Patent Term Adjustment: When does the RCE End?

Mayo Foundation v. Iancu (Fed. Cir. 2019)

This case involves a patent term adjustment (PTA) challenge by Mayo, the owner of of U.S. Patent 8,981,063.  On appeal, the Federal Circuit has affirmed the PTO’s statutory interpretation — holding that the RCE period (pausing PTA Calculation) is not ended by an interference proceeding.

Utility patents have a term of 20-years from the effective filing date of the patent application (not counting national-stage priority or provisional applications).  Since patent rights are not complete until the patent issues, a long period of prosecution can eat-into the effective length of the patent term.  However, Congress has provided for a generous Patent Term Adjustment (PTA) designed to add extra days to the patent term in order to compensate for lengthy prosecution periods.

This appeal is focused on the PTA guarantee of “no more than 3-year application pendency.”  35 U.S.C. § 154(b)(1)(B).  If the application is pending for more than three years, then the patentee will receive day-for-day additional patent term.  One major exception to the 3-year timeline is that it does not include RCE time: “not including — (i) any time consumed by continued examination of the application requested by the applicant under § 132(b).”

In Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014), the Federal Circuit held that this RCE-time exception stops at the mailing of the notice-of-allowance.

Mayo’s here prosecution was complicated by an interference proceedings that was declared after Mayo initially filed its RCE. Timeline below comes from Mayo’s brief.

From the chart above: Mayo filed an RCE and then a few months later the PTO declared an interference (at Mayo’s suggestion).  Once the interference ended, the PTO sua sponte re-reopened prosecution before finally issuing a notice of allowance.

Mayo’s argued that the time “consumed by continued examination” was only Period-1 that ended with the interference declaration.  Its reasoning has to do with interference declarations that require examination to be “completed” and the invention otherwise “patentable” before declaring the interference.

On appeal here, the Federal Circuit sided with the PTO — holding that a declaration of an interference not is the equivalent of a Notice of Allowance.  Rather, here “examination clearly did not end until the date the Notice of Allowance was mailed.”  Bottom line was that the court counted the post-interference examination time as caused by the RCE filing — and thus not eligible for PTA.

Although interference proceedings are now rare (and on their way out), the reasoning here would apply equally to cases where an examiner reopens prosecution following a successful appeal by the patent applicant. 

The majority opinion was penned by Judge Lourie and joined by Judge Dyk.  Writing in dissent, Judge Newman sided with Mayo since all of the claims pending in the interference had been indicated to be allowable by the examiner.

21 thoughts on “Patent Term Adjustment: When does the RCE End?

  1. 8

    To my astigmatic/slightly dyslexic eyes, Fig. 1B looks a lot like the script for a scene from Dog Day Afternoon…

    ATTICA ATTICA ATTICA ATTICA

    Just felt the need to share that..

  2. 7

    Hmmm … what if the interference had been declared before the RCE was filed?

    1. 7.1

      Filing an RCE after an interference is declared? Want to see P-ode APJs?

      1. 7.1.1

        Can that even happen, Paul?

        37 C.F.R. 41.103 Jurisdiction over involved files.

        The Board acquires jurisdiction over any involved file when the Board initiates a contested case. Other proceedings for the involved file within the Office are suspended except as the Board may order.

        1. 7.1.1.1

          Right.

  3. 6

    Anyone care to comment on the validity of these antibody claims under 35 USC 112?

    Wow.

  4. 5

    The lodestar of statutory construction is Congressional intent. Daw Indust. v. United States, 714 F.2d 1140, 1142 (Fed. Cir. 1983). On the question, I very much doubt that the Congress even had an intent. I would be surprised to discover that any more than 10% of the legislators even know what either an RCE or an interference is. I doubt that anyone drafting this legislation even considered the possibility that an interference might chew up time after an RCE had been filed.

    In other words, the “lodestar” of this analysis is a black hole. I do not see that there is a good reason—as a matter of application of the canons of statutory construction—to prefer one answer or another to this question. Similarly, I do not see that there is a public policy reason to favor one outcome over the other. Basically, it really did not matter what might be the outcome to this question, so long as it receives a clear answer.

    The court here gave a clear answer. It will be easy to apply this precedent going forward. We will all know what to tell our clients (to the extent that any of them might ask) about the affect on PTA of re-opened prosecution following an interference (or derivation) after an RCE.

    1. 5.1

      To add to Greg’s remarks, my recollection is that the present patent term statute’s Byzantine and parallel term adjustment provisions were drafted in a rush. [To try to meet CA Congressman R’s insistence that everyone must always get at least the same 17 year patent term as before except for delays due to the applicants.]
      Not surprisingly, this is yet another of several lawsuits that have been had over different issues over those Byzantine terms.

    2. 5.2

      We will all know what to tell our clients… about the affect on PTA…

      Er, “… about the effect n PTA… .” Mea culpa.

    3. 5.3

      Greg,

      The intent of PTA is very much known and recognized, and is tied to the foundational Quid Pro Quo (publication for Grant).

      The driver was intended to make sure that the Office was not dilatory and that the applicant had a proper measure of likelihood of obtaining grant before a publication event.

    4. 5.4

      Greg, I’m surprised you did not get any kickback on “The lodestar of statutory construction is Congressional intent. Daw Indust. v. United States, 714 F.2d 1140, 1142 (Fed. Cir. 1983).” There have been Sup. Ct. justices since then who don’t seem to give “Congressional intent” much weight as compared to the plain meaning of statutory text, or even credibility depending on the source.

  5. 4

    The good news is that the interference only took two years.

    1. 4.1

      But note that it is quite common in an interference, and fairly often succcessful, for claims previously held allowable by an examiner to be attacked in preliminary interference motions as unpatentable [over newly cited prior art, 112, or otherwise].

  6. 3

    At a first glance, it does not help the case that after the interference concluded that there was an Office Action on the merits (instead of a direct Notice of Allowance).

    This points out that examination mode was not really ended with the interference (even if the write-up here seems to indicate otherwise).

    1. 3.1

      I think Crouch mixed up some quotes.

      “First, [Mayo] asserted that the holding of Novartis is that continued examination ends
      once the claims are “deemed allowable,” not necessarily on the date of mailing of the Notice of Allowance, and since the PTO’s regulations require an application “otherwise be in condition for allowance” before an interference is declared, the declaration is tantamount to a Notice of Allow-
      ance.

      But the court found:
      “Thus, the PTO’s regulations as a whole do not indicate that a declaration of an interference is tantamount to a Notice of Al-
      lowance.”

      1. 3.1.1

        I didn’t mean to make this a subreply to any other post, but I’m not going to bother to post it again.

        1. 3.1.1.1

          (np – and thanks for clarifying)

  7. 2

    Judge Lourie now writing opinions using the genetic code! Cool.

  8. 1

    The second sentence seems to be cut off in the middle :)

    1. 1.1

      The “U” after the insertion of the figure should not have been capitalized (I had to take a double read too).

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