Grant of Interim Extension of the Term of U.S. Patent No. 7,199,162-GRAFAPEXTM (Treosulfan), 79899 [2024-22480]
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Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices
Notification to Interested Parties
We are issuing and publishing these
results in accordance with sections
751(a)(1) and 777(i)(1) of the Act and 19
CFR 351.221(b)(4).
Dated: September 6, 2024.
Abdelali Elouaradia,
Deputy Assistant Secretary for Enforcement
and Compliance.
Appendix
List of Topics Discussed in the Preliminary
Decision Memorandum
I. Summary
II. Background
III. Scope of the Order
IV. Discussion of the Methodology
V. Currency Conversion
VI. Recommendation
[FR Doc. 2024–22521 Filed 9–30–24; 8:45 am]
BILLING CODE 3510–DS–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2024–0047]
Grant of Interim Extension of the Term
of U.S. Patent No. 7,199,162—
GRAFAPEXTM (Treosulfan)
United States Patent and
Trademark Office, Commerce.
ACTION: Notice of interim patent term
extension.
AGENCY:
khammond on DSKJM1Z7X2PROD with NOTICES
Charles Kim,
Deputy Commissioner for Patents, United
States Patent and Trademark Office.
[FR Doc. 2024–22480 Filed 9–30–24; 8:45 am]
The United States Patent and
Trademark Office has issued a
certificate for a one-year interim
extension of the term of U.S. Patent No.
7,199,162.
FOR FURTHER INFORMATION CONTACT:
Kathleen Kahler Fonda, Senior Legal
Advisor (telephone (571) 272–7754;
email kathleen.fonda@uspto.gov).
Alternatively, mail may be addressed to
Commissioner for Patents, Mail Stop
Hatch-Waxman PTE, P.O. Box 1450,
Alexandria, VA 22313–1450, and
marked to the attention of Ms. Fonda.
SUPPLEMENTARY INFORMATION: Section
156 of title 35, United States Code,
generally provides that the term of a
patent may be extended for a period of
up to five years if the patent claims a
product, or a method of making or using
a product, that has been subject to
certain defined regulatory review, and
that the patent may be extended for
interim periods of up to one year if the
regulatory review is anticipated to
extend beyond the expiration date of the
patent.
On August 20, 2024, Medac
Gesellschaft für Klinische
Spezialpräparate mbH, the patent owner
of record, timely filed an application
SUMMARY:
VerDate Sep<11>2014
17:42 Sep 30, 2024
Jkt 265001
under 35 U.S.C. 156(d)(5) for a fourth
interim extension of the term of U.S.
Patent No. 7,199,162. The patent claims
a method of using the human drug
product GRAFAPEXTM (treosulfan). The
application for patent term extension
indicates that New Drug Application
214759 was submitted to the Food and
Drug Administration on August 11,
2020, and its review in order for the
patent owner to obtain permission to
market and use the product
commercially is ongoing.
Review of the patent term extension
application indicates that, except for
permission to market or use the product
commercially, the subject patent would
be eligible for an extension of the patent
term under 35 U.S.C. 156, and that the
patent should be extended for one year
as required by 35 U.S.C. 156(d)(5)(B).
Because the regulatory review period
will continue beyond the thriceextended expiration date of the patent,
October 12, 2024, interim extension of
the patent term under 35 U.S.C.
156(d)(5) is appropriate.
A fourth interim extension under 35
U.S.C. 156(d)(5) of the term of U.S.
Patent No. 7,199,162 is granted for a
period of one year from the thriceextended expiration date of the patent.
BILLING CODE 3510–16–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO–P–2024–0051]
Extension and Termination of the After
Final Consideration Pilot Program 2.0
United States Patent and
Trademark Office, Department of
Commerce.
ACTION: Notice.
AGENCY:
On April 3, 2024, the United
States Patent and Trademark Office
(USPTO), when setting and adjusting
patent fees for fiscal year 2025,
proposed a new fee to recuperate costs
affiliated with the submission of a
request for consideration under the
After Final Consideration Pilot Program
2.0 (AFCP 2.0). Commenters on the
proposal expressed concerns about the
AFCP 2.0 and the proposed fee. In view
of these comments, the USPTO has
decided to allow AFCP 2.0 to expire.
While the program currently runs
through September 30, 2024, to
accommodate those who may be in the
SUMMARY:
PO 00000
Frm 00015
Fmt 4703
Sfmt 4703
79899
process of preparing to use the program,
the USPTO will provide a short
extension of the expiration of the
program. The USPTO is setting
December 14, 2024, as the last day to
submit a request for participation under
the program.
DATES: The USPTO will not accept
requests for consideration under the
AFCP 2.0 filed after December 14, 2024.
FOR FURTHER INFORMATION CONTACT: Kery
Fries, Senior Legal Advisor, at 571–272–
7757; or Raul Tamayo, Senior Legal
Advisor, at 571–272–7728, both with
the Office of Patent Legal
Administration, Office of the Deputy
Commissioner for Patents.
SUPPLEMENTARY INFORMATION: On May
19, 2013, the USPTO modified the After
Final Consideration Pilot Program
(AFCP) to create the AFCP 2.0. The
three main differences between the
AFCP and the AFCP 2.0 are: (1) an
applicant must request to participate in
AFCP 2.0; (2) a response to an after final
rejection under AFCP 2.0 must include
a non-broadening amendment to at least
one independent claim; and (3) the
examiner will schedule an interview
with the applicant if the after-final
response did not result in a
determination by the examiner that all
pending claims in the application were
in condition for allowance.
The goal of the AFCP 2.0 was to
improve pendency by reducing the
number of Requests for Continued
Examination (RCE) and encourage
increased collaboration between the
applicant and the examiner to
effectively advance prosecution of the
application. The AFCP 2.0 does not
require any additional fees for an
applicant to request consideration of an
amendment after final rejection, but any
necessary existing fee, e.g., the fee for an
extension of time, is required. Initially,
the pilot program was scheduled to run
for approximately one year and was set
to end on September 30, 2014. The
USPTO notified the public that the
AFCP 2.0 may be extended (with or
without modifications) depending on
feedback from participants and based on
a determination of the effectiveness of
the pilot program. The USPTO
repeatedly extended the pilot program,
with the most recent extension set to
end on September 30, 2024.
Since 2016, applicants have filed
more than 60,000 AFCP 2.0 requests
annually. Due to the high usage of the
AFCP 2.0, costs to administer the
program are significant. A large part of
the AFCP 2.0’s high usage is due to
economic inefficiencies where
participants receive program benefits
without paying for the cost of the
E:\FR\FM\01OCN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Notices]
[Page 79899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22480]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2024-0047]
Grant of Interim Extension of the Term of U.S. Patent No.
7,199,162--GRAFAPEXTM (Treosulfan)
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice of interim patent term extension.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office has issued a
certificate for a one-year interim extension of the term of U.S. Patent
No. 7,199,162.
FOR FURTHER INFORMATION CONTACT: Kathleen Kahler Fonda, Senior Legal
Advisor (telephone (571) 272-7754; email [email protected]).
Alternatively, mail may be addressed to Commissioner for Patents, Mail
Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313-1450, and
marked to the attention of Ms. Fonda.
SUPPLEMENTARY INFORMATION: Section 156 of title 35, United States Code,
generally provides that the term of a patent may be extended for a
period of up to five years if the patent claims a product, or a method
of making or using a product, that has been subject to certain defined
regulatory review, and that the patent may be extended for interim
periods of up to one year if the regulatory review is anticipated to
extend beyond the expiration date of the patent.
On August 20, 2024, Medac Gesellschaft f[uuml]r Klinische
Spezialpr[auml]parate mbH, the patent owner of record, timely filed an
application under 35 U.S.C. 156(d)(5) for a fourth interim extension of
the term of U.S. Patent No. 7,199,162. The patent claims a method of
using the human drug product GRAFAPEXTM (treosulfan). The
application for patent term extension indicates that New Drug
Application 214759 was submitted to the Food and Drug Administration on
August 11, 2020, and its review in order for the patent owner to obtain
permission to market and use the product commercially is ongoing.
Review of the patent term extension application indicates that,
except for permission to market or use the product commercially, the
subject patent would be eligible for an extension of the patent term
under 35 U.S.C. 156, and that the patent should be extended for one
year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory
review period will continue beyond the thrice-extended expiration date
of the patent, October 12, 2024, interim extension of the patent term
under 35 U.S.C. 156(d)(5) is appropriate.
A fourth interim extension under 35 U.S.C. 156(d)(5) of the term of
U.S. Patent No. 7,199,162 is granted for a period of one year from the
thrice-extended expiration date of the patent.
Charles Kim,
Deputy Commissioner for Patents, United States Patent and Trademark
Office.
[FR Doc. 2024-22480 Filed 9-30-24; 8:45 am]
BILLING CODE 3510-16-P
