“Working of the patented invention for experimental or research purposes” as referred to in Article 69, paragraph (1) of the Patent Act
(Conclusion)
Patent infringement is denied.
Conducting necessary tests for filing an application as prescribed in Article 14, paragraph (1) etc. of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices with regard to what is generally referred to “as a pioneer drug” constitutes the “working of the patented invention for experimental or research purposes” as referred to in Article 69, paragraph (1) of the Patent Act.
*Supreme Court 1998 (Jyu) 153 judged the same for a “generic drug”
<Writer: Hideki Takaishi (Attorney-at-law licensed in Japan and California)>
https://www.ip.courts.go.jp/app/files/hanrei_en/934/002934.pdf