Grant of Interim Extension of the Term of U.S. Patent No. 7,199,162; GrafapexTM, 59064 [2022-21117]

Download as PDF 59064 Federal Register / Vol. 87, No. 188 / Thursday, September 29, 2022 / Notices DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO–P–2021–0052] Grant of Interim Extension of the Term of U.S. Patent No. 7,199,162; GrafapexTM (Treosulfan) United States Patent and Trademark Office, Department of Commerce. ACTION: Notice of interim patent term extension. AGENCY: khammond on DSKJM1Z7X2PROD with NOTICES VerDate Sep<11>2014 17:52 Sep 28, 2022 Jkt 256001 Robert Bahr, Deputy Commissioner for Patents, United States Patent and Trademark Office. [FR Doc. 2022–21117 Filed 9–28–22; 8:45 am] BILLING CODE 3510–16–P The United States Patent and Trademark Office has issued an order granting a one-year interim extension of the term of U.S. Patent No. 7,199,162 (’162 patent). FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, Office of Patent Legal Administration, at 571– 272–7728 or raul.tamayo@uspto.gov. SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 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. 35 U.S.C. 156(d)(5) generally provides that the term of such a patent may be extended for no more than five interim periods of up to one year each, if the approval phase of the regulatory review period (RRP) is reasonably expected to extend beyond the expiration date of the patent. On August 25, 2022, Medac Gesellschaft fuer Klinische Spezialpraparate M.B.H., the owner of record of the ’162 patent, timely filed an application under 35 U.S.C. 156(d)(5) for a second interim extension of the term of the ’162 patent. The ’162 patent claims a method of using the human drug product known by the tradename GRAFAPEXTM (treosulfan). The application for interim patent term extension indicates that a RRP as described in 35 U.S.C. 156(g)(1)(B)(ii) began for GRAFAPEXTM (treosulfan) and is ongoing before the Food and Drug Administration for permission to market and use the product commercially. Review of the interim patent term extension application indicates that, except for permission to market or use the product commercially, the ’162 patent would be eligible for an extension of the patent term under 35 U.S.C. 156. Because it is apparent that the RRP will continue beyond the onceextended expiration date of the ’162 patent, i.e., October 12, 2022, a second interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate. SUMMARY: A second 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 onceextended expiration date of the ’162 patent. COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities under OMB Review Commodity Futures Trading Commission. ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995 (‘‘PRA’’), this notice announces that the Information Collection Request (‘‘ICR’’) abstracted below has been forwarded to the Office of Information and Regulatory Affairs (‘‘OIRA’’), of the Office of Management and Budget (‘‘OMB’’), for review and comment. The ICR describes the nature of the information collection and its expected costs and burden. DATES: Comments must be submitted on or before October 31, 2022. ADDRESSES: Written comments and recommendations for the proposed information collection should be submitted within 30 days of this notice’s publication to OIRA, at https:// www.reginfo.gov/public/do/PRAMain. Please find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the website’s search function. Comments can be entered electronically by clicking on the ‘‘comment’’ button next to the information collection on the ‘‘OIRA Information Collections Under Review’’ page, or the ‘‘View ICR—Agency Submission’’ page. A copy of the supporting statement for the collection of information discussed herein may be obtained by visiting https:// www.reginfo.gov/public/do/PRAMain. In addition to the submission of comments to https://Reginfo.gov as indicated above, a copy of all comments submitted to OIRA may also be submitted to the Commodity Futures Trading Commission (the ‘‘Commission’’ or ‘‘CFTC’’) by clicking on the ‘‘Submit Comment’’ box next to the descriptive entry for OMB Control No. 3038–0067, at https:// SUMMARY: PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 comments.cftc.gov/FederalRegister/ PublicInfo.aspx. Or by either of the following methods: • Mail: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581. • Hand Delivery/Courier: Same as Mail above. All comments must be submitted in English, or if not, accompanied by an English translation. Comments submitted to the Commission should include only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission’s regulations.1 The Commission reserves the right, but shall have no obligation, to review, prescreen, filter, redact, refuse or remove any or all of your submission from https://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the ICR will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act. FOR FURTHER INFORMATION CONTACT: Andrew Chapin, Associate Chief Counsel, Market Participants Division, Commodity Futures Trading Commission, (202) 418–5465; email: achapin@cftc.gov, and refer to OMB Control No. 3038–0067. SUPPLEMENTARY INFORMATION: Title: Part 162—Protection of Consumer Information under the Fair Credit Reporting Act (OMB Control No. 3038–0067). This is a request for extension of a currently approved information collection. Abstract: On July 21, 2010, President Obama signed into law the Dodd-Frank Wall Street Reform and Consumer Protection Act (‘‘Dodd-Frank Act’’).2 Title X of the Dodd-Frank Act, which is titled the Consumer Financial Protection Act of 2010 (‘‘CFP Act’’), amends a number of federal consumer protection laws enacted prior to the Dodd-Frank Act including, in relevant part, the Fair Credit Reporting Act 1 17 CFR 145.9. L. 111–203, 124 Stat. 1376 (2010). 2 Pub. E:\FR\FM\29SEN1.SGM 29SEN1

Agencies

[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Page 59064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21117]



[[Page 59064]]

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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2021-0052]


Grant of Interim Extension of the Term of U.S. Patent No. 
7,199,162; GrafapexTM (Treosulfan)

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 an 
order granting a one-year interim extension of the term of U.S. Patent 
No. 7,199,162 ('162 patent).

FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, 
Office of Patent Legal Administration, at 571-272-7728 or 
[email protected].

SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 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. 35 U.S.C. 
156(d)(5) generally provides that the term of such a patent may be 
extended for no more than five interim periods of up to one year each, 
if the approval phase of the regulatory review period (RRP) is 
reasonably expected to extend beyond the expiration date of the patent.
    On August 25, 2022, Medac Gesellschaft fuer Klinische 
Spezialpraparate M.B.H., the owner of record of the '162 patent, timely 
filed an application under 35 U.S.C. 156(d)(5) for a second interim 
extension of the term of the '162 patent. The '162 patent claims a 
method of using the human drug product known by the tradename 
GRAFAPEXTM (treosulfan). The application for interim patent 
term extension indicates that a RRP as described in 35 U.S.C. 
156(g)(1)(B)(ii) began for GRAFAPEXTM (treosulfan) and is 
ongoing before the Food and Drug Administration for permission to 
market and use the product commercially.
    Review of the interim patent term extension application indicates 
that, except for permission to market or use the product commercially, 
the '162 patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156. Because it is apparent that the RRP will continue 
beyond the once-extended expiration date of the '162 patent, i.e., 
October 12, 2022, a second interim extension of the patent term under 
35 U.S.C. 156(d)(5) is appropriate.
    A second 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 
once-extended expiration date of the '162 patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2022-21117 Filed 9-28-22; 8:45 am]
BILLING CODE 3510-16-P
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