In Wyeth v. Dudas (Civil Action No. 07-1492), the U.S. District Court for the District of Columbia recently found that the U.S. Patent and Trademark Office (USPTO) had misconstrued U.S. law relating to the calculation of patent term extension and, therefore, had denied a patent holder a portion of the patent term to which it is entitled. As a result of the American Inventors Protection Act of 1999, a patentee is entitled to recoup certain periods of delay by the USPTO that occurred during the prosecution of a patent application. However, 35 U.S.C. § 154(b)(2)(A) prevents double counting periods of delay that overlap one another. In Wyeth, the court found that the USPTO’s interpretation of § 154(b)(2)(A) was incorrect. As a result, it may be possible for patent holders to petition for and obtain additional patent term for their patents that had Patent Term Adjustments determined using the incorrect interpretation.
35 U.S.C. § 154(b)(1) provides several adjustments to patent term based on prosecution delays. More specifically, subsection (b)(1)(A) provides for a one-day extension of patent term for every day that the issuance of a patent is delayed by failure of the USPTO to comply with various enumerated statutory deadlines, such as fourteen months for a first office action or four months to respond to an applicant’s reply to an office action. Subsection (b)(1)(B) provides for a one-day extension of patent term for every day greater than three years after the filing date of a patent application that it takes for the patent to issue, regardless of whether the delay is the fault of the USPTO. In its explanation of 35 U.S.C. § 154(b)(2)(A), the USPTO took the position that if an application is entitled to an adjustment under the three-year pendency provision, then the entire period during which the application was pending before the USPTO is the relevant period for determining whether periods of delay are overlapping. In other words, the USPTO reduced any delay following three years of pendency by the amount of other delays.
In Wyeth, the court first found that the USPTO’s construction of the statute is not entitled to any deference because Congress has not delegated authority to the USPTO generally to make rules carrying the force of law (Wyeth at pg. 6). The court then disagreed with the USPTO’s construction of the overlap provision of § 154(b)(2)(A), stating that it considers an application delayed during a period of time before it has been delayed due to the three-year pendency provision (Id. at pp. 8-9). A delay based upon the three-year pendency provision may only be calculated starting on the date that the application has been pending for three years. Further, the court found that the only way that periods of time can overlap is if they occur on the same day (Id. at pg. 8).
The court recognized that delays during the first three years of an application’s pendency may inevitably lead to three-year pendency delays. Thus, although the court appreciated the USPTO’s concern that one cause of delay may be counted twice, the court found that the USPTO’s construction cannot be squared with the language of 35 U.S.C. § 154(b)(1)(B). The court stated that any unintended results of the outcome commanded by the plain text of the statute are for Congress to remedy rather than the USPTO (Id. at pg. 10).
As a result of the decision in Wyeth, it may be possible for patent holders to obtain additional term for recently issued or future-issued patents. The provisions of 37 C.F.R. § 1.705(d) set forth a two-month period from the date that a patent is issued for a patentee to request reconsideration of the patent term adjustment. The USPTO has not indicated whether it will consider Wyeth to have any retroactive effect and, if so, what the deadline for requesting patent term adjustment reconsideration would be for a patent that was issued two or more months earlier than the decision. Additionally, it is not known whether the USPTO will appeal the decision in Wyeth or issue any guidelines regarding the submission of requests for Patent Term Adjustment. While there is no specific time requirement to request Patent Term Adjustment corrections in previously issued patents in view of this decision, petitions for correction of an erroneous term should be filed sooner rather than later to reflect an appropriate level of diligence by the patent holder. Patentees that have any questions about Wyeth or the potential for requesting additional patent term should contact a patent attorney in the near future.