[Federal Register Volume 67, Number 37 (Monday, February 25, 2002)]
[Notices]
[Pages 8547-8548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4383]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0099]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Menicon Z Rigid Gas Permeable Contact Lens

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 Menicon Z Rigid Gas Permeable Contact Lens 
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: Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of 
Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 Menicon Z 
Rigid Gas Permeable Contact Lens. This product is indicated for 
extended wear (from 1 to 7 days between removals for cleaning and 
disinfection of the lenses, as recommended by the eyecare practitioner) 
for the correction of refractive error (myopia, hyperopia, presbyopia 
and/or astigmatism) in non-aphakic persons with non-diseased eyes. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for Menicon Z Rigid Gas Permeable 
Contact Lens (U.S. Patent No. 4,594,401) from Menicon Co., and the 
Patent and Trademark Office requested FDA's

[[Page 8548]]

assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated September 6, 2001, FDA advised the 
Patent and Trademark Office that this medical device had undergone a 
regulatory review period and that the approval of Menicon Z Rigid Gas 
Permeable Contact Lens 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 
Menicon Z Rigid Gas Permeable Contact Lens is 1,917 days. Of this time, 
1,435 days occurred during the testing phase of the regulatory review 
period, while 482 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 14, 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 April 4, 1995. However, FDA records 
indicate that the IDE was determined substantially complete for 
clinical studies to have begun on April 14, 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): March 18, 
1999. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for Menicon Z Rigid Gas Permeable Contact 
Lens (PMA P990018) was initially submitted March 18, 1999.
    3. The date the application was approved: July 11, 2000. FDA has 
verified the applicant's claim that PMA P990018 was approved on July 
11, 2000.
    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 1,205 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (address above) 
written or electronic comments and ask for a redetermination by April 
26, 2002. Furthermore, any interested person may petition FDA by for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period by August 26, 2002. 
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. Three copies of any information are to be submitted, 
except that individuals may submit one copy. Comments are to be 
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: January 24, 2002.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-4383 Filed 2-22-02; 8:45 am]
BILLING CODE 4160-01-S