Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices 16163

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: April 20, 1991. The

applicant claims April 18, 1991, as the

date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was April 20, 1991,

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(b) of the Federal Food, Drug, and

Cosmetic Act: June 16, 1995. The

applicant claims June 14, 1995, as the

date the new drug application (NDA) for

XALATANTM (NDA 20–597) was

initially submitted. However, FDA

records indicate that NDA 20–597 was

submitted on June 16, 1995.

3. The date the application was

approved: June 5, 1996. FDA has

verified the applicant’s claim that NDA

20–597 was approved on June 5, 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 1,116 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. 97–8619 Filed 4–3–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0509]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; PHOTOFRIN

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

PHOTOFRIN 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 PHOTOFRIN

(porfimer sodium). PHOTOFRIN is

indicated for palliation of patients with

completely obstructing esophageal

cancer, or of patients with partially

obstructing esophageal cancer who, in

the opinion of their physician, cannot

be satisfactorily treated with

neodymium:yttrium:aluminum:garnet

(Nd:YAG) laser therapy. Subsequent to

this approval, the Patent and Trademark

Office received a patent term restoration

application for PHOTOFRIN (U.S.

Patent No. 5,145,863) from Health

Research, 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 February 18, 1997, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of PHOTOFRIN

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

PHOTOFRIN is 4,065 days. Of this

time, 3,441 days occurred during the

testing phase of the regulatory review

period, while 624 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: November 11, 1984.

The applicant claims October 15, 1984,

as the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was November 11,

1984, which was 30 days after FDA

receipt of the IND on October 12, 1984.

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: April 13, 1994. The

applicant claims April 12, 1994, as the
16164 Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices

date the new drug application (NDA) for

PHOTOFRIN (NDA 20–451) was

initially submitted. However, FDA

records indicate that NDA 20–451 was

submitted on April 13, 1994.

3. The date the application was

approved: December 27, 1995. FDA has

verified the applicant’s claim that NDA

20–451 was approved on December 27,

1995.

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 915 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. 97–8621 Filed 4–3–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0507]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; ACCOLATE

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

ACCOLATE 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 ACCOLATE

(zafirlukast). ACCOLATE is indicated

for the prophylaxis and chronic

treatment of asthma in adults and

children 12 years of age and older.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

ACCOLATE (U.S. Patent No.

4,859,692) from Zeneca, 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 February

18, 1997, FDA advised the Patent and

Trademark Office that this human drug

product had undergone a regulatory

review period and that the approval of

ACCOLATE 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

ACCOLATE is 3,110 days. Of this

time, 2,651 days occurred during the

testing phase of the regulatory review

period, while 459 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: March 24, 1988. FDA

has verified the applicant’s claim that

the date that the investigational new

drug application became effective was

on March 24, 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: June 26, 1995. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

ACCOLATE (NDA 20–547) was

initially submitted on June 26, 1995.

3. The date the application was

approved: September 26, 1996. FDA has

verified the applicant’s claim that NDA

20–547 was approved on September 26,

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 1,496 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