[Federal Register: July 29, 2004 (Volume 69, Number 145)]
[Page 45335-45336]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2002E-0342]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; LEA'S SHIELD

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for LEA'S SHIELD 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 medical device.

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.

Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 240-453-6699.

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 medical devices, the testing 
phase begins with a clinical investigation of the device and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the device and continues until 
permission to market the device is granted. 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 (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 medical device will include 
all of the testing phase and approval phase as specified in 35 U.S.C. 
    FDA recently approved for marketing the medical device LEA'S 
SHIELD. LEA'S SHIELD is indicated for use by

[[Page 45336]]

women of childbearing age who desire to prevent or postpone pregnancy. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for LEA'S SHIELD (U.S. Patent No. 
4,703,752) from Shlome Gabbay, 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 3, 2003, FDA 
advised the Patent and Trademark Office that this medical device had 
undergone a regulatory review period and that the approval of LEA'S 
SHIELD 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 
LEA'S SHIELD is 5,596 days. Of this time, 5,418 days occurred during 
the testing phase of the regulatory review period, while 178 days 
occurred during the approval phase. These periods of time were derived 
from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this 
device became effective: November 19, 1986. FDA has verified the 
applicant's claim that the date the investigational device exemption 
required under section 520(g) of the act for human tests to begin 
became effective November 19, 1986.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): September 18, 
2001. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for LEA'S SHIELD (PMA P010046) was initially 
submitted September 18, 2001.
    3. The date the application was approved: March 14, 2002. FDA has 
verified the applicant's claim that PMA P010046 was approved on March 
14, 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 1,825 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 September 27, 2004. 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 January 
25, 2005. 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: June 24, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-17209 Filed 7-28-04; 8:45 am]