Grant of Interim Extension of the Term of U.S. Patent No. 4,585,597; ANTHÉLIOS ®, 16766 [E6-4832]
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Federal Register / Vol. 71, No. 64 / Tuesday, April 4, 2006 / Notices
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2006–0021]
Grant of Interim Extension of the Term
of U.S. Patent No. 4,585,597;
´
ANTHELIOS SP Topical Cream
(Mexoryl SX (Ecamsule))
United States Patent and
Trademark Office, Department of
Commerce.
ACTION: Notice of interim patent term
extension.
AGENCY:
The United States Patent and
Trademark Office has issued a
certificate under 35 U.S.C. 156(d)(5) for
a third one-year interim extension of the
term of U.S. Patent No. 4,585,597.
FOR FURTHER INFORMATION CONTACT:
Mary C. Till by telephone at (571) 272–
7755; by mail marked to her attention
and addressed to the Commissioner for
Patents, Mail Stop Patent Ext., P.O. Box
1450, Alexandria, VA 22313–1450; by
fax marked to her attention at (571) 273–
7755, or by e-mail to
Mary.Till@uspto.gov.
SUMMARY:
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 a year if the
regulatory review is anticipated to
extend beyond the expiration date of the
patent.
On May 17, 2005, patent owner
L’Oreal S.A., timely filed an application
under 35 U.S.C. 156(d)(5) for a third
subsequent interim extension of the
term of U.S. Patent No. 4,585,597. The
patent claims the active ingredient
Mexoryl SX (ecamsule), in the human
drug product ANTHELIOS SP Topical
Cream (HELIOBLOCK SX Cream), a
method of use of the active ingredient,
and a method of manufacturing the
active ingredient. The application
indicates, and the Food and Drug
Administration has confirmed, that a
New Drug Application for the human
drug product Mexoryl SX (ecamsule)
has been filed and is currently
undergoing regulatory review before the
Food and Drug Administration for
permission to market or use the product
commercially.
Review of the application indicates
that, except for permission to market or
use the product commercially, the
subject patent would be eligible for an
sroberts on PROD1PC70 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
18:55 Apr 03, 2006
Jkt 208001
extension of the patent term under 35
U.S.C. 156, and that the patent should
be extended for an additional year as
required by 35 U.S.C. 156(d)(5)(B).
Since it is apparent that the regulatory
review period has continued beyond the
extended expiration date of the patent
(June 16, 2005), interim extension of the
patent term under 35 U.S.C. 156(d)(5) is
appropriate.
An interim extension under 35 U.S.C.
156(d)(5) of the term of U.S. Patent No.
4,585,597 is granted for a period of one
year from the expiration date of the
patent, i.e., until June 16, 2006.
Dated: March 29, 2006.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. E6–4832 Filed 4–3–06; 8:45 am]
BILLING CODE 3510–16–P
CONSUMER PRODUCT SAFETY
COMMISSION
Request for Comments Concerning
Proposed Extension of Approval of a
Collection of Information—Electrically
Operated Toys and Children’s Articles
Consumer Product Safety
Commission.
ACTION: Notice.
AGENCY:
SUMMARY: As required by the Paperwork
Reduction Act (44 U.S.C. Chapter 35),
the Consumer Product Safety
Commission requests comments on a
proposed extension of approval of a
collection of information from
manufacturers and importers of certain
electrically operated toys and children’s
articles. The collection of information
consists of testing and recordkeeping
requirements in regulations entitled
‘‘Requirements for Electrically Operated
Toys or Other Electrically Operated
Articles Intended for Use by Children,’’
codified at 16 CFR part 1505.
The Commission will consider all
comments received in response to this
notice before requesting an extension of
this collection of information from the
Office of Management and Budget.
DATES: The Office of the Secretary must
receive written comments not later than
June 5, 2006.
ADDRESSES: Written comments should
be captioned ‘‘Electrically Operated
Toys’’ and sent by e-mail to cpscos@cpsc.gov. Written comments may
also be sent to the Office of the
Secretary by facsimile at (301) 504–
0127, or by mail to the Office of the
Secretary, Consumer Product Safety
Commission, Room 502, 4330 East-West
Highway, Bethesda, MD 20814.
PO 00000
Frm 00011
Fmt 4703
Sfmt 4703
For
information about the proposed
extension of the collection of
information, or to obtain a copy of 16
CFR part 1505, call or write Linda L.
Glatz, Office of Planning and
Evaluation, Consumer Product Safety
Commission, Washington DC 20207;
telephone (301) 504–7671.
SUPPLEMENTARY INFORMATION: In 1973,
the Commission issued safety
requirements for electrically operated
toys and children’s articles to protect
children from unreasonable risks of
injury from electric shock, electrical
burns, and thermal burns. These
regulations are codified at 16 CFR part
1505 and were issued under the
authority of sections 2 and 3 of the
Federal Hazardous Substances Act (15
U.S.C. 1261, 1262).
FOR FURTHER INFORMATION CONTACT:
A. Requirements for Electrically
Operated Toys
These regulations are applicable to
toys, games, and other articles intended
for use by children that are powered by
electrical current from a 120 volt circuit.
Video games and articles designed
primarily for use by adults that may be
incidentally used by children are not
subject to these regulations.
The regulations prescribe design,
construction, performance, and labeling
requirements for electrically operated
toys and children’s articles. The
regulations also require manufacturers
and importers of those products to
develop and maintain a quality
assurance program. Additionally,
section 1505.4(a)(3) of the regulations
requires those firms to maintain records
for three years containing information
about: (1) Material and production
specifications; (2) the quality assurance
program used; (3) results of all tests and
inspections conducted; and (4) sales and
distribution of electrically operated toys
and children’s articles.
The Office of Management and Budget
(OMB) approved the collection of
information requirements in the
regulations under control number 3041–
0035. OMB’s most recent extension of
approval expires on June 30, 2006. The
Commission now proposes to request an
extension of approval without change
for the information collection
requirements in the regulations.
The safety need for this collection of
information remains. Specifically, if a
manufacturer or importer distributes
products that violate the requirements
of the regulations, the records required
by section 1505.4(a)(3) can be used by
the firm and the Commission (i) to
identify specific lots or production lines
of products which fail to comply with
applicable requirements, and (ii) to
E:\FR\FM\04APN1.SGM
04APN1
]]>Agencies
[Federal Register Volume 71, Number 64 (Tuesday, April 4, 2006)]
[Notices]
[Page 16766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-4832]
[[Page 16766]]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2006-0021]
Grant of Interim Extension of the Term of U.S. Patent No.
4,585,597; ANTH[Eacute]LIOS [reg] SP Topical Cream (Mexoryl
[reg] SX (Ecamsule))
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice of interim patent term extension.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office has issued a
certificate under 35 U.S.C. 156(d)(5) for a third one-year interim
extension of the term of U.S. Patent No. 4,585,597.
FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571)
272-7755; by mail marked to her attention and addressed to the
Commissioner for Patents, Mail Stop Patent Ext., P.O. Box 1450,
Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-
7755, or by e-mail to Mary.Till@uspto.gov.
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 a year if the regulatory review is anticipated to
extend beyond the expiration date of the patent.
On May 17, 2005, patent owner L'Oreal S.A., timely filed an
application under 35 U.S.C. 156(d)(5) for a third subsequent interim
extension of the term of U.S. Patent No. 4,585,597. The patent claims
the active ingredient Mexoryl[reg] SX (ecamsule), in the
human drug product ANTHELIOS[reg] SP Topical Cream
(HELIOBLOCK[reg] SX Cream), a method of use of the active
ingredient, and a method of manufacturing the active ingredient. The
application indicates, and the Food and Drug Administration has
confirmed, that a New Drug Application for the human drug product
Mexoryl[reg] SX (ecamsule) has been filed and is currently
undergoing regulatory review before the Food and Drug Administration
for permission to market or use the product commercially.
Review of the 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 an additional year as required
by 35 U.S.C. 156(d)(5)(B). Since it is apparent that the regulatory
review period has continued beyond the extended expiration date of the
patent (June 16, 2005), interim extension of the patent term under 35
U.S.C. 156(d)(5) is appropriate.
An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S.
Patent No. 4,585,597 is granted for a period of one year from the
expiration date of the patent, i.e., until June 16, 2006.
Dated: March 29, 2006.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. E6-4832 Filed 4-3-06; 8:45 am]
BILLING CODE 3510-16-P
