Federal Circuit Affirms Patent-Term Adjustment For Alzheimer’s Drug Patent

MARK TERRY, ESQ.

The Federal Circuit affirmed a district court ruling that extended the term of a Wyeth Alzheimer’s drug patent because of delay by the U.S. Patent and Trademark Office.

The dispute concerned how patent-term adjustment should be calculated under 35 U.S.C. § 154(b). The USPTO argued for a narrower calculation that would have produced a shorter extension, while Wyeth maintained that the statute entitled it to additional days.

The Federal Circuit rejected the USPTO’s interpretation and affirmed the longer adjustment. The decision therefore has precedential importance for how the agency calculates delay-based extensions.

Patent owners should carefully review the patent-term adjustment shown on an issued patent and compare it with the governing statute and relevant precedent. An incorrect calculation can shorten the enforceable life of a valuable patent.

The issue is especially important in the pharmaceutical industry, where even a small number of additional patent days can represent substantial revenue and market exclusivity.