[Federal Register Volume 71, Number 182 (Wednesday, September 20, 2006)]
[Notices]
[Pages 54995-54996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15553]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0033]


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

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 APTIVUS 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

[[Page 54996]]

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 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 APTIVUS 
(tipranavir). APTIVUS is indicated for combination antiretroviral 
treatment of HIV-1 infected adult patients with evidence of viral 
replication who are highly treatment-experienced or have HIV-1 strains 
resistant to multiple protease inhibitors. Subsequent to this approval, 
the Patent and Trademark Office received a patent term restoration 
application for APTIVUS (U.S. Patent No. 5,852,195) from Pharmacia & 
Upjohn Co., LLC, and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated February 24, 2006, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of APTIVUS 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 
APTIVUS is 3,114 days. Of this time, 2,931 days occurred during the 
testing phase of the regulatory review period, while 183 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 14, 1996. The applicant claims December 13, 1996, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was December 
14, 1996, which was 30 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: December 22, 
2004. The applicant claims December 21, 2004, as the date the new drug 
application (NDA) for Aptivus (NDA 21-814) was initially submitted. 
However, FDA records indicate that NDA 21-814 was submitted as a 
complete marketing application on December 22, 2004.
    3. The date the application was approved: June 22, 2005. FDA has 
verified the applicant's claim that NDA 21-814 was approved on June 22, 
2005.
    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 1,278 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. E6-15553 Filed 9-19-06; 8:45 am]
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