[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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