In Daiichi Sankyo Co. v. Lee, the Federal
Circuit upheld the USPTO's post-Wyeth Patent Term
Adjustment (PTA) procedures, and found that the USPTO did not abuse
its discretion when it limited the Interim Procedures to petitions
filed within 180 days of the patent's grant date. This decision
highlights the deferential standard of review applied to USPTO
procedures implemented under its rule-making authority.
The Patents At Issue
The patents at issue were U.S. Patent 7,342,014 (granted March
11, 2008) and U.S. Patent 7,365,205 (granted April 29, 2008). Also
relevant to the underlying facts was U.S. Patent 7,576,135 (granted
August 18, 2009).
The '135 patent was terminally disclaimed over the '014
and '205 patents, which were terminally disclaimed over each
other. Thus, by operation of the terminal disclaimers filed in each
of the underlying applications, all three patents would expire on
the earliest expiration date of any of the three patents.