[Federal Register Volume 63, Number 242 (Thursday, December 17, 1998)]
[Notices]
[Pages 69632-69633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0227]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Silicone AMO ARRAY Multifocal IOL

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 Silicone AMO ARRAY 
multifocal IOL 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

[[Page 69633]]

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 Silicone 
AMO ARRAY multifocal IOL. Silicone AMO 
ARRAY multifocal IOL is indicated for the visual correction 
of aphakia in persons 60 years of age or older in whom a cataractous 
lens has been removed and who may benefit from useful near vision 
without reading aid and increased spectacle independence across a range 
of distances where the potential visual effects associated with 
multifocality are acceptable. Subsequent to this approval, the Patent 
and Trademark Office received a patent term restoration application for 
Silicone AMO ARRAY multifocal IOL (U.S. Patent No. 
4,898,461) from Vision Pharmaceuticals, L.P., 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 19, 1998, FDA advised the Patent and Trademark Office that this 
medical device had undergone a regulatory review period and that the 
approval of Silicone AMO ARRAY multifocal IOL 
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 
Silicone AMO ARRAY multifocal IOL is 2,846 days. Of 
this time, 2,478 days occurred during the testing phase of the 
regulatory review period, while 368 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: November 22, 1989. 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 June 15, 1989. However, FDA records 
indicate that the IDE was determined substantially complete for 
clinical studies to have begun on November 22, 1989, 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): September 3, 
1996. The applicant claims August 30, 1996, as the date the premarket 
approval application (PMA) for Silicone AMO ARRAY 
multifocal IOL (PMA P960028) was initially submitted. However, FDA 
records indicate that PMA P960028 was submitted on September 3, 1996.
    3. The date the application was approved: September 5, 1997. FDA 
has verified the applicant's claim that PMA P960028 was approved on 
September 5, 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 1,533 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. 98-33453 Filed 12-16-98; 8:45 am]
BILLING CODE 4160-01-F