[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