On April 1, 2013, the USPTO published an interim final rule1 implementing various provisions of the AIA Technical Corrections Act (“AIA TCA”).2 This new legislation and its implementing regulations significantly alter how patent term adjustment (“PTA”) is calculated and challenged.3
STREAMLINED PTA DETERMINATION TO REDUCE THE COMPLEXITY AND COST OF CORRECTING PTA ERRORS
One of the most significant changes brought about by the AIA TCA is the streamlining of PTA calculations by the USPTO.
Prior to the enactment of the AIA TCA, there were two points in time at which the USPTO notified an applicant of its PTA calculation. The first occurred with a Notice of Allowance.4 In this instance, the PTA calculation was based on the USPTO’s assumption that the allowed patent would issue on a certain predicted date. An applicant that disagreed with the USPTO’s PTA determination had to file a request for PTA reconsideration on or before the payment of the issue fee.5 However, as it could not be known on what day the patent would issue and whether additional PTA would accrue, a second PTA notification would be provided when the patent actually issued.6 If the PTA printed on the issued patent was still in error, an applicant had to file a second request for reconsideration no later than two months from the date the patent issued. However, this second request for reconsideration could not raise any PTA issues that could have been raised in the first, pre-issuance PTA determination.7
Under the AIA TCA, the USPTO is no longer required to provide a PTA determination when issuing the Notice of Allowance and is instead only required to provide a single PTA determination on or before the patent issuance date.8 The USPTO has indicated it will continue to provide (as it has in the past)9 an indication of the PTA with a patent’s Issue Notification, but the PTA indicated on the patent itself will now serve as the USPTO’s “official” PTA determination.10 A request for reconsideration of this official PTA determination may now be filed up to seven months after the patent grant date.11
The changes discussed above reduce the complexity and thus the costs associated with challenging a PTA. These changes also provide applicants with a longer period of time to decide whether or not to challenge any USPTO errors in calculating PTA.
NEW START DATE FOR USPTO 14-MONTH DEADLINE FOR U.S. NATIONAL STAGE APPLICATIONS
Another significant change brought about by the AIA TCA is that Part A delay for the USPTO’s failure to issue a first office action within 14 months now begins to accrue upon commencement of the U.S. national stage. This occurs when an applicant pays the fee for entry into the U.S. national stage and submits a copy of the international application (and its English translation, if the application was initially filed in a language other than English).12
Prior to the enactment of the AIA TCA, Part A delay for the USPTO’s failure to issue a first office action within the prescribed 14-month period began to accrue on “the date on which an international application fulfilled the requirements of section 371.” This required the submission of: (1) the fee for entry into the U.S. national stage; (2) a copy of the international application and its English translation (if such a translation was necessary)13; (3) amendments to the claims, if any, and their English translation (if necessary); (4) the inventor’s oath or inventor’s declaration; and (5) an English translation of any annexes to the International Preliminary Examination Report, if any such annexes were initially filed in a language other than English.14
This change permits U.S. national stage applicants to delay submission of an executed inventor oath/declaration without risking a loss of potential PTA.
NEW LIMITS ON THE TIMING AND SCOPE OF PTA CHALLENGES
Another significant change brought about by the AIA TCA is the imposition of new limits on the timing and scope of PTA challenges. Patent applicants dissatisfied with the USPTO’s official PTA determination must first file a request for reconsideration with the USPTO Director within seven months of the patent grant date. Applicants then wait for the Director’s decision on this request before filing a civil action in district court under 35 U.S.C. § 154(b)(4). Additionally, the AIA TCA declares that a civil action under 35 U.S.C. § 154(b)(4) is the “exclusive” judicial remedy for a dissatisfied patentee, and it also specifies that such a civil action must be brought in the District Court for the Eastern District of Virginia within 180 days of the date of the Director’s decision on the applicant’s request for PTA reconsideration.15
Prior to the AIA TCA, 35 U.S.C. § 154(b)(4)A) permitted applicants dissatisfied with a PTA determination to bring an action directly in district court within 180 days of the patent grant date. Thus, if the USPTO did not act on a request for PTA reconsideration in a timely fashion, an applicant could still bring an action in district court within 180 days of the patent grant date to address the issue.
However, under the AIA TCA, if the USPTO fails to timely respond to a request for PTA reconsideration, an applicant will have to wait for the Director’s decision prior to filing a civil action in district court under 35 U.S.C. § 154(b)(4). Furthermore, with the insertion of the word “exclusive” into 154(b)(4)(A), it may now be more difficult for an applicant to invoke alternative theories of recovery, such as challenging a PTA determination as an unconstitutional taking, in order to circumvent the timing and administrative exhaustion requirements set forth in the AIA TCA.16
Given the important changes brought about by the AIA TCA, clients with patent applications pending before the USPTO or patents that have been granted on or after January 14, 2013 should review any PTA calculations they have received from the USPTO with great care to ensure that the changes brought about by the AIA TCA have been taken into consideration.