4066 Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Notices

(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 product DIFFERIN

Solution (adapalene). DIFFERIN

Solution is indicated for the topical

treatment of acne vulgaris. Subsequent

to this approval, the Patent and

Trademark Office received a patent term

restoration application for DIFFERIN

Solution (U.S. Patent No. 4,717,720)

from Centre International de Recherches

Dermatologiques (CIRD), 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 24, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of DIFFERIN

Solution 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

DIFFERIN Solution is 2,814 days. Of

this time, 1,651 days occurred during

the testing phase of the regulatory

review period, while 1,163 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: September 18, 1988.

FDA has verified the applicant’s claim

that the date that the investigational

new drug application became effective

was on September 18, 1988.

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: March 26, 1993. The

applicant claims March 19, 1993, as the

date the new drug application (NDA) for

DIFFERIN Solution (NDA 20–338) was

initially submitted. However, FDA

records indicate that NDA 20–338 was

submitted on March 26, 1993.

3. The date the application was

approved: May 31, 1996. FDA has

verified the applicant’s claim that NDA

20–338 was approved on May 31, 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 1,512 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before March 31, 1997, submit to

the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthrmore,

any interested person may petition FDA,

on or before July 28, 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: January 17, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–2066 Filed 1–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0379]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; CAMPTOSAR

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

CAMPTOSAR 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
Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Notices 4067

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

CAMPTOSAR (irinotecan

hydrochloride). CAMPTOSAR is

indicated for the treatment of patients

with metastatic carcinoma of the colon

or rectum whose disease has recurred or

progressed following 5–FU based

therapy. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for CAMPTOSAR (U.S.

Patent No. 4,604,463) from Kabushiki

Kaisha Yakult Honsha, 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 24, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of CAMPTOSAR

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

CAMPTOSAR is 2,111 days. Of this

time, 1,941 days occurred during the

testing phase of the regulatory review

period, while 170 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: September 5, 1990.

FDA has verified the applicant’s claim

that the date that the investigational

new drug application became effective

was on September 5, 1990.

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: December 28, 1995. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

CAMPTOSAR (NDA 20–571) was

initially submitted on December 28,

1995.

3. The date the application was

approved: June 14, 1996. FDA has

verified the applicant’s claim that NDA

20–571 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 1,139 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before March 31, 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 July 28, 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: January 17, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–2067 Filed 1–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0361]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; DIFFERIN Solution

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

DIFFERIN Solution 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 product DIFFERIN

Solution (adapalene). DIFFERIN

Solution is indicated for the topical

treatment of acne vulgaris. Subsequent

to this approval, the Patent and

Trademark Office received a patent term

restoration application for DIFFERIN

Solution (U.S. Patent No. 5,015,758)

from Centre International de Recherches

Dermatologiques (CIRD), and the Patent

and Trademark Office requested FDA’s