Earlier this year, the Tokyo District Court provided useful comment on the circumstances in which a patent with an extended term may be enforced against products equivalent to the product for which the extended term of protection was granted.
The Japanese Patent Act allows for extension of the patent term beyond the usual 20 years from the filing date, in the situation where some form of approval (for example regulatory approval) is required before the patentee can work the invention. This provision is designed to compensate the patentee for patent term which was ’lost’ while marketing authorisation for the patent product was being obtained, and is similar to that which leads to a Supplementary Protection Certificate in Europe. The procedure for obtaining such an extension is set out in Articles 67 and 68 of the Japanese Patents Act. The resulting extensions are known (unsurprisingly) as Patent Term Extensions or PTEs, and may result in up to five years of additional protection.
Our earlier blog related to how the Japanese Patent Office (JPO) applied the law which allows PTEs. The latest developments concern how the Japanese Courts interpret the scope of PTEs.
Tokyo District Court case No 2015 (wa) 12414 (30 March 2016) concerns a PTE for the product ELPLAT, based on Debiopharm’s patent JP 3547755 (‘the patent’). Debiopharm filed a request for an injunction against manufacture of the product TOWA, arguing that this infringed the PTE.
The Court considered Article 68(2) of the patent act and took the view that it was not necessary for the infringing product to be identical to the product for which the PTE was granted. There could (theoretically) be infringement if the defendant’s product was held to be equivalent to the product for which the PTE was granted, for example if the formulation was changed by addition of a commonly used new or equivalent excipient, or removal of an excipient, in a way that did not lead to a new effect.
The Court actually found that there was not infringement in this case, because TOWA included concentrated glycerine to stabilise the active ingredient, which was different to ELPLAT; the addition of glycerine was not found to be a commonly used alternative or additional excipient in this technical field.
However, the decision does open the door for holders of Japanese PTEs to enforce these against products ’equivalent’ to those covered by the PTE, for example when the difference between the two products represents a commonly known variation, and does not lead to a new effect.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.