By Donald Zuhn --
Shortly before leaving the U.S. Patent and Trademark Office, former Director Jon Dudas was served with three last complaints from patentees seeking additional Patent Term Adjustment (PTA) for their patents. The three complaints bring the number of 35 U.S.C. § 154(b)(4)(A) actions to 14, involving 15 patentees and 21 separate patents (including Wyeth and Elan Pharma International Ltd., which secured a favorable decision against the Director with regard to two of their patents on September 30, 2008).
The most recent additions to the growing list of patentees that have filed complaints under § 154(b)(4)(A) include:
• Bayer Bioscience GmbH and Max-Planck-Gesellschaft zur Foderung der Wissnschaften eV of Berlin, Germany, which filed a complaint on January 15, 2009 asserting that the correct PTA for U.S. Patent No. 7,402,420 (which issued July 22, 2008) should be 667 days rather than the 259-day period determined by the Office (see complaint);
• Syntonix Pharmaceuticals, Inc. of Waltham, MA, which filed a complaint on January 16, 2009 asserting that the correct PTA for U.S. Patent No. 7,404,956 (which issued July 29, 2008) should be 752 days rather than the 423-day period determined by the Office (see complaint); and
• The General Hospital Corporation of Boston, MA, which filed a complaint on January 16, 2009 asserting that the correct PTA for U.S. Patent No. 7,367,341 (which issued May 6, 2008) should be 515 days rather than the 214-day period determined by the Office (see complaint).
As noted in our previous reports regarding complaints filed under § 154(b)(4)(A), this section 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." Interestingly, General Hospital Corp. becomes the first patentee to seek additional PTA for a patent that issued more than 180 days prior to the filing of its complaint (the deadline for filing a complaint under § 154(b)(4)(A) for a patent issuing on May 6, 2008 was November 2, 2008). (While Biogen and Molecular Insight Pharmaceuticals filed § 154(b)(4)(A) actions on December 1, 2008 -- rather than November 30, 2008 -- for patents that issued on June 3, 2008, November 30th was a Sunday, and therefore, their complaints were timely filed under Fed. R. Civ. P. 6(a)(3).)
In its complaint, General Hospital Corp. contends that the complaint was timely filed in view of the doctrine of equitable tolling. In particular, the complaint states that "[the District Court for the District of Columbia's] decision in Wyeth v. Dudas constituted a change in the law sufficient to invoke the doctrine of equitable tolling to allow for the filing of this complaint at this time." The doctrine of equitable tolling preserves a plaintiff's claims when strict application of the statute of limitations would be inequitable.
Patentees who were unable to file complaints within the 180-day deadline proscribed by § 154(b)(4)(A) will no doubt be watching with great interest to see whether the District Court permits General Hospital Corp. to move forward with its case despite missing the 180-day deadline by 76 days. Whether the District Court gives any weight to the fact that Wyeth was decided 34 days before General Hospital Corp.'s 180-day deadline will also be of interest. Of course, even if the District Court were to refuse to apply the doctrine of equitable tolling in this case, whether the doctrine could be applied in a case involving a patent issuing on or before April 1, 2008 (i.e., more than 180 days before the Court's decision in Wyeth v. Dudas) would remain an open question. While awaiting the Court's decision in General Hospital Corp. v. Dudas, patentees seeking additional PTA would be wise to file their complaints within the 180-day deadline.
Patent Docs will continue to monitor newly filed actions in the District Court for the District of Columbia in order to identify other patentees seeking corrected PTA determinations. A recent search of the District Court for the District of Columbia case management electronic case filing system indicated that no complaints have yet been filed against Acting Director John Doll.
For information regarding this topic, please see:
• "Three More Patentees File § 154(b)(4)(A) Actions against Director Dudas," January 12, 2009
• "Top Stories of 2008: #13 to #10," January 1, 2009
• "More Patentees Follow Wyeth's Lead in Seeking Additional PTA," December 3, 2008
• "USPTO to Appeal Wyeth v. Dudas," December 2, 2008
• "Two Patentees Follow Wyeth's Lead in Seeking Additional PTA," November 12, 2008
• "Wyeth v. Dudas (D.D.C. 2008)," October 16, 2008
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