JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners
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. 4.2 Paediatric Extensions Patent term extensions specific to paediatric drugs are not available in Japan. But Japan gives a ten-year data exclusivity period for paediatric drugs. 4.3 Paediatric-Use Marketing Authorisations Additional MAs are available for new doses for chil ‑ dren, and a ten-year data exclusivity period is avail ‑ able for such new doses. The statute amendment for medicines specifically for children is currently under discussion in Japan. 4.4 Orphan Medicines Extensions General patent term extensions are available for orphan medicines. A ten-year data exclusivity period is available for orphan medicines.
return of the deposit after it wins the patent infringe ‑ ment 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 impos ‑ ing 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 prelimi ‑ nary 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 fulfil ‑ ment of preliminary injunction requirements, irrepara ‑ ble harm, etc, in opposition or revocation procedure. A bond is required for the stay. Also, if the preliminary injunction order allows pay ‑ ment of a certain amount of deposit to lift the order, such a deposit will be a basis for revocation of the order. 5.2 Final Injunctive Relief 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. 5.3 Discretion to Award Injunctive Relief (Final or Preliminary) The court does not have the discretion to award dam ‑ ages in lieu of an injunction. An accused infringer often makes public interest arguments to avoid an injunc ‑
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
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 pharmaceu ‑ tical disputes. Thus, preparing for bond well before the order is necessary. A patent owner may require a
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