New USPTO Procedures PTA Under Supernus

09 May 2019 PharmaPatents Blog
Authors: Courtenay C. Brinckerhoff

The USPTO has announced new procedures patent holders can follow to obtain additional Patent Term Adjustment (PTA) under the Federal Circuit’s January 2019 decision in Supernus Pharm., Inc. v. Iancu. According to the May 9, 2019, Federal Register Notice, patent owners can request reconsideration of PTA awards that are based on a deduction for “applicant delay” during a period of time when “there was no identifiable effort” the patentee could have taken to avoid the delay. The USPTO is not providing a new window for requesting reconsideration of PTA on this basis, but a request for reconsideration still could be filed for patents granted within the past seven months.

The Supernus PTA Decision

In Supernus, the USPTO had charged a PTA deduction for an IDS filed November 29, 2012 after an RCE filed February 22, 2011. The USPTO had charged the entire 646 day period as “applicant delay,” even though the IDS submitted information from an Opposition in a related European application that the EPO did not issue notice of until August 21, 2012. The Federal Circuit “agree[d] with Supernus that there were no efforts that it could have taken in the period of time during the preceding 546 days,” and 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.”

Read my full article on Supernus here.

In its Federal Register Notice, the USPTO states that “the Federal Circuit restricted the patent term adjustment reduction … to 100 days, corresponding to the period between the notice issued by the EPO on August 21, 2012 and the filing of the [IDS] on November 29, 2012.” However, I think it is important that Supernus had conceded delay during this period. The Federal Circuit was not asked to, and did not, consider the earliest date on which Supernus might have been able to take action.

The New Supernus PTA Procedures

As set forth in the Federal Register Notice, because the availability of additional PTA under Supernus may depend on events that are not in the USPTO Patent Application Locating and Monitoring (PALM) system for the patent at issue, the USPTO will not apply Supernus in its initial PTA determinations. Instead, the USPTO is requiring that patent owners file a request for reconsideration of PTA awards to benefit from the Supernus decision.

According to the Notice, “the request for reconsideration must provide any relevant information, including factual support, which is not recorded in the USPTO’s PALM system to show that there was no identifiable effort the patentee could have undertaken to conclude prosecution” during the time period at issue. The Notice draws a distinction between the new “no identifiable effort” standard and situations involving a justified failure to engage in efforts that could have been taken, which are encompassed by 35 USC § 154(b)(3)(C) and 37 CFR § 1.705(c), and submitting a showing before the patent is granted.

As noted above, the USPTO is not providing a new window for requesting reconsideration of PTA under Supernus, but notes in the Notice that a request for reconsideration of PTA can be filed “as late as seven months after the date the patent was granted” by paying the maximum (five month) extension of time fees.

Paying For A PTA Award In Accordance With Law

It is frustrating that the USPTO is implementing procedures that require affected patent owners to pay extra to obtain a PTA award that is in accordance with law. The Notice attempts to justify this requirement by explaining that it does not have all the information it needs in its PALM system, and by asserting that delays as extensive as those at issue in Supernus “should be a rare occurrence,” but there is no excuse for deliberately implementing new procedures that require patent owners to pay $200 for a corrected PTA calculation. Indeed, it is puzzling that the USPTO did not implement a procedure similar to the new procedures for flagging an IDS filed with a 37 CFR § 1.704(d) certification and permitting patent owners to request recalculation of PTA on that basis without requiring the $200 request for reconsideration fee.

Perhaps someone will challenge these new procedures as arbitrary and capricious and contrary to law themselves.

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