February 9, 2018
In Actelion Pharmaceuticals, Ltd. v. Matal, the Federal Circuit held that to enter national stage processing of an international patent application earlier than 30 months from the priority date, an applicant must make an express request to the U.S Patent and Trademark Office (USPTO). The request may be an express statement within the application or even as simple as checking a box on the transmittal form. This somewhat technical requirement is important for any entity (foreign or domestic) entering the U.S. national stage from a PCT application who wishes to begin national stage processing before the 30-month date. The requirement is particularly significant for pharmaceutical companies and other companies with an acute interest in maximizing patent term adjustment (PTA).
On February 6, 2018, the Federal Circuit affirmed the district court’s grant of summary judgment that the USPTO correctly calculated the PTA for Acterlion’s U.S. Patent No. 8,658,675. The court relied, in part, on Actelion’s failure to expressly request early national stage processing when filing its national stage application. Actelion likely would have received additional PTA if it had simply checked the requisite box on the PCT transmittal form when filing the application.
Title 35 U.S.C. § 154(b)(1)(A)(i)(II) was amended in 2013 (after the filing of the application for, but before issuance of, the ’675 patent) and currently provides for “A” delay:
(A) GUARANTEE OF PROMPT PATENT AND TRADEMARK OFFICE RESPONSES.—Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to—
(i) provide at least one of the notifications under section 132 or a notice of allowance under section 151 not later than 14 months after—
. . . .
(II) the date of commencement of the national stage under section 371 in an international application;
. . . .
the term of the patent shall be extended 1 day for each day after the end of the period specified in clause (i), (ii), (iii), or (iv), as the case may be, until the action described in such clause is taken (emphasis added).
Before this amendment, the PTA was premised on “(II) the date on which an international application fulfilled the requirements of section 371of this title” (emphasis added).
The requirements specified in 35 U.S.C. § 371 for commencing the national stage of an international PCT patent application are as follows:
(b) Subject to subsection (f) of this section, the national stage shall commencewith the expiration ofthe applicable time limit under article 22(1) or (2),or under article 39(1)(a) of the treaty.
(c) The applicant shall file in the Patent and Trademark Office—
(1) the national fee provided in section 41(a);
(2) a copy of the international application . . . and a translation into the English language . . . if it was filed in another language;
(3) amendments, if any, to the claims in the international application . . . .
. . . .
(4) an oath or declaration of the inventor . . . ;
. . . .
(f) At the express requestof the applicant, the national stage of processing may be commenced at any time at which the application is in orderfor such purpose and the applicable requirements of subsection (c) of this section have been complied with (emphasis added).
In other words, without “an express request of the applicant,” the national stage processing begins “at the expiration of 30 months from the priority date,” as provided for in § 371(b).
Actelion filed its national stage application on January 12, 2012, and claimed priority to an international patent application filed on July 16, 2009. In its January 2012 filing, Actelion satisfied the requirements of § 371(c) (fee, copy of international application, applicable preliminary amendment, and declaration of the inventor). In its preliminary amendment, Actelion remarked that it “earnestly solicits early examination and allowance of these claims.” The 30-month deadline for entering the national stage fell on January 16, 2012, which was Martin Luther King, Jr. Day (a federal holiday). The following business day was January 17, 2012.
On April 26, 2013 (more than 14 months later), the USPTO issued a restriction requirement. This unquestionably entitled Actelion to some PTA based on “A” delay, and the only question was how many days. Was Actelion entitled to delay beginning on March 12, 2013 (14 months after the application met the national stage filing requirements), on March 16, 2013 (14 months after the expiration of the 30-month deadline), or on March 17, 2017 (14 months after the date of national stage commencement, measured from the first available business day)?
The USPTO calculated the PTA for “A” delay as 40 days, from March 17, 2013, to April 26, 2013. Actelion argued that the correct PTA calculation was 45 or 41 PTA days, based on its filing date of January 12, 2012 (when Actelion purportedly met the requirements of § 371) or at least the PCT 30-month date of January 16, 2012, respectively.
The Federal Circuit affirmed the 40-day PTA calculation. The court concluded that Actelion had failed to comply with the entirety of § 371 by not expressly requesting early national stage processing under § 371(f) and, further, because the actual 30-month date was a federal holiday. Although Actelion asserted that only the prior version of 35 U.S.C. § 154(b)(1)(A)(i)(II) applied, the Federal Circuit reasoned that regardless of whether the pre- or post-amendment version applied, the requirements of all subsections of § 371 must be satisfied because the statutory language does not limit fulfillment to only some subsections of § 371.
Actelion fulfilled all requirements of § 371(c) but failed to check the applicable box on its PCT transmittal form (PTO Form 1390) to “express[ly] request to begin national examination procedures” under § 371(f). Further, the remark in its preliminary amendment that Actelion “earnestly solicits early examination” amounted to “mere boilerplate language it had used in a number of its non-PCT based applications” without any reference to an “express request” for early examination under § 371(f).
According to the court, “even viewed most favorably to Actelion, the casual ‘solicits early examination’ language . . . when combined with the unchecked [box] of its completed PTO [form], was, if not an express election not to commence the national stage early, at least an inconsistent or ambivalent request.”
Absent a timely express request for early examination, § 371(b) provides the operative start date for the 14-month term for PTA calculation in Actelion’s national stage case was the 30-month date from the claimed priority date. However, that 30-month date (January 16, 2012) fell on a federal holiday. PCT Rule 80.5 provides that the national stage commencement cannot occur on a federal holiday. Thus, the court agreed that the statutory 14-month calculation must begin from January 17, 2012, the day after the federal holiday.
This case illustrates an important practice pointer for applicants seeking early action on their PCT national stage applications. The case is of particular interest to those applicants concerned with PTA. To avoid these same pitfalls and possible loss of PTA, all applicants (foreign or domestic) entering the national stage from a PCT or who are specifically worried about PTA calculations should ensure that they expressly state such an intention to enter the national stage processing to the PTO in their applications.
An applicant who files a national stage application with all the required parts before the 30-month date should check the box on the Transmittal Letter Form PTO-1390 to expressly request to begin national examination procedures. Please note that Form PTO-1390 was amended in January 2018, and this express request is nowbox 1 on the form. If one of the required elements (such as the declaration) is filed at a later time but within the 30-month window, then an applicant may submit a further transmittal with box 1 checked along with the additional element(s). As a precautionary measure, an applicant may also include an additional separate express request under § 371(f) to commence U.S. national stage processing and examination procedures.
If you have any questions regarding this issue, please contact Fitch Even partner Kendrew W. Colton, coauthor of this alert.
Coauthored by Fitch Even attorney Margaret A. Wojkowski
Fitch Even IP Alert®