By Donald Zuhn --
Last Friday, U.S. Patent and Trademark Office Director Jon Dudas filed a Notice of Appeal in the District Court for the District of Columbia appealing the Court's September 30th decision in Wyeth v. Dudas to the United States Court of Appeals for the District of Columbia Circuit. Director Dudas challenges District Judge James Robertson's grant of summary judgment to plaintiffs Wyeth and Elan Pharma International Ltd. and denial of summary judgment to Director Dudas.
As we reported in October, the Wyeth decision could have a significant impact on the manner in which Patent Term Adjustment (PTA) determinations are made. In particular, the Wyeth Court determined that the U.S. Patent and Trademark Office had misconstrued 35 U.S.C. § 154(b)(2)(A), and as a result, had denied Wyeth a portion of patent term to which it was entitled under U.S. Patent Law.
At issue in the case was the interplay, under § 154(b)(2)(A), between the patent term guarantee provision of § 154(b)(1)(A) that provides a one-day extension of patent term for every day that the issuance of a patent is delayed by the failure of the USPTO to comply with various enumerated statutory deadlines ("A delay") and the patent term guarantee provision of § 154(b)(1)(B) that provides a one-day term extension for every day greater than three years after the filing date that it takes for the patent to issue ("B delay"). According to the Patent Office's interpretation of § 154(b)(2)(A), the start of the B delay period is an application's filing date rather than the date occurring three years after the application's filing date, and as a result, any A delay occurring during the first three years of prosecution would overlap with any B delay the application might accumulate. Thus, under the USPTO's procedure for determining PTA, "the applicant gets credit for 'A delay' or for 'B delay,' whichever is larger, but never A + B." The Wyeth Court determined, however, that the proper formula for determining PTA is:
A delay plus B delay less A delay that overlaps with B delay less applicant's delay
In November, we reported that two patentees had followed in Wyeth's footsteps by filing complaints in the District Court for the District of Columbia against Director Jon Dudas for similar PTA "miscalculations." On September 5th, San Francisco-based Napo Pharmaceuticals, Inc. filed a complaint asserting that the correct PTA for U.S. Patent No. 7,341,744 (issued March 11, 2008) is 1007 days rather than the 453-day period calculated by the Patent Office. On November 7th, Ironwood Pharmaceuticals, Inc. of Cambridge, MA filed a complaint asserting that the correct PTA for U.S. Patent No. 7,371,727 (issued May 13, 2008) is 702 days rather than the 411-day period determined by the Office. Both complaints question the Office's interpretation that the B delay period begins on the date of an application's filing.
We thank the Patent Docs reader who brought the Director's Notice of Appeal to our attention.
For additional information regarding this and other related topics, please see:
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008
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