Determination of Regulatory Review Period for Purposes of Patent Extension; ApligrafSUPTM/SUP

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0846]

Determination of Regulatory Review Period for Purposes of Patent

Extension; ApligrafTM

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 ApligrafTM 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 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

ApligrafTM. ApligrafTM is indicated for use with

standard therapeutic compression in the treatment of uninfected partial

and/or full-thickness skin loss ulcers due to venous insufficiency of

greater than 1 month duration and which have not adequately responded

to conventional ulcer therapy. Subsequent to this approval, the Patent

and Trademark Office received a patent term restoration application for

ApligrafTM (U.S. Patent No. 4,485,096) from Organogenesis,

and the Patent and Trademark Office requested FDA's assistance in

determining this patent's eligibility for patent term restoration. In a

letter dated December 16, 1998, FDA advised the Patent and Trademark

Office that this medical device had undergone a regulatory review

period and that the approval of ApligrafTM 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

ApligrafTM is 4,013 days. Of this time, 3,051 days occurred

during the testing phase of the regulatory review period, while 962

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: May 29, 1987. 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 July 2, 1987. However, FDA records

indicate that the IDE was determined substantially complete for

clinical studies to have begun on May 29, 1987, 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): October 4,

1995. FDA has verified the applicant's claim that the

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premarket approval application (PMA) for ApligrafTM (PMA

P950032) was initially submitted on October 4, 1995.

3. The date the application was approved: May 22, 1998. FDA has

verified the applicant's claim that PMA P950032 was approved on May 22,

1998.

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 1,826 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before June 29, 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 October 27, 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: April 20, 1999.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 99-10795 Filed 4-29-99; 8:45 am]

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