On January 20, 2017, the Intellectual Property High Court (IP High Court) of Japan dismissed an Appeal to seek an injunction for patent infringement which was based on a patent which term was extended (PTE patent) . This is the 11th grand panel case, and the first case in which the scope of a PTE patent is at issue (Grand Panel Case, No.2016(Ne)10046).
Under current patent term extension practice in Japan, a patent term can be extended for up to five years when a patent invention cannot be carried out due to circumstances where the patentee or its licensee is required to obtain market approval(s) to produce or sell their product. Despite at least three district court decisions regarding the scope of PTE patents having been made up to present, there was no unified standard for interpreting Article 68-2 of the Patent Law which stipulates the effects of PTE patents. Thanks to the Grand Panel's decision, the standard for the effects of PTE patents has been clarified and, as such, pharmaceutical companies will be able to develop marketing strategies with some predictability.
The IP High Court ruled that PTE patents cover not only products identical to an approved product, but also products substantially the same as the approved product, and it also provided the standard for determining said "substantially the same" scope. Based on the rulings, the IP High Court decided that the alleged product is not substantially the same as the approved product. The IP High Court further stated that the Doctrine of Equivalents cannot be applied or analogically applied when determining the "substantially the same" scope.
As a Grand Panel decision by the IP High Court, the rulings of this decision will be treated as a unified standard for determing the scope of PTE patents. Nevertheless, we may have to wait for a Supreme Court decision if the case is appealed.
IP High Court Web page: http://www.ip.courts.go.jp/eng/hanrei/g_panel/index.html