CAFC affirms PTA calculation because patentee did not properly request early national stage examination

CAFC affirms PTA calculation because patentee did not properly request early national stage examinationActelion 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.

Take Away

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.



The Author

Joseph Robinson

Joseph Robinson has over 20 years of experience in all aspects of intellectual property law. He focuses his practice in the pharmaceutical, life sciences, biotechnology, and medical device fields. His practice encompasses litigation, including Hatch-Waxman litigation; licensing; counseling; due diligence; and patent and trademark prosecution. He has served as litigation counsel in a variety of patent and trademark disputes in many different jurisdictions, and has also served as appellate counsel before the Court of Appeals for the Federal Circuit. Joe also focuses on complex inter partes matters before the U.S Patent and Trademark Office, inventorship disputes, reexaminations and reissues. His experience includes numerous interferences, a particular advantage in new U.S. Patent and Trademark Office post-grant proceedings. He also counsels on patent–related U.S. Food and Drug Administration issues, including citizen petitions, Orange Book listing, and trademark issues. For more information and to contact Joe please visit his profile page at the Troutman Sanders website.

Joseph Robinson

Robert Schaffer is an intellectual property partner at Troutman Sanders. Bob applies more than 30 years of experience to IP counseling and litigation. His work includes patent procurement, strategic planning and transactional advice, due diligence investigations, district court patent cases, and Federal Circuit appeals. He regularly handles complex and high-profile domestic and international patent portfolios, intellectual property agreements and licensing, IP evaluations for collaborations, mergers, and acquisitions. In disputed court cases Bob’s work includes representing and counseling client in ANDA litigations, complex patent infringement cases and appeals, and multidistrict and international cases. In disputed Patent Office matters his work includes representing and counseling clients in interferences, reexaminations, reissues, post-grant proceedings, and in European Oppositions. For more information and to contact Bob please visit his profile page at the Troutman Sanders website.

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Gene Quinn is a Patent Attorney and Editor and President & CEO ofIPWatchdog, Inc.. Gene founded in 1999. Gene is also a principal lecturer in the PLI Patent Bar Review Course and Of Counsel to the law firm of Berenato & White, LLC. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

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