[Federal Register Volume 73, Number 218 (Monday, November 10, 2008)]
[Notices]
[Pages 66646-66647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26678]
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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]
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