National Stage Applications Must Comply with Entirety of § 371 Prior to Commencement of National Stage, Unless Early Commencement Expressly Requested

Regardless of whether an application is filed before or after the amendments made to the Technical Corrections Act (TCA), the entirety of §371 must be complied with before national stage commencement of an international PCT application may begin. To commence the national stage early, an express request to do so must be made, regardless of whether pre- or post-TCA versions of §154(b)(1)(A)(i)(II) applies.

The Technical Corrections Act, as amended, extends the patent term by one day for each day after the period specified, if the issue of a patent is delayed due to the failure of the PTO to provide certain notifications not later than 14 months after the date of commencement of the national stage under §371 in an international application. Prior to its amendment, the TCA stated the date on which an international application fulfilled the requirements of §371, instead of the date on which the national stage commenced.

Here, Actelion filed an international and US application as follows: first International Patent Application (first PCT application) filed July 16, 2009 (priority date); second PCT application claiming priority from the first PCT application, filed July 15, 2010; US application ‘619, filed on January 12, 2012 and claiming priority to July 16, 2009. The 30-month date for commencement of the national stage – January 16, 2012 – fell on a federal holiday.

The national stage of an international application cannot commence prior to the expiration of 30 months unless early examination is expressly requested by the applicant. Along with the ‘619 application, Actelion filed a statement that “Applicant earnestly solicits early examination and allowance of these claims.” However, Actelion did not check the box on PTO Form 1390, which is an express request to begin national examination procedures. After disagreeing with the PTO on the amount of PTA days it was allowed, Actelion filed suit.

The Federal Circuit found that it did not matter which version of the TCA applied, as the result was the same. The A Delay calculation must be based on the date on which the entirety of §371, including §371(b) and (f), is complied with – the national stage shall commence 30 months after the international application is filed (§371(b)), unless the applicant makes an express request to commence the national stage early (§371(f)). Both pre- and post-TCA provisions refer to §371; the lack of reference to any particular subsection indicated that Congress intended for the entirety of §371 to be satisfied. Even though Actelion filed all necessary documents required by §371(c), it did not comply with §371(b) or §371(f).

Under either pre- or post-TCA, Actelion was required to make an express request for early examination, since it filed its national stage application prior to the 30-months expiration date of January 16, 2012. Actelion did not clearly make an express request; it failed to check box 3, and used boiler plate language of “earnestly solicits early examination” – language it used in a number of non-PCT based applications. This language did not refer to §371(f), the PCT, or the national stage.

Actelion alternatively argued that the A Delay date should be based strictly on the 30-month expiration date of January 16, 2012, based on §371(b) language that the national stage “shall commence” on the expiration date. However, according to governing PCT articles and regulations, national stage commencement cannot occur on a federal holiday, and Actelion’s argument on this issue again primarily relied on the fact that it met all of its filing requirements before the 30-month date.

The Federal Circuit thus affirmed the district court’s ruling upholding the calculation of the PTA done by the PTO.


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