薫製倶楽部 filed a 3-item request for clarification with the Osaka District Court seeking identification of the strains used in KOBAYASHI PHARMACEUTICAL's Netsusama Cholesterol Help and other products.
The plaintiff's request for clarification asks, as its first item, whether the red yeast rice raw material used in KOBAYASHI PHARMACEUTICAL's Netsusama Cholesterol Help was manufactured using strain NITE BP-412, specified in Patent No. 5283363. The second item asks for the monacolin K content of 3P-D20 listed in the raw-material catalogue and identification of the strain used, including the strain actually used. The plaintiff argues that differences between the strains used in the 2 products affect whether a recall was necessary and whether there was a duty to provide an explanation.
KOBAYASHI PHARMACEUTICAL acknowledged in its answer that the products used different raw materials, but denied a breach of its duty to provide an explanation, stating that the recall request was a precautionary measure. Mori (森氏) compared the patent publication, company website and raw-material catalogue and pointed to evidence suggesting the use of strain NITE BP-412. The patent publication expressly identifies strain NITE BP-412, and the content of 3P-D20 is also stated to be 2,000mg/100g.