Intellectual Property

Responding to a provisional disposition (interim injunction) to stop pharmaceutical sales immediately before launch

If a patent holder applies for a provisional disposition (interim injunction) to stop sales of a pharmaceutical product that a company plans to launch, the company needs to identify the documents received, check the hearing dates and filing deadlines set by the court, and compare them with its launch, manufacturing, and shipping schedules. The company needs to address the court proceedings and make business decisions in parallel, without waiting for a conclusion on infringement.

Provisional disposition proceedings are separate from litigation on the merits. The issues to be decided, the conduct of the proceedings, and the effects of an order are different. The decisions to be made also differ between the stage when an application is received and the stage when an order has been issued.

This article is for companies facing an application for a provisional disposition immediately before a product launch. It outlines the initial checks, how to organize the disputed issues, the materials to gather, and the stages at which decisions on shipments and dealings with business partners need to be made.

Reviewed by Keishi Yoshikawa, Attorney at Law and Patent Attorney (Dai-Ichi Tokyo Bar Association)

Last updated: September 27, 2026

Points to check immediately after receiving an application

Whether the documents received are an application, a summons to a hearing, or an order that has already been issued
The applicant, the products concerned, and the activities the application seeks to restrain, such as manufacture, transfer, offers for transfer, and import
The patent numbers and claims asserted, the outline of the infringement allegations, and the attached evidence for a prima facie showing
The hearing dates and filing deadlines set by the court
The company's planned launch date, manufacturing and shipping schedules, inventory, and orders received
Notification obligations and deadlines under supply agreements, sales partnership agreements, and procedures for listing the drug on the National Health Insurance drug price list

How we can helpIdentifying the documents received and checking hearing dates and filing deadlines / Structuring arguments on the right to be preserved (whether infringement is established) and the need for provisional relief / Considering the scope of an investigation into grounds for patent invalidity / Organizing information for deciding whether to continue manufacture and shipments / Considering procedures if an order is issued (an objection to the provisional disposition order, a stay of enforcement, an order to file an action on the merits, and revocation) / Communications with business partners and responses to notices from the patent holder

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Contents

1 The documents received and what happens next
2 Organizing the disputed issues: the right to be preserved and the need for provisional relief
3 Materials to gather: technical and business materials
4 Business decisions at each stage
How we can assist
Key legislation and official sources
Frequently asked questions

1 The documents received and what happens next

The difference between the application stage and the stage after an order is issued

The first step is to identify the documents at hand. If an application and a summons to a hearing have been received, the court has not yet ruled on the application. If an order has already been issued, the next steps are to check its terms and the scope of its effect, and then consider the procedures for challenging it.

At either stage, deadlines are usually short. The company records the date of receipt, hearing dates, and filing deadlines, and assigns responsibilities among its personnel, external lawyers, and patent attorneys.

Types of documents and the next steps

Documents received	Current position	Next steps
Application and summons to a hearing	The court has not yet ruled on the application	Present arguments and evidence for a prima facie showing at the scheduled hearing
Application only, with no hearing date specified	A hearing date has yet to be set	Consider whether a hearing date is to be set and the possibility that, exceptionally, an order may be issued without a hearing
An order that has been issued	The court has already ruled	Check the terms and scope of the order and consider the procedures for challenging it
Enforcement documents in addition to the order	Enforcement proceedings may be underway	Check the terms of the order and consider whether to seek a stay of enforcement

Misidentifying these stages may lead to taking steps in the wrong order. In particular, treating the matter as still at the application stage when an order has already been issued may delay the steps needed after issuance, such as seeking a stay of enforcement. There is no time limit for filing an objection to the provisional disposition order itself, but an appeal concerning provisional remedies against the ruling on that objection is subject to a non-extendable statutory period of two weeks from the date of service. The company should check not only the document's title but also whether it contains an operative part and what the court is ordering.

Whether there is an opportunity to be heard

A provisional disposition seeking to stop sales is a provisional disposition that determines a provisional legal status. The Civil Provisional Remedies Act requires the court to hold oral arguments or a hearing that the respondent, referred to as the debtor in these proceedings, may attend before issuing this type of order. The Act also provides an exception where holding that hearing would prevent the application from achieving its purpose.

As a general rule, therefore, there is an opportunity to be heard, but this is not always the case. If a hearing date has been set, the company needs to decide what arguments to make and what materials to submit by that date.

Security

The court may require security when issuing a provisional disposition order. This security is intended to secure a claim for damages that the opposing party, the debtor, may acquire as a result of the provisional remedy order. Guidance published by the courts also explains that cancellation of security is permitted where the provisional remedy order is ultimately recognized as justified and there is no possibility of the debtor acquiring a claim for damages. Security does not automatically compensate for losses caused by the injunction.

The court sets the amount of security by considering factors such as the damage the debtor may suffer if the order is issued. Presenting information about the company's scale of sales and supply situation to the court is therefore relevant to this issue as well. The Civil Provisional Remedies Act also permits the court to issue an order without requiring security.

2 Organizing the disputed issues: the right to be preserved and the need for provisional relief

Distinguishing infringement from the need for provisional relief

In provisional disposition proceedings, the court considers separately whether the right exists and infringement is established (the right to be preserved), and whether interim measures are needed without waiting for a judgment (the need for provisional relief). The Civil Provisional Remedies Act requires the applicant to make a prima facie showing of both. The fact that the proceedings concern a provisional disposition does not remove the need for a specific explanation of infringement.

These are separate issues, so the arguments and materials are prepared separately. The Civil Provisional Remedies Act provides that the court may issue a provisional disposition determining a provisional legal status when it is necessary to avoid substantial damage or imminent danger to the applicant. Whether infringement is established and whether circumstances require this provisional disposition are considered separately.

The infringement analysis involves considering the technical scope based on the claim language, comparing that scope with the company's product, and considering arguments that the patent is subject to grounds for invalidity. The Patent Act provides that, if the court finds that the patent should be invalidated in patent invalidation proceedings before the Japan Patent Office (JPO), or that the registration of a patent term extension should be invalidated in proceedings to invalidate that registration before the JPO, the patent holder is not entitled to enforce the right against the opposing party. Grounds for invalidity may therefore also be raised in infringement litigation.

If an injunction is sought against activities during an extended patent term, the analysis also includes whether the effect of the extended patent right covers the company's product and activities. The fact that a patent term extension has been registered is separate from whether the activities in question take place during the extended term. This analysis is also separate from the analysis of technical scope. Please see the separate article (Injunctions based on pharmaceutical patents with extended terms: responses by companies facing claims and by patent holders).

The relevance of effects on supply

In addressing the need for provisional relief, the company may explain the effects on supply to patients and on business partners. Showing an effect on supply or patients does not, however, necessarily prevent an injunction. The court considers these matters case by case in relation to the measures sought, the disadvantage to the applicant if an order is not issued, and the urgency of the case.

After an order has been issued, it may also be possible to seek revocation on the basis of damage caused by a suspension of supply. This concerns revocation due to special circumstances, which has different requirements from revocation due to a change in circumstances.

Revocation due to special circumstances concerns circumstances such as a risk that the provisional disposition may cause damage that cannot be compensated. An ordinary decline in sales alone is not sufficient. This procedure also makes the provision of security by the party seeking revocation a condition of revocation. The party providing security is different from the applicant that provides security when the order is issued.

In any of these situations, an explanation that patients may be affected does not by itself determine the outcome.

The scope of the restraint sought

The company checks which products and activities are covered by the relief sought in the application. Manufacture, transfer, offers for transfer, and import are distinct activities. The immediate response depends on which of the company's planned activities are covered by the application.

The company also checks how products outside the application and products with modified specifications are to be treated.

3 Materials to gather: technical and business materials

Technical materials

The company organizes materials concerning its product's ingredients, quantities, dosage and administration, indications and effects, formulation composition, and manufacturing methods. It also checks how the materials used in the application for approval correspond to what is actually being manufactured.

For the opposing party's patent, the review covers the patent publication, prosecution history, examination records and records of JPO trial and appeal proceedings, and the details of any registered patent term extension. A prior art search is needed if grounds for invalidity are to be asserted.

Business materials

The company organizes information on orders received, inventory, supply plans, production lead times, the availability of alternative supply, and contractual obligations to business partners. These materials provide a basis for arguments concerning the need for provisional relief and are also relevant to the amount of security and estimates of damage if an order is issued.

A preliminary estimate of the losses that an injunction may cause is also prepared at this stage.

Matching arguments to materials

The work of gathering materials begins after identifying which arguments they are intended to support. The relationship can be organized as follows.

Argument	Supporting materials
The company's product does not fall within the technical scope of the claims	Materials concerning the product's ingredients, quantities, dosage and administration, formulation composition, and manufacturing methods; materials used in the application for approval; analysis comparing the product with the claim language
The patent is subject to grounds for invalidity	Prior art documents, prosecution history, examination records and records of JPO trial and appeal proceedings, and technical opinion reports
The effect of the extended patent right does not cover the product or activities	Patent register, details of the registered extension, details of the regulatory approval on which it was based, and test results explaining differences from the product in question
There are no circumstances requiring a provisional disposition	Circumstances on the applicant's side, including product sales, the history of negotiations, and the period between the warning and the application
An order would cause substantial disadvantage	Orders received, inventory, supply plans, production lead times, contractual obligations to business partners, and loss estimates

If materials are gathered before the arguments in the left-hand column are identified, the volume of materials may increase while the evidence needed to support the necessary arguments remains insufficient. Particularly when preparation time is limited, the company should narrow the arguments and first secure the materials needed to support them.

4 Business decisions at each stage

As the stage changes, so do the decisions to be made and the procedures available. The following table provides an overview.

Stage	Decisions to make	Available procedures
When an application is received	What arguments to make and materials to submit by the hearing; whether to continue manufacture and shipments	Filing a written response and evidence for a prima facie showing; presenting arguments at the hearing
When an order is issued	Which procedure to use to challenge the order while complying with it	An objection to the provisional disposition order; an application for a stay of enforcement; an application for an order requiring the applicant to file an action on the merits
After an objection is filed	Whether enforcement needs to be stayed; how to assess the prospects of the case on the merits	An application for a stay of enforcement; revocation due to a change in circumstances; revocation due to special circumstances
When circumstances change	Whether to seek revocation or explore settlement	Revocation due to a change in circumstances; revocation due to special circumstances; negotiations

Each stage is explained below.

The application stage

The filing of an application alone does not mean that the court has ordered manufacture or shipments to stop.

Even without a court order, however, activities that infringe a patent may give rise to claims for injunctive relief or damages under the Patent Act. The fact that no order has been issued does not mean that the activities may be continued. Working of the invention during any period in which the activities continue may later form the basis for calculating damages.

At this stage, the decision whether to continue manufacture and shipments therefore takes into account the prospects on infringement, potential liability from continuing, and the effects on the business if an order is issued. This includes deciding whether to avoid a situation in which products need to be recalled after shipment. The company should keep a record of the facts on which the decision was based and the decision-making process.

If administrative procedures concerning drug price listing or supply are underway, their timing also needs to be checked.

Responding when an order is issued

If an order is issued, the company is required to comply with its terms while also considering the following procedures.

An objection to the provisional disposition order is filed with the court that issued it. It is different from a challenge filed with a higher court.

Filing an objection does not by itself stay enforcement. To seek a stay of enforcement, the company must file a separate application and make a prima facie showing of both circumstances that clearly constitute grounds for revoking the provisional remedy order and a risk that enforcement may cause damage that cannot be compensated. Security is required for this stay. The court may make the provision of security a condition of the stay.

An order to file an action on the merits is an order issued by the court, on the debtor's application, requiring the applicant for provisional relief (the creditor) to file an action on the merits within a specified period and to submit a document proving that it has been filed. If the action has already been filed, the creditor is required to submit a document proving that it is pending. The Civil Provisional Remedies Act requires this period to be at least two weeks. This does not mean that an action on the merits is always filed within two weeks after a provisional disposition order is issued. If the required document is not submitted within the period specified, the court must revoke the provisional remedy order on the debtor's application.

Separate procedures are also provided for seeking revocation due to a change in circumstances, such as where the right to be preserved or the need for provisional relief no longer exists, and for seeking revocation due to special circumstances. Both serve purposes different from an objection challenging the original decision itself.

The choice of procedure depends on the prospects on the disputed issues, the time available, and the requirements concerning security, and is therefore considered case by case.

Communications with business partners

Communications with wholesalers, medical institutions, and sales partners are made after considering their content and timing. A patent holder may also send notices alleging infringement to business partners, so the response to such notices is considered in advance.

The Unfair Competition Prevention Act defines as unfair competition the communication or dissemination of false facts that harm the business reputation of another person in a competitive relationship. Whether a notice to business partners falls within this definition requires separate consideration of whether the parties are in a competitive relationship, whether the facts communicated are false, and whether they harm business reputation.

It cannot be said either that a notice is always lawful if described as an exercise of rights, or that it automatically becomes unlawful if a court later finds no infringement. The assessment is made case by case, taking into account the investigations and negotiations preceding the notice, its recipients, and its content and manner of communication.

How we can assist

We check the documents received and review the hearing dates, filing deadlines, and the company's internal arrangements for responding.
We consider how to structure the arguments and materials to be submitted on infringement and the need for provisional relief.
We consider the scope of the investigation into grounds for patent invalidity and how to structure the arguments.
We consider the procedures available if an order is issued, including an objection to the provisional disposition order, a stay of enforcement, and an application for an order to file an action on the merits.
We review the information needed for decisions on shipments, supply, and communications with business partners in light of the legal analysis.
We also consider negotiations with the patent holder and settlement terms, including competition law issues.

Key legislation and official sources

English translations of legislation are provided for reference. The Japanese texts are authoritative.

Article topic	Legislation or official source	Source type and English version reviewed
Requirements for a provisional disposition, a prima facie showing, and the opportunity to be heard	Civil Provisional Remedies Act— Japanese text on e-Gov	Legislation. English translation (earlier version). The translation identifies its last version as Act No. 53 of 2023.
Security when a provisional disposition order is issued; cancellation of security	Civil Provisional Remedies Act— Japanese text on e-Gov	Legislation. English translation (earlier version). The translation identifies its last version as Act No. 53 of 2023.
An objection to a provisional disposition order, the period for appealing the ruling on the objection, and a stay of enforcement	Civil Provisional Remedies Act— Japanese text on e-Gov	Legislation. English translation (earlier version). The translation identifies its last version as Act No. 53 of 2023.
An order to file an action on the merits; revocation due to a change in circumstances or special circumstances	Civil Provisional Remedies Act— Japanese text on e-Gov	Legislation. English translation (earlier version). The translation identifies its last version as Act No. 53 of 2023.
Technical scope, infringement, injunctive relief, and damages; invalidity arguments; the effect of a patent right during its extended term	Patent Act— Japanese text on e-Gov	Legislation. English translation (earlier version). The translation's version labels differ (Act No. 48 of 2022 in the Japanese label; Act No. 48 of 2024 in the English label).
Notices alleging infringement and harm to business reputation	Unfair Competition Prevention Act— Japanese text on e-Gov	Legislation. English translation (earlier version). The translation identifies its last version as Act No. 51 of 2023.
Changes to matters covered by pharmaceutical marketing approval	Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices— Japanese text on e-Gov	Legislation. English translation (earlier version). The translation identifies its last version as Act No. 50 of 2015.

Legal information reviewed: September 27, 2026

Frequently asked questions

Q1 Must a company stop shipments when it has only received the application?

Receipt of the application alone does not mean that the court has ordered shipments to stop. However, the absence of a court order is separate from whether shipments may be continued. Infringing activities may give rise to claims for injunctive relief or damages, whether they occur before or after an order is issued.

The decision therefore depends on the prospects on infringement. The company may decide to adjust shipping dates to avoid a situation in which a recall becomes necessary after an order is issued. The company should keep a record of the facts on which the decision was based and the decision-making process.

Q2 If a company believes the patent is invalid, can it raise that argument in provisional disposition proceedings?

It may raise that argument. The Patent Act provides that, if the court finds that a patent should be invalidated in patent invalidation proceedings before the JPO, the patent holder is not entitled to enforce the right against the opposing party. The same applies if the court finds that a registered patent term extension should be invalidated in proceedings to invalidate that registration before the JPO. However, because time is limited in provisional disposition proceedings, the company needs to narrow down which grounds for invalidity to assert and which materials to use.

Q3 Does explaining that a supply interruption would affect patients prevent an injunction?

Not necessarily. The effects on supply are one factor that the court may consider when assessing the need for provisional relief, but they do not by themselves determine the outcome. The court considers them case by case in relation to the measures sought and the disadvantage to the applicant if an order is not issued. The same applies when revocation is sought after an order is issued on the basis of damage caused by a suspension of supply.

Q4 Can an order still be challenged after it has been issued?

Procedures for challenging it are available. In addition to an objection to the provisional disposition order, there are procedures to seek a stay of enforcement, an order requiring the filing of litigation on the merits, revocation when circumstances change, and revocation where special circumstances exist.

Filing an objection to the provisional disposition order does not by itself stay enforcement. To seek a stay, the company must file a separate application, make a prima facie showing of both circumstances that clearly constitute grounds for revoking the provisional remedy order and a risk that enforcement may cause damage that cannot be compensated, and provide security. The choice of procedure depends on the prospects on the disputed issues and the time available, and is considered in light of the terms of the order.

Q5 Would changing the product's specifications take it outside the scope of the injunction?

The scope of the activities covered is determined by the relief sought in the application and the terms of the order. Whether a product with modified specifications falls outside the technical scope of the asserted claims is assessed in light of the changes made, applying the rules for interpreting technical scope under the Patent Act.

Where changes are made to matters covered by marketing approval for a pharmaceutical product, the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the "PMD Act") distinguishes between changes requiring approval for a partial change and minor changes for which notification is sufficient. Which category applies depends on the nature of the changes and needs to be checked separately from the patent analysis.

Contact

Making an inquiry

If an application for a provisional disposition to stop sales is filed immediately before launch, you can consult us about checking documents and hearing dates, structuring arguments and evidence for a prima facie showing, decisions on manufacture and shipments, and the procedures available if an order is issued. If you bring copies of the application and order, together with materials showing the launch, manufacturing, and shipping schedules, we can begin considering the specifics at the initial consultation.