Patent Term Adjustments and Extensions

109 Pages·2014·3.03 MB·English

by  Erika Simon

Presenting a live 90-minute webinar with interactive Q&A
Patent Term Adjustments and Extensions:
Leveraging Exelixis, Novartis, Other
Decisions, and USPTO Rule Changes

THURSDAY, MARCH 13, 2014
1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific
Today’s faculty features:
Donna M. Meuth, Associate General Counsel, Eisai, Andover, Mass.
Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Deborah M. Herzfeld, Of Counsel, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
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Patent Term Adjustments and Extensions:
Leveraging Exelixis, Novartis, Other
Decisions, and USPTO Rule Changes
DONNA MEUTH TOM IRVING DEB HERZFELD

©Copyright Finnegan, 2014
Disclaimer
These materials are public information and have been prepared solely for
educational and entertainment purposes to contribute to the understanding
of U.S. intellectual property law. These materials reflect only the personal
views of the speakesr and are not individualized legal advice and do not
reflect the views of FINNEGAN and EISAI, INC. It is understood that each
case is fact-specific, and that the appropriate solution in any case will vary.
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Patent Term Adjustment and AIA
• AIA SEC. 9: A patentee’s challenge to the
USPTO’s PTA calculation that is filed on or after
September 16, 2011, must be filed with the U.S.
district court for the Eastern District of Virginia
(“ED VA”), instead of the U.S. district court for
the District of Columbia (“D DC”).
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Patents Eligible for PTA
• 37 C.F.R. §1.702 Grounds for adjustment of
patent term due to examination delay under the
Patent Term Guarantee Act of 1999 (original
applications, other than designs, filed on or after
May 29, 2000).

• 37 C.F.R. §1.701 Extension to patent term for
examination delay for utility patent applications
filed on or after June 8, 1995, and before May
29, 2000.

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Importance of Patent Term Adjustment
Nature Biotechnology, 29(9):298-801 (Sept. 2011)
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Three Types of Patent Term Adjustment
35 U.S.C. § 154(b)(1)(A)-(C)
“A Guarantee / A Delay” – “Guarantee of prompt [PTO]
responses”: 1 day of patent term extension for each day of
delay due to the failure of the Patent and Trademark Office
to meet specific deadlines in (i)-(iv) (“14-4-4-4”);

“B Guarantee / B Delay” – “Guarantee of no more than 3-
year application pendency”: 1 day of patent term
extension for each day beyond 3 years from filing until the
patent issues (subject to certain exclusions);

“C Guarantee / C Delay” – “Guarantee or adjustments for
delays due to interferences, secrecy orders, and appeals”:
1 day for each day of the pendency of the proceeding,
order, or review.
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Example of A-Delay
Univ. of Mass. v. Kappos, 903 F.Supp.2d 77 (DDC, Nov. 9, 2012)
File First Office Second Office
14-month 3 Years
application Action Action
April 4, 2006 Feb. 4, 2008
Feb. 4, 2005 July 13, 2007 Feb. 21, 2008
A-Delay 223 days
• First OA was a restriction requirement.
• PTO and UMass agreed there should be new restriction requirement.
• UMass argued that PTA should include 223 days between 1st and 2nd OA
because the first OA was incorrect.
• District Court: No.
• A-delay clock stops when first OA issues.
• No requirement that the first OA be correct.
• A-delay = 465 days.
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