Actelion Pharmaceuticals, Ltd. v. Matal (Fed. Cir. 2018)

By Donald Zuhn –-

Last week, the Federal Circuit affirmed the grant of summary judgment by the District Court for the Eastern District of Virginia in favor of the U.S. Patent and Trademark Office with respect to the USPTO's determination of Patent Term Adjustment ("PTA") for U.S. Patent No. 8,658,675.  In particular, the Federal Circuit determined that the District Court did not err in affirming the USPTO's finding that Actelion failed to make an express request for early examination of the '619 application, as required by 35 U.S.C. § 371(f), and that the District Court also did not err in affirming the USPTO's A Delay calculation for the '675 patent, which was based on national stage commencement occurring on the day after a federal holiday.

The '675 patent, which is directed to pyridin-4-yl derivatives that are agonists for the G protein-coupled receptor S1P1/EDG1, is assigned to Actelion Pharmaceuticals, Ltd.  The '675 patent issued from U.S. Application No. 13/383,619, which was filed on January 12, 2012 as a national stage application from International Application No. PCT/IB2010/053224, which claims priority from International Application No. PCT/IB2009/053089, which was filed on July 16, 2009.  The 30-month date for national stage entry of International Application No. PCT/IB2010/053224 was therefore January 16, 2012, which fell on Martin Luther King, Jr. Day, a federal holiday.

When the '619 application was filed, Actelion also filed a preliminary amendment, which stated that "Applicant earnestly solicits early examination and allowance of these claims."  In addition, Actelion filed a PTO Form 1390 ("Transmittal Letter to the United States Designated/Elected Office (DO/EO/US) Concerning a Submission under 35 U.S.C. 371") when filing the '619 application, but did not check the box indicating that "[t]his is an express request to begin national examination procedures (35 U.S.C. [§] 371(f)). . . ."  The USPTO thereafter issued a restriction requirement on April 26, 2013.

An Issue Notification was subsequently issued for the '675 patent, which included a PTA determination of 41 days.  Actelion filed a request for reconsideration of PTA in view of the AIA Technical Corrections Act, and the USPTO responded by reducing the PTA for the '675 patent to 40 days.  Actelion then filed a petition for reconsideration, contending that the '675 patent was entitled to 45 days of PTA based on its January 12, 2012 filing date, or alternatively, 41 days based on the 30-month date of January 16, 2012.  The USPTO denied Actelion's petition, Actelion filed a second petition for reconsideration, and then Actelion filed suit against the USPTO in the Eastern District of Virginia pursuant to 35 U.S.C. § 154(b)(4).

Before the District Court, Actelion filed a motion for summary judgment and the USPTO filed a cross-motion for summary judgment.  The District Court granted summary judgment in favor of the USPTO, finding that Actelion had failed to meet the conditions under 35 U.S.C. § 371(b) and (f) on the day the '619 application was filed, and that the USPTO had properly determined that the national stage did not commence on the 30-month date that fell on a federal holiday.  Actelion appealed to the Federal Circuit.

The Federal Circuit began by noting that the only dispute in this case was the A Delay calculation under 35 U.S.C. § 154(b)(1)(A)(i)(II) for the '675 patent, which issued from the '619 application, which was filed as a national stage application pursuant to 35 U.S.C. § 371.  The Court also noted that under the current version of § 154(b)(1)(A)(i)(II), which was amended pursuant to the Technical Corrections—Leahy-Smith America Invents Act ("Technical Corrections Act" or "TCA"), the USPTO was required to "provide at least one of the notifications under section 132 or a notice of allowance under section 151 not later than 14 months after . . . the date of commencement of the national stage under section 371 in an international application."  Prior to enactment of the TCA, § 154(b)(1)(A)(i)(II) required that the USPTO provide such notification not later than 14 months after "the date on which an international application fulfilled the requirements of section 371 of this title."  The Court further noted that the commencement of national stage of an international patent application is specified in 35 U.S.C. § 371, which provides in § 371(b) that "[s]ubject to subsection (f) of this section, the national stage shall commence with the expiration of the applicable time limit under article 22(1) or (2), or under article 39(1)(a) of the treaty"; provides applicant filing requirements in § 371(c); and provides in § 371(f) that "[a]t the express request of the applicant, the national stage of processing may be commenced at any time at which the application is in order for such purpose and the applicable requirements of subsection (c) of this section have been complied with."

On appeal, Actelion argued that the A Delay calculation for the '675 patent should be based on the '619 application's filing date because Actelion "fulfilled the requirements of section 371" by fulfilling the applicant filing requirements of § 371(c).  Actelion also argued that it made an "express request" as required by § 371(f), despite not checking the box on PTO Form 1390, by stating in its preliminary amendment that it "earnestly solicits early examination."  Actelion further argued that even if the A Delay calculation for the '675 patent was not based on the '619 application's filing date, the A Delay calculation should be based on the 30-month date without regard to the fact that the 30-month date fell on a federal holiday.  Actelion based this last argument on § 371(b), which requires that the national stage "shall commence" on the expiration of the date that is 30 months from the priority date.  In affirming the District Court's grant of summary judgment to the USPTO, the Federal Circuit disagreed with all three of Actelion's arguments above.

With regard to Actelion's first argument, the Court determined that § 154(b)(1)(A)(i)(II) -- regardless of whether the pre- or post-TCA version is considered -- requires compliance with the entirety of § 371, which includes the requirements under § 371(b) and (f).  With regard to Actelion's second argument that the preliminary amendment filed by Actelion with the '619 application contained an "express request" to commence national stage early (as required by § 371(f)), the Federal Circuit called such argument "unsound," explaining that:

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.

Finally, the Federal Circuit found Actelion's third argument to be unpersuasive, noting that Actelion's 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," and "[a]s such, Actelion emphasizes its alleged lack of fault during the time periods in question" (emphasis in opinion).  The Court, however, responded that:

[B]y the same logic, inaction on a holiday is also not attributable to the PTO.  Although the PTA statutes do serve a remedial purpose of restoring patent term lost during prosecution of an application, they only restore "undue delays in patent examination caused by the PTO" as provided by Congress [emphasis in opinion].

The Federal Circuit therefore concluded that the USPTO did not err in calculating a 40-day PTA for the '675 patent under § 154(b)(1)(A)(i)(II), and affirmed the District Court's decision granting summary judgment in favor of the USPTO.

Actelion Pharmaceuticals, Ltd. v. Matal (Fed. Cir. 2018)
Panel: Circuit Judges Lourie, O'Malley, and Wallach
Opinion by Circuit Judge Lourie

Comments

[Atari Man]

It ain't rocket science, people: even if y'all file early, USPTO don't pick up no 371 application until the 30 month date, unless you tells them (in a form 1390) to pick it up early.

I'm guessin' these lawyers learned their lesson. Lots o' bear traps in them there USPTO woods.