JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners
1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action Patentee
1.3 Preliminary Injunction Proceedings 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 opportuni ‑ ties 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 themselves is implementing the patent. Only one who has legal interest in the case can access the docu ‑ ments, 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 Ser ‑ vice 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 care ‑ fully 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 them ‑ selves. Life Sciences Cases Drug sales/manufacturing application itself does not constitute infringement in Japan. Thus, a patent own ‑
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 pat ‑ ent 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 con ‑ sent 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 par ‑ ties) 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 infringe ‑ ment 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 con ‑ strued by the court and is met if a petitioner’s future business conflicts with the patent. 1.2 Defendants/Other Parties to an Action Usually, suppliers, manufacturers, and local distribu ‑ tors/wholesalers are sued as defendants in infringe ‑ ment 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.
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