Actelion Pharmaceuticals, Ltd. v. Joseph Matal (USPTO)


Docket No. 2017-1238

LOURIE, O’MALLEY, WALLACH
February 6, 2018

Brief summary: DC grant of SJ to the PTO that it correctly calculated the § 1.54 patent term adjustment “A delay” since Actelion did not expressly request to begin national examination procedures by checking the box on PTO Form 1390, and “national commencement cannot occur on a federal holiday” but instead “commence[s] on the next workday”.

Summary: Actelion appealed DC grant of SJ regarding the length of the patent term adjustment (“PTA” under § 1.54 “to account for any undue delays in patent examination caused by the PTO”) for US 8,658,675, “which was filed as a national stage application pursuant to 35 U.S.C. § 371” (Daiichi Sankyo, FC 2015). The dispute is with respect to the “A Delay calculation” (§ 154(b)(1)(A) (“Guarantee of Prompt Patent and Trademark Office Responses”)). Under Congress’ 2013 “Techincal Corrections Act” (TCA) making “certain technical corrections” amended section 154(b)(1)(A) to require the PTO “provide at least one of the notifications under section 132 or a notice of allowance…not later than 14 months after…the date of commencement of the national stage under section 371”. Prior to the TCA, 154(b)(1)(A) referred to “the date on which an international application fulfilled the requires of section 371”. The TCA also provided that “the amendments made by this Act shall take effect on the date of enactment of this Act, and shall apply to proceedings commenced on or after such date of enactment.” The FC panel explained that “[t]he commencement of the national stage” of a PCT application “is specified in 35 U.S.C. § 371” “subject to subsection (f)” which provides that “the national stage of processing may be commenced at any time at which the application is in order for such purpose and the applicable requirements of subsection (c) of this section have been complied with” “[a]t the express request of the applicant” (unchanged by the TCA). When the application leading to the ‘675 patent (the ‘619 application) was filed, Actelion submitted the “completed PTO Form 1390, which provides checkboxes for the applicant to indicate various information concerning the national stage application” without “check[ing] the…box 3…next to the statement reading: ‘This is an express request to begin national examination procedures (35 U.S.C. [§] 371(f)….’” The PTO initially indicated a 41-day PTA, and Actelion requested recalculation. The PTO then reduced the PTA by 40 days. Actelion then filed a petition for reconsideration arguing it was entitled to 45 days as the A delay of the PTA “should have been calculated basedon the ‘619 application’s filing date, January 12, 2012, or at least based on the 30-month date, January 16, 2012”. The petition was denied. “[T]he PTO did not issue a decision on Actellion’s second petition “in view of the pendency of this suit.” The DC granted SJ to the PTO, agreeing with it that “under either pre- or post-TCA law, the PTA for the ‘675 patent should be the same because the conditions under 35 U.S.C. § 371(b) and (f) were not met on the day the ‘619 application was filed” and “the national stage did not commence on the 30-month date that fell on a federal holiday.” The FC panel agreed with the PTO that “the A Delay calculation must be based on the date on which the entirety of § 371 is complied with, including § 371(b) and (f)”. The FC panel also found “Actelion was required to comply with the ‘express request’ provision of § 371(f) if it wished to commence the national stage before the” 30-month national stage deadline and did not, even with its remark in its preliminary amendment that “it ‘earnestly solicits early examination and allowance of these claims.” The FC panel further concluded the PTO corrected calculated the A delay (i.e., not the ‘619 application’s filing date as there was no express request and “national commencement cannot occur on a federal holiday” but instead “commenced on January 17, 2012, the next workday”). The DC decision was therefore affirmed.

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