[Federal Register Volume 74, Number 162 (Monday, August 24, 2009)]
[Notices]
[Page 42678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20307]



[[Page 42678]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-E-0048 and FDA 2009-E-0047]


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

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 LEXISCAN and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of applications to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of patents 
which claim 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.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

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 LEXISCAN 
(regadenoson monohydrate). LEXISCAN is indicated for radionuclide 
myocardial perfusion imaging in patients unable to undergo adequate 
exercise stress. Subsequent to this approval, the Patent and Trademark 
Office received patent term restoration applications for LEXISCAN (U.S. 
Patent Nos. 6,403,567 and 6,642,210) from CV Therapeutics, Inc., and 
the Patent and Trademark Office requested FDA's assistance in 
determining the patents' eligibilities for patent term restoration. In 
a letter dated February 26, 2009, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of LEXISCAN represented the first 
permitted commercial marketing or use of the product. 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 
LEXISCAN is 2,446 days. Of this time, 2,113 days occurred during the 
testing phase of the regulatory review period, while 333 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: 
August 1, 2001. The applicant claims August 2, 2001, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was August 1, 2001, 
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: May 14, 2007. 
FDA has verified the applicant's claim that the new drug application 
(NDA) 22-161 was submitted on May 14, 2007.
    3. The date the application was approved: April 10, 2008. FDA has 
verified the applicant's claim that NDA 22-161 was approved on April 
10, 2008.
    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 
applications for patent extension, this applicant seeks 1,024 days and 
977 days of patent term extension, respectively.
    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 October 23, 2009. 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 
February 22, 2010. 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: July 31, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-20307 Filed 8-21-09; 8:45 am]
BILLING CODE 4160-01-S