely proceed as envisioned in the above trial model, and in complex cases, trials are often prolonged for much longer than the trial model.
According to the statistics provided by the Intellectual Property High Court, the average time intervals from commencement to disposition in intellectual property-related civil cases in 2023 were 14.9 months (in all district courts) and 7.6 months (in all high courts).
In patent litigation, examination of fact witnesses or experts is rarely conducted. In cases of examination of witnesses, opportunities for cross-examination are provided.
A case is determined solely by a legal judge. The Japanese legal system has neither technical judges nor jury trials for intellectual property cases.
In the Tokyo District Court and the Osaka District Court, there are special divisions for intellectual property matters (four divisions at the Tokyo District Court and two at the Osaka District Court), where judges experienced in intellectual property matters hear and decide cases. The judges in these courts and the IPHC do not necessarily have technical backgrounds; the courts retain judicial research officials who have a technical background to help judges understand any technology issues involved in a case (see 3.6 Role of Experts). The courts can also appoint and request expert advisers to assist judges with any case involving advanced, complicated or specialised technology issues.
Parties cannot influence who will judge a case, although a party can request to avoid a certain judge if they have reason to believe that said judge cannot be impartial due to a particular relationship with the other party (eg, being a relative of one party).
A judge usually takes the initiative in settlement negotiations unless the parties clearly refuse to settle a case. In no event will a defendant be obliged to settle a case. Generally, courts prefer settlements rather than judgments to resolve cases. A judge may disclose or imply their unofficial, tentative opinion on a case to the parties in order to facilitate settlement negotiations. A judge will cease settlement negotiations if one party decides and requests to receive a court decision rather than a settlement.
Even if there are any pending parallel revocation or infringement proceedings, the current proceedings will not normally be stayed, and the courts will separately and independently make a judgment for a case. The courts can even dismiss a claim for infringement on the grounds that the patent is invalid without needing a revocation proceeding. Therefore, it is possible for a conflict between two cases on the same subject matter to exist. However, in practice, the High Court, as the court of the second instance, will make consistent judgments so that any contradiction in the first instance will be resolved.
There have been no cases where anti-suit injunctions have been issued against litigation in Japan, and it is unclear whether Japanese courts would take into account foreign anti-suit injunctions. In addition, in Japan, there is no statutory basis for granting injunctions against litigation by patentees, and there have been no examples of Japanese courts recognising anti-suit injunctions.
Remedies Available for the Patentee
The typical remedies available for a patentee include injunctive relief and damages. As part of injunctive relief, the patentee can request necessary measures to prevent further infringement, which may include the disposal of the infringing goods. While lawyers’ fees can be recovered as part of the damages, this recovery is quite limited – typically around 10% of the total amount of actual damages awarded by the courts.
A patentee is only entitled to seek compensatory damages, as claims for enhanced damages, such as punitive damages, are not permitted, even in cases of willful infringement. The Patent Act establishes certain presumptions for calculating damages based on the profits generated from the infringement or the expected royalties. Ultimately, a judge has the discretion to determine the appropriate remedies or the amount of damages, but this discretion is limited to the amount claimed by the plaintiff.
In addition, where an applicant has given a warning, together with documents stating the contents of the invention claimed in the patent application, that applicant may also claim compensation equivalent to the licence fee against any person who has worked the invention as a business after the warning and before the registration of the patent. Furthermore, even without such a warning, the applicant may claim compensation against those who, while being aware that the invention relates to a patent application that has been published, have worked the invention as a business before the registration. The right to claim compensation may only be executed after the patent has been registered.
A patentee may also demand measures necessary to restore its business credibility, but this remedy is rarely used.
Enforcement of Remedies
The methods for enforcement of remedies depend on the contents of those remedies. For example, with respect to judgments ordering patent infringers to pay damages, the remedies are enforced by seizing the infringers’ properties and receiving dividends from the money obtained through auctions, etc. With regard to judgments ordering patent infringers to cease and desist from manufacturing the infringing products, if the infringers do not perform the obligations ordered in the judgment, the court in charge of enforcement will enforce the remedies by ordering the infringers to pay to the obligees certain amounts of money which are found to be reasonable for securing performance of the obligation.
If a defendant prevails, the courts can order the plaintiff to pay court costs (eg, transportation fees to attend court hearings, expenses for delivering documents and daily allowances for witnesses); however, such costs do not include the defendant’s legal fees or other costs incurred by the defendant in the course of the procedure. There is no right or remedy for a prevailing defendant to recover their own costs.
A prevailing defendant may seek damages arising out of the infringement litigation, including their lawyers’ fees if the litigation itself is considered to constitute a tort on the grounds that it is found to be unreasonable (eg, if an allegation of patent infringement is entirely baseless and the patentee is fully aware of the lack of legal grounds). However, the courts rarely accept such a claim.
There are no different remedies for different types of technical intellectual property in Japan.
In an effort to stop the execution of an injunction granted at first instance, an infringer will (upon filing an appeal) have to file a petition to seek a ruling on the suspension of compulsory execution. Here, the infringer will need to provide a security deposit (to be returned after litigation).
Under the laws of Japan, injunctions are enforceable pending appeal. However, in practice, when infringers file an appeal, the infringers also file a motion for suspension of compulsory execution in most cases, and such suspensions are usually granted if the motion is filed.
The above refers to judgments for injunctions of the first instances in main lawsuits. On the other hand, if right-owners request preliminary injunctions separately from (or in parallel with) the main lawsuits and the first instance courts grant the requests and issue preliminary injunction orders, it is difficult to stop enforcement of such preliminary injunction orders in practice, although there is a legal way to challenge such preliminary injunction orders (see 2.7 Interim Injunctions).
Generally, there are no special provisions concerning the appellate procedure for patent litigation. However, the IPHC has exclusive jurisdiction over appeals from decisions made by the Tokyo District Court and the Osaka District Court on patent litigations. A court normally consists of three judges, but if the case includes an important issue of law, five judges may sit to consider the matter and deliver their opinion.
As the court of the second instance, the IPHC reviews not only issues of law but also the facts from the proceedings in District Courts in the first instance. The IPHC may also conduct factual findings of its own. A party may submit additional legal arguments, facts or evidence to the appeal court, unless such an additional claim is considered to be causing delay to the procedure and to be that party’s fault. However, the Supreme Court, as the court of final instance, only reviews the legal issues of a case.
With respect to patent infringement litigation in Japan, costs normally incurred are for:
Stamp fees and expenses for delivering documents are required in order to file a lawsuit in Japan. The amount of stamp fees is calculated according to a formula prepared by the court based on the value of the subject matter of the suit.
In general, the losing party typically pays court costs – including stamp fees, expenses for delivering documents, and daily allowances for witnesses. However, the allocation of these costs is at the court’s discretion. The court may also assign a portion of the costs to the winning party based on the extent to which their claims were not accepted.
It should be noted that court costs do not include lawyers’ fees, and thus, generally speaking, each party must bear their own lawyers’ fees. A plaintiff may seek compensation for their lawyer’s fees as part of damages, but the recovery rate is left to the court’s discretion and is usually quite limited, even if the plaintiff wins the case (in practice, around 10% of the total amount of actual damages admitted by the courts).
Alternative dispute resolution (ADR) is not commonly used to settle intellectual property cases in Japan. However, ADR, such as mediation or arbitration, is available, and JIPAC and IACT (see 2.4 Specialised Bodies/Organisations for the Resolution of Disputes) are the ADR organisations that provide dispute resolution in the field of intellectual property.
Moreover, the Tokyo District Court and the Osaka District Court introduced mediation procedures for intellectual property rights matters on 1 October 2019. This procedure is designed to resolve disputes regarding intellectual property rights matters in a speedy and efficient manner by using a mediation committee made up of a judge from the special division for intellectual property matters and experts such as lawyers or patent attorneys who orally express their opinions. In principle, the procedure should be concluded within around three hearing dates.
Patent rights may be freely assigned. However, no assignment will take effect without having been registered on the patent registry, except in cases of general succession, such as inheritance or merger. Where a patent right is jointly owned, no joint owner may assign their share without the consent of all the other joint owners. Neither an agreement in writing nor approval from the JPO is necessary for conducting an assignment.
Assignment of a patent right comes into effect when it is registered on the patent registry. In the case of a general succession, such as through inheritance or merger, the assignment takes effect without being registered, but the registration is made by providing notification of that assignment.
In terms of licensing patent rights, licences are granted merely by an agreement between the parties (non-registered licences) and licences granted upon registration at the JPO (registered as exclusive licences), in addition to an agreement between the parties. As for the former type of licence, there are no particular restrictions regarding formalities, such as the existence of a written agreement or notification to the JPO, etc. However, the latter type of licence requires registration at the JPO in order for it to enter into force. It should be noted that if a registered exclusive licence is granted, other parties may not execute the scope of rights subject to that grant (even the patent right-holder).
As the grant of a registered exclusive licence requires registration at the JPO in order for it to come into force, it is necessary to make an application to the JPO setting forth the content of the licence agreed by both parties and to receive registration thereof. The granting of a non-registered licence comes into force merely by way of the execution of an agreement between the parties. Thus, generally, a licence of this kind is granted by preparing a licence agreement, as well as orally or even implicitly.
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info_general@tmi.gr.jp www.tmi.gr.jpIntellectual Property High Court Grand Panel Decisions
The rulings of the Intellectual Property High Court (the “IP High Court”) have a major impact on the interpretation of intellectual property rights in Japan. In cases involving particularly important legal issues and where decisions could significantly impact business activities and the industrial economy, the Grand Panel, which is made up of five judges of the IP High Court, is formed ad hoc to render its decisions. However, there is no pending case at the Grand Panel of the IP High Court at this moment (December 2024).
Life sciences
In 2024, several significant rulings by Japanese Courts, including the IP High Court, have been made in the field of life sciences. The first case below shows the criteria for determining the inventive step with regard to a patent relating to a vaccine adjuvant, which enhances a vaccine’s effectiveness. The second case showcases another interesting discussion regarding the patent linkage system in Japan.
KM Biologics Co, Ltd. v Seqirus UK Limited, Case No 2023 (Gyo-Ke) 10056, Intellectual Property High Court (decision rendered on 25 March 2024)
In a recent case concerning a patented invention titled “Hydrophilic Filtration During the Manufacture of Vaccine Adjuvants,” the IP High Court rescinded the decision of the Japan Patent Office (JPO) that the request for a trial for patent invalidation for the patent owned by the defendant (the “Invention”) is groundless, stating that, at the time of the priority date, a person skilled in the art could have easily conceived the structure of the Invention based on the cited invention and well-known techniques. Furthermore, the Court noted that the effects achieved by the Invention were neither unpredictable by a person skilled in the art based on the structure of the Invention nor demonstrated to exceed the scope of effects reasonably expected from the structure. As a result, the decision of the JPO to invalidate the patent was overturned.
The Invention in question provided a method for manufacturing a squalene-containing oil-in-water emulsion, and this method comprised of:
In Japan, the concept of an inventive step is defined in Article 29(2) of the Patent Act. This article states that a patent cannot be granted for an invention if it could have been easily created, prior to the filing of the patent application, by someone with ordinary skill in the relevant field based on existing prior art.
The patent examiner determines whether the claimed invention is novel by comparing it with the prior art cited to identify the differences between them. Where there is no difference, the claimed invention lacks novelty. If there is any difference, the examiner determines whether the claimed invention has an inventive step. If there is an invention-specific feature in the claimed invention that is not described in the prior cited invention, that feature will be recognised as a difference. If a person skilled in the art can easily think of that difference based on the state of the art at the time of filing, the claimed invention will be judged to lack an inventive step based on the cited invention.
In its inventive step analysis, the Court first determined that the technique related to the structure of filtration using a membrane of a commercially available product listed in a product catalogue was a well-known technique at the time of the priority date. This commercially available product had a hydrophilic heterogenous bilayer polyethersulfone membrane that combined a polyethersulfone prefiltration membrane with a pore size of 0.45 µm and a polyethersulfone final filtration membrane with a pore size of 0.2 µm, and the product catalogue state that the product was designed to filter a wide range of pharmaceutical products. Therefore, the Court noted that this product could naturally be applied to the manufacturing of a vaccine adjuvant emulsion, and thus, the technical field to which the Invention and this product belong are the same. The Court reasoned that the difference between the filtration process of the Invention and that in cited inventions could have easily been conceived by a person ordinarily skilled in the art by applying this well-known technique.
Furthermore, regarding the effect of the Invention, the Court referred to data from the description in the specification and determined that, only based on such data, it is not proved that the significant recovery rate is achieved thanks to the effect of the hydrophilic double layer polyethersulfone membrane related to the Invention. The Court noted that according to the evidence, it is reasonable to find that a person ordinarily skilled in the art at the time of the priority date could have easily understood that if approximately 50 litres of emulsion is filtered using the commercially available product, the clogging degree of the membrane is reduced and a high recovery rate (as stated in the description of the specification) can be achieved.
Based on its analysis, the Court denied the inventive step of the Invention and set aside the decision of the JPO that the invalidation trial was not successful. The Court concluded that a person ordinarily skilled in the art at the time of the priority date could have conceived of the configuration of Invention based on the cited invention and well-known art above. Furthermore, the Court did not find that:
A skilled individual in the field would have easily recognised the well-established filtration technology using a membrane made from a commercially available product. Furthermore, based on the comparison presented in the specifications, the Invention did not produce any significant effect. The impact of the Invention was predictable, considering the information contained in the catalogue listing the commercially available product.
Samsung Bioepis Co., Ltd. v Bayer Healthcare LLC., Case No 2024 (Yo) 30029, Tokyo District Court (decision rendered on 28 October 2024)
Patent linkage system in Japan
The patent linkage system refers to a mechanism in which regulatory authorities consider the infringement of patent rights related to the original drugs in the procedures for the approval of generics. The purpose of patent linkage is to ensure a stable supply of generics by considering the patent rights related to the original drugs. The implementation of the system and its contents differ from country to country.
In Japan, the patent linkage system has no clear legal basis, and it is handled as an administrative practice under the guidance of the Ministry of Health, Labour and Welfare (MHLW) based on two administrative notifications (both are notifications by a section chief and are thus collectively referred to as the “Two Section Chief Notifications”). The details of the practice are as follows.
In the procedure of the National Health Insurance (NHI) price listing of generic drugs, the Two Section Chief Notifications require that matters with patent-related concerns be adjusted between the parties in advance and that listing procedures be taken only for items considered capable of stable supply. However, this preliminary adjustment between the parties is to be made during the NHI price listing after obtaining approval for the generic, and the actual practice is that, even if discussions or adjustments between the parties are unsuccessful, the MHLW permits the NHI price listing of the generic if there is an application from a generic drug manufacturer. Also, as mentioned above, although the MHLW is responsible for determining whether the generic drug infringes the patents of the original drug, there is no mechanism in place for the MHLW to rely on any judicial judgment.
Rulings
Bayer Yakuhin Co., Ltd., a Japanese subsidiary of the defendant, manufactured and sold an anti-VEGF agent using the recombinant fusion protein Aflibercept (the “Defendant’s Original Drug”) for indications such as age-related macular degeneration (AMD).
After the launch of the Defendant’s Original Drug, the defendant obtained a patent for a specific use aimed at treating a particular subgroup of wet age-related macular degeneration (AMD) patients who meet certain inclusion and exclusion criteria (the “Defendant Patent”). The Defendant Patent is characterisedcharacterised as a use invention, based on the discovery of a previously unknown property of Aflibercept—a known substance—showing superior therapeutic effects in patients meeting specific criteria, and creating a novel use with remarkable effectiveness.
Through its manufacturing and sales subsidiary in Japan, the plaintiff submitted an application to the MHLW for marketing approval of the plaintiff’s product (the “Plaintiff’s Biosimilar Drug”), as a biosimilar to the Defendant’s Original Drug. The Plaintiff’s Biosimilar Drug included wAMD as an indication and adopted the same descriptions as the Defendant’s Original Drug in its dosage and administration.
Under the patent linkage system, the defendant notified the MHLW that the generic drug manufacturer’s act of manufacturing and selling a biosimilar to the Defendant’s Original Drug would infringe the Defendant Patent (the “Notice in Question”).
The plaintiff asserted that it was evident that the Plaintiff’s Biosimilar Drug did not infringe the Defendant Patent, and therefore the Notice in Question by the defendant constituted a clearly false statement. The plaintiff further argued that this act of the defendant amounted to “the act of disseminating or notifying false facts harmful to the business reputation of a competitor” under Article 2(1)(21) of the Unfair Competition Prevention Act, posing a potential risk of damaging the plaintiff’s business interests. Consequently, the plaintiff sought a provisional injunction to stop the defendant from issuing the Notice in Question.
Does the Notice in Question Constitute a False Statement?
A use invention is an invention characterised by the discovery of an unknown property of a known substance and the creation of a novel use with significant effects based on that property. Therefore, “implementing” a use invention refers to acts such as manufacturing or using the known substance for the purpose of the novel use.
The Court recognised that the Defendant Patent was also a use invention and defined its “implementation” as acts such as manufacturing or using a preparation containing the known substance for administration to a specific patient group, among wAMD patients, that satisfies certain inclusion and exclusion criteria defined by the Defendant Patent.
In its assessment, the Court concluded the following:
The Court addressed the validity of the Defendant’s Patent and noted that the Plaintiff’s Biosimilar Drug is equivalent and identical to the Defendant’s Original Drug. It observed that the Defendant’s Original Drug had been manufactured and sold before the filing date of the Defendant’s Patent. Additionally, the Defendant’s Original Drug was administered to a specific group of patients as part of the general treatment for wAMD. Therefore, the manufacture and sale of the Defendant’s Original Drug constituted prior public use, which rendered the Defendant’s Patent invalid.
For these reasons above, the Court concluded that the Notice in Question constituted a false statement.
Unfair Conduct
As described, the Court determined that the Notice in Question issued by the defendant constituted a false statement. The Court further examined whether such an act amounts to unfair conduct under the Unfair Competition Prevention Act within the context of the patent linkage system based on the following criteria:
Scope of statements under the patent linkage system
The defendant issued the Notice in Question to the MHLW under the patent linkage system. This system has no specific restrictions on the content of such statements. Patent holders are not prohibited from expressing their opinion regarding the existence or absence of patent conflicts between their patented drug and a follow-on generic drug.
Purpose of the patent linkage system
The patent linkage system aims to confirm the existence or absence of patent conflicts between patented drugs and follow-on generic products during the approval process of generic drugs, ensuring the stable supply of generic drugs. However, this system does not permit patent holders to provide arbitrary or misleading information.
Evaluation of false statements
If a patent holder makes a false statement claiming a patent conflict under the guise of providing information within the patent linkage framework, while the substance of such a statement is to disadvantage the applicant seeking approval for a generic drug and to secure a competitive advantage for themselves, such conduct would disrupt fair competition among businesses.
Determination of unfair conduct
Acts by a patent holder under the patent linkage system that involve providing false information about patent conflicts could amount to unfair competition if “exceptional circumstances exist where such acts are deemed grossly inappropriate in light of the purpose of the patent linkage system.”
Application to this Case
The defendant argued that:
The Court noted that even though the defendant’s view above may be considered its own interpretation, it is a potentially arguable position when alleging patent infringement. Therefore, the mere act of adopting this viewpoint does not immediately render the defendant’s argument baseless. Patent infringement disputes require careful deliberation based on expert knowledge, and the limited examination conducted during preliminary injunction proceedings is insufficient to determine that the defendant’s argument is entirely unfounded.
Thus, although the defendant’s issuance of the Notice in Question may be considered careless, it was not the case that “exceptional circumstances exist where such acts are deemed grossly inappropriate in light of the purpose of the patent linkage system.” Accordingly, the Notice in Question does not amount to an unfair act under the Unfair Competition Prevention Act.
The above ruling is rendered to determine whether the defendant’s act constitutes an unfair act under the Unfair Competition Prevention Act. However, as the plaintiff argued, there is a question about the current practice that the MHLW determines the patent infringement, and there is no mechanism for prior co-ordination between the parties at the approval or prior approval stage. Future discussions on the Japanese patent linkage practice are therefore expected.
Technology
The following recent decisions by the Japanese Courts also show important developments in the field of technology. The first case below shows interesting discussions regarding the eligibility of AI as an inventor, which have been attracting particular attention all over the world in recent years. The second case shows how the standard established in the past IP High Court’s decision regarding the support requirement is specifically applied.
A v Japanese Government, Case No 2023 (Gyo-U) 5001, Tokyo District Court (decision rendered on 16 May 2024)
In recent years, with the remarkable advancements in artificial intelligence (AI), AI – particularly generative AI – has come to be widely utilised even in creative activities. This case involves a patent application for an invention (titled “Food Container and Devices and Methods for Attracting Enhanced Attention”) submitted by the plaintiff who developed the AI known as “DABUS”. The application listed “DABUS, The invention was autonomously generated by an artificial intelligence” as an inventor. However, the JPO rejected the patent application on the grounds that it did not include the name of a natural person as an inventor. The plaintiff challenged this decision as unlawful and sought its cancellation at the Tokyo District Court.
In this case, the key issue was whether the interpretation of an “inventor” as defined under Japan’s Patent Act could include AI. The Court ruled that AI cannot be considered an “inventor” based on the following findings:
In this case, the invention was filed as a PCT international application. With the exception of South Africa, which conducts only formal examinations, the eligibility of AI as an inventor has been denied in other jurisdictions, including the United States (USPTO), the United Kingdom (UKIPO), and Europe (EPO). Similarly, in this ruling, the Court held that it is reasonable to interpret “inventor” as stipulated in the Patent Act as being limited to natural persons. This marked the first time in Japan that the eligibility of AI as an inventor was explicitly denied.
In this case, the plaintiff argued that despite the emergence of AI-generated inventions in the industrial sector, adhering uncritically to the traditional inventor-centric view – where only natural persons can be inventors – fails to consider the incentives for AI-generated inventions. The plaintiff claimed this approach contradicts the purpose of the Patent Act, which is to “contribute to the development of industry” (Article 1 of the Patent Act).
However, the Court took a conservative stance, emphasising the difficulties of defining inventorship in AI-generated inventions within the framework of the existing Patent Act, which was designed with natural persons in mind. The judgment highlighted that current patent law does not clearly specify who among those associated with an AI invention (such as the AI itself, the rights holders of the AI’s source code or software, or those who exclusively control the AI) should be granted inventorship and the right to a patent. This ambiguity made it challenging to create new legal principles through judicial precedent in this domain, given the critical importance of determining the ownership of patent rights.
Given the ongoing advancements in AI, developing intellectual property frameworks and legislation that address these emerging issues will be necessary. The Court also acknowledged the importance of AI-generated inventions in industrial policy and expressed the need for legislative efforts to address the challenges surrounding such inventions. It emphasised the importance of examining AI-generated inventions from a legislative perspective and reaching conclusions on the matter as promptly as possible.
Future legislative developments will be expected to resolve the issues surrounding the recognition of AI as an inventor, ensuring that the intellectual property system evolves in line with technological advancements.
JFE Steel Corporation v Nippon Steel Corporation, Case No 2023 (Gyo-Ke) 10020 and 10021, Intellectual Property High Court (decision rendered on 23 January 2024)
Support requirement under the Patent Act
Article 36(6)(i) of the Patent Act stipulates the so-called support requirement that the invention set out in the claims must not exceed the scope described in the detailed explanation of the invention. This is because, if the claims included an invention not disclosed in the detailed explanation, rights would be conferred on an undisclosed invention. The support requirement is intended to prevent such a situation. Failure to meet the support requirement not only constitutes grounds for refusing a patent application but also provides grounds for cancellation in patent opposition proceedings and for invalidation in patent invalidation trials.
Rulings from past cases
In the past, with respect to the support requirement, there was debate over whether the wording in the specification needed to formally include the language of the claims, or whether a more substantive assessment was permissible. In The Nippon Synthetic Chemical Industry Co., Ltd. v Commissioner, Japan Patent Office, Case No 2005 (Gyo-Ke) 10042 (decision rendered on 11 November 2005), the Intellectual Property High Court, in a decision by its Special Division, held as follows:
At present, these rulings have become firmly established in practice. JFE Steel Corporation v Nippon Steel Corporation also adopted the same rulings.
Determining whether the support requirement was satisfied in JFE Steel Corporation v Nippon Steel Corporation
The invention in question relates to a steel pipe pile-type jetty constructed by driving multiple steel pipe piles into the seabed and integrating the heads of these piles with a reinforced concrete superstructure. Among such steel pipe pile-type jetties, those designated as seismic reinforcement facilities are required, under port regulations, to have no piles that have reached full plasticity at two or more points (ie, no piles in which the bending moment has reached the full plastic moment).
To ensure that piles located in areas with significant Level 2 seismic activity meet the necessary full plastic performance requirements, one might consider measures such as increasing the wall thickness of the steel pipe piles or enlarging their diameter; however, the effectiveness of such measures is often limited, can sometimes have adverse effects, and leads to increased construction costs, which posed a significant challenge.
There are three claims (Claims 1 to 3) of the invention in question. The IP High Court found that, with respect to the inventions defined by Claims 1 and 2, the specification did not contain any examples directly disclosing them.
The IP High Court recognised, based on common technical knowledge, that the curvature found in the steel pipe piles described in the specifications would yield nearly identical results despite variations among the embodiments. Consequently, the court concluded that a person skilled in the art – upon reviewing the specified embodiments and taking into account established technical knowledge – would understand that the issue of increased construction costs could be addressed for both inventions claimed in Claims 1 and 2.
As a result, the IP High Court ruled that the invention in question satisfies the support requirements and overturned the invalidation decision by the JPO.
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