By Donald Zuhn --
As we reported last month, the District Court for the District of Columbia issued an important decision on September 30th that could impact the manner in which Patent Term Adjustment (PTA) determinations are made. In Wyeth v. Dudas, the District Court granted summary judgment in favor of Wyeth, determining 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 Wyeth 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
Following in Wyeth's footsteps, two patentees recently filed complaints in the District Court for the District of Columbia against USPTO Director Jon Dudas for similar PTA "miscalculations." In particular, San Francisco-based Napo Pharmaceuticals, Inc. filed a complaint on September 5th 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 (see complaint). And just last week, 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 (see complaint). Both complaints question the Office's interpretation that the B delay period begins on the date of an application's filing.
Because 35 U.S.C. § 154(b)(4)(A) specifies that "[a]n applicant dissatisfied with a [PTA] determination made by the Director . . . shall have remedy by a civil action against the Director filed in the United States District Court for the District of Columbia within 180 days after the grant of the patent," neither Napo nor Ironwood could wait to see how the Office reacted to the Wyeth decision (i.e., Napo had until September 7th to file its complaint and Ironwood had until November 7th). Interestingly, Napo filed a Request for Reconsideration on November 6, 2007, which the PTO held in abeyance until after issuance, and then filed a second Request for Reconsideration on May 6, 2008 (within the two-month period specified by Rule 705(d)), which the PTO had still not acted on as of the filing of the complaint. In its second Request, Napo sought the same 1007-day PTA that it seeks in its complaint.
Patent Docs will continue to monitor newly filed actions in the the District Court for the District of Columbia in order to identify other patentees seeking corrected PTA determinations.
For additional information regarding this topic, please see:
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008
Comments