On September 30, 2008, the U.S. District Court for the District of Columbia issued a decision that changes how the U.S. Patent and Trademark Office (PTO) calculates a patent term adjustment under 35 U.S.C. § 154. Wyeth v. Dudas, No. 07-1492 (D.D.C. 2008).
Under current law, § 154 establishes that a patent term is 20 years from the earliest relevant filing date of a patent application. Because patentees do not benefit from patent term during prosecution, § 154(b)(1) further provides a patent term adjustment (PTA) to account for PTO delays under certain circumstances. For example, the statute provides a one-day extension of term for every day corresponding to an “A delay,” that is, where the PTO fails to meet particular deadlines such as issuing a first Office Action within 14 months, responding to a reply within four months, and so forth. In addition, the statute addresses a “B delay” by giving a one-day extension of term for every day of prosecution that occurs three years after the filing date.
To prevent double-counting, § 154 dictates that, to the extent that “A delays” and a “B delay” overlap, the patent term adjustment “shall not exceed the actual number of days the issuance of the patent was delayed.” § 154(b)(2)(A). The PTO has interpreted this language to mean that a patentee may obtain credit for “A delays” or a “B delay,” whichever is larger, but not A + B. According to the PTO, any period of “B delay” necessarily overlaps with any periods of “A delays.”
In Wyeth, the D.C. District Court overruled the PTO’s interpretation. In short, the court concluded that periods of time only “overlap” if they actually occur on the same day. Thus, if an “A delay” occurs on one day, and a “B delay” occurs on another, a patentee may obtain an extension of A + B days. Consequently, the Wyeth decision could provide greater terms for many patents relating to fields such as biotechnology, pharmaceuticals, and chemistry, where prosecution often lasts more than three years.
Although it is possible that the PTO will appeal this decision, patentees should consider taking immediate relevant action regarding PTAs. Notably, 37 C.F.R. § 1.705 indicates that any request for reconsideration of a final PTA determination by the PTO must be filed within two months after the grant of a patent. Thus, patentees should consider immediately filing such requests for any patents that may benefit from the Wyeth ruling.
At the moment, it is not clear whether any avenue exists at the PTO regarding patents that issued more than two months previously. Section 154 itself, however, indicates that an applicant dissatisfied with a PTO determination regarding PTA may file a civil action in the D.C. District Court within 180 days after a patent issues. § 154(b)(4). Thus, even assuming the PTO fails to provide a means to fix PTAs for patents issuing more than two months earlier, patentees should consider filing a court action in the District of Columbia within 180 days of grant to pursue possible additional term adjustment.
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Sharon R. Barner
Jackie Wright Bonilla