“Judge Reyna explained that the statute clearly imposes two limitations. First, that any applicant-attributable delay ‘be equal’ to the time period in which the applicant fails to reasonably engage in efforts to prosecute. Second, the statute specifically ties patent term adjustment reduction to the time period ‘during which’ the applicant fails to engage in reasonable efforts to prosecute.”
Last week, the U.S. Court of Appeals for the Federal Circuit reversed a ruling of the U.S. District Court for the Eastern District of Virginia, which had affirmed a patent term adjustment (PTA) calculation of the United States Patent and Trademark Office (USPTO). See Supernus Pharmaceuticals, Inc. v. Iancu, No. 2017-1357 (January 23, 2019). The Federal Circuit held that the USPTO cannot count as applicant delay any period of time during which there was no possible action that the applicant could take to reasonably conclude prosecution. A sensible ruling, and one the panel explained was entirely consistent with both the PTA statute and Gilead Sciences, Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015).
To understand the ruling, it is important to travel back to April 27, 2006, the date on which Supernus filed U.S. Patent Application No. 11/412,100 (the ’100 application). After prosecution concluded unsuccessfully, Supernus filed a Request for Continued Examination (RCE) on February 22, 2011. Ultimately, the ’100 application issued on June 10, 2014, as the ’897 patent. The question presented in this appeal deals with how many days of PTA the ‘897 patent was entitled to receive.
On the same day it filed the ’100 application, Supernus also filed international application claiming priority from the ’100 application. This international application ultimately gave rise to European Patent EP2010189 (the EP patent). However, on August 21, 2012, the EPO notified Supernus’s European patent counsel that a Notice of Opposition was filed by Sandoz.
On September 11, 2012, Supernus received a letter from its European patent counsel disclosing the EPO notification and the Sandoz Opposition. On November 29, Supernus submitted a supplemental IDS, informing the USPTO of the Sandoz Opposition and providing the documents cited in the Sandoz Opposition, the Sandoz Opposition itself, the EPO notification, and the letter from Supernus’s European patent counsel.
On September 10, 2013, the USPTO issued a first Office Action responding to Supernus’s RCE. On January 10, 2014, Supernus filed a response. On February 4, 2014, the USPTO issued a Notice of Allowance.
The PTA Calculation
In calculating the PTA, the USPTO found 2,321 days attributable to USPTO delay: 1,656 days for Type A delays (i.e., delay for the USPTO’s failure to meet the mandated statutory response deadlines), and 665 days for Type B delays (i.e., delay for the USPTO’s failure to issue the patent within three years of the application’s filing date). The USPTO then reduced the PTA of 2,321 days by 175 days to account for overlapping Type A and Type B delays, and by 886 days for applicant delay. This led the USPTO to arrive at the total of 1,260-days of PTA.
Of the 886 days attributed to delay by the applicant, 646 days were assessed for the period between the February 22, 2011 filing of the RCE and the November 29, 2012 submission of the IDS. Supernus focused its appeal on this 646-day reduction in the PTA due to what the USPTO characterized as applicant delay in light of Gilead.
Supernus’s most persuasive argument was that, out of the 646-day reduction in PTA between February 22, 2011 and November 29, 2012, it was entitled to at least 546 of those days, which represented the period between its filing of the RCE and the EPO notification of the Sandoz Opposition. In other words, there was no way they did anything to delay prosecution because there was nothing that they could have done, at least until notified about the EPO opposition. The Federal Circuit agreed.
Judge Reyna Rules
The Federal Circuit panel of Judges Reyna, Dyk and Schall concluded that Gilead did not foreclose Supernus’s statutory interpretation of the PTA statute. Supernus argued that any reduction in PTA may not exceed the “time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.” 35 U.S.C. § 154(b)(2)(C)(i). The Federal Circuit reasoned that Gilead “did not hold the regulation was reasonable in reducing PTA for periods during which there was no failure to engage in reasonable efforts to conclude prosecution.”
Judge Reyna, writing for the unanimous panel majority, explained:
In Gilead, Appellant Gilead had two other co-pending patent applications that it disclosed in the supplemental IDS. Gilead could have submitted the supplemental IDS disclosing its co-pending applications when it filed its response to the restriction requirement. Gilead, therefore, involved a period of time during which the applicant could have taken identifiable efforts to conclude prosecution but did not.
In contrast, this case is not about whether efforts taken by Supernus, or those it could have taken, resulted in actual or potential delay. Supernus contends, and the USPTO does not dispute, that Supernus could not have undertaken any efforts to conclude prosecution of the ’100 application during the 546-day period between the filing of the RCE on February 22, 2011, and the EPO’s notification of the Sandoz Opposition on August 21, 2012.
With respect to statutory interpretation, the Federal Circuit did not provide the USPTO with any Chevron deference because the Court found the text of the statute to be plain and unmistakably clear on its face. Judge Reyna explained that the statute clearly imposes two limitations. First, that any applicant-attributable delay “be equal” to the time period in which the applicant fails to reasonably engage in efforts to prosecute. Second, the statute specifically ties PTA reduction to the time period “during which” the applicant fails to engage in reasonable efforts to prosecute.
“A period of time including no identifiable efforts that could have been undertaken cannot be ‘equal to’ the period of failure to undertake reasonable efforts under the terms of the statute,” wrote Judge Reyna.
Without deciding the specific number of days appropriate for PTA, the Federal Circuit held that “the USPTO may not count as applicant delay a period of time during which there was no action that the applicant could take to conclude prosecution of the patent. Doing so would exceed the time during which the applicant failed to engage in reasonable efforts.”
The decision of the Eastern District of Virginia was reversed, and the summary judgment order remanded for further proceeding consistent with the Federal Circuit’s opinion.
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