Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices 41579

patent term restoration. In a letter dated

November 7, 1997, FDA advised the

Patent and Trademark Office that this

animal drug product had undergone a

regulatory review period and that the

approval of Anipryl 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

Anipryl is 2,329 days. Of this time,

2,275 days occurred during the testing

phase of the regulatory review period,

54 days occurred during the approval

phase. These periods of time were

derived from the following dates:

1. The date an exemption under

section 512(j) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360b(j)) became effective: January 15,

1991. The applicant claims December

21, 1990, as the date the investigational

new animal drug application (INAD)

became effective. However, FDA records

indicate that the date of FDA’s letter

assigning a number to the INAD was

January 15, 1991, which is considered to

be the effective date for the INAD.

2. The date the application was

initially submitted with respect to the

animal drug product under section

512(b) of the act: April 7, 1997. The

applicant claims April 2, 1997, as the

date the new animal drug application

(NADA) for Anipryl (NADA 141–080)

was initially submitted. However, a

review of FDA records reveals that the

date of FDA’s official acknowledgement

letter assigning a number to NADA 141–

080 was April 7, 1997, which is

considered to be the initially submitted

date for NADA 141–080.

3. The date the application was

approved: May 30, 1997. FDA has

verified the applicant’s claim that

NADA 141–080 was approved on May

30, 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 448 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 5, 1998, 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 February 1, 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: July 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–20708 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0168]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; BeneFIXTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

BeneFIXTM 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 biological

product.

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 human

biological products, the testing phase

begins when the exemption to permit

the clinical investigations of the

biological becomes effective and runs

until the approval phase begins. The

approval phase starts with the initial

submission of an application to market

the human biological product and

continues until FDA grants permission

to market the biological 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 biological 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 biological product

BeneFIXTM (coagulation factor IX

(Recombinant)). BeneFIXTM is indicated

for the control and prevention of

hemorrhagic episodes in patients with

hemophilia B, including the perioperative management of hemophilia B

patients undergoing surgery.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

BeneFIXTM (U.S. Patent No. 5,171,569)

from British Technology Group Ltd.,

and the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

May 21, 1997, FDA advised the Patent

and Trademark Office that this human

biological product had undergone a

regulatory review period and that the

approval of BeneFIXTM 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
41580 Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices

BeneFIXTM is 749 days. Of this time,

583 days occurred during the testing

phase of the regulatory review period,

while 166 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 351 of the Public Health Service

Act became effective: January 26, 1995.

FDA has verified the applicant’s claim

that the date the investigational new

drug application became effective was

on January 26, 1995.

2. The date the application was

initially submitted with respect to the

human biological product under section

351 of the Public Health Service Act:

August 30, 1996. The applicant claims

August 29, 1996, as the date the Product

License Application (PLA) for

BeneFIXTM (PLA 96–1048) was initially

submitted. However, FDA records

indicate that PLA 96–1048 was

submitted on August 30, 1996.

3. The date the application was

approved: February 11, 1997. FDA has

verified the applicant’s claim that PLA

96–1048 was approved on February 11,

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 423 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 5, 1998, 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 February 1, 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: July 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–20742 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0292]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; AQUEOUS ARYL

FLUOROPHOSPHITE SUSPENSION

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

AQUEOUS ARYL FLUOROPHOSPHITE

SUSPENSION 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 food additive.

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 food additives,

the testing phase begins when a major

health or environmental effects test

involving the food additive begins and

runs until the approval phase begins.

The approval phase starts with the

initial submission of a petition

requesting the issuance of a regulation

for use of the food additive and

continues until FDA grants permission

to market the food additive 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 food additive will include all of the

testing phase and approval phase as

specified in 35 U.S.C. 156(g)(2)(B).

FDA recently approved for marketing

the food additive AQUEOUS ARYL

FLUOROPHOSPHITE SUSPENSION

(2,2′-ethylidenebis(4,6-ditertbutylpheny)fluorophosphonite).

AQUEOUS ARYL FLUOROPHOSPHITE

SUSPENSION is used as an antioxidant

in adhesives and in the preparation of

polymers intended for contact with

food. Subsequent to this approval, the

Patent and Trademark Office received a

patent term restoration application for

AQUEOUS ARYL FLUOROPHOSPHITE

SUSPENSION (U.S. Patent No.

4,867,907) from Albemarle Corp., and

the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

October 21, 1997, FDA advised the

Patent and Trademark Office that this

food additive had undergone a

regulatory review period and that the

approval of AQUEOUS ARYL

FLUOROPHOSPHITE SUSPENSION

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

AQUEOUS ARYL FLUOROPHOSPHITE

SUSPENSION is 2,930 days. Of this

time, 935 days occurred during the

testing phase of the regulatory review

period, 1,995 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date a major health or

environmental effects test was begun:

January 9, 1989. The applicant claims

July 21, 1986, as the date the test was

begun. However, FDA records indicate

that the test was begun on January 9,

1989.