Life Sciences and Pharma IP 2026

JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners

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 specifical ‑ ly 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 litiga ‑ tion 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 (injunc ‑ tion only) and about 18 months (injunction and dam ‑ ages). 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 conclu ‑ sion 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.

er typically must wait for a drug sales/manufacturing approval grant of infringing products for a preliminary injunctions grant. 1.4 Structure of Main Proceedings on Infringement/Validity Infringement and Validity Are Bifurcated Usually, both infringement and validity issues are dis ‑ puted 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 dis ‑ puted 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 infringe ‑ ment 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. 1.5 Timing for Main Proceedings on An injunction claim may be filed as long as the infringe ‑ ment of an unexpired patent continues. On the other hand, a damages claim should be filed within the ear ‑ lier 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. Infringement/Validity Statute of Limitations Litigation

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