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Actelion Pharma. v. Matal

decided on February 6, 2018 by the Court of Appeals for the Federal Circuit

review by J. Matt Buchanan | published February 12, 2018 | updated February 21, 2018

tags: prosecution, patent cooperation treaty, patent term adjustment, statutory construction

In Actelion Pharmaceuticals v. Matal, the Court of Appeals for the Federal Circuit considered three (3) arguments aimed at gaining a maximum of five (5) days of patent term adjustment (PTA) for U.S. Patent No. 8,658,675 [text]. All three arguments focus on so-called "A delays" that relate to failures by the Patent and Trademark Office to meet certain deadlines under the PTA framework provided by 35 U.S.C. §154(b)(1)(A). First, Actelion argued that the PTA calculation for the '675 patent should be anchored by the filing date of its U.S. national stage entry, which was made four days before the 30-month deadline for making the filing. Second, Actelion argued that boilerplate language in its application transmittal cured its failure to check the box for expressly requesting early commencement of national stage examination proceedings. Lastly, as a last ditch effort to gain a single day of Patent Term Adjustment, Actelion argued that the A Delay calculations should be based strictly on the 30-month deadline, which fell on Martin Luther King Jr. Day, a federal holiday, and not on the following business day. The Federal Circuit rejected each of these arguments in turn, ultimately concluding that "the PTO did not err in its 40-day determination of the PTA for the '675 patent...."

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statutory construction | patent term adjustment

'A delay' patent term adjustment calculations for U.S. national stage applications are based on the 30-month deadline unless early commencement is expressly requested

Dismissing Actelion's attempt to draw a distinction between the national stage language of the Patent Term Adjustment framework of 35 U.S.C. §154(b)(1)(A) as it existed before enactment of the Technical Corrections—Leahy-Smith America Invents Act (“Technical Corrections Act” or “TCA”), and the post-TCA language, the Federal Circuit concluded that both versions of the language require that the 30-month national stage entry deadline applies unless the applicant expressly requested early commencement.

prosecution | patent cooperation treaty | national stage | patent term adjustment

Boilerplate language insufficient as an express request for early commencement of national stage examination

Acknowledging that it did not check the box on the official Patent and Trademark Office form that expressly indicates the making of a request for early commencement of national stage examination, Actelion pointed to language in a Preliminary Amendment it submitted with its national stage entry paperwork. The Preliminary Amendment laguage stated that the applicant "earnestly solicits early examination and allowance of these claims." Actelion argued that this language should be enough to qualify as an express indication of a request for early commencement, which would move the base date for the A delays calculation from the 30-month deadline to the actual filing date.

The Federal Circuit rejected this argument as unsound, dismissing the optional nature of the PTO form and the avaailability of other compliant means for making a request as no excuse for "an applicant's failure to make its intention clear."

Sure the official forms are optional, but using them eliminates doubt. I'm not sure if Actelion wanted early commencement at the time of filing, or simply viewed it as an opportunity for additional patent term adjustment later, but had they used the form and checked the box, there would be no doubt on the matter.

The Federal Circuit underscored this point by suggesting that the boilerplate transmittal language might even be viewed as an express election not to commence the national stage early:

"Even viewed most favorably to Actelion, the casual 'solicits early examination' language with no reference to § 371(f), the PCT, or the national stage, when combined with the unchecked box 3 of its completed PTO Form 1390, was, if not an express election not to commence the national stage early, at least an inconsistent or ambivalent request."

statutory construction | patent cooperation treaty | national stage | patent term adjustment

'A delay' patent term adjustment calculations for U.S. national stage applications take federal holidays into account

The Court dismissed Actelion's argument that the patent term adjustment calculation should be based stricly on the actual 30-month deadline and should not take into account the federal holiday that permitted the applicant to make its national stage entry on the day after the 30-month deadline. This argument, if successful, would provide a single day of patent term adjustment.

To support its position, Actelion argued that that statutory language requires that the national stage shall commence on the 30 month date. Beyond that, Actelion boldly argued that, as a national stage applicant, it should not be harmed by the holiday exception since it didn't take advantage of it, having filed its national stage entry four days before the 30-month deadline.

In dismissing these arguments, the Court cleverly turned the rationale underlying Actelion's arguments against it:

"Actelion’s 'no holiday exception' argument, similar to its pre-TCA statutory argument, is premised on the assumption that any time period of inaction that is not attributable to the applicant should inure to the applicant’s benefit. As such, Actelion emphasizes its alleged lack of fault during the time periods in question. However, by the same logic, inaction on a holiday is also not attributable to the PTO."

Remember, the PTA framework functions to restore "undue delays in patent examination caused by the PTO." Absent a legitimate argument that an undue delay has occured, the challenge to add a day—or five— to a patent term based on seems to be a silly exercise indeed.