[Federal Register Volume 59, Number 113 (Tuesday, June 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14445]


[[Page Unknown]]

[Federal Register: June 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93E-0290]

 

Determination of Regulatory Review Period for Purposes of Patent 
Extension; RealityTM Female Condom

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 RealityTM Female Condom 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 Commissioner of Patents and Trademarks, Department of Commerce, 
for the extension of a patent which claims that medical device.

ADDRESSES: Written comments and petitions should be directed to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health 
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1382.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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 Commissioner of Patents and Trademarks may award 
(half the testing phase must be subtracted as well a 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. 
156(g)(3)(B).
    FDA recently approved for marketing the medical device 
RealityTM Female Condom. The RealityTM Female Condom is 
indicated for use to help prevent pregnancy and sexually transmitted 
diseases, including the human immunodeficiency virus (HIV) infection, 
during vaginal intercourse. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for the 
RealityTM Female Condom (U.S. Patent No. 4,735,621) from Chartex 
International Plc, and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. FDA, in a letter dated August 10, 1993, advised the Patent 
and Trademark Office that this medical device had undergone a 
regulatory review period, and that the approval of the RealityTM 
Female Condom represented the first commercial marketing or use of the 
product. Shortly thereafter, the Patent and Trademark Office requested 
that the FDA determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for 
RealityTM Female Condom is 2,017 days. Of this time, 1,460 days 
occurred during the testing phase of the regulatory review period, 
while 557 days occurred during the approval phase. These periods of 
time were derived from the following dates:
    1. The date on which the first clinical trial on the device was 
begun: October 31, 1987. The clinical trial cited by the applicant was 
conducted outside the United States and was not subject to FDA's 
requirement for an investigational device exemption (IDE) under section 
520(g) of the Federal Food, Drug and Cosmetic Act (the act) nor FDA's 
requirement for an institutional review board (IRB) approval under 
section 520(g) (3) of the act. Therefore, the testing phase begins on 
the date the device is first used with human subjects as part of a 
clinical investigation to be filed with FDA to secure premarket 
approval of the device (21 CFR 60.22(c)(1)(iii)). The applicant has 
stated that the date on which the device was first used with human 
subjects as part of a clinical investigation to be filed with FDA to 
secure premarket approval of the device was October 31, 1987. Because 
of the circumstances previously described for the clinical trial cited 
by the applicant, FDA has no record in which to review this date (21 
CFR 60.20(c)(6)). Although FDA cannot, therefore, confirm that testing 
began as stated by the applicant, FDA is using this date as the start 
of the testing phase.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the Federal Food, Drug, and Cosmetic 
Act: October 29, 1991. FDA has verified the applicant's claim that the 
premarket approval application (PMA) for the RealityTM Female 
Condom (PMA P910064) was initially submitted on October 29, 1991.
    3. The date the application was approved: May 7, 1993. FDA has 
verified the applicant's claim that PMA P910064 was approved on May 7, 
1993.
    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 762 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before August 15, 1994, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before December 12, 1994, for a determination regarding whether 
the applicant for extension acted with due diligence during the 
regulatory review period. 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 (address above) in three copies (except that 
individuals may submit single copies) and 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: June 8, 1994.
 Stuart L. Nightingale,
 Associate Commissioner for Health Affairs.
[FR Doc. 94-14445 Filed 6-13-94; 8:45 am]
BILLING CODE 4160-01-F