Source: https://www.patentdocs.org/2009/01/three-more-patentees-file-154b4a-actions-against-director-dudas.html
Timestamp: 2019-09-22 08:00:34
Document Index: 118252803

Matched Legal Cases: ['§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154', '§ 154']

Patent Docs: Three More Patentees File § 154(b)(4)(A) Actions against Director Dudas
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Three More Patentees File § 154(b)(4)(A) Actions against Director Dudas
Last month, Medarex, Inc., Eurand, Inc., and Alexion Pharmaceuticals, Inc. joined the growing list of patentees that have filed complaints against U.S. Patent and Trademark Office Director Jon Dudas alleging that the Patent Office miscalculated the Patent Term Adjustment (PTA) for their patents. Medarex, Eurand, and Alexion became the eighth, ninth, and tenth patentees to file suit against Director Dudas seeking revised PTA determinations.
As we reported last fall, the District Court for the District of Columbia issued an important decision that impacts the manner in which PTA determinations are made (see "Wyeth v. Dudas (D.D.C. 2008)"). In Wyeth v. Dudas, the District Court determined that the USPTO 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 + B delay - A delay that overlaps with B delay - applicant's delay
While the District Court's decision in Wyeth specifically impacts only the two patents that were at issue in that case (U.S. Patent Nos. 7,179,892 and 7,189,819), the decision has had a significant, albeit indirect, impact by raising awareness concerning the Patent Office's flawed interpretation of § 154(b)(2)(A). In addition, 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" (emphasis added), patentees finding themselves in Wyeth's position have had little choice but to file complaints seeking revised PTA determinations or risk waiving the additional patent term. Prior to the new filings, the list of patentees filing complaints included:
• Complaint filed on August 16, 2007 -- Wyeth seeks additional 294 days of PTA for U.S. Patent No. 7,179,892, and additional 230 days of PTA for U.S. Patent No. 7,189,819;
• September 5, 2008 -- Napo Pharmaceuticals, Inc. seeks additional 554 days of PTA for U.S. Patent No. 7,341,744;
• November 7, 2008 -- Ironwood Pharmaceuticals, Inc. seeks additional 291 days of PTA for U.S. Patent No. 7,371,727;
• November 28, 2008 -- Solvay Pharmaceuticals GmbH seeks additional 99 days of PTA for U.S. Patent No. 7,381,729;
• December 1, 2008 -- Biogen Idec Inc. seeks additional 649 days of PTA for U.S. Patent No. 7,381,560;
• December 1, 2008 -- Purac Biochem B.V. seeks additional 563 days of PTA for U.S. Patent No. 7,410,556;
• December 1, 2008 -- Molecular Insight Pharmaceuticals, Inc. seeks 669 days of PTA for U.S. Patent No. 7,381,399; and
• December 1, 2008 -- Molecular Insight Pharmaceuticals, Inc. seeks 669 days of PTA for U.S. Patent No. 7,381,745.
The most recent additions to the above list include:
• Medarex, Inc. of Princeton, NJ, which filed a complaint on December 12, 2008 asserting that the correct PTA for U.S. Patent No. 7,387,776 (which issued June 17, 2008) should be 521 rather than the 231-day period determined by the Office (see complaint);
• Eurand, Inc. of Vandalia, OH, which filed a complaint on December 12, 2008 asserting that the correct PTA for U.S. Patent No. 7,387,793 (which issued June 17, 2008) should be 655 days rather than the 470-day period determined by the Office (see complaint); and
• Alexion Pharmaceuticals, Inc. of Chesire, CT, which filed a complaint on December 23, 2008 asserting that the correct PTA for:
• U.S. Patent No. 7,393,648 (which issued July 1, 2008) should be 758 days rather than the 462-day period determined by the Office (see complaint);
• U.S. Patent No. 7,396,917 (which issued July 8, 2008) should be 654 days rather than the 413-day period determined by the Office (see complaint);
• U.S. Patent No. 7,399,594 (which issued July 15, 2008) should be 990 days rather than the 512-day period determined by the Office (see complaint);
• U.S. Patent No. 7,408,041 (which issued August 5, 2008) should be 306 days rather than the 258-day period determined by the Office (see complaint);
• U.S. Patent No. 7,414,111 (which issued August 19, 2008) should be 870 days rather than the 549-day period determined by the Office (see complaint);
• U.S. Patent No. 7,427,665 (which issued September 23, 2008) should be 812 days rather than the 379-day period determined by the Office (see complaint); and
• U.S. Patent No. 7,435,412 (which issued October 14, 2008) should be 1,012 days rather than the 343-day period determined by the Office (see complaint).
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.
• "Top Stories of 2008: #13 to #10," January 1, 2009
Posted at 11:57 PM in District Court, Patent Office Rules & Procedures | Permalink