Wyeth v. Kappos.

Section 154(b)’s language is clear, unambiguous, and intolerant of the PTO’s suggested interpretation.  

(Fed. Cir. 2010, 09-1120)

 The CAFC affirmed summary judgment for Wyeth, holding that the USPTO has been calculating patent term adjustments (PTA) under 35 U.S.C. § 154 incorrectly.  

Prior to June 8, 1995, patents were enforceable for 17 years from the date of issuance. As of June 8, 1995, the patent term was changed to 20 years from the filing date.  To mitigate any negative impact on patentees, Congress formulated a number of patent term “guarantees” that results in PTA.  The guarantees are codified as 35 U.S.C. 154(b)(1)(A-C), namely: 

(A) Guarantee of prompt Patent and Trademark Office responses;

(B) Guarantee of no more than 3-year application pendency; and

(C) Gurantee or adjustments for delays due to interferences, secrecy orders, and appeals.

Under its interpretation of the PTA rules, the USPTO had been calculating PTA such that the patentee received the longer of the (A) adjustment or the (B) adjustment under the statute.  Wyeth contended, and the CAFC agreed, that an applicant deserves both the (A) adjustment and the (B) adjustment, minus any time that the adjustments overlap.  In view of the PTA rules, as clarified by the CAFC, Wyeth is entitled to an extra 294 days adjustment for U.S. Pat. No. 7,179,892, and an extra 386 days adjustment for U.S. Pat. No. 7,189,819.

In response to the CAFC decision, the USPTO has issued the following announcement.

On January 7, 2010, the Federal Circuit issued a decision in Wyeth v. Kappos, No. 2009-1120, regarding the calculation of patent term adjustments under 35 U.S.C. 154(b). The Federal Circuit’s decision rejects the USPTO’s interpretation of the “overlap” limitation in Section 154(b)(2)(A). The Solicitor General will determine whether to seek further review of this decision. Pending that determination, the USPTO is in the process of changing the manner it will calculate patent term adjustments under Section 154(b) to conform with the Federal Circuit’s decision.

Applicants and Patent Owners dissatisfied with a patent term adjustment determination by the agency are reminded of the requirement to seek review of that determination within 180 days of patent issuance and the time periods set in the implementing regulations. See 35 USC 154(b)(4) and 37 CFR 1.705.

JW Note:  All applicants with allowed applications that have been pending more than three years, as well as any patentee  whose patent has issued in the last six months, should carefully check any PTA identified by the USPTO against the rules clarified by this decision.  Pertinent PTA calculation rules, and the regulations identified by the USPTO in the above announcement for seeking review of PTA, follow for our readers’ convenience. 

35 U.S.C. § 154 provides certain guarantees that lead to PTA, namely: 

(b) ADJUSTMENT OF PATENT TERM.-

(1) PATENT TERM GUARANTEES.-

(A) GUARANTEE OF PROMPT PATENT AND TRADEMARK OFFICE RESPONSES.- Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to-

(i) provide at least one of the notifications under section 132 of this title or a notice of allowance under section 151 of this title not later than 14 months after- the date on which an application was filed under section 111(a) of this title; or the date on which an international application fulfilled the requirements of section 371 of this title;

(ii) respond to a reply under section 132, or to an appeal taken under section 134, within 4 months after the date on which the reply was filed or the appeal was taken;

(iii) act on an application within 4 months after the date of a decision by the Board of Patent Appeals and Interferences under section 134 or 135 or a decision by a Federal court under section 141, 145, or 146 in a case in which allowable claims remain in the application; or

(iv) issue a patent within 4 months after the date on which the issue fee was paid under section 151 and all outstanding requirements were satisfied, the term of the patent shall be extended 1 day for each day after the end of the period specified in clause (i), (ii), (iii), or (iv), as the case may be, until the action described in such clause is taken.

(B) GUARANTEE OF NO MORE THAN 3-YEAR APPLICATION PENDENCY.- Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application in the United States, not including-

(i) any time consumed by continued examination of the application requested by the applicant under section 132(b);

(ii) any time consumed by a proceeding under section 135(a), any time consumed by the imposition of an order under section 181, or any time consumed by appellate review by the Board of Patent Appeals and Interferences or by a Federal court; or

(iii) any delay in the processing of the application by the United States Patent and Trademark Office requested by the applicant except as permitted by paragraph (3)(C), the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued.

(C) GUARANTEE OR ADJUSTMENTS FOR DELAYS DUE TO INTERFERENCES, SECRECY ORDERS, AND APPEALS.- Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to-

(i) a proceeding under section 135(a);

(ii) the imposition of an order under section 181; or

(iii) appellate review by the Board of Patent Appeals and Interferences or by a Federal court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability, the term of the patent shall be extended 1 day for each day of the pendency of the proceeding, order, or review, as the case may be.

35 USC 154(b)(4) states:

4) APPEAL OF PATENT TERM ADJUSTMENT DETERMINATION.-

(A) An applicant dissatisfied with a determination made by the Director under paragraph (3) 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. Chapter 7 of title 5 shall apply to such action. Any final judgment resulting in a change to the period of adjustment of the patent term shall be served on the Director, and the Director shall thereafter alter the term of the patent to reflect such change.

(B) The determination of a patent term adjustment under this subsection shall not be subject to appeal or challenge by a third party prior to the grant of the patent.

37 C.F.R. § 1.705(b) states:

Any request for reconsideration of the patent term adjustment indicated in the notice of allowance, except as provided in paragraph (d) of this section, and any request for reinstatement of all or part of the term reduced pursuant to § 1.704(b) must be by way of an application for patent term adjustment.  An application for patent term adjustment under this section must be filed no later than the payment of the issue fee but may not be filed earlier than the date of mailing of the notice of allowance.

37 C.F.R. § 1.705(d) states:

If the patent indicates or should have indicated a revised patent term adjustment, request for reconsideration of the patent term adjustment indicated in the patent must be filed within two months of the date the patent issued and must comply with the requirements of paragraphs (b)(1) and (b)(2) of this section.  Any request for reconsideration under this section that raises issues that were raised, or could have been raised, in an application for patent term adjustment under paragraph (b) of this section shall be dismissed as untimely as to those issues.