Determination of Regulatory Review Period for Purposes of Patent Extension; JEVTANA, 26558-26559 [2012-10828]

Download as PDF erowe on DSK2VPTVN1PROD with NOTICES 26558 Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Notices review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product FERAHEME (ferumoxytol). FERAHEME is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for FERAHEME (U.S. Patent No. 6,599,498) from AMAG Pharmaceuticals, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated May 2, 2011, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of FERAHEME represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for FERAHEME is 3,680 days. Of this time, 3,120 days occurred during the testing phase of the regulatory review period, while 560 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: June 5, 1999. The applicant claims June 4, 1999, as the date the investigational new drug application (IND) became effective. VerDate Mar<15>2010 15:20 May 03, 2012 Jkt 226001 However, FDA records indicate that the IND effective date was June 5, 1999, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: December 19, 2007. The applicant claims December 18, 2007, as the date the new drug application (NDA) for FERAHEME (NDA 22–180) was initially submitted. However, FDA records indicate that NDA 22–180 was submitted on December 19, 2007. 3. The date the application was approved: June 30, 2009. FDA has verified the applicant’s claim that NDA 22–180 was approved on June 30, 2009. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,209 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by July 3, 2012. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 31, 2012. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 Dated: April 16, 2012. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2012–10849 Filed 5–3–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2010–E–0661 and FDA– 2010–E–0662] Determination of Regulatory Review Period for Purposes of Patent Extension; JEVTANA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for JEVTANA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions along with three copies and written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6284, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when SUMMARY: E:\FR\FM\04MYN1.SGM 04MYN1 erowe on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 87 / Friday, May 4, 2012 / Notices the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product JEVTANA (cabazitaxel). JEVTANA, in combination with prednisone, is indicated for treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxelcontaining treatment regimen. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for JEVTANA (U.S. Patent Nos. 5,847,170 and 6,331,635) from Aventis Pharma S.A., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated February 11, 2011, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of JEVTANA represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for JEVTANA is 4,250 days. Of this time, 4,171 days occurred during the testing phase of the regulatory review period, while 79 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: October 30, 1998. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on October 30, 1998. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: March 31, 2010. VerDate Mar<15>2010 15:20 May 03, 2012 Jkt 226001 FDA has verified the applicant’s claim that the new drug application (NDA) for JEVTANA (NDA 201023) was submitted on March 31, 2010. 3. The date the application was approved: June 17, 2010. FDA has verified the applicant’s claim that NDA 201023 was approved on June 17, 2010. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,591 days and 5 years of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by July 3, 2012. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 31, 2012. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written petitions. It is only necessary to send one set of comments. However, if you submit a written petition, you must submit three copies of the petition. Identify comments with the docket number found in brackets in the heading of this document. Comments and petitions that have not been made publicly available on https:// www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 16, 2012. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. 2012–10828 Filed 5–3–12; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 26559 DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Project: 2012 National Mental Health Services Survey (N–MHSS) (OMB No. 0930–0119)—Revision The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Behavioral Health Statistics and Quality (CBHSQ), is requesting approval for a revision to the National Mental Health Services Survey (N–MHSS) (OMB No. 0930– 0119), which expires on February 28, 2013. The N–MHSS provides national and state-level data on the number and characteristics of mental health treatment facilities in the United States. An immediate need under N–MHSS in 2012 is to update the information about facilities on SAMHSA’s online Mental Health Facility Locator (see: https://store.samhsa.gov/mhlocator), which was last updated with information from the 2010 N–MHSS. A full N–MHSS is anticipated within about two years, and a separate request for OMB approval will be submitted for that collection. However, until then, an abbreviated version of the N–MHSS will be conducted to collect only the information needed to update the Locator, such as the facility name and address, specific services offered, and special client groups served. The data on the Locator are becoming outdated and need an update method. Other fields in the full N–MHSS not needed for updating the Locator, such as client counts and client demographics, will not be collected in the Locator survey. In addition to the data collection for updating facilities on the Locator, a data collection in conjunction with adding new facilities to the Locator is being requested. Both activities will use the same abbreviated N–MHSS–Locator instrument. This requested revision seeks to change the content of the currently approved full-scale N–MHSS survey instrument into an abbreviated survey E:\FR\FM\04MYN1.SGM 04MYN1

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[Federal Register Volume 77, Number 87 (Friday, May 4, 2012)]
[Notices]
[Pages 26558-26559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10828]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0661 and FDA-2010-E-0662]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; JEVTANA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for JEVTANA and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of applications to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that human drug product.

ADDRESSES: Submit electronic comments to https://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6284, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 100-670) generally provide 
that a patent may be extended for a period of up to 5 years so long as 
the patented item (human drug product, animal drug product, medical 
device, food additive, or color additive) was subject to regulatory 
review by FDA before the item was marketed. Under these acts, a 
product's regulatory review period forms the basis for determining the 
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human drug products, the 
testing phase begins when

[[Page 26559]]

the exemption to permit the clinical investigations of the drug becomes 
effective and runs until the approval phase begins. The approval phase 
starts with the initial submission of an application to market the 
human drug product and continues until FDA grants permission to market 
the drug product. Although only a portion of a regulatory review period 
may count toward the actual amount of extension that the Director of 
Patents and Trademarks may award (for example, half the testing phase 
must be subtracted as well as any time that may have occurred before 
the patent was issued), FDA's determination of the length of a 
regulatory review period for a human drug product will include all of 
the testing phase and approval phase as specified in 35 U.S.C. 
156(g)(1)(B).
    FDA recently approved for marketing the human drug product JEVTANA 
(cabazitaxel). JEVTANA, in combination with prednisone, is indicated 
for treatment of patients with hormone-refractory metastatic prostate 
cancer previously treated with a docetaxel-containing treatment 
regimen. Subsequent to this approval, the Patent and Trademark Office 
received patent term restoration applications for JEVTANA (U.S. Patent 
Nos. 5,847,170 and 6,331,635) from Aventis Pharma S.A., and the Patent 
and Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
February 11, 2011, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of JEVTANA represented the first permitted commercial 
marketing or use of the product. Thereafter, the Patent and Trademark 
Office requested that FDA determine the product's regulatory review 
period.
    FDA has determined that the applicable regulatory review period for 
JEVTANA is 4,250 days. Of this time, 4,171 days occurred during the 
testing phase of the regulatory review period, while 79 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: October 30, 1998. FDA has verified the applicant's claim 
that the date the investigational new drug application became effective 
was on October 30, 1998.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: March 31, 
2010. FDA has verified the applicant's claim that the new drug 
application (NDA) for JEVTANA (NDA 201023) was submitted on March 31, 
2010.
    3. The date the application was approved: June 17, 2010. FDA has 
verified the applicant's claim that NDA 201023 was approved on June 17, 
2010.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
applications for patent extension, this applicant seeks 1,591 days and 
5 years of patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) either electronic or written comments and ask for a 
redetermination by July 3, 2012. Furthermore, any interested person may 
petition FDA for a determination regarding whether the applicant for 
extension acted with due diligence during the regulatory review period 
by October 31, 2012. To meet its burden, the petition must contain 
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the 
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is only necessary to send one set of comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket number found in brackets in 
the heading of this document.
    Comments and petitions that have not been made publicly available 
on http:[sol][sol]www.regulations.gov may be viewed in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-10828 Filed 5-3-12; 8:45 am]
BILLING CODE 4160-01-P

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