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 for the Federal Circuit
September 16, 2019
Appeal from the United States District Court for the Eastern District of Virginia in No. 1:17-cv-01153-TSE-JFA, Judge T. S. Ellis, III.
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.
Opinion for the court filed by Circuit Judge LOURIE.
Dissenting opinion filed by Circuit Judge NEWMAN.
LOURIE,
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
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
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
This appeal concerns the calculation of B Delay. While
(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.
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.
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
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,
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. Freeman, 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
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.
The PTO disagreed, asserting that RCE time did not end when the interference was declared, but instead when the Notice of Allowance was mailed.
Mayo then appealed to the United States District Court for the Eastern District of Virginia. See
The district court carefully evaluated, but rejected, Mayo‘s interpretations of both
This appeal followed. We have jurisdiction under
DISCUSSION
We review a district court‘s grant of summary judgment according to
Patent term adjustments are reviewed in accordance with the Administrative Procedure Act (“APA“),
Mayo contends that
The PTO responds that a declaration of an interference does not close prosecution on the merits, and the PTO‘s operating procedures, as well as the previous version of
We agree with the PTO. While the PTO‘s regulations do indicate that at least one claim in an application should be in condition for allowance before an interference is declared, see
Neither does Novartis. We find Mayo‘s interpretation of Novartis—that examination ends once the claims are “deemed allowable“—strained, given that we said there that “[t]he common-sense understanding of ‘time consumed by continued examination’ . . . is time up to allowance, but not later, unless examination on the merits resumes.” 740 F.3d at 602 (citation omitted). We held in Novartis that the time between the date of mailing of the Notice of Allowance and issuance is not RCE time, absent special circumstances where examination is reopened after allowance, because examination on the merits closes upon allowance in the great majority of cases. Id.
This case is no exception. Upon remand, the examiner updated her search in accordance with M.P.E.P. § 2308, and, finding Mayo‘s continuation application had issued as the ‘927 patent, issued a rejection for obviousness-type double patenting. Mayo, for its part, argued against that rejection on the merits, succeeded in persuading the examiner that the claims were patentably distinct, and secured an allowance. But examination clearly did not end until the date the Notice of Allowance was mailed. Thus, Mayo‘s interpretation of Novartis is incorrect.
Mayo‘s novel reading of the term “requested” also does not show that
At the heart of Mayo‘s appeal is the misapprehension that the examiner could not have issued a rejection that “had nothing to do with any issue raised in the [RCE],” Mayo Br. 24, or, at the very least, that such time should not be deducted from B Delay. But continued examination, both on its own terms and as interpreted by the PTO, see
We are also persuaded by the PTO‘s point that Mayo‘s rule could require an
CONCLUSION
We have considered the parties’ other arguments but find them unpersuasive. For the foregoing reasons, we hold that, where an RCE has previously been filed, the time between termination of an interference and the date of mailing of the Notice of Allowance is “time consumed by continued examination of the application requested by the applicant under section 132(b)” pursuant to
AFFIRMED
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 for the Federal Circuit
Appeal from the United States District Court for the Eastern District of Virginia in No. 1:17-cv-01153-TSE-JFA, Judge T. S. Ellis, III.
NEWMAN, Circuit Judge, dissenting.
This appeal concerns calculation of the patent term adjustment (“PTA“) that is established by statute to compensate for the patent life consumed by prolonged (over three years) examination of the patent application. The aspect on appeal relates to the period of ex parte examination conducted after termination of an interference and ending with mailing of the notice of allowance. The district court, affirming the United States Patent and Trademark Office (“PTO“), held that this additional period of examination is not subject to any term adjustment,1 and my colleagues agree. This holding does not comport with the statutory provisions and precedent, and is contrary to the purpose of term adjustment. Mayo is correct that the calculation of PTA includes the period of examination after termination of the interference.
The panel majority holds that this post-interference examination period is not included in the patent term adjustment, although it plainly is examination delay due to PTO procedures. I respectfully dissent.
The PTA Statute and Regulations
Until 1994, the United States patent term was seventeen years from the date of patent issuance, irrespective of the length of examination in the PTO. After the term was re-set as twenty years from the earliest priority date,
Third,
At issue is the post-interference examination of the ‘063 patent application, after the decision awarding priority to Mayo and ending with mailing of the notice of allowance. The PTO held that this period is excluded from adjustment, based on PTO interpretation of a statutory exception to B Delay, shown in boldface:
§ 154(b)(1)(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) . . . .
(emphasis added).
The PTO cites
37 C.F.R. § 1.703(b)(1). The number of days, if any, in the period beginning on the date on which any request for continued examination of the application under 35 U.S.C. § 132(b) was filed and ending on the date of mailing of the notice of allowance under 35 U.S.C. § 151 . . . .
In turn,
The Examination Proceedings
Mayo‘s patent application was initially rejected on grounds that included anticipation by a recently issued patent. The examiner duly advised that some of the claims in U.S. Patent Application No. 12/421,310 (“the ‘310 application“) were allowable but for the conflicting patent. Mayo then amended some claims, and moved other claims into a separate application.
Priority was awarded to Mayo. The application was then returned to the examiner, who conducted a prior art search and rejected the claims on the ground of “double patenting.” The rejection was based on Mayo‘s separate patent containing the claims that had been removed from Mayo‘s application. Mayo explained this background, and the examiner withdrew the double patenting rejection. On November 3, 2014, a notice of allowance was mailed, and the application issued as the ‘063 patent on March 17, 2015.
With issuance of the patent, the PTO calculated the term adjustment. The PTO held that the period starting with Mayo‘s request for declaration of interference, until mailing of the notice of allowance, was “time consumed by continued examination of the application requested by the applicant” and that
My colleagues cite Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014) as authority. However, Novartis was not concerned with this aspect. Novartis held that “‘examination’ presumptively ends at allowance, when prosecution is closed and there is no further examination on the merits in the absence of a special reopening.” Id. at 602. Novartis did not relate to ongoing or continuing prosecution or any activity before mailing of the notice of allowance. Novartis was concerned only with the “time from allowance to issuance.” Id.
Mayo argued in the district court that “the time after the interference proceedings ended was attributable to the PTO, and not to Mayo, because the examiner sua sponte reopened examination after interference.” Dist. Ct. Op. at 435. Mayo does not dispute the PTO‘s authority to reopen examination, but argues that PTA applies to that period of examination. Mayo points out that the examiner‘s only rejection after the interference decision pertained to a new rejection for double patenting; the examiner wrote that “[i]n view of the [interference] [j]udgment,” the claims “directed to an antibody that binds specifically to human B7-H1 polypeptide are deemed to be free of grounds of rejection, except for the Double Patenting rejection set forth herein.” J.A. 790 (Office Action, dated June 30, 2014, Paper No. 12-1, at 2) (underline in original).
PTO Regulations Authorize post-interference examination:
37 C.F.R. § 41.127(c). The [interference] judgment may include a recommendation for further action by the examiner or by the Director. If the Board recommends rejection of a claim of an involved application, the examiner must enter and maintain the recommended rejection unless an amendment or showing of facts not previously of record is filed which, in the opinion of the examiner, overcomes the recommended rejection.
Here the interference judgment contained no recommendation for further action. MPEP § 2308 guides further examination when there is no recommendation in the interference judgment:
MPEP § 2308. If there is no recommendation in the judgment, the examiner should update the search and may, but is not required to, reopen prosecution for any claim not disposed of in the judgment.
An interference judgment simply resolves any question of priority between
the two parties to the interference. The judgment does not prevent the examiner from making a rejection in further examination in the same application or a different application.
Such “further examination” is at the initiative of the examiner. Here the double patenting rejection was based on Mayo‘s continuation patent as separated from the original application; Mayo provided this history, and the examiner withdrew the rejection and issued the notice of allowance. It is not disputed that Mayo did not request further examination.
My colleagues hold that Mayo‘s initial request that an interference be declared, applied to eliminate adjustment for the period of examination after termination of the interference. That is not an appropriate view of the statute or of patent examination procedure. The panel majority errs in holding that post-interference examination is part of the “continued examination of the application requested by the applicant” that led to the interference proceeding. Maj. Op. at 12–13.
The Result is Contrary to Statute, Regulation, and Policy
The House Committee Report explains the legislative purpose to adjust for “administrative delays caused by the PTO that were beyond the control of the applicant.” H.R. Rep. No. 106-287, pt. 1, at 49 (1999). The Report states the intent to “compensate applicants fully for PTO-caused administrative delays,” and “guarantee[s] diligent applicants at least a 17-year term by extending the term of any patent not granted within three years of filing.” Id. at 49–50.
Congress intended that “[o]nly those who purposely manipulate the system to delay the issuance of their patents will be penalized.” Id. at 50. It is not suggested that Mayo “manipulate[d] the system to delay issuance.” Id.
The PTO argues that this court should defer to the PTO‘s calculation of term adjustment. However, “it is elementary that ‘no deference is due to agency interpretations at odds with the plain language of the statute itself.‘” Wyeth v. Kappos, 591 F.3d 1364, 1372 (Fed. Cir. 2010) (quoting Smith v. City of Jackson, 544 U.S. 228, 267 (2005)).
Here the post-interference examination was PTO activity, part of the examination procedure before issuance of the notice of allowance. It plainly is within the purpose of the term adjustment statute. Indeed, were this post-interference activity deemed part of interference delay, as my colleagues’ ruling requires, this examination would be included in C Delay. Whether as B Delay or C Delay, the adjusted term would include this period of examination.
From the panel majority‘s contrary holding, I respectfully dissent.
