Maier & Maier

Federal Circuit Rules on Patent Term Adjustment (PTA) in PCT Cases

In Actelion Pharms., Inc. v. Matal, the USPTO granted a Patent Term Adjustment (PTA) of 40 days for Actelion’s patent relating to pyridine derivatives.  The patent at issue was a national stage application filed under the Patent Cooperation Treaty.  Actelion contended that it should have been entitled to either 41 days from the 30-month deadline for filing or 45 days from the application’s actual filing date.

When filing the application, Actelion did not mark the check box on the USPTO form to expressly request early commencement of the national stage examination.  However, Actelion did submit a statement in a Preliminary Amendment that “Applicant earnestly solicits early examination and allowance of these claims.”  The USPTO determined that this statement did not comply with 35 U.S.C. § 371(f), which requires an express request for early commencement.  The Federal Circuit affirmed the USPTO determination, indicating that it is possible to request early commencement without using the optional USPTO form, but that Actelion’s statement failed to expressly request early commencement, particularly since it failed to even referenced § 371(f).

In the alternative, Actelion argued that even if the PTA was calculated from the 30-month deadline, it should have resulted in 41 days rather than 40 days.  The 30-month deadline happened to fall on a federal holiday and therefore examination did not commence until the following day.  Actelion argued that the federal holiday should have been included in the PTA calculation from the 30-month deadline, which would have resulted in 41 days rather than 40 days.  The Federal Circuit agreed with the USPTO calculation of 40 days because PCT regulations prohibited national stage commencement on a federal holiday.  Therefore, the additional day was not “undue delay” caused by the PTO, which would warrant PTA.

The USPTO determination of 40 days was affirmed.  Based on this ruling, it is advisable to ensure that § 371(f) is expressly invoked or the appropriate box is checked when requesting to commence national stage examination at an earlier date.

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