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Wyeth v. Kappos.

Posted in Opinion Commentary by Jake Ward on January 18, 2010

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.