Grant of Interim Extension of the Term of U.S. Patent No. 4,585,597; ANTHÉLIOS ®, 16766 [E6-4832]

Download as PDF 16766 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]]

-----------------------------------------------------------------------

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