Actelion Pharm., Ltd. v. Matal

881 F.3d 1339

ACTELION PHARMACEUTICALS, LTD., Plaintiff-Appellant

v.Joseph MATAL, performing the functions and duties of the Under Secretary of Commerce for Intellectual Property and Director, U.S. Patent and Trademark Office, Defendant-Appellee

2017-1238

United States Court of Appeals, Federal Circuit.

Decided February 6, 2018

Thomas Hoxie, Hoxie & Associates, LLP, Millburn, NJ, argued for plaintiff-appellant.

Dana Kaersvang, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, argued for defendant-appellee. Also represented by Chad A. Readler, Dana J. Boente ; Kimere Jane Kimball, Office of the United States Attorney for the Eastern District of Virginia, Alexandria, VA; Nathan K. Kelley, Brian Racilla, Molly R. Silfen, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.

Before Lourie, O'Malley, and Wallach, Circuit Judges.

Lourie, Circuit Judge.

Actelion Pharmaceuticals, Ltd. ("Actelion") appeals from the grant of summary judgment by the United States District Court for the Eastern District of Virginia in favor of the United States Patent and Trademark Office ("PTO") regarding the length of the patent term adjustment ("PTA") for U.S. Patent 8,658,675 ("the '675 patent"), entitled "Pyridin-4-yl Derivatives." See Actelion Pharm., Ltd. v. Lee , 216 F.Supp.3d 680 (E.D. Va. 2016). For the reasons that follow, we affirm.

BACKGROUND

Congress has established a framework in 35 U.S.C. § 154 (2012) to adjust a patent's term "[t]o account for any undue delays in patent examination caused by the PTO." Pfizer, Inc. v. Lee , 811 F.3d 466, 468 (Fed. Cir. 2016). One such delay is designated an "A Delay," which "arises when the PTO fails to meet statutory deadlines for events that occur during prosecution, such as providing notice to the applicant of the rejection of a claim or taking action on an applicant's reply to such a rejection." Daiichi Sankyo Co. v. Lee , 791 F.3d 1373, 1374 (Fed. Cir. 2015).

The only dispute in the instant case is the A Delay calculation, under 35 U.S.C. § 154(b)(1)(A)(i)(II) in particular, for the '675 patent granted from U.S. Patent Application 13/383,619 ("the '619 application"), which was filed as a national stage application pursuant to 35 U.S.C. § 371.

I. Relevant Statutes

On January 14, 2013, Congress enacted the Technical Corrections—Leahy-Smith America Invents Act ("Technical Corrections Act" or "TCA"), Pub. L. No. 112-274, 126 Stat. 2456 (2013). As the name of the Act suggests, the TCA made certain technical corrections to various sections of Title 35 following the enactment of the Leahy-Smith America Invents Act ("AIA"), including amendments to certain provisions of 35 U.S.C. § 154.

The current version of 35 U.S.C. § 154(b)(1)(A), as amended by the TCA, provides in part:

(A) GUARANTEE OF PROMPT PATENT AND TRADEMARK OFFICE RESPONSES .—Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to—

(i) provide at least one of the notifications under section 132 or a notice of allowance under section 151 not later than 14 months after—

...

(II) the date of commencement of the national stage under section 371 in an international application;

...,

the term of the patent shall be extended 1 day for each day after the end of the period specified in clause (i), (ii), (iii), or (iv), as the case may be, until the action described in such clause is taken.

35 U.S.C. § 154(b)(1)(A) (post-TCA) (emphasis added).

Prior to the amendments under the TCA, § 154(b)(1)(A)(i)(II) read:

(II) the date on which an international application fulfilled the requirements of section 371 of this title;

35 U.S.C. § 154(b)(1)(A)(i)(II) (pre-TCA) (emphasis added).

Subsection 1(n) of the TCA provides that "[e]xcept as otherwise provided in this Act, the amendments made by this Act shall take effect on the date of enactment of this Act, and shall apply to proceedings commenced on or after such date of enactment." TCA, Pub. L. No. 112-274, § 1(n), 125 Stat. at 2459.

A patent applicant may file an international patent application pursuant to the Patent Cooperation Treaty ("PCT" or "Treaty"), which was implemented in 35 U.S.C. § 351 et seq. , and enter a national stage in the PTO by complying with certain filing requirements. See Exela Pharma Scis., LLC v. Lee , 781 F.3d 1349, 1350 (Fed. Cir. 2015) ; see also PCT, June 19, 1970, 28 U.S.T. 7645, 1160 U.N.T.S. 231, as amended on Sept. 28, 1979 and modified on Feb. 3, 1984 and Oct. 3, 2001. The commencement of the national stage of an international patent application filed under the PCT is specified in 35 U.S.C. § 371, which provides in part:

(b) Subject 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.

(c) The applicant shall file in the Patent and Trademark Office—

(1) the national fee provided in section 41(a);

(2) a copy of the international application, ..., and a translation into the English language ..., if it was filed in another language;

(3) amendments, if any, to the claims in the international application ...;

(4) an oath or declaration of the inventor ...;

....

(f) At 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.

35 U.S.C. § 371(b), (c), (f) (emphases added). Section 371 was unchanged by the TCA. See generally Pub. L. No. 112-274, 125 Stat. at 2456–59.

Article 22 of the PCT, which is referenced in § 371(b), specifies the national stage filing requirements under the Treaty, including the requirement to file the national stage application "not later than at the expiration of 30 months from the priority date." PCT art. 22(1); see 35 U.S.C. § 371(b).

II. Filing History of the '675 Patent

Actelion filed International Patent Application PCT/IB2009/053089 ("the first PCT application") on July 16, 2009 ("the priority date"), and International Patent Application PCT/IB2010/053224 ("the second PCT application") on July 15, 2010, claiming priority from the first PCT application.

On January 12, 2012, four days before January 16, 2012, i.e. , 30 months from the priority date ("the 30-month date"), Actelion filed the '619 application as a national stage application of the second PCT application, claiming priority from the July 16, 2009 priority date. Along with the '619 application, Actelion filed a preliminary amendment with remarks, including one stating that "Applicant earnestly solicits early examination and allowance of these claims," J.A. 162, and submitted a completed PTO Form 1390, which provides checkboxes for the applicant to indicate various information concerning the national stage application. Notably, in its PTO Form 1390, Actelion did not check the box numbered 3 ("box 3") next to the statement reading: "This is an express request to begin national examination procedures ( 35 U.S.C. [§] 371(f) )...." J.A. 151.

It is undisputed that the requirements under 35 U.S.C. § 371(c) were met on January 12, 2012. See Appellant's Br. 4; Appellee's Br. 7; J.A. 163. It is also undisputed that the 30-month date, January 16, 2012, fell on a federal holiday, namely, Martin Luther King, Jr. Day. On April 26, 2013, the PTO issued a restriction requirement, which constituted "at least one of the notifications under section 132," 35 U.S.C. § 154(b)(1)(A)(i), undisputedly ending the accrual of A Delay, which started from "14 months after," id. , the date specified in § 154(b)(1)(A)(i)(II), the identity of which is at issue in this appeal.

On February 5, 2014, the PTO issued an Issue Notification of the '675 patent, providing a grant of 41 PTA days, encompassing 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 filed PTO Form 132, entitled "Request for Recalculation of Patent Term Adjustment in View of AIA Technical Corrections Act ," requesting recalculation of the PTA for the '675 patent. J.A. 178. In September 2014, the PTO did recalculate the PTA for the '675 patent, but reduced it to 40 days, encompassing the period from March 17, 2013 to April 26, 2013.

In November 2014, Actelion filed a petition for reconsideration under 37 C.F.R. § 1.705, contending that the '675 patent is entitled to 45 PTA days, or alternatively, at least 41 PTA days. Actelion argued that the accrual of A Delay for the '675 patent should have been calculated based on the '619 application's filing date, January 12, 2012, or at least based on the 30-month date, January 16, 2012. In September 2015, the PTO denied Actelion's petition. Actelion filed a second petition for reconsideration in November 2015, for which the PTO did not issue a decision in view of the pendency of this suit.

On March 18, 2016, Actelion filed suit against the PTO in the Eastern District of Virginia pursuant to § 154(b)(4). Actelion and the PTO filed, respectively, a motion and a cross-motion for summary judgment in the district court, and the court granted summary judgment in favor of the PTO.¹ Actelion , 216 F.Supp.3d at 688. The district court agreed with the PTO that under either pre- or post-TCA law, the PTA for the '675 patent should be the same because the conditions under 35 U.S.C. § 371(b) and (f) were not met on the day the '619 application was filed. Id. at 686. The district court further agreed with the PTO that it properly determined that the national stage did not commence on the 30-month date that fell on a federal holiday. Id. at 687–88.

Actelion timely appealed. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(C) (2012).

DISCUSSION

We review the district court's grant of summary judgment de novo , "applying the same standard as the district court." Pfizer...