"The Japanese Intellectual Property High Court (referred to as the IP High Court hereunder) rendered an interesting decision (Case No. Hei 22 (Gyo ke) 10178) on March 28, 2011 that a patent term extension application for a combination drug of known drugs should not be rejected on the ground that each of the known drugs has been already approved for the same medical use as that of the combination drug. Also, the IP High Court rendered the same decision on even date (Case No. Hei 22 (Goy ke) 10177).
Thus, in Japan, a patent term extension for the patented combination drug of known drugs would be granted even when the approved medical use of the combination drug is the same as those of each of the known drugs , unlike in the USA where an AstraZeneca patent term extension application for a combination drug was rejected by the USPTO in June, 2008 (Patent Term Extension Application of USP No. 5,674,860).
Therefore, this decision would be extremely beneficial to new drug makers developing and marketing a combination drug of a blockbuster drug with other drugs after the expiration of the original patent term of the blockbuster drug."