Daiichi Sankyo Company Ltd., v. Michelle Lee (USPTO)


Docket No. 2014-1280

MOORE, REYNA, TARANTO
July 2, 2015

Brief Summary: Daiichi’s requests and petitions regarding section 154 (prosecution-related) patent term adjustment (PTA) determinations for two patents denied because the same were filed outside of the two-month (request for reconsideration) and 180 day (judicial review) windows.

Summary: Daiichi appealed DC grant of SJ to the PTO regarding section 154 (prosecution-related) patent term adjustment (PTA) determinations for two patents. Daiichi argued the terms of its patents were shortened by at least 321 days under the pre-Wyeth calculation which does not adjust for A and B delays together but for the greater of the two. Following the 2010 Wyeth FC decision, the PTO adopted an “Interim Procedure” under which a patentee could request reconsideration within two months of the determination. Judicial review of PTAs may be requested within 180 days. An “Optional Interim Procedure” was also established for patents that issued before March 2, 2010, under which patentees could file a petition for reconsideration based solely on the PTO’s use of the pre-Wyeth adjustment formula, within 180 days of patent issuance. Two of Daiichi’s patents (US 7,342,014 and 7,365,205) issued in 2009 and did not qualify for the Optional Interim Procedure. Daiichi filed a request for reconsideration of these patent terms outside the two-month window but also filed a petition to waive the window given the “extraordinary situation” resulting from the Wyeth decision. The requests and petitions were denied because both were filed outside the two-month window. Daiichi then filed a lawsuit resulting in the PTA of another patent, US 7,567,135, being adjusted from 86 to 503 days (after remand from the DC). All three patents are terminally disclaimed over each other so the 503 day PTA “made no practical difference.” Regarding the ‘014 and ‘205 patents, the FC concluded the PTO correctly established procedures for determining PTAs and acted within its discretion in denying Daiichi’s requests and petitions because the same were filed outside of the two-month (request for reconsideration) and 180 day (judicial review) windows. Daiichi’s arguments that other patents had been treated differently (Merck, DDC 2014), that the judicial review period only applied to “A” delays, and “the 180-day limitation period is subject to equitable tolling” were also rejected. Thus, the DC decision was affirmed.

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