[Federal Register Volume 68, Number 76 (Monday, April 21, 2003)]
[Notices]
[Pages 19546-19547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03E-0032]


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

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 IMAGENT 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 Dockets 
Management Branch (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: Claudia Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3460.

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 drug 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 IMAGENT 
(perfluorohexane and DMPC). IMAGENT is indicated for use in subjects 
with suboptimal echocardiograms to opacify the left ventricular chamber 
and to improve the delineation of the left venricular endocardiol 
border. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for IMAGENT (U.S. Patent 
No. 5,639,443) from Alliance Pharmaceutical 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 
February 4, 2003, FDA advised the Patent and Trademark Office that this 
human drug product had

[[Page 19547]]

undergone a regulatory review period and that the approval of IMAGENT 
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 
IMAGENT is 2,264 days. Of this time, 1,303 days occurred during the 
testing phase of the regulatory review period, while 961 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: 
March 21, 1996. The applicant claims February 20, 1996, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was March 21, 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: October 14, 
1999. The applicant claims October 11, 1999, as the date the new drug 
application (NDA) for IMAGENT (NDA 21-191) was initially submitted. 
However, FDA records indicate that NDA 21-191 was submitted on October 
14, 1999.
    3. The date the application was approved: May 31, 2002. FDA has 
verified the applicant's claim that NDA 21-191 was approved on May 31, 
2002.
    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 423 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (see ADDRESSES) 
written or electronic comments and ask for a redetermination by June 
20, 2003. 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 20, 2003. 
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 Dockets 
Management Branch (see ADDRESSES). 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: March 31, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-9809 Filed 4-18-03; 8:45 am]
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