Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices 41581

2. The date the petition requesting the

issuance of a regulation for use of the

food additive under section 409 of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 348) was initially submitted:

August 1, 1991. The applicant claims

August 1, 1991, as the date the petition

for AQUEOUS ARYL

FLUOROPHOSPHITE SUSPENSION

was initially submitted.

3. The date the regulation for the food

additive petition became effective:

January 15, 1997. FDA has verified the

applicant’s claim that the regulation for

the food additive became effective on

January 15, 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 1,268 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. 98–20707 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–0152]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Dostinex Tablets

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

Dostinex Tablets 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,

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 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 product Dostinex

Tablets (cabergoline). Dostinex Tablets

is indicated for the treatment of

hyperprolactinemic disorders, either

idiopathic or due to pituitary adenomas.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

Dostinex Tablets (U.S. Patent No.

4,526,892) from Upjohn & Pharmacia,

and the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

March 31, 1998, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the

approval of Dostinex Tablets

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

Dostinex Tablets is 2,188 days. Of this

time, 1,825 days occurred during the

testing phase of the regulatory review

period, 363 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505 of the Federal Food, Drug,

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

355) became effective: December 29,

1990. FDA has verified the applicant’s

claim that the date the investigational

new drug application became effective

was on December 29, 1990.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: December 27, 1995. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

Dostinex Tablets (NDA 20–664) was

initially submitted on December 27,

1995.

3. The date the application was

approved: December 23, 1996. FDA has

verified the applicant’s claim that NDA

20–664 was approved on December 23,

1996.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.
41582 Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 / Notices

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 1,273 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. 98–20739 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–0462]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Posicor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

Posicor 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,

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 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 product Posicor

(mibefradil dihydrochloride). Posicor

is indicated for the treatment of

hypertension and chronic stable angina

pectoris. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for Posicor (U.S. Patent

No. 4,808,605) from Hoffman-La Roche,

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

December 29, 1997, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of Posicor 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

Posicor is 1,793 days. Of this time,

1,326 days occurred during the testing

phase of the regulatory review period,

467 days occurred during the approval

phase. These periods of time were

derived from the following dates:

1. The date an exemption under

section 505 of the Federal Food, Drug,

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

355) became effective: July 25, 1992.

The applicant claims July 24, 1992, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was July 25, 1992,

which was 30 days after FDA receipt of

the IND.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: March 11, 1996. The

applicant claims March 8, 1996, as the

date the new drug application (NDA) for

Posicor (NDA 20–689) was initially

submitted. However, FDA records

indicate that NDA 20–689 was

submitted on March 11, 1996.

3. The date the application was

approved: June 20, 1997. FDA has

verified the applicant’s claim that NDA

20–689 was approved on June 20, 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 1,130 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.