[Federal Register Volume 64, Number 103 (Friday, May 28, 1999)]
[Notices]
[Pages 29046-29047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13671]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 98E-0485 and 98E-0850]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Therma ChoiceTM Uterine Ballon Therapy System
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 Therma ChoiceTM Uterine Ballon
Therapy System 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, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-6620.
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,
[[Page 29047]]
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
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. 156(g)(3)(B).
FDA recently approved for marketing the medical device Therma
ChoiceTM Uterine Ballon Therapy System. Therma
ChoiceTM Uterine Ballon Therapy System is indicated for use
as a thermal ablation device intended to ablate the endometrial lining
of the uterus in premenopausal women with menorrhagia (excessive
uterine bleeding) due to benign causes for whom childbearing is
complete. Subsequent to this approval, the Patent and Trademark Office
received patent term restoration applications for Therma
ChoiceTM Uterine Ballon Therapy System (U.S. Patent Nos.
5,105,808 and 4,949,718) from Gynelab Products, Inc., and the Patent
and Trademark Office requested FDA's assistance in determining these
patents' eligibility for patent term restoration. In a letter dated
December 17, 1998, FDA advised the Patent and Trademark Office that
this medical device had undergone a regulatory review period and that
the approval of Therma ChoiceTM Uterine Ballon Therapy
System 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
Therma ChoiceTM Uterine Ballon Therapy System is 1,031 days.
Of this time, 852 days occurred during the testing phase of the
regulatory review period, while 179 days occurred during the approval
phase. These periods of time were derived from the following dates:
1. The date a clinical investigation involving this device was
begun: February 17, 1995. The applicant claims that the investigational
device exemption (IDE) required under section 520(g) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) for human
tests to begin became effective on November 30, 1994. However, FDA
records indicate that the IDE was determined substantially complete for
clinical studies to have begun on February 17, 1995, which represents
the IDE effective date.
2. The date the application was initially submitted with respect to
the device under section 515 of the act (21 U.S.C. 360e): June 17,
1997. The applicant claims June 16, 1997, as the date the premarket
approval application (PMA) for Therma ChoiceTM Uterine
Ballon Therapy System (PMA P970021) was initially submitted. However,
FDA records indicate that PMA P970021 was submitted on June 17, 1997.
3. The date the application was approved: December 12, 1997. FDA
has verified the applicant's claim that PMA P970021 was approved on
December 12, 1997.
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 446 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before July 27, 1999, 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 November 24, 1999, 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: May 7, 1999.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 99-13671 Filed 5-27-99; 8:45 am]
BILLING CODE 4160-01-F