Do Clinical Trials for Original Drugs Fall Under The Experimental Use Exception


The 1999 Japanese Supreme Court judgment in the case of Ono Pharmaceuticals Co Ltd vs Kyoto Pharmaceutical Industries Ltd, held that carrying out necessary experiments to apply for approval of generic drugs stipulated in article 14 of the Pharmaceutical Affairs Act (at that time) falls within “working of the patented invention for experiment or research”, however the original drugs are not mentioned.