[Federal Register Volume 60, Number 151 (Monday, August 7, 1995)]
[Notices]
[Pages 40183-40184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19425]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0147]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ExcimedTM UV200LA/SVS APEX Excimer Laser Systems
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for ExcimedTM UV200LA/SVS APEX Excimer
Laser Systems 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 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
ExcimedTM UV200LA/SVS APEX Excimer Laser Systems. ExcimedTM
UV200LA/SVS APEX Excimer Laser Systems are indicated for
phototherapeutic keratectomy (PTK) procedures which treat superficial
pathology located in the anterior 100 microns of the cornea. Subsequent
to this approval, the Patent and Trademark Office received a patent
term restoration application for ExcimedTM UV 200LA/SVS APEX
Excimer Laser Systems (U.S. Patent No. 4,941,093) from Summit
Technology, 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 June 21, 1995, FDA advised the Patent
and Trademark Office that this medical device had undergone a
regulatory review period and that the approval of ExcimedTM
UV200LA/SVS APEX Excimer Laser Systems represented the first commercial
marketing 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
ExcimedTM UV200LA/SVS APEX Excimer Laser Systems is 2,271 days. Of
this time, 1,156 days occurred during the testing phase of the
regulatory review period, while 1,115 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: December 22, 1988. FDA has verified the applicant's claim that
the date the investigational device exemption (IDE) required under
section 520(g) of the Federal Food, Drug, and Cosmetic Act for human
tests to begin became effective on December 22, 1988.
[[Page 40184]]
2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): February 20, 1992. The applicant claims November
19, 1991, as the date the premarket approval application (PMA) for
ExcimedTM UV200LA/SVS APEX Excimer Laser Systems was initially
submitted. However, FDA records indicate that PMA P910067 submitted on
November 19, 1991, was incomplete. FDA refused this application and
notified the applicant of this fact by letter dated February 7, 1992.
The completed PMA was then submitted on February 20, 1992, which is
considered to be the PMA initially submitted date.
3. The date the application was approved: March 10, 1995. FDA has
verified the applicant's claim that PMA P910067 was approved on March
10, 1995.
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 609 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before October 6, 1995, 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 February 15, 1996, 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: July 28, 1995.
Stuart L. Nightingale,
Associate Commissioner for Health Affairs.
[FR Doc. 95-19425 Filed 8-4-95; 8:45 am]
BILLING CODE 4160-01-F
