Mayo Clinic Found. v. Iancu
Mayo Clinic Found. v. Iancu
Opinion of the Court
This is an appeal from a decision by the United States Patent & Trademark Office ("PTO"), calculating the patent term adjustment for United States Patent No. 8,981,063, owned by plaintiff, the Mayo Foundation for Medical Education and Research ("Mayo"). Specifically, the PTO determined that the six-month period extending from the conclusion of the interference proceeding until the PTO's mailing of the notice of allowance constituted "time consumed by continued examination requested by the applicant" pursuant to
I.
Because Congress has relatively recently altered the patent law landscape in a manner particularly pertinent to this appeal, a brief description of this new landscape provides necessary context for resolution of the issues here.
The patent process begins when an applicant seeking a United States patent files an application with the PTO. See *428
Throughout this process, the examiner or the applicant can also recommend an application for an "interference" proceeding. See
Once an interference is declared, the PTAB takes evidence and "enters final judgment on questions of priority and patentability arising in an interference." Manual of Patent Examining Procedure (" MPEP") § 2301.
If, at the end of this process, a patent issues, the patent term will last for twenty years from the date the initial patent application was filed. Prior to 1994, patent terms were seventeen years from the date the patent issued. In 1994, Congress changed the patent term to twenty years from the date the application was first filed. In changing the start date of the patent term to the date when the application was first filed, Congress acknowledged that PTO delays in the processing of applications would now consume some portion of the patent term. Accordingly, to account for certain of these delays, Congress passed the American Inventors Protection ("AIPA") of 1999, requiring the PTO to grant several patent term adjustments based on delays in the application processing attributable to the PTO. See
Most relevant to this case is the PTO's calculation of B Delay. As described above, B Delay accounts for delays "due to the failure of the [PTO] to issue a patent within [three] years after the actual filing date of the application ...."
In addition to establishing these categories of delay, the statute delegates to the PTO Director the authority to "prescribe regulations establishing procedures for the application for and determination of patent term adjustments ...."
(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....
Given this description of the patent application examination process and given the changes Congress implemented, it is appropriate to consider the parties' dispute.
*430II.
Plaintiff, Mayo, a Minnesota non-profit corporation, is the owner of United States Patent No. 8,981,063 ("the '063 Patent"), relating to antibodies that bind to polypeptides. On April 9, 2009, Mayo filed Application No. 12/421,310 ("the '310 Application"), the application that culminated in the issuance of the '063 Patent. On October 14, 2010, the PTO issued a final office action rejecting the claims in the '310 Application. Specifically, the PTO determined that all of the claims in the '310 Application were unpatentable as anticipated by existing United States Patent No. 7,635,757 ("the '757 Patent") and that a subset of the claims were also unpatentable due to the lack of a written description. See AR 327-33. Approximately one year later, on September 14, 2011, Mayo filed an RCE pursuant to
Thereafter, on February 9, 2012, the assigned Administrative Patent Judge issued a declaration of interference between the remaining 26 claims in the '310 Application and 13 claims in the '757 Patent. Two years later, on February 19, 2014, the PTAB issued a judgment, granting Mayo's motion for judgment on the basis of priority and canceling 13 of the claims in the '757 Patent. The interference terminated as of April 23, 2014, when the losing party's time for filing an appeal expired. See
Four months later, on March 17, 2015, the PTO issued the '063 Patent and awarded a 604-day patent term adjustment. Specifically, the PTO calculated 898 days of A Delay, 0 days of B Delay, and 805 days of C Delay-a total of 1703 days of delay. Because 294 days of this delay was attributable to the applicant and the 805 days of C Delay overlapped entirely with the A Delay days, the PTO then subtracted the 294 days of applicant delay and 805 days of the overlapping delay to reach a patent term adjustment of 604 days.
The parties agree that the PTO correctly calculated the A Delay, C Delay, applicant delay, and overlap; the only issue on which the parties part company here concerns the calculation of B Delay. The PTO calculated 0 days of B Delay by determining that the "time consumed by continued examination of the application requested by the applicant" lasted 1147 days from the day Mayo filed the RCE on September *43114, 2011 until the day the PTO mailed the notice of allowance on November 3, 2014. The PTO then subtracted that 1147 days consumed by continued examination from the 2169 days of total time from the date of the application's filing to the date of the patent's issuance. See AR 834. Because the remaining time (1022 days) did not exceed three years (1095 days), the PTO determined that the B Delay was 0 days.
The PTO also provided an alternative calculation that reached the same result. Specifically, in its alternative calculation, the PTO interpreted the interference proceeding as "pausing" the continued examination requested by the applicant. AR 834. Accordingly, the PTO calculated that the 148 days between the RCE and the declaration of interference were consumed by continued examination requested by the applicant, after which the continued examination was paused for the 805 days devoted to the interference. Finally, according to the PTO, the applicant's requested continued examination then resumed for the 194 days between the termination of the interference and the allowance of the claims. The PTO then subtracted the period of continued examination (342 days) and the period of interference (805 days)
Following the PTO's decision denying any B Delay, Mayo filed a request for reconsideration, contending that the B Delay was 119, and not 0 days, and as such, Mayo was entitled to a 723-day patent term adjustment. Specifically, Mayo argued that the "time consumed by continued examination of the application requested by the applicant" lasted from the date that Mayo filed the RCE to the date the interference was declared, not, as the PTO contended, from the date of the RCE until the mailing of the notice of allowance. In essence, Mayo argued that the applicant's requested continued examination permanently ended when the interference was declared, and as such, the time between the termination of interference on April 23, 2014 and the issuance of the notice of allowance on November 3, 2014 should not have been excluded from the B Delay calculation.
On July 12, 2017, the PTO issued a final decision denying the request for reconsideration and confirming that Mayo was entitled to a patent term adjustment of only 604 days. See AR 832-33. Mayo timely filed the instant action on October 13, 2017, pursuant to
The parties subsequently filed the cross-motions for summary judgment at issue here. The PTO contends that "time consumed by continued examination of the application requested by the applicant" includes any time after the filing of an RCE, which occurred in September 2011, up until the mailing of the notice of allowance, which occurred in November 2014. As such, the time from April 2014 when the interference proceeding ended until November 2014 was properly excluded. Mayo counters by arguing that continued examination permanently ended when the interference proceedings began, and as such, the time from the termination of the interference proceeding until the notice of allowance should not be excluded and instead *432should be credited to Mayo as B Delay.
III.
The standard of review on motions for summary judgment is too well-settled to warrant extensive discussion. Under Rule 56, Fed. R. Civ. P., summary judgment is appropriate only where there is "no genuine dispute as to any material fact" such that the moving party "is entitled to judgment as a matter of law." Celotex v. Catrett ,
IV.
The dispute here is whether the time from the close of the interference proceedings until the notice of allowance was mailed in this matter constitutes "time consumed by continued examination of the application requested by the applicant" pursuant to § 154(b)(1)(B), or whether the applicant's requested continued examination ended when the interference was declared. In Novartis AG v. Lee ,
Although Novartis involved a somewhat different factual scenario, the decision nonetheless announces a principle that points persuasively to the conclusion that the time prior to the mailing of the notice of allowance for the '310 Application constituted "time consumed by continued examination of the application requested by the applicant" pursuant to § 154(b)(1)(B). Until November 3, 2014, when the examiner mailed the notice of allowance, prosecution of the '310 Application remained open. Examination of merits of the application continued on the question of priority during the interference proceedings, and thereafter examination continued on the question of patentability as the examiner updated prior art searches and considered the question of double patenting. AR 698-703. Because prosecution was not closed and examination on the merits continued until November 3, 2014, the time from the end of the interference until November 3 is clearly "time consumed by continued examination of the application requested by the applicant" as defined by Novartis .
The result reached here is consistent with Congress's purpose in enacting the patent term adjustments. As the Federal Circuit in Novartis made clear, "154(b)(1)(B) is best understood as making distinctions based on whether certain delays are attributable to the PTO." Novartis ,
Mayo, in attempting to avoid this conclusion compelled by Novartis , argues that a declaration of interference is analogous to allowance for the purposes of § 154(b)(1)(B) because the claims in the patent are otherwise "deemed allowable" by the patent examiner before an interference is declared. But this argument is unpersuasive because allowance and interference are distinct in several respects that the Federal Circuit considered important in Novartis . Significantly, in Novartis , the Federal Circuit made clear that "continued examination of the application requested by the applicant" presumptively ends at allowance because at that point, "prosecution is closed and there is no further examination on the merits in the absence of a special reopening." Novartis ,
These factors, considered significant by the Novartis court in defining the end point of continued examination requested by the applicant, do not apply where, as here, an interference is declared. To begin with, the examiner here never indicated that the prosecution on the merits was closed by mailing a written notice stating as much. Indeed, the examiner specifically told Mayo that an interference proceeding was likely to occur and that the claims would continue through that process. See AR 615. And importantly, examination on the merits both during and after interference proceedings is routine, not exceptional. During the interference proceedings themselves, the PTAB "may refer a matter to the examiner or may consult with the examiner on an issue." MPEP § 2301. And, once interference terminates, the MPEP indicates that "[j]urisdiction over an application returns to the examiner."
*434
Moreover, to adopt Mayo's argument that the applicant's requested continued examination ends when the claims are "deemed allowable" would lead to absurd results not envisioned by the Federal Circuit in Novartis . For example, if an examiner were to indicate in a conversation with the applicant that he or she believed the claims in the RCE were allowable, Mayo's interpretation of the statute would then attribute any additional examination of the application to the PTO, not to the applicant. This result, in addition to discouraging patent examiners from communicating with applicants about the status of their applications, would require the PTO to delve into each day of the continued examination process and to assess whether the examiner had effectively finished its prosecution of the application at any point in time before the examiner mailed the notice of allowance. The Federal Circuit plainly sought to avoid these intensive day-by-day factual inquiries when it established in Novartis that "time consumed by continued examination of the application requested by the applicant" ends at allowance, when prosecution is formally closed, and further examination on the merits does not occur absent truly exceptional circumstances. Novartis ,
In sum, Mayo's efforts to draw an analogy between a declaration of interference and an allowance fail because the Federal Circuit held that allowance marks the end of the applicant's requested continued examination precisely because after allowance, as notices of allowance make clear, prosecution is closed and does not continue absent a special reopening. Interference, by contrast, does not signal the end to prosecution; instead, prosecution continues throughout the interference proceedings and jurisdiction automatically returns to the examiner to take any remaining action following interference.
Even assuming, arguendo , that a declaration of interference is analogous to allowance as Mayo contends, the Federal Circuit in Novartis noted that "time consumed by continued examination of the application requested by the applicant" pursuant to § 154(b)(1)(B) is "time up to allowance, but not later, unless examination on the merits resumes." Novartis ,
Mayo next argues 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. This argument mischaracterizes the nature of examination following an interference. An examiner's updating of prior art searches following an interference proceeding is not a sua sponte reopening of examination; rather, it is the resumption of the continued examination that was initially requested by the applicant. As the MPEP notes, "[j]urisdiction over an application returns to the examiner once the interference has been terminated," and at that point, if there is no recommendation in the PTAB's judgment, the examiner "should update the search ...." MPEP § 2308 (emphasis added). Notably, the word "should," the "past of shall,"
Finally, Mayo contends that when the PTO excluded the time from the termination of interference until the mailing of a notice of allowance, the PTO improperly differentiated between continued-examination cases and cases not involving continued examination. But the PTO's differentiation in this respect was not improper because the statute mandates that the PTO distinguish cases in which the patentee files an RCE by excluding "time consumed by continued examination of the application requested by the applicant" from its calculation of B Delay.
In the end, Mayo's arguments fail because Federal Circuit precedent makes clear that "time consumed by continued examination of the application requested by the applicant" includes time up until "allowance"-that is, when the notice of allowance is mailed, prosecution is closed, and further examination on the merits does not occur absent a special reopening. Novartis ,
V.
In sum, Novartis makes clear that "time consumed by continued examination of the application requested by the applicant" pursuant to § 154(b)(1)(B)"presumptively ends at allowance, when prosecution is closed and there is no further examination on the merits in the absence of a special reopening." Novartis ,
An appropriate Order will issue.
The 2013 America Invents Act ("AIA") replaced "interferences" with "derivation proceedings." See
See also Capon v. Eshhar ,
The Federal Circuit has made clear that the "MPEP does not have the force and effect of law; however, it is entitled to judicial notice as the agency's official interpretation of statutes or regulations, provided that it is not in conflict with the statutes or regulations." Refac Intn'l, Ltd. v. Lotus Dev. Corp. ,
But in certain circumstances, the PTAB "may refer a matter to the examiner or may consult with the examiner on an issue." MPEP § 2301.
The facts recited here are derived from the Administrative Record ("AR"). The parties do not identify any disputed material facts, nor does the record reflect that any exist.
Mayo correctly concedes that the 805 days consumed by the interference proceedings are properly excluded from the B Delay calculation pursuant to
WEBSTER's THIRD NEW INT'L DICTIONARY 2104 (3d ed. 2002).
Reference
- Full Case Name
- MAYO CLINIC FOUNDATION v. Andrei IANCU
- Cited By
- 1 case
- Status
- Published