[Federal Register Volume 72, Number 62 (Monday, April 2, 2007)]
[Notices]
[Pages 15699-15700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6053]


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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