[Federal Register: April 2, 2007 (Volume 72, Number 62)]
[Notices]
[Page 15699-15700]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap07-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005E-0245]
Determination of Regulatory Review Period for Purposes of Patent
Extension; KEPIVANCE
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 KEPIVANCE 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 biological 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
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 an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the human biological product becomes effective and
runs until the approval phase begins. The approval phase starts with
the initial complete submission of an application to market the human
biological 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 biological 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 biological product
KEPIVANCE (palifermin). KEPIVANCE is indicated to decrease the
incidence and duration of severe oral mucositis in patients with
hematologic malignancies receiving myelotoxic therapy requiring
hematopoietic stem cell support. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for KEPIVANCE (U.S. Patent No. 5,677,278) from Chiron
Corp., and the Patent and Trademark Office requested FDA's assistance
in determining this patent's eligibility for patent term restoration.
In a letter dated June 14, 2006, FDA advised the Patent and Trademark
Office that this human biological product had undergone a regulatory
review period and that the approval of KEPIVANCE represented the first
permitted commercial marketing or use of the product. Shortly
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
KEPIVANCE is 3,303 days. Of this time, 3,119 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:
December 2, 1995. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
December 2, 1995.
2. The date the application was initially submitted with respect to
the human biological product under section
[[Page 15700]]
505(b) of the act: June 15, 2004. The applicant claims May 14, 2004, as
the date the biologics license application (BLA) for KEPIVANCE (BLA
125103) was initially submitted. However, FDA records indicate that the
final reviewable unit of BLA 125103 was submitted on June 15, 2004.
3. The date the application was approved: December 15, 2004. FDA
has verified the applicant's claim that BLA 125103 was approved on
December 15, 2004.
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 1,417 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 June 1, 2007. 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 1,
2007. 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.
Dated: February 26, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-6053 Filed 3-30-07; 8:45 am]
BILLING CODE 4160-01-S