Actelion Pharm., Ltd. v. Matal, No. 2017-1238, (Fed. Cir. Feb. 6, 2018) (Before Lourie, O’Malley, and Wallach, J.) (Opinion for the court, Lourie, J.).
The Federal Circuit affirmed a district court decision granting summary judgment in favor of the Patent and Trademark Office regarding Actelion’s patent term adjustment.
Under 35 U.S.C. § 154, patent terms can be adjusted to account for undue delays in examination caused by the PTO. The issue on appeal was whether the PTO erred when making its patent term adjustment calculation for Actelion’s patent.
Actelion filed an international patent application under the Patent Cooperation Treaty on July 16, 2009. To enter the “national stage” and begin examination in the United States, applicants must satisfy 35 U.S.C. § 371, which requires paying a fee and providing a copy of the application, an inventor’s oath, and any claim amendments. Once these requirements have been met, the applicant can then expressly request that national stage examination begin early under § 371(f). Otherwise, examination will begin 30 months from filing of the international application, which in this case was January 16, 2012, which was also Martin Luther King, Jr. Day, a federal holiday.
Actelion filed its national stage application on January 12, 2012, four days prior to the 30-month date. The submission included a preliminary amendment, which stated that “[Actelion] earnestly solicits early examination and allowance.” However, in accompanying paperwork, Actelion did not check the box stating: “This is an express request to begin national examination procedures.” The PTO found that Actelion had not expressly requested early examination, and it began examination on January 17, 2012 (30 months from Actelion’s international filing date including the federal holiday).
On February 5, 2014, the PTO issued an Issue Notification for U.S. Patent 8,658,675, granting 41 days of PTA, which related to delay during the period from March 16, 2013 to April 26, 2013. The ‘675 patent thereafter was issued on February 25, 2014, bearing a notice of 41 PTA days.
In July 2014, Actelion requested recalculation of Patent Term Adjustment for the ‘675 patent. In September 2014, the PTO recalculated the PTA for the ‘675 patent, reducing it to 40 days, encompassing the period from March 17, 2013 to April 26, 2013.
In effect, the PTO granted Patent Term Adjustment based on the January 17, 2012 entry into examination as of thirty months after the filing of the PTC application. Actelion argued that the adjustment should have been based on its national stage filing date, January 12, 2012, or at least the 30-month commencement date, not counting the federal holiday.
Actelion filed suit against the PTO, arguing for 45 days of PTA, or in the alternative at least 41 days (which would not take into account the federal holiday on January 17, 2012). The district court affirmed the PTO’s calculation, and Actelion appealed.
The Federal Circuit found that Actelion was required to make an express request to commence early national stage examination. Actelion’s statement “earnestly soliciting early examination,” which made no reference to § 371(f), the PCT, or the national stage, combined with failure to check the box expressly requesting early examination, was an “inconsistent or ambivalent request.” While Actelion was not required to check any boxes, it was still required to make its intentions clear. Thus, the district court did not err in affirming the PTO’s finding that Actelion failed to make an express request for early examination. The Federal Circuit also found no error in the PTO’s determination that the national stage commenced on January 17, 2012, the next workday after a 30-month date that fell on a federal holiday. The PTO’s determination of the patent term adjustment was not in error.
Applicants must expressly state that they wish to begin early examination procedures in the national stage, otherwise examination will begin 30 months from international filing; application language such as “Applicant earnestly solicits early examination” is insufficient to form an express request.
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