SUMMARY: On January 7, 2010, the U.S. Court of Appeals for the Federal Circuit affirmed a decision by the U.S. District Court for the District of Columbia that will cause the United States Patent and Trademark Office (PTO) to fundamentally change the manner in which patent term adjustment, under 35 U.S.C. § 154, is calculated. Wyeth v. Kappos, __ F.3d __, 93 U.S.P.Q.2d 1257 (Fed. Cir. 2010), aff’g, Wyeth v. Dudas, 580 F. Supp. 2d 138, 88 U.S.P.Q.2d 1538 (D.D.C. 2008). The PTO has now announced an interim procedure for requesting recalculation of patent term adjustment for recently issued patents affected by the Wyeth v. Kappos decision. In view of the reduced requirements for requesting recalculation of patent term adjustment under the interim procedure, applicants may wish to consider whether they would benefit from recalculation of the patent term adjustment for any patent issued within the last 180 days.  

BACKGROUND: For patent applications filed after May 28, 2000, 35 U.S.C. § 154(b)(1), has provided three guarantees: (A) guarantee of prompt PTO responses; (B) guarantee of no more than three-year application pendency; and, (C) guarantee or adjustments for delays due to interferences, secrecy orders, and appeals.  

The (A) guarantees include: (i) that the PTO will provide a first action on the merits of an application within 14 months of filing; (ii) that the PTO will provide a response to an applicant reply within four months; (iii) that the PTO will act on an application within four months after the date of a decision of the Board of Patent Appeals and Interferences; and, (iv) that the PTO will issue an application within four months of the payment of the issue fee and all other requirements are satisfied. The term of a patent is adjusted one day for each day of PTO delay under the (A) guarantee until the requisite action is taken by the PTO.  

The (B) guarantee provides one day of additional term "for each day after the end of [the] three-year period until the patent is issued" not including any time after a request for continued examination. Time consumed by an interference, appeal, or secrecy order is also excluded from the (B) guarantee as those delays are addressed the (C) guarantee.

The (A) and (B) adjustments are subject to limitations set forth in 35 U.S.C. § 154(b)(2). The limitation at issue in the Wyeth case was that "[t]o the extent that periods of delay attributable to grounds specified in [35 U.S.C. § 154(b)(1)] overlap, the period of any adjustment granted under this subsection shall not exceed the actual number of days the issuance of the patent was delayed." The previous position of the PTO was that any period of delay under the (B) guarantee of not more than a three year pendency was overlapping with any and all periods of delay under the (A) guarantees for purposes of the limits set forth in 35 U.S.C. § 154(b)(2).

The District Court held and the Federal Circuit affirmed that the period of delay under 35 U.S.C. § 154(b)(1)(B) does not start until the expiration of three years of pendency. Therefore, type A delays within the first three years of pendency cannot overlap with any period of B delay, which only begins after three years. The decision in Wyeth v. Kappos means that the PTO will now be required to grant one day of patent term adjustment for each day of delay under the (A) guarantees that occurs in the first three years of pendency in addition to one day of adjustment under the (B) guarantee for each day of pendency after three years.  

THE NEW PROCEDURE: The PTO has announced that neither it nor the Justice Department will seek further review of the Federal Circuit decision in Wyeth. The PTO has submitted a notice for publication in the Federal Register providing details of an interim procedure for requesting recalculation of patent term adjustment.

The interim procedure permits patentees to submit a form to request recalculation of patent term in place of the petition and fee required by 37 C.F.R. § 1.705(d) as long as the patent issued prior to March 2, 2010, and the request is submitted within 180 days after the patent issued. A copy of the announcement may be found on the PTO website at http://www.uspto.gov/patents/announce/pta_wyeth.pdf and has been published in the Federal register at 75 FR 5043 (February 1, 2010). Copies of form PTO/SB/131 will be available on the PTO website at http://www.uspto.gov/forms/index.jsp.

The interim procedure announced by the PTO applies only to patents issued prior to March 2, 2010, where the sole problem to be addressed concerns recalculation under the Wyeth decision. For applications with circumstances that are not addressed by the interim procedures, patentees should rely on the existing statutory and regulatory framework for requesting recalculation of the patent term adjustment. As discussed in our previous advisory of January 28, 2010, if an applicant is not satisfied with the patent term adjustment that has been calculated by the PTO, there are three opportunities to seek review and reconsideration of the patent term adjustment.  

The PTO issues an estimate of patent term adjustment with each notice of allowance. Thus, the first window for review and reconsideration arises under 37 C.F.R. § 1.705(b), whereby "any request for reconsideration of the patent term adjustment indicated in the notice of allowance must be by way of an application for patent term adjustment … filed no later than the payment of the issue fee … ." Such requests must be accompanied by the fee and contain the statements of fact set forth in 37 C.F.R. § 1.705(b)(1) & (b)(2).

The second window for review and reconsideration arises under 37 C.F.R. § 1.705(d), whereby "if the patent indicates or should have indicated a revised patent term adjustment, any request for reconsideration of the patent term adjustment indicated in the patent must be filed within two months of the date the patent issued." This second window cannot be used to raise issues that should have been raised at the time that the issue fee was raised.

Thus, for example, if a patent is entitled to a (B) time adjustment that is dependant on the actual date of issuance, and the PTO has not, or does not, correctly calculate the adjustment on the face of the patent, then a petition under 35 U.S.C. § 1.705(d) within two months of the issue date that raises an issue related to the calculation of the (B) time adjustment should be timely. The estimated patent term adjustment provided with the notice of allowance purports to be based upon a projected issue date. In the past, the PTO has returned petitions filed at the time the issue fee was paid that raised an issue of (B) time adjustments based upon the projected issue date as premature and indicated that the appropriate time to raise such issues is the time period set forth in 37 C.F.R. § 1.705(d).  

The interim procedure announced by the PTO may not be used to request a reconsideration of the patent term adjustment indicated in the notice of allowance. Therefore, the procedure cannot be used to request reconsideration of the patent term adjustment of allowed, but not yet issued, applications entitled to both type (A) adjustment for delays by the PTO within the first three years and type (B) adjustment for pendency in excess of three years, but in which a first request for continued examination (RCE) was filed after three years of pendency. For such applications, the amount of (B) adjustment is cut off at the time the RCE is filed and is no longer dependent on the issue date. Under these circumstances, an applicant can and should file a petition under 37 C.F.R. § 1.705(b). It is unclear how the PTO will treat requests under the interim procedure for recalculation of patent term adjustment filed after such applications have issued. Under 37 C.F.R. § 1.705(d), if a patent is entitled to a (B) time adjustment, but that adjustment is not dependent on the date of issue because a request for continued examination in the application has cut off accrual of (B) time, then the PTO may consider a request for reconsideration of the patent term adjustment after the issuance of the patent to be untimely.  

The announcement indicates that the PTO is deciding any currently pending requests for reconsideration in accordance with the Wyeth decision. If a patentee has received an adverse decision under the pre-Wyeth interpretation may request reconsideration within two months. If the sole basis for requesting reconsideration of the decision is the Wyeth decision, then the request need only state that reconsideration is being requested in view of the Federal Circuit's decision in Wyeth.

The third and final window for seeking review of the PTO calculation of patent term adjustment expires 180 days after the issue date of the patent. Under 35 U.S.C. § 154(b)(4)(A), "an applicant dissatisfied with a determination made by the [PTO] shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent."