Addressing the patent term adjustment (PTA) calculations under 35 USC § 154(b)(1)(A)(i)(II), the US Court of Appeals for the Federal Circuit held that an applicant must comply with the “express request” provision of § 371(f) to commence the national stage, and that the national stage commences on the next workday if the 30-month date falls on a federal holiday. Actelion Pharm., Ltd. v. Matal, Case No. 17-1238 (Fed. Cir., Feb. 6, 2018) (Lourie, J). At issue in the appeal were four days of patent term extension.
Actelion filed an International Patent Application on July 16, 2009. On January 12, 2012, four days before the 30-month deadline for national phase entry, Actelion filed a US national stage patent application claiming priority to the International Patent Application. The US Patent and Trademark Office (PTO) issued the first office action on April 26, 2013, which was after the statutory deadline for action, leading to accrual of “A Delay” under 35 USC § 154.
Upon issuance, the PTO calculated “A Delay” of 41 days (March 16, 2013, to April 26, 2013). Actelion requested recalculation of the PTA in view of § 154, claiming it was entitled to a PTA of 45 days because accrual should have been calculated based on the application’s January 12, 2012, filing date. In recalculating, the PTO reduced the PTA to 40 days (March 17, 2013, to April 26, 2013). Actelion filed suit against the PTO in the Eastern District of Virginia. The district court granted the PTO’s motion for summary judgment, agreeing that the PTO correctly calculated the PTA. Actelion appealed.
The Federal Circuit affirmed. The Court agreed with the PTO that calculating “A Delay” is based on the date of full compliance with the “entirety of § 371.” To commence the national stage before the 30-month deadline, Actelion was required to make an express request under § 371(f). Since Actelion failed to make an express request for early examination, the national stage did not commence until the 30-month deadline, which was January 16, 2012. Moreover, because the 30-month deadline fell on a federal holiday, the national stage did not commence until the next workday, which was January 17, 2012. The Court therefore concluded that the PTO correctly calculated the PTA to be 40 days.