The Federal Circuit recently decided Wyeth and Elan Pharma Int’l Ltd. v. Kappos (Appeal No. 2009-1120, January 7, 2010) affirming that the United States Patent and Trademark Office (USPTO) has been miscalculating, and typically under-calculating, patent term adjustment. Patent term adjustment extends the effective term of a patent due to delays in its issuance. Under 35 U.S.C. § 154(b), a patent can receive a term adjustment for, among other things, (A) delays caused by the USPTO in meeting certain examination deadlines and (B) each day that issuance of the patent is delayed longer than 3 years due to delays by the USPTO. These delays are subject to an “overlap limitation,” which says the “the period of any adjustment granted…shall not exceed the actual number of the days the issuance of the patent was delayed.” The dispute in this case centered on the interpretation of how to calculate the actual number of days the issuance of the patent was delayed in an overlap situation.
Previous to this case, if there were any overlaps in delays, the USPTO would simply adjust the patent term by the greater of the A and B delays. For example, if the A delay was 610 days, the B delay was 345 days, and there were 51 days of overlap, the USPTO would grant a patent term adjustment of 610 days. However, the Federal Circuit determined that the patent term adjustment should instead be calculated by adding the A and B delays and subtracting the actual number of days overlapping. For example, if the A delay was 610 days, the B delay was 345 days, and there were 51 days of overlap, the patent term adjustment should be 904 days (610 + 345 – 51). As a result, the decision may give many patent holders an increase in patent term.
In response to the Wyeth decision, the USPTO issued a notice indicating that the Solicitor General will not seek further review of the decision, and that 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 dissatisfied with a patent term adjustment determination by the USPTO can seek review of that determination either by: (1) in response to a notice of allowance and before payment of the issue fee, filing a request for reconsideration of the patent term adjustment under 37 CFR 1.705 or (2) within 180 days of patent issuance, suing the USPTO in the United States District Court for the District of Columbia pursuant to 35 USC § 154(b)(4). Under some circumstances, it is also possible to request reconsideration of the PTA within 2 months of the issue date of a patent pursuant to 37 CFR 1.705(d).
A copy of the Wyeth opinion can be found on the Federal Circuit’s website at the following link.