[Federal Register Volume 63, Number 242 (Thursday, December 17, 1998)]
[Notices]
[Pages 69633-69634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0849]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Vitreon

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 Vitreon 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, 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

[[Page 69634]]

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 
Vitreon. Vitreon is indicated for use as an 
intraoperative surgical aid during vitreoretinal surgery in patients 
with primary and recurrent complicated retinal detachments. Subsequent 
to this approval, the Patent and Trademark Office received a patent 
term restoration application for Vitreon (U.S. Patent No. 
4,490,351) from Vitrophage, Inc., and the Patent and Trademark Office 
requested FDA's assistance in determining this patent's eligibility for 
patent term restoration. In a letter dated October 29, 1998, FDA 
advised the Patent and Trademark Office that this medical device had 
undergone a regulatory review period and that the approval of 
Vitreon 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 
Vitreon is 2,729 days. Of this time, 603 days occurred during 
the testing phase of the regulatory review period, while 2,126 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: April 13, 1990. 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 10, 1989. However, FDA 
records indicate that the IDE was determined substantially complete for 
clinical studies to have begun on April 13, 1990, 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): December 6, 
1991. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for Vitreon (PMA P910068) was 
initially submitted December 6, 1991.
    3. The date the application was approved: September 30, 1997. FDA 
has verified the applicant's claim that PMA P910068 was approved on 
September 30, 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 
application for patent extension, this applicant seeks 1,826 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before February 16, 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 July 15, 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: December 4, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-33457 Filed 12-6-98; 8:45 am]
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