PTO Has Broad Discretion In Considering Extraordinary Situations For Patent Term Adjustment

Daiichi Sankyo Co. Ltd. v. Michelle K. Lee

Addressing the U.S. Patent Office's (USPTO) discretion in connection with patent term adjustments, the U.S. Court of Appeals for the Federal Circuit agreed with the district court that the USPTO acted within its discretion in calculation of a patent term extension. Daiichi Sankyo Co. Ltd. v. Michelle K. Lee, Case No. 14-1280 (Fed. Cir., July 2, 2015) (Reyna, J.).

Daiichi is a pharmaceutical company that owns three patents related to compounds that are useful in treating tissue death due to lack of oxygen, blood clots, and other ailments. Daiichi brought suit in the U.S. District Court for the District of Columbia under 35 U.S.C. § 154, challenging patent term adjustments made by the Patent and Trademark Office (PTO) for two of its patents. The crux of the dispute arises out of the 2010 Federal Circuit decision in Wyeth v. Dudas ( IP Update, Vol. 11, No. 11), which changed the way the PTO calculates patent term adjustment.