Determination of Regulatory Review Period for Purposes of Patent Extension; Silicone AMORegister ARRAYRegister Multifocal IOL

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]

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