Actelion Pharmaceuticals, Ltd. v. Matal

881 F.3d 1339
CourtCourt of Appeals for the Federal Circuit
DecidedFebruary 6, 2018
Docket2017-1238
StatusPublished
Cited by2 cases

This text of 881 F.3d 1339 (Actelion Pharmaceuticals, Ltd. v. Matal) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Actelion Pharmaceuticals, Ltd. v. Matal, 881 F.3d 1339 (Fed. Cir. 2018).

Opinion

Lourie, Circuit Judge.

Actelion Pharmaceuticals, Ltd. (“Actel-ion”) 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 Aetelion 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)(l)(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 Le-ahy-Smith America Invents Act (“ALA”), 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— ■
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(II) the date of commencement of the national stage under section 371 in an international application;
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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 TGA, § 154(b)(l)(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)(l)(A)(i)(II) (pre-TCA) (emphasis addéd).

Subsection l(n) of the TCA provides that “[ejxcept 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, § l(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 undér article 39(l)(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 ..
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(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.

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