Novartis Ag v. Focarino

740 F.3d 593, 109 U.S.P.Q. 2d (BNA) 1385, 2014 WL 128577, 2014 U.S. App. LEXIS 746
CourtCourt of Appeals for the Federal Circuit
DecidedJanuary 15, 2014
Docket20-1724
StatusPublished
Cited by16 cases

This text of 740 F.3d 593 (Novartis Ag v. Focarino) 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
Novartis Ag v. Focarino, 740 F.3d 593, 109 U.S.P.Q. 2d (BNA) 1385, 2014 WL 128577, 2014 U.S. App. LEXIS 746 (Fed. Cir. 2014).

Opinion

TARANTO, Circuit Judge.

Novartis AG, Novartis Vaccines and Diagnostics, Inc., and Novartis Corporation (collectively, Novartis) filed suits that challenged the determinations by the Patent and Trademark Office of how much time to add, under 35 U.S.C. § 154(b), to the otherwise-applicable term of various Novartis patents. Of the eighteen patents before us, the district court dismissed Novartis’s claims regarding fifteen as untimely asserted. For the other three, the court rejected the PTO’s construction of the statutory provision that governs patent term adjustment here.

We affirm the district court’s ruling on timeliness as to the claims at issue, agreeing with its interpretation of § 154(b)(3) and (b)(4). As to the standards for patent term adjustment, however, we conclude that the PTO was partly correct and partly incorrect in its interpretation of § 154(b)(1)(B). The result is that, for three patents, Novartis is entitled to most, but not all, of the patent term adjustment it seeks.

Background

In 1994, Congress changed the method of measuring the effective term of a patent. Before the change, a patent’s term generally ran from the date that the patent issued until the end of a period measured from that date — typically seventeen years, subject to certain extensions (e.g., those provided by the 1984 Hatch-Wax-man Act, 35 U.S.C. § 156). Under the 1994 law, the term still begins on the issuance date, but it generally ends twenty *596 years after the relevant application for that patent was filed. Pub.L. No. 103-465, § 532, 108 Stat. 4809, 4984 (1994) (revising 35 U.S.C. § 154). As a result, delays in processing the application at the PTO now reduce a patent’s term.

In 1999, Congress provided for extensions of patent terms to compensate for certain application-processing delays caused by the PTO. See Pub.L. No. 106-113, § 1000(a)(9), 113 Stat. 1501, 1536. Specifically, 35 U.S.C. § 154(b)(1) makes three “[pjatent term guarantees” — “(A) Guarantee of prompt patent and trademark office responses,” “(B) Guarantee of no more than 3-year application pen-dency,” and “(C) Guarantee of adjustments for delays due to derivation proceedings, secrecy orders, and appeals.” The statute provides that “the term of the patent shall be extended 1 day for each day” that the PTO does not meet certain response deadlines, § 154(b)(1)(A), for each day after the PTO fails to issue the patent within three years, subject to exclusions, § 154(b)(1)(B), and for each day of delay due to an interference, secrecy order, or successful applicant appeal, § 154(b)(1)(C).

This appeal involves § 154(b)(1)(B), which builds on a goal of application pen-dency of three years, reflecting the replacement of a term of seventeen years from issuance by a term starting at issuance but ending twenty years after application. See S.Rep. No. 105-42, at 42. The provision states:

(B) Guarantee of no more than 3-year application pendency. — Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application under section 111(a) in the United States or, in the case of an international application, the date of commencement of the national stage under section 371 in the international application, not including—
(i) any time consumed by continued examination of the application requested by the applicant under section 132(b);
(ii) any time consumed by a proceeding under section 135(a), any time consumed by the imposition of an order under section 181, or any time consumed by appellate review by the Patent Trial and Appeal Board or by a Federal court; or
(iii) any delay in the processing of the application by the United States Patent and Trademark Office requested by the applicant except as permitted by paragraph (3)(C),
the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued.

35 U.S.C. § 154(b)(1)(B) (2011).

The PTO regulations call for implementing this provision in two steps. First, “the term of an original patent shall be adjusted if the issuance of the patent was delayed due to the failure of the Office to issue a patent within three years after the date on which the application was filed ..., but not including (1) [a]ny time consumed by continued examination of the application under 35 U.S.C. 132(b)....” 37 C.F.R. § 1.702(b)(1). Second, if an applicant is entitled to an extension, “[t]he period of adjustment ... is the number of days, if any, in the period beginning on the day after the date that is three years after the date on which the application was filed ... and ending on the date a patent was issued, but not including ... (1) [t]he number of days, if any, in the period beginning on the date on which a request for continued examination of the application under 35 U.S.C. § 132(b) was filed and ending on *597 the date the patent was issued....” 37 C.F.R. § 1.703(b)(1).

In 35 U.S.C. § 154(b)(3) & § 154(b)(4), Congress provided administrative and judicial remedies for applicants who are dissatisfied with the PTO Director’s determination of a patent term adjustment. First, under § 154(b)(3)(B)(ii), an applicant must have “one opportunity to request reconsideration of any patent term adjustment determination made by the Director.” Second, under § 154(b)(4)(A), in the version applicable here (before recent revisions), “[a]n applicant dissatisfied with a determination made by the Director under paragraph (3) shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent.” Id. The PTO has interpreted the 180-day statute of limitations to apply to all patent term adjustment determinations, including those made under § 154(b)(l)(B)(i).

Between June 2009 and May 2011, Novartis filed four lawsuits in the District Court for the District of Columbia claiming that, for twenty-three of its patents, the Director had improperly determined the amount of patent term adjustment. See, e.g., Second Amended Complaint, ¶ 2, Novartis AG v.

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Bluebook (online)
740 F.3d 593, 109 U.S.P.Q. 2d (BNA) 1385, 2014 WL 128577, 2014 U.S. App. LEXIS 746, Counsel Stack Legal Research, https://law.counselstack.com/opinion/novartis-ag-v-focarino-cafc-2014.