Mayo Found. for Med. Educ. & Research v. Iancu

• Decision Date: 16 September 2019
• Docket Number: 2018-2031
• Citation: 938 F.3d 1343
• Parties: MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH, Plaintiff-Appellant v. Andrei IANCU, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Defendant-Appellee
• Court: U.S. Court of Appeals — Federal Circuit

938 F.3d 1343

MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH, Plaintiff-Appellant

v.Andrei IANCU, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Defendant-Appellee

2018-2031

United States Court of Appeals, Federal Circuit.

Decided: September 16, 2019

Ahmed Jamal Davis, Fish & Richardson PC, Washington, DC, argued for plaintiff-appellant. Also represented by Craig E. Countryman, Jared Alexander Smith, San Diego, CA.

R. Trent Mccotter, Office of the United States Attorney, Alexandria, VA, argued for defendant-appellee. Also represented by G. Zachary Terwilliger; Thomas W. Krause, Kakoli Caprihan, Brian Racilla, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.

Before NEWMAN, LOURIE, and DYK, Circuit Judges.

Lourie, Circuit Judge.

The Mayo Foundation for Medical Education and Research ("Mayo") appeals from a decision of the United States District Court for the Eastern District of Virginia, Mayo Found. v. Iancu , 309 F. Supp. 3d 425 (E.D. Va. 2018) (" Decision "), which affirmed the United States Patent and Trademark Office's (the "PTO's") calculation of patent term adjustment ("PTA") for U.S. Patent 8,981,063 (the "’063 patent") under 35 U.S.C. § 154. Because we conclude that the PTO's interpretation of "any time consumed by continued examination of the application requested by the applicant under section 132(b)" in 35 U.S.C. § 154(b)(1)(B)(i), see 37 C.F.R. § 1.703(b)(1), was correct, we affirm.

BACKGROUND

In 1994, Congress implemented the trade agreements reached during the Uruguay Round of multilateral trade negotiations by enacting the Uruguay Round Agreements Act (the "URAA"). Pub. L. No. 103-465, 108 Stat. 4809 (1994). Pursuant to the URAA, Congress changed the patent term length from seventeen years from the date of issuance of the patent to twenty years from the effective filing date of the application. See id. § 532 (codified as amended at 35 U.S.C. § 154 ) (defining the effective filing date as the filing date of the instant application or that of the application from which it can claim priority under §§ 120, 121 or 365). Congress envisioned in the URAA that this change could disadvantage patent owners whose applications underwent lengthy prosecution, and it provided for PTA compensating for delays attributable to interference proceedings under 35 U.S.C. § 135(a) and certain appeals to the Board or federal courts under 35 U.S.C. §§ 134, 141, 145. See URAA, § 532.

In an effort to streamline patent prosecution, Congress expanded PTA in 1999. American Inventors Protection Act of 1999, Pub. L. No. 106-113, App. I, tit. IV, 113 Stat. 1501, 1501A-552–1501A-591 (1999) (codified as amended, in relevant portion, at 35 U.S.C. § 154(b) ) (the "AIPA"). The statute compensates applicants for three broad classes of delay: § 154(b)(1)(A) ("A Delay") provides PTA when the PTO does not meet certain deadlines in the processing of patent applications; § 154(b)(1)(B) ("B Delay") generally entitles the applicant to PTA for each day the application is pending beyond three years; and § 154(b)(1)(C) ("C Delay") provides PTA for each day the application is pending in an interference proceeding, a secrecy order, or a successful appeal to the Patent Trial and Appeal Board (the "Board") or a federal court. Each of these entitlements is subject to the "[l]imitations" set forth in § 154(b)(2), which, inter alia , reduce PTA "by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution." Id. § 154(b)(2)(C) ; see Supernus Pharm., Inc. v. Iancu , 913 F.3d 1351, 1353–54 (Fed. Cir. 2019).

This appeal concerns the calculation of B Delay. While § 154(b)(1)(B) generally "guarantee[s] ... no more than 3-year application pendency," that 3-year period is subject to several exclusions:

(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) ....

Id. § 154(b)(1)(B)(i)–(iii). The time consumed during one of the proceedings referred to in § 154(b)(1)(B)(ii) —interferences, secrecy orders, and appeals, respectively—is excluded because it is already counted as C Delay. See § 154(b)(2)(A) ("[PTA] shall not exceed the actual number of days the issuance of the patent was delayed.").

On several occasions since 2000, the PTO has promulgated regulations setting forth its interpretation of "time consumed by continued examination of the application requested by the applicant under section 132(b)." Id. § 154(b)(1)(B)(i) ("RCE time"). Section 132(b) was also enacted as part of the AIPA, id. § 4403, 113 Stat. at 1501A-560, and it requires the PTO to "prescribe regulations to provide for ... continued examination ... at the request of the applicant," commonly referred to as an "RCE." As set forth by the PTO in 37 C.F.R. § 1.114, filing an RCE "withdraw[s] the finality of any Office action" and allows prosecution to proceed.

In Novartis AG v. Lee , 740 F.3d 593 (Fed. Cir. 2014), we held that the PTO's previous interpretation of RCE time—as extending from the filing date of the RCE to issuance, see 37 C.F.R. § 1.703(b)(1) (2013)—was incorrect because, absent resumption of examination after the date of mailing of the Notice of Allowance, which is an exceptional circumstance, "allowance-to-issuance time" is "plainly attributable to the PTO," regardless "whether there is a continued examination in a prosecution." Novartis , 740 F.3d at 602. Thereafter, the PTO promulgated and finalized a new regulation, interpreting RCE time as "[t]he number of days ... in the period beginning on [the RCE filing date] and ending on the date of mailing of the notice of allowance ...." 37 C.F.R. § 1.703(b)(1) (2019).

The ’063 patent claims certain antibodies purportedly useful for treating "disease conditions characterized by immunosuppression: e.g., cancer, AIDS or AIDS-related complex[es], other virally or environmentally-induced conditions, and certain congenital immune deficiencies." Id. col. 14 ll. 20–23. The ’063 patent issued from Application 12/421,310 (the " ’310 application"), filed on April 9, 2009, with an effective filing date of November 30, 1999. The PTO issued a final rejection of the pending claims on October 14, 2010, as anticipated by U.S. Patent 7,635,757 (the "’757 patent"), and, for some of the claims, as lacking written description. J.A. 419–25. The PTO also noted in its rejection that Mayo had suggested an interference with the ’757 patent in its previous response, and it invited Mayo to make the requisite priority showing under 37 C.F.R. § 41.202(d)(1) (2010). On September 14, 2011, Mayo filed an RCE along with remarks arguing that Mayo had priority of invention over the ’757 patent and suggesting an interference.

Mayo filed a supplemental amendment shortly afterward cancelling certain claims that the examiner had indicated, in an apparently off-the-record discussion, would not correspond to the count in the impending interference. Some of these claims had previously been withdrawn in response to a restriction requirement, and the examiner advised Mayo that, for the purposes of eventual PTA calculation, claims not relevant to the impending interference should be removed. Mayo accordingly cancelled those claims and pursued them in a separate continuation application, which later issued as U.S. Patent 8,460,927 (the "’927 patent").

On February 9, 2012, an interference was declared between all the remaining claims of the ’310 application and all the claims of the ’757 patent. The interference proceeded for two years. On February 19, 2014, the Board awarded priority to Mayo's ’310 application claims and cancelled all the claims of the ’757 patent. See Chen v. Free-man , Int. No. 105,872, 2014 WL 664019 (P.T.A.B. Feb. 19, 2014) ; J.A. 764–787. The interference decision became final on April 23, 2014, when the sixty-day period for appeal expired. See 35 U.S.C. § 142 ; 37 C.F.R. § 90.3.

Following termination of the interference, the Board returned the ’310 application to the examiner. The examiner conducted a further prior art search, and on June 30, 2014, issued an Office Action rejecting the claims of the ’310 application on the ground of non-statutory obviousness-type double patenting in view of the ’927 patent, which contained the claims that had been cancelled in the ’310 application. Mayo filed a reply on October 24, 2014, arguing on the merits that the claims of the ’310 application were patentably distinct. The examiner then withdrew the rejection and mailed a Notice of Allowance on November 3, 2014. The ’310 application issued as the ’063 patent on March 17, 2015.

Mayo provides the following timeline to summarize the prosecution events:

Mayo Br. 7. The first bracketed time period is 148 days; the second, 805 days; and the third, 194 days. The parties agree that the first period is RCE time and the second period is not. This appeal concerns the third period.

Upon issuance of the ’063 patent, the PTO calculated a PTA of 621 days, with no B Delay. Mayo filed a request for redetermination, claiming that it was due 685 days, because "[t]he examiner's sua sponte reopening of prosecution after termination of the interference was not [RCE time under 35 U.S.C. § 154(b)(1)(B)(i) ]." J.A. 877–79. Mayo calculated the RCE time as 148 days, the time between the filing of the RCE and the declaration of the interference.

The PTO disagreed, asserting that RCE time did not end when the interference was declared, but instead when the Notice of Allowance was...