Idera Pharmaceuticals is challenging recently enacted interim procedures1 for revising patent term extensions as being inequitable.2 The U.S. Patent and Trademark Office ("Patent Office") established the interim procedures in response to the recent Federal Circuit ruling in Wyeth v. Kappos.3 Under the interim procedures, the two month time period to request reconsideration of patent term adjustment is being extended to 180 days. This 180 day deadline, however, is being challenged. Click here for more background on the interim procedures.
Idera filed suit on January 29, 2010, asserting that the Patent Office calculation ("Patent Office new math") truncated extension days from two of their patents and challenging the equity of the interim procedures. Idera alleges in the complaint that the Wyeth decision "constitutes a change in law sufficient to invoke the doctrine of equitable tolling" with regard to the '554 patent.4 Equitable tolling, as explained by the Federal Circuit in a previous case5 on the doctrine, will not allow a statue of limitations to run against a plaintiff who is unaware of its possible cause of action.
Idera's patents at issue are U.S. Patent No. 7,569,554 (the '554 patent) and U.S. Patent No. 7,517,862 (the '862 patent). Idera contends the '862 patent should receive 1,174 days of extension rather than the 594 days as originally miscalculated by the Patent Office. Idera notes in the complaint that the '554 patent is subject to a terminal disclaimer in light of the '862 patent, and thus, the permissible patent term adjustment of the '554 patent is dependent on the term of the '862 patent. Absent the terminal disclaimer, the '554 patent would be due 1,275 days of extension instead of the 722 days per the original Patent Office's new math method. Idera concludes the '554 patent should be granted a 606 day patent term extension to match the term of the '862 patent. The '554 patent issued August 4, 2009, within 180 days of January 29, 2010, and thus entitled to consideration for a revised patent term extension under the interim procedures. The '862 patent on the other hand, issued April 14, 2009, outside the 180 day window, and not currently reviewable under the interim procedures. The doctrine of equitable tolling, argues Idera, supersedes the Patent Office's interim procedures to dictate the '862 patent term extension should be reviewable and, therefore, properly recalculated.
A significant issue that is likely to be decided in this action is: when did Idera's cause of action arise? Idera has taken the position that its cause of action arose on January 7, 2010 when the Wyeth opinion informed patent owners and the Patent Office how patent term extensions should be calculated. The Patent Office, however, is likely to argue that prior to the Wyeth ruling, patent owners had opportunity for reconsideration and appeal of unfavorable patent term extensions under 35 U.S.C. § 154(b)(3) and 154(b)(4). Idera had the same opportunity for redress available to and taken by Wyeth in its action. Thus, the Patent Office may respond that Idera was aware of its cause of action when their Request for Reconsideration of Patent Term Adjustment was dismissed. Aware a cause of action was available, a civil action against the director should have been brought within the allotted 180 day time period.6
If Idera is successful with its arguments based on the doctrine of equitable tolling, patent owners may ultimately recapture portions of patent terms errantly truncated by the Patent Office's new math. Until that issue is settled, patent owners should continue diligently analyzing all patents issued within the past 180 days for eligibility of term extension recalculation under the interim procedures. Because a ruling of equitable tolling may favorably affect all patent term extensions determined after the promulgation of 37 C.F.R § 1.703(f) by the Patent Office, i.e., after May 24, 2004; patent owners should also consider reviewing all patents issued since that date.