Patent Term Adjustments Just Got Longer

Wyeth v. Dudas (D.D.C., Sept. 30, 2008).

35 U.S.C. § 154(a) establishes the patent term at twenty years from the filing date. Section 154(b) introduces various term adjustments due to PTO delay. One of the adjustment provisions broadly works toward a "guarantee of no more than 3-year application pendency." The other primary adjustment provision more narrowly focuses on the timeliness of individual PTO actions – such as providing an office action within 14-months. (These are §154(b)(2) and (b)(1) respectively).

Because some delays may qualify under multiple provisions, the statute also includes a clause to prevent double counting. This double counting statute – §154(b)(2)(A) – is written to ensure that "the period of any adjustment granted under this subsection shall not exceed the actual number of days the issuance of the patent was delayed."

In calculating the adjustment, the PTO calculates the adjustment under the broad rule and separately calculates the adjustment under the narrow rule. Then, to avoid double counting, uses only the adjustment that is greater. Thus, the applicant only gets credit for either the broad rule adjustment or the narrow rule adjustment, whichever is larger.

In this case, Wyeth has successfully challenged the PTO's interpretation. As the court holds, the double-counting problem does not arise when the specific PTO (b)(1) delay occurs before the application has been pending for 3-years.

This case, if it holds on appeal, will potentially add 22-months to the eventual term of the patents awaiting examination in the PTO bottleneck.

Already issued patents: 37 C.F.R. § 1.705(d) provides a two month deadline for reconsidering the PTO's calculations.

Notes:

 

9 thoughts on “Patent Term Adjustments Just Got Longer

  1. The statute is not really ambigous, unless by ambiguous it is meant that a mistakely is easy to make.

    Note that at three years and one day after filing and without allowance, only a single day of B adjustment is due.

    As the court correctly noted the accumulation of ‘B’ adjustment starts at the end of the three years and continues up until issue. Thus the applicble delay is the time after 3 years.

    Despite the fact that the 3 year delay is partially “explained” by the failure to get to the application for some significant amount of time beyond 14 months, the applicable delays do not overlap simply because the excuses are partially common.

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  2. Checked, it does seem that the rule in this case is substantive, however, it is merely an interpretation of the statute. And I’m pretty sure Chevy said something about agency deferral in interpreting the statute governining it where the statute is ambiguous. I don’t have time to look it up atm. Also, as I just showed above, the rule is not inconsistent with the “plain text” of the statute because the statute includes the filing date in the definition of the second type of delay period.

    In any case, this might be a good excuse for congress to step in and take a look at patent matters … and you never know what (AQS, F2F) might find its way into the bill cleaning this up.

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  3. “Already issued patents: 37 C.F.R. ยง 1.705(d) provides a two month deadline for reconsidering the PTO’s calculations.”

    Does anyone know if that 2 year deadline has been the subject of a court’s opinion? If s, please advise. Thanks!

    BTW # 1 I assume treatng the two classes unequally [pending apps v issued patents] is Constitutional…

    BTW #2–The PTO’s maintenace fee website continues to publish future maintenance fees for patents the pto deems EXPIRED under the statute…..

    Reply
  4. Random,

    Perhaps you missed a crucial aspect regarding the beloved Chevron deference (as put so eloquently by the Patent Hawk at the Patent Prospector blog):

    Since at least 1996, the Federal Circuit has held that the PTO is not afforded Chevron deference because it does not have the authority to issue substantive rules, only procedural regulations regarding the conduct of proceedings before the agency. See Merck & Co. v. Kessler, 80 F.3d 1543, 1549-50 (Fed. Cir. 1996).

    Also of interest is the applicability of Chevron when the deference is asked for points “that cannot be reconciled witht he plain text of the statute”.

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  5. No offense, but the amount of Chevron deference this current PTO is due is slightly less than the probability that your patent application will issue the day it is filed.

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  6. And also that the PTO’s interpretation of “the actual number of days the issuance of the patent was delayed” is completely reasonable if you consider that any delay under A does in fact tack on a day of delay under B, but in truth that “extra” day of delay is the exact same day of delay pushed back, that is the nature of a “delay”.

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  7. Looking at the opinion the court seems to err on one major point they say that the problem with the PTO’s interpretation is that it considers the application “delayed” under B during the period “before it has been delayed”. Unfortunately it is on it’s face apparent that any application that does not issue the next day after it is filed (or indeed the day of filing) is necessarily “delayed”. There is no dispute as to that fact.

    Based at least on this error an appeal will be filed. Mark my words. PTO’s interpretation might be unnecessarily heavy handed, but the statute is ambiguous because B includes “to issue a patent within 3 years after the actual filing date of the application in the United States” which specificallhy seems to indicate the period in question involves the filing date as its beginning.

    On first reading everyone would agree with the patentee, but after you read it a few times it becomes more apparent that there is room for Chevron interpretation.

    Reply
  8. All I can say is that, when this change came out around Y2K, I thought PTA checking might become a new billing boon for first year associates, especially for pharma clients. Can anyone confirm whether they have seen time billed to PTA checking activities?

    Reply

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