In Actelion Pharm., Ltd. v. Matal (Fed. Cir. Feb. 6, 2018), the Federal Circuit affirmed the District Court’s holding that the PTO properly determined the patent term adjustment (PTA) for U.S. Patent No. 8,658,675 (“the ‘675 patent”).

This case relates to “A” delay, which is the adjustment to patent term based upon PTO delays,¹ specifically PTO delay in issuing an office action or notice of allowance after filing of a national stage application.  This type of “A” delay is calculated as the number of days beginning on the day after the date that is fourteen months after the date the national stage commenced under 35 U.S.C. § 371(b) or (f) and ending on the date of mailing of either an office action or a notice of allowance, whichever occurs first.

Thus, the “A” delay clock for national stage commencement is triggered fourteen months after:

1. the 30-month date²; or
2. “[a]t the express request of the applicant … 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.”³

The ‘675 patent was filed as a national stage application on January 12, 2012, four days before its 30-month date of January 16, 2012.  Actelion filed a preliminary amendment stating that it “earnestly solicits early examination and allowance of these claims.”  However, Acetlion did not check box 1 on PTO Form 1390 indicating that the filing was “an express request to begin national examination procedures.”

According to the Federal Circuit, the language in Actelion’s preliminary amendment did not comply with the “express request” provision of § 371(f).  At best, the Federal Circuit characterized Actelion’s “casual ‘solicits early examination’ language” with no reference to § 371(f) and combined with the unchecked box in Form 1390 as “an inconsistent or ambivalent request.”  Thus, the Federal Circuit held that the PTO did not err in its PTA determination and Actelion was not entitled to an additional four days of PTA.

Note that the Federal Circuit did not indicate that checking the box on Form 1390 was the only way to comply with the “express request” requirement.  The court appeared to acknowledge that there were “other ways” besides checking the box to communicate an “express request” pursuant to § 371(f) to the PTO.

Practice Tips: 

• If entering the national stage before the 30-month deadline, check the “Express Request” box on PTO Form 1390 to maximize PTA.
• Remember to file the declaration when expressly requesting to enter the national stage before the 30-month date.⁴
• In order to trigger the “A” delay clock if filing on a 30-month date that also falls on a federal holiday, check the box on PTO Form 1390 to make an “express request.”⁵

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[1] 35 U.S.C. § 154(b)(1)(A)(i)-(iv)

[2] § 371(b)

[3] § 371(f)

[4] An early entry filing must also comply with § 371(c) requirements to trigger the “A” delay clock.

[5] If the 30-month date falls on a federal holiday, national stage commencement cannot occur on a federal holiday, but rather commences on the next business day.