
[Federal Register: November 10, 2008 (Volume 73, Number 218)]
[Notices]               
[Page 66646-66647]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no08-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0093]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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

[[Page 66647]]

an approval phase. For human drug products, the testing phase begins 
when the exemption to permit the clinical investigations of the human 
drug product 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 IXEMPRA 
(ixabepilone). IXEMPRA in combination with capecitabine is indicated 
for the treatment of metastatic or locally advanced breast cancer in 
patients after failure of an anthracycline and a taxane. IXEMPRA as 
monotherapy is indicated for the treatment of metastatic or locally 
advanced breast cancer in patients after failure of an anthracycline, a 
taxane, and capecitabine. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
IXEMPRA (U.S. Patent No. 6,605,599) from Bristol Myers Squibb Co., and 
the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated April 22, 2008, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of IXEMPRA 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 
IXEMPRA is 3,002 days. Of this time, 2,818 days occurred during the 
testing phase of the regulatory review period, while 184 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 act) (21 U.S.C. 355(i)) became effective: 
July 30, 1999. The applicant claims June 30, 1999, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was July 30, 1999, 
which was thirty 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 act: April 16, 2007. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for Ixempra (NDA 22-065) was initially submitted on April 16, 
2007.
    3. The date the application was approved: October 16, 2007. FDA has 
verified the applicant's claim that NDA 22-065 was approved on October 
16, 2007.
    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 854 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) written or electronic comments and ask for a redetermination 
by January 9, 2009. 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 May 11, 2009. 
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.
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: October 20, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-26678 Filed 11-7-08; 8:45 am]

BILLING CODE 4160-01-S
