JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners
4.3 Paediatric-Use Marketing Authorisations
Unlike the Biologics Price Competition and Innovation Act (BPCIA) in the US, Japan does not have specific litigation procedures (ie, pat - ent dance) for biosimilars. Thus, typically, a new drug applicant of biologics files litigation against biosimilars after launch. 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates 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 Euro - pean 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 approv - al as long as the subsequent approval is not encompassed by the preceding approval. To obtain an extension, a patentee or its licen - see 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.
Additional MAs are available for new doses for children, and a ten-year data exclusivity period is available for such new doses. The statute amendment for medicines specifically for chil - dren 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.
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
In order to enforce a preliminary injunction, usu - ally, 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 pharma - ceutical 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 initi - ate 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.
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