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Actelion Pharmaceuticals, Ltd. v. Matal

Fed Cir Clarifies Interpretation of Patent Term Adjustment Statute

Actelion Pharmaceuticals, Ltd. v. Matal, 2018 WL 717185 (Fed. Cir. Feb. 6, 2018) (LOURIE, O’Malley, Wallach) (E.D. Va.: O’Grady) (2 of 5 stars)

Fed Cir affirms summary judgment for PTO regarding adjustments of patent term. The case involved calculation of “A Delay“ per § 154(b)(1)(A), i.e., calculation of the delay resulting from the PTO’s failure to meet statutory deadlines, relating to the prosecution of Actelion’s patent. The district court properly determined that Actelion was entitled to 40 days of term adjustment due to the PTO’s delay in issuing a required § 132 notification. The opinion rejects Actelion’s argument that the delay period should have begun at the filing date of its priority national stage application, which Actelion contends to be the date of compliance with § 371(c), i.e., the provision reciting the requirements for a national stage application. When computing A Delay, the start of the delay period under § 154(b)(1)(A)(i)(II) is the date on which all requirements of § 371 are satisfied, including § 371(b) and § 371(f), and not just § 371(c). Such reasoning applies under both the current statutory text of § 154, and the text that existed prior to Congress’s 2013 amendment. The district court also correctly determined that Actelion did not actually make a § 371(f) early examination request in its priority national stage application. Actelion did not check the relevant box for an “express request,” and did not mention § 371(f) in its remarks. Actelion’s remark that it “earnestly solicits early examination and allowance of these claims” was insufficient. Based on this, the district court was correct in determining that the PTO had accurately calculated the amount of A Delay.

KEYWORDS: PATENT TERM ADJUSTMENT; A DELAY; NATIONAL STAGE