Unless otherwise directed, applications filed with the World International Patent Office will commence national stage processing after 30 months.  The applicant has the option to commence national phase earlier by supplying the requisite documents, paying the fee, and making an express request under 35 U.S.C. § 371(f) to commence national stage processing.

In Actelion Pharmaceuticals, Ltd. v. Matal (2017-1238), the Federal Circuit recently clarified that 371(f) must be explicitly invoked to initiate national stage prosecution.

Actelion Pharmaceuticals filed an international application on July 16, 2009, setting the date of national phase commencement in the US for January 16, 2012.  Four days prior to this date, Actelion submitted the necessary paper work and paid the fee to begin the national phase examination.  Notably, and unfortunately for Actelion, Box 3 of the transmittal form (PTO-1390), which expressly requests initiation of national stage examination procedures, was not checked.  Moreover, Actelion never referenced § 371(f) in any of their filing documents.

Fast-forward to February 2014, the PTO issued a Notice of Allowance (US 8,658,675) and a patent term adjustment of 41 days due to a delay in mailing of the first office action (an A delay).  The A-delay was based on a national phase commencement date of January 16, 2012.

Actelion petitioned the PTO to recalculate the PTA based on their January 12, 2012 submission.  Upon review, the PTO adjusted the PTA to 40 days, rather than the original 41 days, noting that: 1) Actelion “failed to make an express request to begin national examination procedures”; and 2) January 16, 2012, was a federal holiday (Martin Luther King Jr. Day) so the national stage commenced on the next business day (January 17).

Actelion filed a motion for summary judgment in the Eastern District of Virginia.  Actelion then appealed a grant of summary judgment in favor of the PTO on the grounds that: 1) all the requirements of 35 U.S.C. § 371(c) were met on January 12, 2012; 2) it had made an express request under § 371(f), despite not checking Box 3 on the transmittal form; and 3) the A delay should be based on January 16, irrespective of it being a holiday.

The Federal Circuit was not persuaded by Actelion’s arguments.  The court noted that according to statute, the time period for PTO to initiate examination of an international application begins on the date that the applicant has fulfilled the requirements all subsections of § 371, not just § 371(c).  Because Actelion did not make an express request to begin the national phase early under 371(f), they were not due the benefit of a January 12 national stage commencement date.

The Court also disputed whether Actelion made an “express request” to begin the national phase.  In the transmittal letter filed on January 12, 2012, Actelion stated: “Applicant earnestly solicits early examination and allowance of these claims.”  The Federal Circuit noted that there is no explicit invocation of § 371(f) in this statement and that absent such an invocation, Actelion’s comment was “an inconsistent or ambivalent request.”

Regarding the federal holiday, the Court agreed with the PTO that national stage commencement cannot occur on a federal holiday.  The Court noted that PTA is to compensate for undue delays caused by the Patent Office, and that fact that January 16, 2012, was a federal holiday means that any delay caused by the federal holiday was not caused by the PTO.

While it is unknown whether Actelion will suffer any consequence for their reduced PTA, patent term adjustments of even a few days can be worth millions of dollars, particularly in the pharmaceutical arts.  It is important to ensure a correct date for commencement of the national stage of international applications for a proper PTA.  That means checking Box 1 of the current transmittal form PTO-1390 (formerly Box 3) or making an explicit statement to invoke 35 U.S.C. § 371(f).  Otherwise, the 30 month date will apply.