Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices 16165

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: March 27, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–8622 Filed 4–3–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0020]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; REMERONTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

REMERONTM 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 human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

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 human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

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 (for example,

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 human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug REMERONTM

(mirtazapine). REMERONTM is indicated

for the treatment of depression.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

REMERONTM (U.S. Patent No.

4,062,848) from Akzona 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 January 13,

1997, FDA advised the Patent and

Trademark Office that this human drug

product had undergone a regulatory

review period and that the approval of

REMERONTM 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

REMERONTM is 5,003 days. Of this

time, 4,501 days occurred during the

testing phase of the regulatory review

period, while 502 days occurred during

the approval phase. These periods of

time were derived from the following

dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: October 5, 1982. FDA

has verified the applicant’s claim that

the date that the investigational new

drug application became effective was

on October 5, 1982.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: January 30, 1995. The

applicant claims April 29, 1994, as the

date the new drug application (NDA) for

REMERONTM (NDA 20–415) was

initially submitted. However, FDA

records indicate that the submission

received on April 29, 1994, was

withdrawn before filing. The actual

NDA receipt date was January 30, 1995

(the date the fileable NDA was received

at FDA), which is considered to be the

NDA initially submitted date.

3. The date the application was

approved: June 14, 1996. FDA has

verified the applicant’s claim that NDA

20–415 was approved on June 14, 1996.

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 730 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 3, 1997 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 1, 1997 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: March 27, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–8623 Filed 4–3–97; 8:45 am]

BILLING CODE 4160–01–F