[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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