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« USPTO Extends Missing Parts Pilot Program Once Again | Main | Allergan, Inc. v. Athena Cosmetics, Inc. (Fed. Cir. 2013) »

January 15, 2014

Comments

Don,

This ruling is hugely troubling. I'll grant that this ruling by the Federal Circuit panel regarding RCEs and/or appeals periods not adding to B period PTA is plausible based on how the PTA statute is worded. But it frankly flies in the face of the INTENT of the PTA statute to not have the USPTO "sandbag" the applicant, consume patent term, and have the applicant be unable to have recourse to recapture the patent term lost due to USPTO delay.

Most significantly, this ruling raises a HUGE practical concern that the USPTO could, for example, delay issuance of the substantive Office Action and then simply unreasonably (and improperly) frustrate the applicant into filing an RCE and/or appeal, thus stretching out the prosecution indefinitely with no PTA recourse and no legal “stick” to get the USPTO to act in a reasonable and timely fashion. For drug makers like Novartis, this ruling is especially bad.

I do hope Novartis asks for a rehearing en banc because this issue on PTA is too important to be based simply on single Federal Circuit panel of 3 judges. I'm also surprised that Newman went along with Taranto's opinion (I'm not surprised that Dyk did).

Don,

After reviewing carefully the B period provision of the PTA statute, as well as the ED of Va opinion in Exelixis, the more I become convinced that, while this Federal Circuit panel’s reading of the B period provision is plausible, it isn't the best, or in my opinion, correct reading of it. This panel's reading is especially in conflict with the intent of the B period provision to not have patent term consumed due to delays caused by the USPTO (rather than by the applicant) in issuing the patent within 3 years of the filing date.

If you read the "not including" exclusion language of the B period provision in context, these exclusions all relate to actions taken by the applicant that will delay issuance of the patent in this 3-year window. That's very apparent from the third exclusion which relates to "any delay in the processing of the application by the [USPTO] requested by the applicant." In other words, if, for example, the applicant filed an RCE within that 3-year window, that would be treated presumptively as a "delay by applicant" that caused the patent to not issue within 3 years of the filing date. In fact, and using the example of the RCE, you might also interpret these B period exclusions to be tolled (as the Federal Circuit panel apparently did) once the RCE period ends (e.g., there is a Notice of Allowance). In sum, I agree with how the ED of VA ruled in Exelixis that these exclusions are applicable to B period PTA only when they occur within that 3-year window.

I do hope Novartis requests rehearing en banc, and that the Federal Circuit grants it. Leaving this panel ruling as it is has huge, negative consequences for patent prosecution, and is simply not how this B period provision should be properly interpreted.

There are other inherent problems in the decision.

For example, the decision stresses the point about how the legislative intent was to hold the Office accountable for its delays.

The period of time after allowance and before issue was thus excused.

But what about other times during the RCE process that the Office is STILL responsible for the delays? Those delays are not accounted for, even though such delays - if they were to happen outside of an RCE would count (which mirrors the logic used by the court).

Did the court notice this logic breakdown?

I am...

@ Skeptical--also if you look at how the PTO calculates PTA at present (i.e., prior to Novartis v. Lee), they dock Applicant for delay during the NOA to issue period (at least in a case that I have) if for example any petitions are filed, even though the PTO itself is not docked for any delays during this same period.

Note for anyone looking to file a Request for Reconsideration of PTA--37 CFR 1.705(b) seems to have been modified by the interim final rule "Revisions to Patent Term Adjustment" (Fed. Reg. v. 78, no.62, April 1, 2013), but I cannot find a 'final' final rule...??? Also note the online MPEP 1.705 available via the PTO website does not include the changes from the interim final rule, although I have noticed the e-version of the MPEP is out of date in a number of places. So I'm not sure exactly what rule to follow in filing a Request for Reconsideration. Then again, maybe that's the way the PTO wants it ;)

Clark:

I would recommend that practitioners and applicants refer to the version of 37 CFR that is posted on the Government Printing Office website. The GPO's version of 37 CFR appears to be updated as soon as rules changes take effect.

Also, I have not been able to locate a "final rule" for the "interim final rule" that was published on April 1, 2013. Last fall, I spoke with someone at the USPTO who confirmed that the version of § 1.705 that appeared in the final rule was in effect.

Thanks for the comment,

Don

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