[Federal Register Volume 71, Number 182 (Wednesday, September 20, 2006)]
[Notices]
[Pages 54996-54997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004E-0019]


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

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 FUZEON 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.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 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 product. 
Although only a portion of a regulatory review period may count

[[Page 54997]]

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 approved for marketing the human drug product FUZEON 
(enfuvirtide). FUZEON is indicated for use in combination with other 
antiretroviral agents for the treatment of HIV-1 infection in 
treatment-experienced patients with evidence of HIV-1 replication 
despite ongoing antiretroviral therapy. Subsequent to this approval, 
the Patent and Trademark Office received a patent term restoration 
application for FUZEON (U.S. Patent No. 6,133,418) from Duke 
University, 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 6, 2004, FDA advised the Patent 
and Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of FUZEON 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 
FUZEON is 2,312 days. Of this time, 2,133 days occurred during the 
testing phase of the regulatory review period, while 179 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: 
November 14, 1996. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on 
November 14, 1996.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: September 16, 
2002. The applicant claims June 24, 2002, as the date the new drug 
application (NDA) for FUZEON (NDA 21-481) was initially submitted. The 
applicant claims this is the date it submitted the first module of NDA 
21-481, which was submitted in several units as part of a rolling NDA 
submission procedure. It is FDA's position that the approval phase 
begins when the marketing application is complete. A review of FDA 
records reveals that the final module of the marketing application was 
submitted on September 16, 2002, which is considered to be the NDA 
initially submitted date.
    3. The date the application was approved: March 13, 2003. FDA has 
verified the applicant's claim that NDA 21-481 was approved on March 
13, 2003. 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 569 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 November 20, 2006. 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 March 
19, 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: September 1, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-15554 Filed 9-19-06; 8:45 am]
BILLING CODE 4160-01-S