Debiopharm International SA, the appellant, owns a patent for an invention titled "pharmaceutically stable oxaliplatinum preparation". Debiopharm was granted registrations of patent term extension (PTE) for the patent based on approvals provided in the Pharmaceutical Affairs Law for "ELPLAT I.V. Infusion Solution" which is oxaliplatin (equal to oxaliplatinum) preparations. Towa Pharmaceutical Co, Ltd, the appellee, manufactured and sold generic drugs of ELPLAT. Debiopharm sought an injunction on manufacturing, etc of Towa's products alleging that the effect of the extended patent right covers the manufacturing and selling of those products.