[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]



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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.

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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