Life Sciences & Pharma IP Litigation 2024

Last Updated January 30, 2024

Japan

Law and Practice

Author



Ohno & Partners is one of the leading intellectual property law firms located in Tokyo, Japan. Currently, the firm has 27 attorneys highly specialised in IP litigation and prosecution. Despite its relatively small size, the firm has represented many difficult litigations and has established numerous case laws before the Supreme Court and the Intellectual Property High Court. Attorneys-at-law Mr Seiji Ohno and Mr Hirofumi Tada have handled many pharmaceutical litigations of both small molecules and biologics. For example, the current Japanese antibody patent practice is largely based on the case law established by the team. The firm promises to offer its clients the highest quality total solution service in all areas of intellectual property rights.

Patentee

A patentee may file an infringement action. Even when a patentee has granted an exclusive licence to a third party, they may file an action without consent or involvement of the licensee. A co-owner of a patent may file an infringement action without consent or involvement of the other co-owners.

Exclusive Licensee

An exclusive licensee may file an infringement action and seek both injunction and damages without consent or involvement of a patentee. Registration is required for a valid exclusive licence.

Non-exclusive Licensee

Japan distinguishes a sole non-exclusive licensee (a licensor may not grant a licence to other third parties) from a usual non-exclusive licensee (a licensor may grant a licence to other third parties). A sole non-exclusive licensee may file an infringement action without consent or involvement of a patentee but can seek only damages, not an injunction. A usual non-exclusive licensee may not file an infringement action.

Standing for Invalidity Trial

A defendant may raise an invalidity defence in infringement litigation. Another option is an invalidity trial before the Japan Patent Office (JPO). A petitioner at an invalidity trial before the JPO must have some legal interests. This standing requirement is liberally construed by the court and is met if a petitioner’s future business conflicts with the patent.

Usually, suppliers, manufacturers, and local distributors/wholesalers are sued as defendants in infringement actions. It is highly unlikely that a patentee sues pharmacists, doctors, hospitals, or HRAs in Japan. Infringement and nullity proceedings do not require notification to, or involvement of, HRAs/IPOs.

Preliminary Injunctions Are Available in Japan

Preliminary injunctions are generally available in Japan, but they are almost always inter partes and not quick.

Procedures

The procedures are very similar to those of permanent injunctions. Inter partes hearings will be held every one to two months, both parties are given opportunities to file allegations and evidence several times, and it takes about six to ten months in total to determine the case as Japanese judges carefully review both infringement and validity. Typically, a patent owner can initiate a preliminary injunction procedure soon after patent registration as far as the patent owner themself is implementing the patent. Only one who has legal interest in the case can access the documents, and even such access may be prohibited upon request by a party showing that the part contains a trade secret.

Notification of Preliminary Injunction

A written demand for preliminary injunction is served on an opponent. It can be served by Express Mail Service on a foreign opponent together with an English translation, which takes only several weeks. However, some countries, including Germany and China, do not accept this type of service, and the service process takes a long time, sometimes more than a year. The following proceedings may be delayed if the service is delayed. The opponent will be given opportunities to file counter-arguments and evidence. The court carefully reviews allegations and evidence submitted by both parties.

Requirements

The requirements for preliminary injunction are not so strict for patent infringement cases, and it will be granted if an accused infringer causes substantial harm to a patent owner by infringing a valid patent. The court usually finds substantial harm as long as a patent owner is implementing the patent by themself.

Life Sciences Cases

Drug sales/manufacturing application itself does not constitute infringement in Japan. Thus, a patent owner typically must wait for a drug sales/manufacturing approval grant of infringing products for a preliminary injunctions grant.

Infringement and Validity Are Bifurcated

Usually, both infringement and validity issues are disputed and reviewed in an infringement action before the courts.

Invalidity Trial Before Japan Patent Office

An accused infringer may separately file an invalidity trial proceeding before the Japan Patent Office (JPO).

Relationship Between Litigation and Invalidity Trial

In Japan, invalidity trial proceedings before the JPO are not restricted by parallel infringement litigation. Therefore, often the same invalidity issues are disputed in these two tracks. Some court judges tend to wait for the JPO decision if it will be granted in a few months, but others do not. Both first instance infringement litigation and the JPO invalidity trial outcomes may be appealed before the Intellectual Property High Court (the “IP High Court”). Inconsistencies between these two tracks are expected to be solved by the IP High Court.

Statute of Limitations

Litigation

An injunction claim may be filed as long as the infringement of an unexpired patent continues. On the other hand, a damages claim should be filed within the earlier of:

  • three years from when a patentee recognises infringement and an infringer; or
  • twenty years from infringement.

Even after this period, an unjust enrichment claim can be filed if it is within the earlier of:

  • five years from when a patentee recognises that the claim can be filed; and
  • ten years from infringement.

Patent Office proceedings

Invalidity trial proceedings before the JPO can be filed even after patent expiration to inhibit a damages claim, which can be filed even after patent expiration within the statute of limitations explained above.

Service of Complaint/Written Demand

Litigation

A complaint should be served on the defendant in an infringement action. Usually, it is served via specifically certified mail. The service usually takes a few weeks if the defendant is a domestic entity. If the defendant is a foreign entity, the plaintiff must prepare a translation of the complaint, and the service itself takes around three months to one year depending on the country where the defendant sits. The whole timeline of litigation will be delayed if service is delayed.

Patent Office proceedings

A written demand for invalidity proceedings before the JPO also should be served on the patent owner under similar requirements. However, a foreign patent owner is supposed to designate a Japanese patent administrator under the Japanese Patent Act, and a written demand against the foreign patent owner will be served on the patent administrator.

Timeline

Litigation

Oral hearings will be held every one to two months. Each party files briefs and evidence every few months. Judgment will be granted in about 12 months (injunction only) and about 18 months (injunction and damages). When a plaintiff seeks both an injunction and damages, a court discloses its preliminary conclusion at the end of the infringement and invalidity stage, and decides whether to proceed to the damages stage.

Patent Office proceedings

Typically, both parties have one or two opportunities to file assertions and evidence before an oral hearing. After the oral hearing, typically, a preliminary conclusion will be disclosed to give the opportunity to amend claims when the JPO considers that the patent claims should be invalidated. A decision will be granted about three to four months after the oral hearing. The total procedure takes about ten months.

A patent must be granted and registered before filing an infringement lawsuit. There are no additional requirements such as validation or translation. The types of patents do not matter to the requirements for bringing an action.

Japan does not have discovery at all. There are pre-action evidence preservation procedures, but availability is significantly limited due to the strict standard. Japanese courts generally accept materials legally obtained in other jurisdictions without limitation. In fact, US discovery under 28 USC Section 1782 is sometimes used to collect evidence for Japanese infringement actions.

Search and seizure orders are not available for patent cases. A court grants a document production order under certain circumstances, but the availability and scope are substantially limited.

Recently, Japan newly established an inspection procedure which allows a court-appointed expert to inspect the manufacturing plant of an accused infringer. However, a patent owner first must show a certain level of probability of infringement to use this procedure, and the availability is limited.

Japanese courts generally accept materials legally obtained in other jurisdictions such as US discovery without limitation.

Declaratory Judgment of Patent Dispute

Currently, Japanese courts are very reluctant to grant declaratory judgments for patent disputes. Typically, a patent owner’s intent to assert a patent with knowledge of details of accused products is required to support the necessity of a declaratory judgment. Once standing is found, the plaintiff of the declaratory judgment proceeding may typically seek judgment declaring non-infringement and/or invalidity.

Declaratory Judgment in the Life Sciences Field

In the life sciences field, the IP High Court recently denied the standing of a declaratory judgment filed by a generic drug company that filed a generic drug marketing application, holding that the application alone does not support the standing of a declaratory judgment, even though a new drug applicant expressed the possibility of patent assertion once the generic drug is approved. Under this decision, it is difficult to judicially resolve the patent issues between a new drug company and a generic drug company before a marketing approval grant.

Once a generic drug is approved (and price listed), a generic drug company likely may file a declaratory judgment action to seek declarations of non-infringement and invalidity. However, often a generic drug application cannot get approval due to the substance/dosage/usage patent of a new drug applicant, and the only option for a generic drug company will be invalidity trials before the JPO under such circumstances.

The Doctrine of Equivalents (DoE) in Japan has five requirements:

  • (1) the difference between a claim and an accused product is not an essential part of a patented invention;
  • (2) the invention can achieve the same purpose and function even with the replacement of the difference;
  • (3) a person ordinarily skilled in the art could easily conceive the replacement at the time of manufacture of the accused product;
  • (4) configuration of the product was neither publicly known nor easily conceived at the time of the patent application; and
  • (5) there are no special circumstances such as prosecution estoppel.

Requirement (3) is a significant difference from other jurisdictions such as the US. If a patent is granted to the replacement, it might be difficult to assert infringement under the DoE.

Requirement (4) corresponds to the Doctrine of Ensnarement or the Formstein Defence.

As to requirement (5), Japanese courts traditionally have adopted a “complete bar”, meaning that, if a patentee excluded part of a claim during a prosecution history, the DoE does not apply to the excluded part whatever the reason for the exclusion was. However, a recent lower court decision adopts a more flexible approach, so future case law will need to be watched closely.

Japan basically does not have patent linkage as to a new drug, and there is no obligation to “clear the way” ahead of a new product launch. As a result, an approved new drug might be sued for patent infringement after launch and can be excluded from the market later on.

Expert declarations often help parties persuade judges on technical issues both on infringement and validity. There are no specific requirements or procedures for evidence from experts, but the parties file written declarations instead of oral testimonies as Japanese procedures are highly focused on written evidence.

Sometimes, a party retains multiple experts, but too much focus on technical issues is usually not effective nor persuasive to the judges as most of them do not have technical backgrounds. However, it is highly important to choose a good expert trustworthy to Japanese judges.

The Japanese court separately appoints an expert who supports the judge’s understanding of technical aspects of the case from a very early stage in the proceedings.

Japan does not have specific mechanisms or procedures to submit experimental results. Any forms of experimental result report are admissible as long as the person who prepared the report signs and/or seals it. As most Japanese judges do not have technical backgrounds, too complicated or lengthy a report is not preferable, and it is helpful to attach an expert declaration explaining the meaning of the results.

Japan does not have discovery even in the post-action stages. There are document production order and inspection procedures, but their availability is limited, as explained in 1.7 Pre-action Discovery/Disclosure.

In Japan, invalidity is the most frequently asserted defence in infringement actions. Also, the consent/licence, prior use, exhaustion, and experimental use defences are available.

In the life science field, it is often asserted that an injunction is vastly against the public good, but it is highly unlikely that the court will refrain from granting an injunction based on this ground. Japan has a compulsory licence system, but it has never been granted.

Japan does not have any official framework to stay litigation due to parallel proceedings. Some court judges tend to wait for the outcome of an invalidity proceeding before the JPO if it will be granted in a few months, but others do not. It is important to know your judge. Japanese courts generally do not wait for foreign proceedings.

Even during infringement litigation, a patent owner may file an amendment demand before the JPO. A patent owner is required to file an amendment demand to raise an amendment re-defence against an invalidity defence in the infringement litigation, so it is highly important to timely file an amendment demand before the JPO. (In some circumstances, such as when a patent owner cannot file an amendment demand due to the timing limitation imposed by the Patent Act, an amendment demand is not required to raise the re-defence.) The amendment re-defence is often used and effective in infringement actions.

All patent litigation cases in Japan are decided by a panel of three judges from IP-specialised divisions. Japanese courts have divisions highly specialised in IP, but they are not specific to pharma/life sciences patent litigation.

There is little room for forum selection in Japan. Tokyo and Osaka District Courts have exclusive jurisdiction over first-instance patent-related cases. In some circumstances, patent owners may have options between these two courts, but there is no significant difference between these two courts. Tokyo District Court has more cases.

Infringement Acts

Japan does not have infringing activities specific to pharmaceutical products. Thus, just like general patent infringement, selling, making, using, exporting, importing, and offering to sell generic drugs constitutes infringement. Other acts such as a marketing approval application or grant; an application for reimbursement, pricing or listing; a submission or award of tender; or offer to supply after patent term expiry usually does not constitute infringement.

Skinny Labelling

In Japan, an invention for a new use of a known substance is allowed as a product patent. This means that a product patent can be granted for a second medical use. But the scope of such a patent is not clear. The government agency (Ministry of Health, Labour and Welfare of Japan (MHLW)) grants approval for skinny labelling generics. However, it is not clear whether and to what extent skinny labelling avoids infringement.

Parallel Importation

Generally speaking, parallel importation usually does not constitute patent infringement unless (i) there is an agreement between a patent owner (or an entity substantially identical to the patent owner) and an original buyer which excludes Japan from the sales area, and (ii) the agreement is displayed on products. Depending on the facts, this exception may apply to drugs and the parallel importation may constitute patent infringement, although there is no case law and it is not clear.

The typical data exclusivity periods in Japan are as follows:

  • new substance drug – eight years;
  • orphan drug – ten years;
  • paediatric drug – ten years;
  • new administration route – six years; and
  • new indications, combinations, reclassifications – four years.

Challenges to data exclusivity is not common in Japan.

(To be more accurate, Japan does not have official data exclusivity periods. There are periods for post-grant re-evaluation of effect/efficacy and safety. The government agency, MHLW, substantially utilises these re-evaluation periods as data exclusivity periods.)

Experimental use exception applies to generics, and activities necessary for clinical trial do not constitute infringement.

Japan does not have a publicly available list of new drug patents such as the Orange Book. New drug applicants voluntarily report substance and use patents covering their new drugs to the government agency, MHLW, so MHLW has a non-public list of patents. MHLW does not grant marketing approval if a generic drug is covered by substance or use patents of new drug applicants.

Japan does not have an official patent linkage scheme but has an informal process based on rules set by notifications by the government agency, the MHLW. The process has two stages.

In the first stage, the MHLW decides if a generic drug infringes (i) substance patent, (ii) effect/efficacy patent, or (iii) use/dosage patent of new drug applicants. In determining this, the MHLW relies on the non-public list of patents voluntarily submitted by new drug applicants. If there is no patent infringement found, it proceeds to the second stage.

In the second stage, the MHLW requests the generic drug applicant to negotiate and solve problems with other patents (such as dosage form or manufacturing method patents), if any, before the drug pricing. Even if the generic drug company fails to solve the problem, it usually does not matter to the price listing.

Typically, even if there is a second medical use patent, a generic drug application can be approved but the patented use should be excluded from the indication. Sometimes it is difficult to exclude the patented use from the label, and the generic drug application will not be granted.

Unlike ANDA in the US, Japan does not have specific litigation procedure for generic drugs. Thus, typically, a new drug applicant files litigation against generics after launch.

There are no differences between small molecules and biologics in terms of infringement acts, skinny label, and parallel importation.

The data exclusivity periods of biologics are basically the same as small molecules.

There are no differences between small molecules and biologics in terms of acceptable pre-launch preparations. Experimental use defence applies to biologics, and activities necessary for clinical trial do not constitute infringement.

There are no differences between small molecules and biologics in terms of publicly available drug and patent information. New drug applicants of biologics voluntarily report substance and use patents covering their new drugs to the government agency, MHLW, so MHLW has a non-public list of patents. MHLW does not grant marketing approval if a biosimilar drug is covered by substance or use patents of new drug applicants.

Japan does not have an official patent linkage scheme. The approval process for biosimilars is unclear, just internally being handled by the government agency, MHLW. But MHLW reveals that the process is similar to the two-stage process of generic drugs.

Unlike the Biologics Price Competition and Innovation Act (BPCIA) in the US, Japan does not have specific litigation procedures (ie, patent dance) for biosimilars. Thus, typically, a new drug applicant of biologics files litigation against biosimilars after launch.

Japan has a patent term extension for a shorter period (i) from the start of clinical trials to the marketing approval grant, and (ii) from the patent registration to the marketing approval grant. The maximum extension period for a patent is five years even if it takes longer than that.

Japan adopts a flexible policy in terms of patent term extension. Not only substance patents but also other patents such as use/dosage patents can be extended. Unlike the US and many European countries, each plurality of patents that covers the same product can be extended. If a plurality of marketing approvals were granted to product(s) covered by one patent, the extension of the patent can be possible for each approval as long as the subsequent approval is not encompassed by the preceding approval.

To obtain an extension, a patentee or its licensee must be the one who was granted marketing approval.

Patent term extensions specific to paediatric drugs are not available in Japan. But Japan gives a ten-year data exclusivity period for paediatric drugs.

In order to enforce a preliminary injunction, usually, a bond to secure potential damages to be incurred by an accused infringer is required. The bond should be deposited within the term determined by the court, which is usually three to seven days from notification of the amount. In determining the amount, the court considers various factors including the monetary size of the case and the degree of proof of infringement. The amount can be huge, especially in pharmaceutical disputes. Thus, preparing for bond well before the order is necessary. A patent owner may require a return of the deposit after it wins the patent infringement litigation.

Usually, the order is enforceable upon proving the deposit of the bond. It is necessary to initiate an ex-parte enforcement procedure before the court to enforce the preliminary injunction order against patent infringement. Typically, it will be enforced by imposing a duty to pay a certain amount of money during continuing infringement. It is also possible to have the drugs retained by a bailiff.

There is no term limitation for the effect of the preliminary injunction, but the accused infringer may require a patent owner to file litigation seeking a permanent injunction; and, if the patent owner fails to do so, the preliminary injunction will be revoked.

To stay the enforcement, the accused infringer must clearly show a change of situation denying the fulfilment of preliminary injunction requirements, irreparable harm, etc, in opposition or revocation procedure. A bond is required for the stay.

Also, if the preliminary injunction order allows payment of a certain amount of deposit to lift the order, such a deposit will be a basis for revocation of the order.

Final injunctions are enforceable when they become final. Usually, it is when the final appeal before the Supreme Court is dismissed.

Final injunctions are enforced through separate enforcement procedures before the courts, but it is not so common to enforce permanent injunctions because many infringers obey the court decisions and voluntarily stop infringement. It will be enforced by imposing a duty to pay a certain amount of money during continuing infringement. Also, the disposition of product stock can be sought and enforced.

The court does not have the discretion to award damages in lieu of an injunction. An accused infringer often makes public interest arguments to avoid an injunction, but the Japanese court does not accept such an argument and grants an injunction.

Damages are presumed based on:

  • marginal profit of plaintiff’s product multiplied by quantity of infringing products sold by defendant;
  • marginal profit of defendant’s product multiplied by quantity sold by defendant; or
  • reasonable royalty.

The first two listed are available when a plaintiff could have obtained profits but for infringement. Typically, it means that the plaintiff has competing products, but it is not strictly limited to such a situation. A plaintiff may assert more than one of these three options, and the court adopts the highest amount among these.

A defendant may rebut the presumption by proving factors such as market difference, existence of other competing products, its marketing effort, or product features other than invention.

Special Damages for Pharma

Basically, there are no special damages for pharma cases. Japan does not allow treble damages for intentional infringement. However, if the drug price dropped because of infringing generic/biosimilar products, the dropped price can be included in damages.

Interest on Damages

Interest of 3% per year from each infringing activity is payable.

Damages Examination

The court first examines infringement and validity. Then, if the court thinks the accused infringer infringes a valid patent, the court discloses a preliminary conclusion, and then proceeds to the damages examination stage.

Timing of Damages Payment

Often, the damages are preliminarily enforceable soon after the first instance court judgment. Theoretically, it must be paid soon after the rendition of the judgment, but usually the accused infringer appeals before the IP High Court and seeks pending enforcement by depositing around 80% of the damages awarded by the first instance court.

Wrongful Injunction Damages

Usually, damages for a wrongful injunction are not available because an injunction is not enforceable until the judgment becomes final.

Third Party

Theoretically, a third party may seek damages (as long as they suffer damage caused by patent infringement) through the usual civil litigation, but it is not common in Japan.

Court costs including court fees paid by a winning party are recoverable from a losing party, but they are often neglected because the amount is small.

In patent infringement lawsuits, the court may not withhold or reduce relief as a penalisation for negative conduct from the plaintiff.

Trade mark disputes in the life sciences and pharma sector are somewhat common in Japan. Just like the usual trade mark disputes, the cases are governed by the Trade Mark Act. Often, the main issue of the case is whether the trade mark causes consumer confusion about the product’s source, just like usual trade mark cases.

The government agency notified rules for generic drug naming, so trade mark disputes between brand-name and generic products are not common.

Copyright disputes are not common in the life sciences and pharma sectors in Japan. Potentially, the copyright of software (such as health tech software or drug research software) can be disputed.

Unlike the tech sector, trade secrets disputes are not so common in the life sciences and pharma sectors in Japan. However, such disputes could happen in the future because many pharma companies now develop and use AI or high-tech software for drug discovery. The Unfair Competition Prevention Act governs trade secrets disputes.

Appeal Against Preliminary Injunction

An accused infringer may file an appeal within two weeks from the service of a preliminary injunction order. The appellate court reviews the case without deference. Also, opposition and revocation procedures are available, and the preliminary injunction will be vacated if the injunctive right no longer exists due to significant situation change after the preliminary injunction order grant.

Appeal Against Permanent Injunction

A defendant may appeal within two weeks from the service of a judgment ordering a permanent injunction. A foreign defendant has an additional 30 days to appeal. The first hearing will be held within a few months from the appeal, and the judgment will be granted about six months after the appeal. The appellate court reviews the case without deference. A party who lost in the appellate court may file a final appeal before the Supreme Court although the success rate of the final appeal is as low as 1%.

A panel of three judges from the IP High Court, which has exclusive jurisdiction over patent appeal cases, hears and decides a patent litigation appeal. The court often retains a court expert who supports judges’ understanding of technical aspects of the case.

Patent litigation is governed by the Civil Procedure Code, just like normal civil litigation. However, the court usually expects more professional litigation activities from both parties, and delayed submission of arguments and evidence might be more strictly evaluated than usual civil cases and can be dismissed.

A custom suspension to prevent the import of infringing products is available. A panel appointed by Japan Customs reviews the case, but they often wait for a court decision, especially in a complex case. Thus, the effectiveness of the custom suspension is often limited for a pharma patent owner. However, it is often effective for suspension based on a trade mark.

The JPO provides a procedure called “hantei” in which a panel of three examiners decides whether a product falls within the technical scope of a patent claim. However, this is not binding on the court, so its impact is very limited.

ADR in the life sciences and pharma sectors is not common at all in Japan so far. Many patent owners choose litigation over mediation or arbitration, trusting formal court procedures. Recently, Tokyo and Osaka District Courts started providing arbitration services for IP-related disputes, but they are directed to simple cases and are not suitable for complex patent infringement disputes.

Japan has not experienced antitrust cases regarding “pay for delay” or “reverse payment”. However, depending on the facts of each case, “pay-for-delay” or “reverse payment” might violate Japan’s Anti-Monopoly Act.

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Trends and Developments


Authors



Nagashima Ohno & Tsunematsu is widely recognised as a leading law firm and one of the foremost providers of international and commercial legal services. The firm’s overseas network includes locations in New York, Singapore, Bangkok, Ho Chi Minh City, Hanoi, Jakarta (associate office) and Shanghai. The firm also maintains collaborative relationships with prominent local law firms. In representing its leading domestic and international clients, Nagashima Ohno & Tsunematsu has successfully structured and negotiated many of the largest and most significant corporate, finance and real estate transactions related to Japan. In addition to the firm’s capabilities spanning key commercial areas, it is known for path-breaking domestic and cross-border risk management/corporate governance cases and large-scale corporate reorganisations. The over 500 lawyers of the firm work together in customised teams to provide clients with the expertise and experience specifically required for each client matter.

Recent Cases in Life Sciences & Pharma IP Litigation in Japan

Overview

Japan has frequently (almost every year) amended its intellectual property (IP) laws in recent years and, in 2023, significant amendments were made mainly regarding the Trademark Act and the Unfair Competition Prevention Act. However, these amendments are likely to have little impact on IP litigation in the life sciences and pharma field in Japan, and thus, it can be said that there have been no acts or amendments regarding intellectual property laws in this field that are noteworthy and expected to influence the practice thereof in the past couple of years.

Several notable IP litigation judgments in the life sciences and pharma field were issued in Japan from late 2022 to 2023. Among those judgments, the following judgments of the Intellectual Property High Court (IPHC) should be noted in particular.

  • Chugai v Sawai et al (IPHC Judgment, 13 December 2022, Case Number: 2022 (Ne) 10065).
  • Regeneron v Amgen (IPHC Judgment, 26 January 2023, Case Number: 2021 (Gyo-ke) 10093 and 10094).
  • Nipro v Eisai et al (IPHC Judgment, 10 May 2023, Case Number: 2022 (Ne) 10093).

Overviews of the cases and some of the key points in the IPHC’s judgments are provided below.

Chugai v Sawai et al

Introduction

In recent years, among pharmaceutical use inventions, there appear to be not only “inventions regarding the specific use of a substance in the treatment of a specific disease” but also inventions where the subject disease to be treated is specified in more detail or a group of target patients is specified in addition to the disease. Regarding such use inventions, the relevant issues are whether or not an invention is novel and involves an inventive step over prior art where the subject disease is specified in a regular manner and a group of target patients is not specified. While there had been a few cases in which this issue was the main disputed issue, it was the main disputed issue in this case.

Facts

Chugai Pharmaceutical Co, Ltd (Chugai) and Taisho Pharmaceutical Holdings Co, Ltd are the joint patentees for JP 5,969,161 entitled “agent for preventing forearm bone fractures comprising eldecalcitol” (the “Patent”). Each of Sawai Pharmaceutical Co, Ltd (Sawai) and Nichi-Iko Pharmaceutical Co, Ltd (Nichi-Iko) respectively obtained marketing authorisation for a drug comprising eldecalcitol as an active ingredient for the treatment of osteoporosis on 17 February 2020 and began selling the drug in the market.

Sawai and Nichi-Iko jointly filed an action for invalidation against the Patent with the Japan Patent Office (JPO) on 23 December 2019. During the action, Chugai filed a request for correction to correct claims 3 and 4 into corrected claims 3 to 8 on 30 November 2020. Though Chugai’s request for correction was accepted, the JPO rendered a trial decision invalidating claims 1 to 8. Chugai filed an appeal against the decision with the IPHC on 21 May 2021.

Chugai filed a patent infringement action with the Tokyo District Court against Sawai and Nichi-Iko seeking an injunction and argued that Sawai and Nichi-Iko infringed the Patent. The court dismissed Chugai’s claim on the ground that the patented inventions in claims 1, 2 and 4 lacked novelty over the invention described in a prior art document B1 (“Invention B1”) and the correction in claim 4 did not resolve the ground for the invalidation. Chugai filed an appeal with the IPHC.

While claim 1 is: “A pharmaceutical composition for inhibiting non-traumatic forearm fractures comprising eldecalcitol”, Invention B1 is: “A drug that comprises ED-71, which has the following chemical structure (1α,25-dihydroxy-2β-(3-hydroxypropoxy)vitaminD3) and is administered orally at a dose of 0.75 μg/day for the treatment of patients with primary osteoporosis.” The difference between claim 1 and Invention B1 (“Difference 1”) is that, while Invention B1 is a drug for the treatment of osteoporosis, claim 1 is a pharmaceutical composition for inhibiting non-traumatic forearm fractures. Please note that the difference between the subject claims (not only claim 1 but also claim 2 and claim 4 before the correction) (collectively, the “Patented Invention”) and Invention B1 is Difference 1.

Chugai argued that the Patented Invention is novel and involves an inventive step. Also, Chugai argued that the ground for the invalidation regarding claim 4 was overcome by the correction.

Among others, the following were the key disputed issues:

  • Does the Patented Invention lack novelty over Invention B1 (Disputed Issue 1)?
  • Is the ground for the invalidation regarding claim 4 resolved by the correction (Disputed Issue 2)?

Decision of the IPHC

Regarding Disputed Issue 1

Regarding the novelty requirement for use inventions, the IPHC held that, “As a general rule, a product that is publicly known lacks novelty according to Article 29(1) of the Patent Act. However, if it can be said that the invention at issue is an invention that discovers an unknown attribute of the product and finds that the product is suitable for a new use, the invention is distinguished from the publicly known product by the existence of the use and therefore is considered to be novel as a use invention.”

The IPHC then held that, “A person skilled in the art would NOT recognise that the pathology of bones in the forearm and the resulting risk of fracture in osteoporosis patients is different from the pathology of bones in other parts of the body and the risk of fracture, NOR would he/she recognise that the purpose of administering eldecalcitol as ‘a drug for the treatment of osteoporosis’ and its effect in Invention B1 is different between the forearm and other parts of the body” based on the following common technical knowledge.

  • A person skilled in the art would recognise that Invention B1’s “drug for the treatment of osteoporosis” is an agent administered to patients who have lost bone mass and bone strength in their bones throughout the body, including the vertebral column, forearm, thigh, and upper arm, due to the deterioration of bone microstructure, in order to reduce the risk of fractures at each site.
  • A person skilled in the art would expect that the effects of eldecalcitol would extend to both the trabecular and cortical bone and would recognise that the effects would extend to the forearm bone, which is composed of the trabecular and cortical bone.
  • A person skilled in the art would recognise that in osteoporosis, any part of the body can be fractured by external forces, and that the risk of fracture in the forearm is similar to that in other parts of the body prone to fracture due to osteoporosis, in that the risk increases as bone strength decreases.

The IPHC, considering the foregoing and others, held that, “by specifying the use of eldecalcitol as ‘for inhibiting non-traumatic forearm fractures’, a person skilled in the art would NOT recognise that eldecalcitol has an unknown action or effect or that it can treat a condition different from that treated by eldecalcitol administered as a drug for the treatment of osteoporosis. As such, it cannot be found that the Patented Invention is a use invention that discovered an unknown attribute of eldecalcitol, which is a publicly known substance and found that eldecalcitol is suitable for use in a new application due to said attribute, and therefore, the use pertaining to Difference 1 is not distinct from the use of ‘a drug for the treatment of osteoporosis’ of Invention B1. Therefore, the use of eldecalcitol for inhibiting non-traumatic forearm fractures is not distinguishable from the use of ‘a drug for the treatment of osteoporosis’ of Invention B1.”

Regarding Disputed Issue 2

The IPHC held that neither the difference between the corrected claim 4 and Invention B1 nor the difference between the corrected claim 5 and Invention B1 was substantive and concluded that the ground for the invalidation of claim 4 was not resolved by the correction.

Conclusion

The IPHC held that the Patented Invention lacked novelty and the ground for invalidation was not resolved by the correction and affirmed the judgment of the Tokyo District Court that dismissed Chugai’s claim. The IPHC also dismissed Chugai’s appeal of the trial decision of the JPO that invalidated the Patent.

Comments

This judgment determined that use “for inhibiting non-traumatic forearm fractures” and use “for the treatment of osteoporosis” were not distinguished based on common technical knowledge and, thus, would be helpful. As a result of this judgment, the JPO decision invalidating the Patent became final and binding.

Regeneron v Amgen

Background

This case concerns litigation over patents regarding an anti-PCSK9 antibody that are also being disputed in the US and Europe. An anti-PCSK9 antibody is used as an active ingredient of drugs for the treatment of hypercholesterolemia. Amgen Inc. (“Amgen”) is marketing Repatha, its drug for hypercholesterolemia whose active ingredient is an anti-PCSK9 antibody, and Sanofi K K was marketing Praluent, its drug for hypercholesterolemia whose active ingredient is an anti-PCSK9 antibody.

In Amgen v Sanofi K K (Amgen’s patent infringement action) and Sanofi v Amgen (Sanofi’s action for invalidation) (eg, Amgen v Sanofi K K (IPHC Judgment, 30 October 2019)), it was found that Amgen’s JP 5,705,288 and JP 5,906,333, entitled “Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (PCSK9)”, conformed to the support requirement. In Regeneron v Amgen, however, the IPHC held that the patented inventions pertaining to the patents did not satisfy the support requirement.

Amgen v Sanofi K K and Sanofi v Amgen (2016–2020)

In the patent litigation cases between Amgen and Sanofi/Sanofi K K in Japan from 2016 to 2020, ie, Sanofi’s action for invalidation of Amgen’s patents and Amgen’s patent infringement action against Sanofi K K seeking an injunction on the grounds that Sanofi K K’s sales of Praluent, comprising alirocumab as an active ingredient, constituted patent infringement, Amgen’s patents were maintained based on the reasoning that they conformed to the support requirement, etc, and it was concluded that Sanofi K K infringed Amgen’s patents, and, therefore, an injunction was issued.

The original claim 1 of JP 5,705,288 is “an isolated monoclonal antibody capable of neutralising binding between PCSK9 and LDLR proteins, competing, on binding to PCSK9, with an antibody comprising a heavy chain containing CDR 1, 2, and 3, consisting of amino acid sequences of SEQ ID NOs 368, 175, and 180, respectively, and a light chain containing CDR 1, 2, and 3 consisting of SEQ ID NOs 158, 162, and 395, respectively.” The corrected claim 1 based on Amgen’s request for correction made in the course of the action for invalidation is “an isolated monoclonal antibody that can neutralize the binding of PCSK9 to LDLR protein and that competes with an antibody comprising a heavy chain containing a heavy chain variable region consisting of the amino acid sequence of SEQ ID NO 49 and a light chain containing a light chain variable region consisting of the amino acid sequence of SEQ ID NO 23 for binding to PCSK9.”

Regarding the support requirement, based on the descriptions contained in the specifications and common technical knowledge, the IPHC stated, “It can be found, in light of the foregoing, that a person skilled in the art can understand from the descriptions contained in each of the Specifications that: it is possible to obtain isolated monoclonal antibodies that neutralize the binding of PCSK9 to LDLR proteins and that compete with Reference Antibody 1 or 2; therefore, monoclonal antibodies of Inventions 1-1 and 2-1, which are new antibodies, are provided; and with the use of pharmaceutical compositions of Inventions 1-2 and 2-2 that utilise them, it is possible to solve the problem of treating or preventing diseases associated with elevated cholesterol levels (such as hypercholesterolemia, etc) and reducing disease risks”, and determined that “it can be found that each of the Inventions conforms to the support requirement.”

Regeneron v Amgen

Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed an action for invalidation of JP 5,705,288 and JP 5,906,333 with the JPO on 12 February 2020. As the JPO rendered the Trial Decision maintaining Amgen’s patents on 7 April 2021, Regeneron filed an appeal with the IPHC on 13 August 2021. The IPHC rendered a judgment revoking the JPO Trial Decision on 16 January 2023. Since Amgen’s final appeal was rejected by the Supreme Court on 14 September 2023, the case was remanded to the JPO.

Decision of the IPHC in Regeneron v Amgen

Regarding the support requirement, the IPHC held, based on the descriptions in the specifications and common technical knowledge, that, “It cannot be deemed that an antibody, if it competes with the 21B12 antibody, directly blocks the site where PCSK9 binds to an LDLR protein by way of binding to the site that interacts with LDLR’s EGFa domain; no other mechanism is disclosed, through which any type of antibody, so long as it competes with the 21B12 antibody, becomes an antibody that inhibits the interaction (ie, binding) between PCSK9 and LDLR’s EGFa domain (and/or LDLR generally); and in light of the foregoing, it must be deemed difficult for a person skilled in the art to arrive at the understanding that antibodies, which compete with the 21B12 antibody, are binding-neutralising antibodies”, and, therefore, determined that Amgen’s patented inventions violated the support requirement.

Comments

There have been few cases where, after the IPHC had held that no grounds for invalidation had been found in relation to a certain patent and the judgment became finalised, the IPHC determined that the same patent should be invalidated. In this regard, where the ground for invalidation in a dispute is a lack of an inventive step, it is possible that the court would come to a different determination on the inventive step if a new prior art document was found and submitted to the court. On the other hand, where the ground for invalidation in a dispute is a violation of the enablement requirement or the support requirement, it is unlikely that the court would reach a different determination on the same ground for invalidation. This judgment is interesting, not only because the IPHC made a different decision, but also because the IPHC stated that the circumstance for the determination of the support requirement changed because of new evidence.

Nipro v Eisai, et al

Background

This dispute concerns the patent linkage system in Japan, an overview of which is provided below:

Japan does not have a statutory patent linkage system like that in the US. In other words, there are no statutes requiring the health authority to consider, when an application for marketing authorisation of a generic drug is filed, the existence of a patent that may cover the generic drug in determining whether to issue the marketing authorisation.

However, there is a non-statutory patent linkage system in Japan. Specifically, the Ministry of Health, Labour and Welfare (MHLW) issued a letter (the “MHLW Letter”) to prefectures stating that when reviewing an application for marketing authorisation of a generic drug:

  • if the manufacture of the active ingredient of the original drug is not possible due to the existence of a patent on the active ingredient, the generic drug will not be approved; and
  • in cases where a patent exists for certain indications, dosage and administration of an original drug (“indications, etc”) and it is possible to manufacture a drug claiming other indications, etc, a generic drug may be approved, but not for the indications, etc, for which the patent exists.

Note that the MHLW Letter is an administrative internal letter and not legally binding.

The health authority can decide whether to issue marketing authorisation at its own discretion, and, based on the MHLW Letter, when a generic company applies for marketing authorisation for a generic product, the authority informally takes into account the relevant patents of the innovator, and if the health authority believes that the generic drug would infringe the patents, the authority denies the application in respect of the generic. The authority does not, however, reveal its reason for this decision. In light of this, generic companies have come to the idea that, if the relevant company were to obtain a declaratory judgment confirming that the drug does not infringe the relevant patent of the innovator, the company would obtain marketing authorisation pursuant to the judgment. This case may have been brought for such purpose.

Facts

Eisai R&D Management Co, Ltd (Eisai RD) owns JP 6,466,339 and JP 6,678,783 entitled “use of eribulin in the treatment of breast cancer” (collectively the “Patents”). On 19 July 2011, Eisai Co, Ltd (Eisai) started selling its drug comprising eribulin as an active ingredient for “inoperable or recurrent breast cancer”, and in February 2016 added “malignant soft-tissue tumor” to its indication.

On 25 February 2022, Nipro Corporation (Nipro) applied for marketing authorisation regarding its generic drug comprising eribulin as an active ingredient. Nipro filed with the Tokyo District Court a declaratory judgment action against Eisai seeking the following declaratory judgment.

Main claims:

  • declaration that Eisai RD does not have a right to seek an injunction against Nipro’s product based on the Patents; and
  • declaration that Eisai and Eisai RD do not have a right to seek compensation for damage caused by manufacture and sale of Nipro’s product based on the infringement of the Patents.

First auxiliary claim:

  • declaration that Eisai RD does not have a right to seek an injunction against Nipro’s product based on the Patents, on condition that Nipro’s product is listed in the NHI drug price standard; and
  • declaration that Eisai and Eisai RD do not have a right to seek compensation for damage caused by manufacture and sale of Nipro’s product, based on infringement of the Patents, under the condition that Nipro’s product is listed in the NHI drug price standard.

Second auxiliary claim:

  • As between Nipro, Eisai and Eisai RD, a declaration that Nipro’s product does not fall within the technical scope of the Patents.

The court dismissed all of Nipro’s claims because of the lack of standing to seek a declaratory judgment, and Nipro filed an appeal with the IPHC.

Decision of the IPHC

The IPHC articulated, as the criterion regarding standing to seek a declaratory judgment, that “standing to seek a declaratory judgment exists only when there is an interest for immediate finality; that is, when it is necessary and appropriate to obtain a declaratory judgment against the defendant in order to resolve a legal dispute concerning the legal relationship, etc, and to eliminate the danger or uncertainty that exists in relation to the plaintiff’s rights or legal status.”

While Nipro stated that the health authority would not issue marketing authorisation for Nipro’s product based on the MHLW Letter and relevant facts, the IPHC held that it was not sufficient to find that there was a high probability that the health authority would issue marketing authorisation for Nipro’s product in the near future, and that Nipro’s product would be listed in the NHI drug price standard; and the IPHC further held that there was not a high probability that Nipro would manufacture and sell its product in the near future.

Regarding Nipro’s argument that marketing authorisation for Nipro’s drug would not be granted based on the MHLW Letter and the Patents, the IPHC stated to the effect that whether or not marketing authorisation for Nipro’s drug would be granted implicated a legal dispute between Nipro and the government, not between Nipro, Eisai, and Eisai R&D; and that the IPHC did not find it necessary and appropriate that a declaratory judgment be obtained against Eisai and Eisai R&D in order to resolve the said legal dispute between Nipro and the government, because the necessary and appropriate legal actions should be pursued, such as filing a lawsuit to seek confirmation of the illegality of the non-action in relation to the application for marketing authorisation, or filing an appeal to the MHLW.

Therefore, it could not be found that there was actually a dispute between the parties and that there was any danger or uncertainty in relation to Nipro’s rights or legal status, with respect to Eisai RD’s right to seek an injunction based on the Patents and Eisai’s and Eisai RD’s right to seek damages based on the infringement of the Patents. The IPHC affirmed the first instance decision and dismissed all of Nipro’s claims.

Comments

The IPHC’s ruling is consistent with the general understanding in respect of standing to seek a declaratory judgment. According to this ruling, even where a generic company, which is willing to manufacture and sell its generic drug and believes that the generic drug does not infringe any patents of an original drug, files for marketing authorisation for the generic drug, the generic company cannot obtain a declaratory judgment that there is no patent infringement in relation to its generic drug, before the health authority makes the decision on the marketing authorisation for which an application was made. If the generic company believes that the health authority’s decision is wrong and ill-founded, it can only be said that there is a dispute between the generic company and the authority, even though it would be difficult in practice to file a lawsuit against the authority.

Nagashima Ohno & Tsunematsu

JP Tower
2-7-2 Marunouchi
Chiyoda-ku
Tokyo 100-7036
Japan

+81-3-6889-7000

+81-3-6889-8000

kenji_tosaki@noandt.com www.noandt.com/en/
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Law and Practice

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Ohno & Partners is one of the leading intellectual property law firms located in Tokyo, Japan. Currently, the firm has 27 attorneys highly specialised in IP litigation and prosecution. Despite its relatively small size, the firm has represented many difficult litigations and has established numerous case laws before the Supreme Court and the Intellectual Property High Court. Attorneys-at-law Mr Seiji Ohno and Mr Hirofumi Tada have handled many pharmaceutical litigations of both small molecules and biologics. For example, the current Japanese antibody patent practice is largely based on the case law established by the team. The firm promises to offer its clients the highest quality total solution service in all areas of intellectual property rights.

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Nagashima Ohno & Tsunematsu is widely recognised as a leading law firm and one of the foremost providers of international and commercial legal services. The firm’s overseas network includes locations in New York, Singapore, Bangkok, Ho Chi Minh City, Hanoi, Jakarta (associate office) and Shanghai. The firm also maintains collaborative relationships with prominent local law firms. In representing its leading domestic and international clients, Nagashima Ohno & Tsunematsu has successfully structured and negotiated many of the largest and most significant corporate, finance and real estate transactions related to Japan. In addition to the firm’s capabilities spanning key commercial areas, it is known for path-breaking domestic and cross-border risk management/corporate governance cases and large-scale corporate reorganisations. The over 500 lawyers of the firm work together in customised teams to provide clients with the expertise and experience specifically required for each client matter.

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